COVAXIN™ (BBV152) Booster Shown to Neutralize Both Omicron and Delta Variants of SARS-CoV-2

 

Research, News, and Market Data on Ocugen

 

• Booster dose of candidate vaccine, COVAXIN™ (BBV152), generated robust neutralizing antibody responses against both Omicron (B.1.529) and Delta (B.1.617.2) using a live virus neutralization assay
• 100% of test serum samples showed neutralization of the Delta variant and more than 90% of serum samples showed neutralization of the Omicron variant
• These data add to the body of evidence that the broad-spectrum mechanism of action of a whole virus inactivated COVID-19 vaccine, like COVAXIN™ (BBV152), is a viable option in this continuously evolving pandemic
  

MALVERN, Pa., Jan. 12, 2022 (GLOBE NEWSWIRE) — Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing novel therapeutics and vaccines, and its partner, Bharat Biotech, a global leader in vaccine innovation and developer of vaccines for infectious diseases, today announced results from a study conducted at Emory University demonstrating that sera from subjects who received a booster dose of candidate vaccine COVAXIN™ (BBV152) six months after getting a primary two-dose series of COVAXIN™ (BBV152) neutralized the SARS-CoV-2 Omicron and Delta variants. Earlier studies demonstrated the neutralizing potential of COVAXIN™ (BBV152) against SARS-CoV-2 Variants of Concern Alpha, Beta, Delta, Zeta and Kappa.

The study will be published on the pre-print server, medRXiv, in the coming days.

Sera samples from individuals who received a booster of COVAXIN™ (BBV152) were observed to be effective in neutralizing Omicron and Delta variants on a live virus neutralization assay. The neutralization activity of COVAXIN™-boosted sera was comparable to what has been observed in mRNA vaccine-boosted sera against the Omicron variant. More than 90% of all individuals boosted with COVAXIN™ (BBV152) showed neutralizing antibodies. All participants received an initial two-dose schedule of COVAXIN™ (BBV152) at Day 0 and Day 28.

“The global impact of Omicron shows us that the fight against COVID-19 continues, and we’re encouraged that these data demonstrate the value of COVAXIN™ as a primary and booster vaccine,” said Dr. Shankar Musunuri, Chairman, CEO and Co-Founder, Ocugen, Inc. “These results show how a broad-spectrum vaccine has the potential ability to address ever-shifting public health challenges such as new variants and mutations.”

“As the dominant COVID-19 variant throughout the world, Omicron poses a serious public health concern,” said Mehul Suthar, Ph.D., Assistant Professor, Emory Vaccine Center and who led the laboratory analysis. “Data from this preliminary analysis show individuals receiving a booster dose of COVAXIN™ have a significant immune response to both the Omicron and Delta variants. These findings suggest that a booster dose has the potential to reduce disease severity and hospitalizations.”

Dr. Krishna Ella, Chairman and Managing Director of Bharat Biotech said, “We are in a continuous state of innovation and product development for COVAXIN™. The positive neutralization responses against the Omicron and Delta variants, validates our hypothesis of a multi epitope vaccine generating both humoral and cell mediated immune responses. Our goals of developing a global vaccine against COVID-19 have been achieved with the use of COVAXIN™ as a universal vaccine for adults and children.”

COVAXIN™ is formulated uniquely such that the same dosage can be administered to adults and children alike. COVAXIN™ is a ready-to-use, liquid vaccine, stored at 2 – 8°C, with 12 months shelf life and multi-dose vial policy. The same doses of vaccine can also be used for two-dose primary immunization in adults and children and for booster dose vaccinations, making it truly a universal vaccine. COVAXIN™ is not currently authorized or approved for use as a primary or booster dose in the United States.

About the study
In order to evaluate the effectiveness of COVAXIN™ (BBV152) against the Omicron variant, Ocugen contracted with the Emory Vaccine Center (Atlanta, GA) to test human immune sera obtained from participants (n=13) in an ongoing Phase 2 clinical trial (ClinicalTrials.gov: NCT04471519). Sera was collected 28-days post booster – six months following the primary two-dose series. Each sera was tested in a neutralization assay. Following three doses, the FRNT50 geometric mean titers (GMTs) of neutralizing antibodies against the Omicron variant measured in the samples was 75, compared to 480 against the Delta variant and 706 against the vaccine strain, D614G.

This study was sponsored by Ocugen, Inc. and Ocugen’s partner, Bharat Biotech, provided the sera of the subjects from the Phase 2 study.

About COVAXIN™ (BBV152)
COVAXIN™ (BBV152) is an investigational vaccine candidate product in the U.S, currently under review by the U.S. Food and Drug Administration for emergency use authorization (EUA) for children 2-18 years of age. Additionally, an Investigational New Drug application (IND) is being discussed with the agency to support an immunobridging study among U.S. participants. It was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). COVAXIN™ (BBV152) is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform.

With more than 180 million doses having been administered to adults and children outside the U.S., COVAXIN™ (BBV152) is currently authorized under emergency use in more than 20 countries, and emergency use authorization is in process in more than 60 other countries. The World Health Organization (WHO) recently added COVAXIN™ (BBV152) to its list of vaccines authorized for emergency use. And, as many as 110 countries have agreed to mutual recognition of COVID-19 vaccination certificates with India that includes vaccination using COVAXIN™ (BBV152). The trade name, COVAXIN™, has not been evaluated by the FDA.

About Ocugen, Inc.
Ocugen, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug – “one to many” and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. We are co-developing Bharat Biotech’s COVAXIN™ vaccine candidate for COVID-19 in the U.S. and Canadian markets. For more information, please visit www.ocugen.com.

About Bharat Biotech 
Bharat Biotech has established an excellent track record of innovation with more than 145 global patents, a wide product portfolio of more than 16 vaccines, 4 bio-therapeutics, registrations in more than 123 countries, and the World Health Organization (WHO) Pre-qualifications. Located in Genome Valley in Hyderabad, India, a hub for the global biotech industry, Bharat Biotech has built a world-class vaccine & bio-therapeutics, research & product development, Bio-Safety Level 3 manufacturing, and vaccine supply and distribution.

Having delivered more than 4 billion doses of vaccines worldwide, Bharat Biotech continues to lead innovation and has developed vaccines for influenza H1N1, Rotavirus, Japanese Encephalitis, Rabies, Chikungunya, Zika, and the world’s first tetanus-toxoid conjugated vaccine for Typhoid. Bharat’s commitment to global social innovation programs and public-private partnerships resulted in introducing path-breaking WHO pre-qualified vaccines BIOPOLIO®, ROTAVAC®, and Typbar TCV® combatting polio, rotavirus, typhoid infections, respectively. The acquisition of the rabies vaccine facility, Chiron Behring, from GlaxoSmithKline (GSK) has positioned Bharat Biotech as the world’s largest rabies vaccine manufacturer. To learn more about Bharat Biotech, visit www.bharatbiotech.com.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such forward-looking statements include information about qualitative assessments of available data, potential benefits, expectations for clinical trials, and anticipated timing of clinical trial readouts and regulatory submissions, including statements about data from the Phase 2 study conducted by Emory University that we sponsored, and the potential for this data to support our application to the U.S. Food and Drug Administration (FDA) for emergency use authorization (EUA) of COVAXIN™ in pediatric patients or our planned biologics license application (BLA), assuming the clinical hold is lifted, for approval of COVAXIN™ for use in adult patients, as well as statements regarding the potential short and long-term benefits of receiving a booster dose of COVAXIN™. This information involves risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates; the risk that we may not resolve the current clinical hold on COVAXIN™ in the near term or at all, or that the FDA could make other decisions that adversely impact our ability to advance the development of COVAXIN™ in the United States, and the implications that this clinical hold may have for our request for EUA of COVAXIN for pediatric use, including the timing and scope of any such authorization; risks associated with preliminary and interim data, including the possibility of unfavorable new clinical trial data and further analyses of existing clinical trial data; the risk that the results of in-vitro studies will not be duplicated in human clinical trials; the risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when data from Bharat Biotech’s clinical trials will be published in scientific journal publications and, if so, when and with what modifications; whether the data and results from the preclinical and clinical studies of COVAXIN™, which have been conducted by Bharat Biotech in India, will be accepted by the FDA or otherwise sufficient to support our EUA submission or planned BLA submission, assuming the clinical hold is lifted; the size, scope, timing and outcome of any additional trials or studies that we may be required to conduct to support an EUA or BLA; any additional chemistry, manufacturing, and controls information that we may be required to submit to the FDA; whether and when a BLA for COVAXIN™ will be submitted to or approved by the FDA; whether developments with respect to the COVID-19 pandemic will affect the regulatory pathway available for vaccines in the United States, Canada or other jurisdictions; market demand for COVAXIN™ in the United States or Canada; decisions by the FDA or Health Canada impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of COVAXIN™ in the United States or Canada, including development of products or therapies by other companies. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release.

Ocugen Contact: 
Ken Inchausti
Head, Investor Relations & Communications
+1 484 237 3398
ken.inchausti@ocugen.com

Please submit investor-related inquiries to: IR@ocugen.com

COVAXIN™ (BBV152) Booster Shown to Neutralize Both Omicron and Delta Variants of SARS-CoV-2

 

Research, News, and Market Data on Ocugen

 

• Booster dose of candidate vaccine, COVAXIN™ (BBV152), generated robust neutralizing antibody responses against both Omicron (B.1.529) and Delta (B.1.617.2) using a live virus neutralization assay
• 100% of test serum samples showed neutralization of the Delta variant and more than 90% of serum samples showed neutralization of the Omicron variant
• These data add to the body of evidence that the broad-spectrum mechanism of action of a whole virus inactivated COVID-19 vaccine, like COVAXIN™ (BBV152), is a viable option in this continuously evolving pandemic
  

MALVERN, Pa., Jan. 12, 2022 (GLOBE NEWSWIRE) — Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing novel therapeutics and vaccines, and its partner, Bharat Biotech, a global leader in vaccine innovation and developer of vaccines for infectious diseases, today announced results from a study conducted at Emory University demonstrating that sera from subjects who received a booster dose of candidate vaccine COVAXIN™ (BBV152) six months after getting a primary two-dose series of COVAXIN™ (BBV152) neutralized the SARS-CoV-2 Omicron and Delta variants. Earlier studies demonstrated the neutralizing potential of COVAXIN™ (BBV152) against SARS-CoV-2 Variants of Concern Alpha, Beta, Delta, Zeta and Kappa.

The study will be published on the pre-print server, medRXiv, in the coming days.

Sera samples from individuals who received a booster of COVAXIN™ (BBV152) were observed to be effective in neutralizing Omicron and Delta variants on a live virus neutralization assay. The neutralization activity of COVAXIN™-boosted sera was comparable to what has been observed in mRNA vaccine-boosted sera against the Omicron variant. More than 90% of all individuals boosted with COVAXIN™ (BBV152) showed neutralizing antibodies. All participants received an initial two-dose schedule of COVAXIN™ (BBV152) at Day 0 and Day 28.

“The global impact of Omicron shows us that the fight against COVID-19 continues, and we’re encouraged that these data demonstrate the value of COVAXIN™ as a primary and booster vaccine,” said Dr. Shankar Musunuri, Chairman, CEO and Co-Founder, Ocugen, Inc. “These results show how a broad-spectrum vaccine has the potential ability to address ever-shifting public health challenges such as new variants and mutations.”

“As the dominant COVID-19 variant throughout the world, Omicron poses a serious public health concern,” said Mehul Suthar, Ph.D., Assistant Professor, Emory Vaccine Center and who led the laboratory analysis. “Data from this preliminary analysis show individuals receiving a booster dose of COVAXIN™ have a significant immune response to both the Omicron and Delta variants. These findings suggest that a booster dose has the potential to reduce disease severity and hospitalizations.”

Dr. Krishna Ella, Chairman and Managing Director of Bharat Biotech said, “We are in a continuous state of innovation and product development for COVAXIN™. The positive neutralization responses against the Omicron and Delta variants, validates our hypothesis of a multi epitope vaccine generating both humoral and cell mediated immune responses. Our goals of developing a global vaccine against COVID-19 have been achieved with the use of COVAXIN™ as a universal vaccine for adults and children.”

COVAXIN™ is formulated uniquely such that the same dosage can be administered to adults and children alike. COVAXIN™ is a ready-to-use, liquid vaccine, stored at 2 – 8°C, with 12 months shelf life and multi-dose vial policy. The same doses of vaccine can also be used for two-dose primary immunization in adults and children and for booster dose vaccinations, making it truly a universal vaccine. COVAXIN™ is not currently authorized or approved for use as a primary or booster dose in the United States.

About the study
In order to evaluate the effectiveness of COVAXIN™ (BBV152) against the Omicron variant, Ocugen contracted with the Emory Vaccine Center (Atlanta, GA) to test human immune sera obtained from participants (n=13) in an ongoing Phase 2 clinical trial (ClinicalTrials.gov: NCT04471519). Sera was collected 28-days post booster – six months following the primary two-dose series. Each sera was tested in a neutralization assay. Following three doses, the FRNT50 geometric mean titers (GMTs) of neutralizing antibodies against the Omicron variant measured in the samples was 75, compared to 480 against the Delta variant and 706 against the vaccine strain, D614G.

This study was sponsored by Ocugen, Inc. and Ocugen’s partner, Bharat Biotech, provided the sera of the subjects from the Phase 2 study.

About COVAXIN™ (BBV152)
COVAXIN™ (BBV152) is an investigational vaccine candidate product in the U.S, currently under review by the U.S. Food and Drug Administration for emergency use authorization (EUA) for children 2-18 years of age. Additionally, an Investigational New Drug application (IND) is being discussed with the agency to support an immunobridging study among U.S. participants. It was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). COVAXIN™ (BBV152) is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform.

With more than 180 million doses having been administered to adults and children outside the U.S., COVAXIN™ (BBV152) is currently authorized under emergency use in more than 20 countries, and emergency use authorization is in process in more than 60 other countries. The World Health Organization (WHO) recently added COVAXIN™ (BBV152) to its list of vaccines authorized for emergency use. And, as many as 110 countries have agreed to mutual recognition of COVID-19 vaccination certificates with India that includes vaccination using COVAXIN™ (BBV152). The trade name, COVAXIN™, has not been evaluated by the FDA.

About Ocugen, Inc.
Ocugen, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug – “one to many” and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. We are co-developing Bharat Biotech’s COVAXIN™ vaccine candidate for COVID-19 in the U.S. and Canadian markets. For more information, please visit www.ocugen.com.

About Bharat Biotech 
Bharat Biotech has established an excellent track record of innovation with more than 145 global patents, a wide product portfolio of more than 16 vaccines, 4 bio-therapeutics, registrations in more than 123 countries, and the World Health Organization (WHO) Pre-qualifications. Located in Genome Valley in Hyderabad, India, a hub for the global biotech industry, Bharat Biotech has built a world-class vaccine & bio-therapeutics, research & product development, Bio-Safety Level 3 manufacturing, and vaccine supply and distribution.

Having delivered more than 4 billion doses of vaccines worldwide, Bharat Biotech continues to lead innovation and has developed vaccines for influenza H1N1, Rotavirus, Japanese Encephalitis, Rabies, Chikungunya, Zika, and the world’s first tetanus-toxoid conjugated vaccine for Typhoid. Bharat’s commitment to global social innovation programs and public-private partnerships resulted in introducing path-breaking WHO pre-qualified vaccines BIOPOLIO®, ROTAVAC®, and Typbar TCV® combatting polio, rotavirus, typhoid infections, respectively. The acquisition of the rabies vaccine facility, Chiron Behring, from GlaxoSmithKline (GSK) has positioned Bharat Biotech as the world’s largest rabies vaccine manufacturer. To learn more about Bharat Biotech, visit www.bharatbiotech.com.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such forward-looking statements include information about qualitative assessments of available data, potential benefits, expectations for clinical trials, and anticipated timing of clinical trial readouts and regulatory submissions, including statements about data from the Phase 2 study conducted by Emory University that we sponsored, and the potential for this data to support our application to the U.S. Food and Drug Administration (FDA) for emergency use authorization (EUA) of COVAXIN™ in pediatric patients or our planned biologics license application (BLA), assuming the clinical hold is lifted, for approval of COVAXIN™ for use in adult patients, as well as statements regarding the potential short and long-term benefits of receiving a booster dose of COVAXIN™. This information involves risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates; the risk that we may not resolve the current clinical hold on COVAXIN™ in the near term or at all, or that the FDA could make other decisions that adversely impact our ability to advance the development of COVAXIN™ in the United States, and the implications that this clinical hold may have for our request for EUA of COVAXIN for pediatric use, including the timing and scope of any such authorization; risks associated with preliminary and interim data, including the possibility of unfavorable new clinical trial data and further analyses of existing clinical trial data; the risk that the results of in-vitro studies will not be duplicated in human clinical trials; the risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when data from Bharat Biotech’s clinical trials will be published in scientific journal publications and, if so, when and with what modifications; whether the data and results from the preclinical and clinical studies of COVAXIN™, which have been conducted by Bharat Biotech in India, will be accepted by the FDA or otherwise sufficient to support our EUA submission or planned BLA submission, assuming the clinical hold is lifted; the size, scope, timing and outcome of any additional trials or studies that we may be required to conduct to support an EUA or BLA; any additional chemistry, manufacturing, and controls information that we may be required to submit to the FDA; whether and when a BLA for COVAXIN™ will be submitted to or approved by the FDA; whether developments with respect to the COVID-19 pandemic will affect the regulatory pathway available for vaccines in the United States, Canada or other jurisdictions; market demand for COVAXIN™ in the United States or Canada; decisions by the FDA or Health Canada impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of COVAXIN™ in the United States or Canada, including development of products or therapies by other companies. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release.

Ocugen Contact: 
Ken Inchausti
Head, Investor Relations & Communications
+1 484 237 3398
ken.inchausti@ocugen.com

Please submit investor-related inquiries to: IR@ocugen.com

electroCore, Inc. Broadens Patient Access to gammaCore with Launch of U.S. Telehealth Portal and Online Store

News and Market Data on electroCore

 

ROCKAWAY, N.J., 
Jan. 11, 2022 (GLOBE NEWSWIRE) — electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced the launch of an e-commerce shop for patients residing in 
the United States. The site, which can be accessed through www.gammacore.com, allows patients to complete a telehealth consult for a prescription and purchase gammaCore Sapphire™, a non-invasive vagus nerve stimulator (nVNS) device, online.

The online store offers therapy to patients for FDA-cleared indications like migraine and cluster headache. The store platform is powered by 
Vytal, LLC and allows patients to obtain a prescription via telehealth consult, purchase the therapy directly from the site, have a member of the 
U.S. electroCore customer service team provide post-purchase video conference training, and receive the device at their doorstep.

“The launch of an online store is a tremendous step forward in our company’s cash pay, direct-to-consumer strategy,” stated  Joshua Lev, Chief Strategy Officer at electroCore. “More and more patients are utilizing online channels to manage their health, and the launch of our new online store builds on the trend of patients taking control of their healthcare. We are very excited to offer patients the ability to obtain nVNS therapy from the comfort of their home. The new functionality provides direct access to millions of migraine and cluster headache sufferers who can benefit from gammaCore nVNS therapy.”

“We are thrilled to be a part of electroCore’s direct-to-consumer initiative to treat migraines and cluster headaches. Our end-to-end solution for patient access to gammaCore allows a seamless patient experience that should help patients access this unique, proven therapy,” said  Jerry Gross, Founder and CEO of Vytal.

About Vytal, LLC.
Vytal is a healthcare technology company offering comprehensive, compliant technology solutions that enable manufacturers, pharmacies, provider networks, wellness ecommerce companies, and virtual health platforms to manage, grow, and scale their operations. Vytal’s data-driven direct-to-consumer ecommerce platform enables healthcare manufacturers to reach more patients and boost brand awareness. For more information visit https://www.vytal.care.

About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic medicine company dedicated to improving patient outcomes through its non-invasive vagus nerve stimulation therapy platform, initially focused on the treatment of multiple conditions in neurology. The company’s current indications are the preventive treatment of cluster headache and migraine, the acute treatment of migraine and episodic cluster headache, the acute and preventive treatment of migraines in adolescents, and paroxysmal hemicrania and hemicrania continua in adults.

For more information, visit www.electrocore.com.

About gammaCore^TM
gammaCoreTM (nVNS) is the first non-invasive hand-held medical therapy applied at the neck as an adjunctive therapy to treat migraine and cluster headache through the utilization of a mild electrical stimulation to the vagus nerve that passes through the skin. Designed as a portable easy-to-use technology, gammaCore can be self-administered by patients, as needed, without the potential side effects associated with commonly prescribed drugs. When placed on a patient’s neck over the vagus nerve, gammaCore stimulates the nerve’s afferent fibers, which may lead to a reduction of pain in patients.

gammaCore (nVNS) is FDA-cleared in 
the United States for adjunctive use for the preventive treatment of cluster headache in adult patients, the acute treatment of pain associated with episodic cluster headache in adult patients, and the acute and preventive treatment of migraine in adolescent (ages 12 and older) and adult patients. gammaCore is CE-marked in the 
European Union for the acute and/or prophylactic treatment of primary headache (Migraine, Cluster Headache, Trigeminal Autonomic Cephalalgias and Hemicrania Continua) and Medication Overuse Headache in adults.

gammaCore is contraindicated for patients if they:

• Have an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
• Have a metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck
• Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)
  

Safety and efficacy of gammaCore have not been evaluated in the following patients:

• Adolescent patients with congenital cardiac issues
• Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
• Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
• Pediatric patients (less than 12 years)
• Pregnant women
• Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia

Please refer to the gammaCore Instructions for Use for all important warnings and precautions before using or prescribing this product.

For more information, please visit www.gammacore.com.

Forward-Looking Statements
This press release and other written and oral statements made by representatives of electroCore may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about electroCore’s business prospects and clinical and product development plans; its pipeline or potential markets for its technologies; the timing, outcome and impact of regulatory, clinical and commercial developments; the Company’s business prospects in 
the United States (including its e-commerce initiative) and other new markets and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “believes,” “intends,” other words of similar meaning, derivations of such words and the use of future dates. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to raise the additional funding needed to continue to pursue electroCore’s business and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to commercialize gammaCore™, the potential impact and effects of COVID-19 on the business of electroCore, electroCore’s results of operations and financial performance, and any measures electroCore has and may take in response to COVID-19 and any expectations electroCore may have with respect thereto, competition in the industry in which electroCore operates and overall market conditions. Any forward-looking statements are made as of the date of this press release, and electroCore assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents electroCore files with the 
SEC available at www.sec.gov.

Investors:
Rich Cockrell

CG Capital
404-736-3838
ecor@cg.capital 

or

Media Contact:
Jackie Dorsky
electroCore
908-313-6331
Jackie.dorsky@electrocore.com 

electroCore Announces Publication of PREMIUM II Trial of gammaCore (Non-Invasive Vagus Nerve Stimulation; nVNS) for the Prevention of Migraine

News and Market Data on electroCore

 

ROCKAWAY, N.J., 
Jan. 10, 2022 (GLOBE NEWSWIRE) — 
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced the publication of a peer-reviewed paper, entitled “Non-invasive vagus nerve stimulation for prevention of migraine: The multicenter, randomized, double-blind, sham-controlled 
PREMIUM II trial” in Cephalalgia, the official journal of the International Headache Society (IHS). The paper reports the results of a randomized, double-blind, sham-controlled trial conducted at twenty-seven sites across 
the United States. Originally designed and powered to randomize 400 patients, the study was closed early due to COVID-19 after enrolling 231 subjects.

The results of the study showed a decrease in the number of monthly headache days of 4.6 vs. -3.0 for sham (p=0.05) with 44.87% of subjects in the gammaCore group having greater than a 50% reduction in the number of migraine days per month compared with 26.81% for the sham group (p=0.05). Quality of life, as measured by the HIT-6 (Headache Impact scale), improved by -4.9 points vs. -2.3 for sham (p<0.05). In the subpopulation of patients diagnosed with migraine with aura, the number of headache days decreased by 5.5 days in the nVNS group compared with 2.7 in the sham group (p=0<0.05), a therapeutic gain of >100% compared to sham. These findings are consistent with previous reports on the mechanisms of action that suggest nVNS may be particularly effective in patients with migraine with aura.

Dr. Umer Najib, Associate Professor, Program Director of the Headache Medicine Fellowship Program at the 
West Virginia University and first author of the paper commented, “We are pleased to have added to the data that helps suggest the types of migraine patients who could likely benefit most from nVNS. The safety and tolerability of nVNS is such that it can be used as a stand-alone or adjunctive treatment, depending on the needs of the patient, and its flexibility allows health care providers to consider it for many of their patients.”

“We congratulate and thank all of the investigators, site staff, and subjects who conducted this study throughout 
the United States despite the challenges that arrived with COVID-19,” commented Eric Liebler, Senior Vice President of Neurology at electroCore. “With seven different indications from the FDA, gammaCore is safe and effective for many patients with primary headache, and the findings of this study highlighting the potential benefits in patients who have migraine with aura are particularly compelling.”

The full publication is available at: https://journals.sagepub.com/doi/10.1177/03331024211068813

About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic medicine company dedicated to improving patient outcomes through its non-invasive vagus nerve stimulation therapy platform, initially focused on the treatment of multiple conditions in neurology. The company’s current indications are the preventive treatment of cluster headache and migraine, the acute treatment of migraine and episodic cluster headache, the acute and preventive treatment of migraines in adolescents, and paroxysmal hemicrania and hemicrania continua in adults.

For more information, visit www.electrocore.com.

About gammaCore^TM
gammaCore^TM (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck as an adjunctive therapy to treat migraine and cluster headache through the utilization of a mild electrical stimulation to the vagus nerve that passes through the skin. Designed as a portable, easy-to-use technology, gammaCore can be self-administered by patients, as needed, without the potential side effects associated with commonly prescribed drugs. When placed on a patient’s neck over the vagus nerve, gammaCore stimulates the nerve’s afferent fibers, which may lead to a reduction of pain in patients.

gammaCore (nVNS) is FDA cleared in 
the United States for adjunctive use for the preventive treatment of cluster headache in adult patients, the acute treatment of pain associated with episodic cluster headache in adult patients, and the acute and preventive treatment of migraine in adolescent (ages 12 and older) and adult patients, and paroxysmal hemicrania and hemicrania continua in adult patients. gammaCore is CE-marked in the 
European Union for the acute and/or prophylactic treatment of primary headache (Migraine, Cluster Headache, Trigeminal Autonomic Cephalalgias and Hemicrania Continua) and Medication Overuse Headache in adults.

gammaCore is contraindicated for patients if they:

• Have an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
• Have a metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck
• Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)
  

Safety and efficacy of gammaCore have not been evaluated in the following patients:

• Adolescent patients with congenital cardiac issues
• Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
• Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
• Pediatric patients (less than 12 years)
• Pregnant women
• Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia

Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.

Forward-Looking Statements
This press release and other written and oral statements made by representatives of electroCore may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about electroCore’s business prospects and clinical and product development plans (including with respect to enrollment in ongoing studies); its pipeline or potential markets for its technologies; the timing, outcome and impact of regulatory, clinical and commercial developments; the issuance of 
U.S. and international patents providing expanded IP coverage; the possibility of future business models and revenue streams from the company’s potential utilizing nVNS for symptoms associated with migraine with aura, the potential of nVNS generally and gammaCore in particular and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “believes,” “intends,” other words of similar meaning, derivations of such words and the use of future dates. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to raise the additional funding needed to continue to pursue electroCore’s business and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to commercialize gammaCore™, the potential impact and effects of COVID-19 on the business of electroCore, electroCore’s results of operations and financial performance, and any measures electroCore has and may take in response to COVID-19 and any expectations electroCore may have with respect thereto, competition in the industry in which electroCore operates and overall market conditions. Any forward-looking statements are made as of the date of this press release, and electroCore assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents electroCore files with the 
SEC available at www.sec.gov.

Investors:
Rich Cockrell

CG Capital
404-736-3838
ecor@cg.capital

or

Media Contact:
Jackie Dorsky
electroCore
908-313-6331
jackie.dorsky@electrocore.com

electroCore Announces Publication of PREMIUM II Trial of gammaCore (Non-Invasive Vagus Nerve Stimulation; nVNS) for the Prevention of Migraine

News and Market Data on electroCore

 

ROCKAWAY, N.J., 
Jan. 10, 2022 (GLOBE NEWSWIRE) — 
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced the publication of a peer-reviewed paper, entitled “Non-invasive vagus nerve stimulation for prevention of migraine: The multicenter, randomized, double-blind, sham-controlled 
PREMIUM II trial” in Cephalalgia, the official journal of the International Headache Society (IHS). The paper reports the results of a randomized, double-blind, sham-controlled trial conducted at twenty-seven sites across 
the United States. Originally designed and powered to randomize 400 patients, the study was closed early due to COVID-19 after enrolling 231 subjects.

The results of the study showed a decrease in the number of monthly headache days of 4.6 vs. -3.0 for sham (p=0.05) with 44.87% of subjects in the gammaCore group having greater than a 50% reduction in the number of migraine days per month compared with 26.81% for the sham group (p=0.05). Quality of life, as measured by the HIT-6 (Headache Impact scale), improved by -4.9 points vs. -2.3 for sham (p<0.05). In the subpopulation of patients diagnosed with migraine with aura, the number of headache days decreased by 5.5 days in the nVNS group compared with 2.7 in the sham group (p=0<0.05), a therapeutic gain of >100% compared to sham. These findings are consistent with previous reports on the mechanisms of action that suggest nVNS may be particularly effective in patients with migraine with aura.

Dr. Umer Najib, Associate Professor, Program Director of the Headache Medicine Fellowship Program at the 
West Virginia University and first author of the paper commented, “We are pleased to have added to the data that helps suggest the types of migraine patients who could likely benefit most from nVNS. The safety and tolerability of nVNS is such that it can be used as a stand-alone or adjunctive treatment, depending on the needs of the patient, and its flexibility allows health care providers to consider it for many of their patients.”

“We congratulate and thank all of the investigators, site staff, and subjects who conducted this study throughout 
the United States despite the challenges that arrived with COVID-19,” commented Eric Liebler, Senior Vice President of Neurology at electroCore. “With seven different indications from the FDA, gammaCore is safe and effective for many patients with primary headache, and the findings of this study highlighting the potential benefits in patients who have migraine with aura are particularly compelling.”

The full publication is available at: https://journals.sagepub.com/doi/10.1177/03331024211068813

About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic medicine company dedicated to improving patient outcomes through its non-invasive vagus nerve stimulation therapy platform, initially focused on the treatment of multiple conditions in neurology. The company’s current indications are the preventive treatment of cluster headache and migraine, the acute treatment of migraine and episodic cluster headache, the acute and preventive treatment of migraines in adolescents, and paroxysmal hemicrania and hemicrania continua in adults.

For more information, visit www.electrocore.com.

About gammaCore^TM
gammaCore^TM (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck as an adjunctive therapy to treat migraine and cluster headache through the utilization of a mild electrical stimulation to the vagus nerve that passes through the skin. Designed as a portable, easy-to-use technology, gammaCore can be self-administered by patients, as needed, without the potential side effects associated with commonly prescribed drugs. When placed on a patient’s neck over the vagus nerve, gammaCore stimulates the nerve’s afferent fibers, which may lead to a reduction of pain in patients.

gammaCore (nVNS) is FDA cleared in 
the United States for adjunctive use for the preventive treatment of cluster headache in adult patients, the acute treatment of pain associated with episodic cluster headache in adult patients, and the acute and preventive treatment of migraine in adolescent (ages 12 and older) and adult patients, and paroxysmal hemicrania and hemicrania continua in adult patients. gammaCore is CE-marked in the 
European Union for the acute and/or prophylactic treatment of primary headache (Migraine, Cluster Headache, Trigeminal Autonomic Cephalalgias and Hemicrania Continua) and Medication Overuse Headache in adults.

gammaCore is contraindicated for patients if they:

• Have an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
• Have a metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck
• Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)
  

Safety and efficacy of gammaCore have not been evaluated in the following patients:

• Adolescent patients with congenital cardiac issues
• Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
• Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
• Pediatric patients (less than 12 years)
• Pregnant women
• Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia

Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.

Forward-Looking Statements
This press release and other written and oral statements made by representatives of electroCore may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about electroCore’s business prospects and clinical and product development plans (including with respect to enrollment in ongoing studies); its pipeline or potential markets for its technologies; the timing, outcome and impact of regulatory, clinical and commercial developments; the issuance of 
U.S. and international patents providing expanded IP coverage; the possibility of future business models and revenue streams from the company’s potential utilizing nVNS for symptoms associated with migraine with aura, the potential of nVNS generally and gammaCore in particular and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “believes,” “intends,” other words of similar meaning, derivations of such words and the use of future dates. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to raise the additional funding needed to continue to pursue electroCore’s business and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to commercialize gammaCore™, the potential impact and effects of COVID-19 on the business of electroCore, electroCore’s results of operations and financial performance, and any measures electroCore has and may take in response to COVID-19 and any expectations electroCore may have with respect thereto, competition in the industry in which electroCore operates and overall market conditions. Any forward-looking statements are made as of the date of this press release, and electroCore assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents electroCore files with the 
SEC available at www.sec.gov.

Investors:
Rich Cockrell

CG Capital
404-736-3838
ecor@cg.capital

or

Media Contact:
Jackie Dorsky
electroCore
908-313-6331
jackie.dorsky@electrocore.com

electroCore, Inc. Broadens Patient Access to gammaCore with Launch of U.S. Telehealth Portal and Online Store

News and Market Data on electroCore

 

ROCKAWAY, N.J., 
Jan. 11, 2022 (GLOBE NEWSWIRE) — electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced the launch of an e-commerce shop for patients residing in 
the United States. The site, which can be accessed through www.gammacore.com, allows patients to complete a telehealth consult for a prescription and purchase gammaCore Sapphire™, a non-invasive vagus nerve stimulator (nVNS) device, online.

The online store offers therapy to patients for FDA-cleared indications like migraine and cluster headache. The store platform is powered by 
Vytal, LLC and allows patients to obtain a prescription via telehealth consult, purchase the therapy directly from the site, have a member of the 
U.S. electroCore customer service team provide post-purchase video conference training, and receive the device at their doorstep.

“The launch of an online store is a tremendous step forward in our company’s cash pay, direct-to-consumer strategy,” stated  Joshua Lev, Chief Strategy Officer at electroCore. “More and more patients are utilizing online channels to manage their health, and the launch of our new online store builds on the trend of patients taking control of their healthcare. We are very excited to offer patients the ability to obtain nVNS therapy from the comfort of their home. The new functionality provides direct access to millions of migraine and cluster headache sufferers who can benefit from gammaCore nVNS therapy.”

“We are thrilled to be a part of electroCore’s direct-to-consumer initiative to treat migraines and cluster headaches. Our end-to-end solution for patient access to gammaCore allows a seamless patient experience that should help patients access this unique, proven therapy,” said  Jerry Gross, Founder and CEO of Vytal.

About Vytal, LLC.
Vytal is a healthcare technology company offering comprehensive, compliant technology solutions that enable manufacturers, pharmacies, provider networks, wellness ecommerce companies, and virtual health platforms to manage, grow, and scale their operations. Vytal’s data-driven direct-to-consumer ecommerce platform enables healthcare manufacturers to reach more patients and boost brand awareness. For more information visit https://www.vytal.care.

About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic medicine company dedicated to improving patient outcomes through its non-invasive vagus nerve stimulation therapy platform, initially focused on the treatment of multiple conditions in neurology. The company’s current indications are the preventive treatment of cluster headache and migraine, the acute treatment of migraine and episodic cluster headache, the acute and preventive treatment of migraines in adolescents, and paroxysmal hemicrania and hemicrania continua in adults.

For more information, visit www.electrocore.com.

About gammaCore^TM
gammaCoreTM (nVNS) is the first non-invasive hand-held medical therapy applied at the neck as an adjunctive therapy to treat migraine and cluster headache through the utilization of a mild electrical stimulation to the vagus nerve that passes through the skin. Designed as a portable easy-to-use technology, gammaCore can be self-administered by patients, as needed, without the potential side effects associated with commonly prescribed drugs. When placed on a patient’s neck over the vagus nerve, gammaCore stimulates the nerve’s afferent fibers, which may lead to a reduction of pain in patients.

gammaCore (nVNS) is FDA-cleared in 
the United States for adjunctive use for the preventive treatment of cluster headache in adult patients, the acute treatment of pain associated with episodic cluster headache in adult patients, and the acute and preventive treatment of migraine in adolescent (ages 12 and older) and adult patients. gammaCore is CE-marked in the 
European Union for the acute and/or prophylactic treatment of primary headache (Migraine, Cluster Headache, Trigeminal Autonomic Cephalalgias and Hemicrania Continua) and Medication Overuse Headache in adults.

gammaCore is contraindicated for patients if they:

• Have an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
• Have a metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck
• Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)
  

Safety and efficacy of gammaCore have not been evaluated in the following patients:

• Adolescent patients with congenital cardiac issues
• Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
• Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
• Pediatric patients (less than 12 years)
• Pregnant women
• Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia

Please refer to the gammaCore Instructions for Use for all important warnings and precautions before using or prescribing this product.

For more information, please visit www.gammacore.com.

Forward-Looking Statements
This press release and other written and oral statements made by representatives of electroCore may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about electroCore’s business prospects and clinical and product development plans; its pipeline or potential markets for its technologies; the timing, outcome and impact of regulatory, clinical and commercial developments; the Company’s business prospects in 
the United States (including its e-commerce initiative) and other new markets and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “believes,” “intends,” other words of similar meaning, derivations of such words and the use of future dates. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to raise the additional funding needed to continue to pursue electroCore’s business and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to commercialize gammaCore™, the potential impact and effects of COVID-19 on the business of electroCore, electroCore’s results of operations and financial performance, and any measures electroCore has and may take in response to COVID-19 and any expectations electroCore may have with respect thereto, competition in the industry in which electroCore operates and overall market conditions. Any forward-looking statements are made as of the date of this press release, and electroCore assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents electroCore files with the 
SEC available at www.sec.gov.

Investors:
Rich Cockrell

CG Capital
404-736-3838
ecor@cg.capital 

or

Media Contact:
Jackie Dorsky
electroCore
908-313-6331
Jackie.dorsky@electrocore.com 

PDS Biotech Granted Patent for its Novel HPV16 Immunotherapy

Research, News, and Market Data on PDS Biotech

 

Extends patent protection of PDS0101 by the United States Patent and Trademark Office Until October 2037

FLORHAM PARK, N.J., Jan. 10, 2022 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies based on the Company’s proprietary Versamune^® T-cell activating technology, today announced that it has been granted U.S. Patent Application No. 15,724,818 titled “Novel HPV16 Non HLA-Restricted T-cell Vaccines, Composition and Methods of Use Thereof” by the United States Patent and Trademark Office (USPTO).

The newly issued patent covers the PDS0101 immunotherapy which consists of a combination of the Versamune technology platform with a unique mixture of short protein fragments derived from the cancer-causing virus, HPV16.  The composition promotes the induction of killer (CD8+) T-cells by the immune system that recognize, and attack cancers caused by infection with HPV16 irrespective of the patients’ genetic makeup. 

HPV16 is the most oncogenic or cancer-causing type of HPV, and is by far the most prevalent in patients with advanced HPV-associated cancers, including anal, cervical, head and neck, penile, vaginal and vulvar cancers.  More than 40,500 patients are diagnosed with HPV16-associated cancers each year according to the International Journal of Cancer.  Some of these cancers have been reported to be increasing in incidence over the last few years. 

“We remain excited about the promising early efficacy and safety data from our ongoing Phase 2 clinical trials.  The early clinical data coupled with the recent grant of the PDS0101 patent that runs into late 2037 puts PDS Biotech in a strong position to progress commercialization of the product to address a significant unmet need for more effective treatment of advanced HPV-associated cancers,” stated Frank Bedu-Addo, Chief Executive Officer of PDS Biotech. 

In partnership with Merck & Co., PDS Biotech is evaluating a combination of PDS0101 and KEYTRUDA^® in a Phase 2 study (NCT04260126) in first-line treatment of recurrent or metastatic head and neck cancer, and also in second-line treatment of recurrent or metastatic head and neck cancer in patients who have failed prior checkpoint inhibitor therapy. PDS Biotech is also conducting a Phase 2 clinical study in both second- and third-line treatment of multiple advanced HPV-associated cancers with the National Cancer Institute (NCI). A third Phase 2 clinical trial in first-line treatment of locally advanced cervical cancer is being performed with The University of Texas, MD Anderson Cancer Center.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer immunotherapies based on the Company’s proprietary Versamune^® T-cell activating technology platform. Our Versamune^®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune^® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them.  The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck) and breast, colon, lung, prostate and ovarian cancers.  To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

Forward Looking Statements

This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune^® based products; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune^® based products and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim results, which are not necessarily indicative of the final results of the Company’s ongoing clinical trials;  any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical  results from its clinical development programs and any collaboration studies; the acceptance by the market of the Company’s product candidates, if approved; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company’s product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company’s annual and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

CONTACT: Investor Contact:

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: pdsb@cg.capital

COVAXIN™ (BBV152) Booster Dose Study Demonstrates Robust Immune Responses and Long-Term Safety

 

Research, News, and Market Data on Ocugen

 

• Participants receiving a booster dose six months after second dose of COVAXIN™ saw significant increase (>10-fold across Alpha, Beta, Delta and Delta Plus variants) in neutralizing titers compared to baseline at six months
• Persistence of memory B and T cell immune responses at six months post second dose
• Pronounced SARS-CoV-2-specific T cell response to COVAXIN™ before and after the booster dose may confer durable and long-term protective efficacy
• No serious adverse events such as hospitalizations or deaths were reported
• Effectiveness of COVAXIN™ against the Omicron strain is currently being studied and will be reported shortly
  

MALVERN, Pa., Jan. 08, 2022 (GLOBE NEWSWIRE) — Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing novel therapeutics and vaccines, announced that its partner, Bharat Biotech, posted positive results from a Phase 2 analysis of the vaccine candidate, COVAXIN™ (BBV152), in participants ages 12-64, receiving a booster dose six months following a second dose on the pre-print server, medRxiv. The analysis found that participants receiving a booster dose saw a significant increase in neutralizing titers, an important predictor of vaccine efficacy.

“As the COVID-19 virus continues to evolve, so does our understanding of the efficacy of vaccines and the critical role they play in protecting people from serious disease, hospitalization and death,” said Dr. Shankar Musunuri, Chairman, CEO and Co-Founder, Ocugen, Inc. “These booster data provide critical information about how COVAXIN™ can be used in the ongoing battle against COVID-19. We are encouraged by these results which continue to suggest that COVAXIN™ remains an important, broad-spectrum vaccine candidate with durability.”

Additional data from the analysis found that more than 75 percent of all participants had a detectible neutralizing antibody response six months post their second dose of COVAXIN^™. After receiving the booster, participants also saw an increase in antibody titers (at day 28) that were higher than those achieved after the two-dose primary series. Wild-type neutralizing antibodies (PRNT₅₀) GMTs at one month after a booster dose against Alpha, Beta, Delta and Delta plus variants were increased 10·9, 161·0, 264·7, and 174·2 fold from baseline at six months post second dose, respectively.

“Although protection against severe disease remains high six months following the second dose, a decline in efficacy against symptomatic disease over time and the continued emergence of variants are expected and consistent with what we are seeing with other vaccines. Based on emerging data, a third dose may be beneficial to maintain the highest levels of protection,” said Huma Qamar, MD, MPH, CMI, Associate Vice President, Clinical Development, Ocugen, Inc.

The booster dose analysis also found no serious adverse events, including hospitalization or death, were reported.

About COVAXIN™ (BBV152)
COVAXIN™ (BBV152) is an investigational vaccine candidate product in the U.S. It was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). COVAXIN™ (BBV152) is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform.

With more than 180 million doses having been administered to adults outside the U.S., COVAXIN™ (BBV152) is currently authorized under emergency use in 17 countries, and applications for emergency use authorization are pending in more than 60 other countries. The World Health Organization (WHO) recently added COVAXIN™ (BBV152) to its list of vaccines authorized for emergency use. And, as many as 110 countries have agreed to mutual recognition of Covid-19 vaccination certificates with India that includes vaccination using COVAXIN™ (BBV152). The trade name, COVAXIN™, has not been evaluated by the FDA.

About Ocugen, Inc.
Ocugen, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug – “one to many” and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. We are co-developing Bharat Biotech’s COVAXIN™ vaccine candidate for COVID-19 in the U.S. and Canadian markets. For more information, please visit www.ocugen.com.

About Bharat Biotech 
Bharat Biotech has established an excellent track record of innovation with more than 145 global patents, a wide product portfolio of more than 16 vaccines, 4 bio-therapeutics, registrations in more than 123 countries, and the World Health Organization (WHO) Pre-qualifications. Located in Genome Valley in Hyderabad, India, a hub for the global biotech industry, Bharat Biotech has built a world-class vaccine & bio-therapeutics, research & product development, Bio-Safety Level 3 manufacturing, and vaccine supply and distribution.

Having delivered more than 4 billion doses of vaccines worldwide, Bharat Biotech continues to lead innovation and has developed vaccines for influenza H1N1, Rotavirus, Japanese Encephalitis, Rabies, Chikungunya, Zika, and the world’s first tetanus-toxoid conjugated vaccine for Typhoid. Bharat’s commitment to global social innovation programs and public-private partnerships resulted in introducing path-breaking WHO pre-qualified vaccines BIOPOLIO®, ROTAVAC®, and Typbar TCV® combatting polio, rotavirus, typhoid infections, respectively. The acquisition of the rabies vaccine facility, Chiron Behring, from GlaxoSmithKline (GSK) has positioned Bharat Biotech as the world’s largest rabies vaccine manufacturer. To learn more about Bharat Biotech, visit www.bharatbiotech.com.

Cautionary Note on Forward-Looking Statements  
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such forward-looking statements include information about qualitative assessments of available data, potential benefits, expectations for clinical trials, and anticipated timing of clinical trial readouts and regulatory submissions, including statements about data published on the preprint server, medRxiv, by Bharat Biotech, which found that COVAXIN™, when administered as a booster dose, generated a five-fold increase in neutralizing titers, an important predictor of vaccine efficacy, and the potential for this data to support our application to the U.S. Food and Drug Administration (FDA) for emergency use authorization (EUA) of COVAXIN™ in pediatric patients or our planned biologics license application (BLA), assuming the clinical hold is lifted, for approval of COVAXIN™ for use in adult patients, as well as statements regarding the potential short and long-term benefits of receiving a booster dose of COVAXIN™. This information involves risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates; the risk that we may not resolve the current clinical hold on COVAXIN™ in the near term or at all, or that the FDA could make other decisions that adversely impact our ability to advance the development of COVAXIN™ in the United States, and the implications that this clinical hold may have for our request for EUA of COVAXIN for pediatric use, including the timing and scope of any such authorization; risks associated with preliminary and interim data, including the possibility of unfavorable new clinical trial data and further analyses of existing clinical trial data; the risk that the results of in-vitro studies will not be duplicated in human clinical trials; the risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when data from Bharat Biotech’s clinical trials will be published in scientific journal publications and, if so, when and with what modifications; whether the data and results from the preclinical and clinical studies of COVAXIN™, which have been conducted by Bharat Biotech in India, will be accepted by the FDA or otherwise sufficient to support our EUA submission or planned BLA submission, assuming the clinical hold is lifted; the size, scope, timing and outcome of any additional trials or studies that we may be required to conduct to support an EUA or BLA; any additional chemistry, manufacturing, and controls information that we may be required to submit to the FDA; whether and when a BLA for COVAXIN™ will be submitted to or approved by the FDA; whether developments with respect to the COVID-19 pandemic will affect the regulatory pathway available for vaccines in the United States, Canada or other jurisdictions; market demand for COVAXIN™ in the United States or Canada; decisions by the FDA or Health Canada impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of COVAXIN™ in the United States or Canada, including development of products or therapies by other companies. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release.

Ocugen Contact: 
Ken Inchausti
Head, Investor Relations & Communications
+1 484 237 3398
ken.inchausti@ocugen.com 

Please submit investor-related inquiries to: IR@ocugen.com 

COVAXIN™ (BBV152) Booster Dose Study Demonstrates Robust Immune Responses and Long-Term Safety

 

Research, News, and Market Data on Ocugen

 

• Participants receiving a booster dose six months after second dose of COVAXIN™ saw significant increase (>10-fold across Alpha, Beta, Delta and Delta Plus variants) in neutralizing titers compared to baseline at six months
• Persistence of memory B and T cell immune responses at six months post second dose
• Pronounced SARS-CoV-2-specific T cell response to COVAXIN™ before and after the booster dose may confer durable and long-term protective efficacy
• No serious adverse events such as hospitalizations or deaths were reported
• Effectiveness of COVAXIN™ against the Omicron strain is currently being studied and will be reported shortly
  

MALVERN, Pa., Jan. 08, 2022 (GLOBE NEWSWIRE) — Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing novel therapeutics and vaccines, announced that its partner, Bharat Biotech, posted positive results from a Phase 2 analysis of the vaccine candidate, COVAXIN™ (BBV152), in participants ages 12-64, receiving a booster dose six months following a second dose on the pre-print server, medRxiv. The analysis found that participants receiving a booster dose saw a significant increase in neutralizing titers, an important predictor of vaccine efficacy.

“As the COVID-19 virus continues to evolve, so does our understanding of the efficacy of vaccines and the critical role they play in protecting people from serious disease, hospitalization and death,” said Dr. Shankar Musunuri, Chairman, CEO and Co-Founder, Ocugen, Inc. “These booster data provide critical information about how COVAXIN™ can be used in the ongoing battle against COVID-19. We are encouraged by these results which continue to suggest that COVAXIN™ remains an important, broad-spectrum vaccine candidate with durability.”

Additional data from the analysis found that more than 75 percent of all participants had a detectible neutralizing antibody response six months post their second dose of COVAXIN^™. After receiving the booster, participants also saw an increase in antibody titers (at day 28) that were higher than those achieved after the two-dose primary series. Wild-type neutralizing antibodies (PRNT₅₀) GMTs at one month after a booster dose against Alpha, Beta, Delta and Delta plus variants were increased 10·9, 161·0, 264·7, and 174·2 fold from baseline at six months post second dose, respectively.

“Although protection against severe disease remains high six months following the second dose, a decline in efficacy against symptomatic disease over time and the continued emergence of variants are expected and consistent with what we are seeing with other vaccines. Based on emerging data, a third dose may be beneficial to maintain the highest levels of protection,” said Huma Qamar, MD, MPH, CMI, Associate Vice President, Clinical Development, Ocugen, Inc.

The booster dose analysis also found no serious adverse events, including hospitalization or death, were reported.

About COVAXIN™ (BBV152)
COVAXIN™ (BBV152) is an investigational vaccine candidate product in the U.S. It was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). COVAXIN™ (BBV152) is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform.

With more than 180 million doses having been administered to adults outside the U.S., COVAXIN™ (BBV152) is currently authorized under emergency use in 17 countries, and applications for emergency use authorization are pending in more than 60 other countries. The World Health Organization (WHO) recently added COVAXIN™ (BBV152) to its list of vaccines authorized for emergency use. And, as many as 110 countries have agreed to mutual recognition of Covid-19 vaccination certificates with India that includes vaccination using COVAXIN™ (BBV152). The trade name, COVAXIN™, has not been evaluated by the FDA.

About Ocugen, Inc.
Ocugen, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug – “one to many” and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. We are co-developing Bharat Biotech’s COVAXIN™ vaccine candidate for COVID-19 in the U.S. and Canadian markets. For more information, please visit www.ocugen.com.

About Bharat Biotech 
Bharat Biotech has established an excellent track record of innovation with more than 145 global patents, a wide product portfolio of more than 16 vaccines, 4 bio-therapeutics, registrations in more than 123 countries, and the World Health Organization (WHO) Pre-qualifications. Located in Genome Valley in Hyderabad, India, a hub for the global biotech industry, Bharat Biotech has built a world-class vaccine & bio-therapeutics, research & product development, Bio-Safety Level 3 manufacturing, and vaccine supply and distribution.

Having delivered more than 4 billion doses of vaccines worldwide, Bharat Biotech continues to lead innovation and has developed vaccines for influenza H1N1, Rotavirus, Japanese Encephalitis, Rabies, Chikungunya, Zika, and the world’s first tetanus-toxoid conjugated vaccine for Typhoid. Bharat’s commitment to global social innovation programs and public-private partnerships resulted in introducing path-breaking WHO pre-qualified vaccines BIOPOLIO®, ROTAVAC®, and Typbar TCV® combatting polio, rotavirus, typhoid infections, respectively. The acquisition of the rabies vaccine facility, Chiron Behring, from GlaxoSmithKline (GSK) has positioned Bharat Biotech as the world’s largest rabies vaccine manufacturer. To learn more about Bharat Biotech, visit www.bharatbiotech.com.

Cautionary Note on Forward-Looking Statements  
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such forward-looking statements include information about qualitative assessments of available data, potential benefits, expectations for clinical trials, and anticipated timing of clinical trial readouts and regulatory submissions, including statements about data published on the preprint server, medRxiv, by Bharat Biotech, which found that COVAXIN™, when administered as a booster dose, generated a five-fold increase in neutralizing titers, an important predictor of vaccine efficacy, and the potential for this data to support our application to the U.S. Food and Drug Administration (FDA) for emergency use authorization (EUA) of COVAXIN™ in pediatric patients or our planned biologics license application (BLA), assuming the clinical hold is lifted, for approval of COVAXIN™ for use in adult patients, as well as statements regarding the potential short and long-term benefits of receiving a booster dose of COVAXIN™. This information involves risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates; the risk that we may not resolve the current clinical hold on COVAXIN™ in the near term or at all, or that the FDA could make other decisions that adversely impact our ability to advance the development of COVAXIN™ in the United States, and the implications that this clinical hold may have for our request for EUA of COVAXIN for pediatric use, including the timing and scope of any such authorization; risks associated with preliminary and interim data, including the possibility of unfavorable new clinical trial data and further analyses of existing clinical trial data; the risk that the results of in-vitro studies will not be duplicated in human clinical trials; the risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when data from Bharat Biotech’s clinical trials will be published in scientific journal publications and, if so, when and with what modifications; whether the data and results from the preclinical and clinical studies of COVAXIN™, which have been conducted by Bharat Biotech in India, will be accepted by the FDA or otherwise sufficient to support our EUA submission or planned BLA submission, assuming the clinical hold is lifted; the size, scope, timing and outcome of any additional trials or studies that we may be required to conduct to support an EUA or BLA; any additional chemistry, manufacturing, and controls information that we may be required to submit to the FDA; whether and when a BLA for COVAXIN™ will be submitted to or approved by the FDA; whether developments with respect to the COVID-19 pandemic will affect the regulatory pathway available for vaccines in the United States, Canada or other jurisdictions; market demand for COVAXIN™ in the United States or Canada; decisions by the FDA or Health Canada impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of COVAXIN™ in the United States or Canada, including development of products or therapies by other companies. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release.

Ocugen Contact: 
Ken Inchausti
Head, Investor Relations & Communications
+1 484 237 3398
ken.inchausti@ocugen.com 

Please submit investor-related inquiries to: IR@ocugen.com 

PDS Biotech Granted Patent for its Novel HPV16 Immunotherapy

Research, News, and Market Data on PDS Biotech

 

Extends patent protection of PDS0101 by the United States Patent and Trademark Office Until October 2037

FLORHAM PARK, N.J., Jan. 10, 2022 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies based on the Company’s proprietary Versamune^® T-cell activating technology, today announced that it has been granted U.S. Patent Application No. 15,724,818 titled “Novel HPV16 Non HLA-Restricted T-cell Vaccines, Composition and Methods of Use Thereof” by the United States Patent and Trademark Office (USPTO).

The newly issued patent covers the PDS0101 immunotherapy which consists of a combination of the Versamune technology platform with a unique mixture of short protein fragments derived from the cancer-causing virus, HPV16.  The composition promotes the induction of killer (CD8+) T-cells by the immune system that recognize, and attack cancers caused by infection with HPV16 irrespective of the patients’ genetic makeup. 

HPV16 is the most oncogenic or cancer-causing type of HPV, and is by far the most prevalent in patients with advanced HPV-associated cancers, including anal, cervical, head and neck, penile, vaginal and vulvar cancers.  More than 40,500 patients are diagnosed with HPV16-associated cancers each year according to the International Journal of Cancer.  Some of these cancers have been reported to be increasing in incidence over the last few years. 

“We remain excited about the promising early efficacy and safety data from our ongoing Phase 2 clinical trials.  The early clinical data coupled with the recent grant of the PDS0101 patent that runs into late 2037 puts PDS Biotech in a strong position to progress commercialization of the product to address a significant unmet need for more effective treatment of advanced HPV-associated cancers,” stated Frank Bedu-Addo, Chief Executive Officer of PDS Biotech. 

In partnership with Merck & Co., PDS Biotech is evaluating a combination of PDS0101 and KEYTRUDA^® in a Phase 2 study (NCT04260126) in first-line treatment of recurrent or metastatic head and neck cancer, and also in second-line treatment of recurrent or metastatic head and neck cancer in patients who have failed prior checkpoint inhibitor therapy. PDS Biotech is also conducting a Phase 2 clinical study in both second- and third-line treatment of multiple advanced HPV-associated cancers with the National Cancer Institute (NCI). A third Phase 2 clinical trial in first-line treatment of locally advanced cervical cancer is being performed with The University of Texas, MD Anderson Cancer Center.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer immunotherapies based on the Company’s proprietary Versamune^® T-cell activating technology platform. Our Versamune^®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune^® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them.  The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck) and breast, colon, lung, prostate and ovarian cancers.  To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

Forward Looking Statements

This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune^® based products; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune^® based products and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim results, which are not necessarily indicative of the final results of the Company’s ongoing clinical trials;  any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical  results from its clinical development programs and any collaboration studies; the acceptance by the market of the Company’s product candidates, if approved; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company’s product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company’s annual and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

CONTACT: Investor Contact:

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: pdsb@cg.capital

BioSig to Present at the 27th Annual International AF Symposium

News and Market Data on BioSig Technologies

 

PURE EP (TM) System to be highlighted in a Spotlight Session by DJ Lakkireddy, M.D., Kansas City Heart Rhythm Institute at HCA Midwest Health

Westport, CT, Jan. 07, 2022 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”), a medical technology company commercializing an innovative signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals, today announced that the Company would be presenting at the 27th Annual International Atrial Fibrillation Symposium on January 13-15, 2022.

Clinical observations collected with BioSig’s PURE EP™ System will be presented by DJ Lakkireddy, M.D., Kansas City Heart Rhythm Institute at HCA Midwest Health during Spotlight Session: Complex AF Case Study Utilizing a New Standard in Signal Processing on January 13, 2022, from 8:30-9:30 AM ET.

“Dr. Lakkireddy is highly regarded for his passionate commitment to those suffering from complex arrhythmias and for his leadership in the field of electrophysiology, and we are thrilled to have him represent our technology at this benchmark industry event. We would like to thank the course directors, Drs. Ruskin, Mansour, Reddy, Keane, Jais, and the entire faculty for bringing the electrophysiology community together during this important industry event. We look forward to reconnecting with our physician partners and our peers as we gear up for an impactful clinical and commercial year,” commented Kenneth L. Londoner, Chairman, and CEO of BioSig Technologies, Inc.

During the event, BioSig will be exhibiting at booth 403. The Company’s executive, commercial and clinical teams will host demonstrations of the PURE EP™ System and some of its platform technology’s latest software and algorithmic features for arrhythmia care.

The conference will also be broadcast live. To register for the event and stream the live presentation, please follow this link: https://register.rcsreg.com/r2/afs2022/ga/top.html

To date, more than 73 physicians have completed over 1800 patient cases with the PURE EP™ System. The Company is in a focused commercial launch of the PURE EP™ System in the Northeast, Texas, and Florida.

Clinical data acquired by the PURE EP™ System in a multi-center study at Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Mayo Clinic Jacksonville, and Massachusetts General Hospital was recently published in the Journal of Cardiovascular Electrophysiology and is available electronically with open access via the Wiley Online Library. Study results showed 93% consensus across the blinded reviewers with a 75% overall improvement in intracardiac signal quality and confidence in interpreting PURE EP™ signals over conventional sources.

One in 18 Americans suffers from a cardiac arrhythmia. Atrial fibrillation is the most common arrhythmia type, affecting over 33 million people worldwide, including over 6 million in the U.S. The number of people suffering from atrial fibrillation is expected to reach 8-12 million by 2050¹. According to the Centers for Disease Control and Prevention (CDC), atrial fibrillation causes more than 750,000 hospitalizations in the U.S. each year, resulting in approximately $6 billion in healthcare spending annually².

About 27^7h Annual International AF Symposium
This intensive, highly focused three-day symposium brings together the world’s leading medical scientists to share in a highly interactive environment the most recent advances in the field of atrial fibrillation. The primary objective of the meeting is to provide attendees with a thorough and practical course on the current state of the art in the field of atrial fibrillation in a scholarly and collegial atmosphere, as well as an opportunity to network with colleagues and faculty between sessions. More information about the event on  www.afsymposium.com.

About BioSig Technologies


BioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals (www.biosig.com).

The Company’s first product, PURE EP™ System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording, and storing electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory.

Forward-looking Statements
This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (ii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iii) difficulties in obtaining financing on commercially reasonable terms; (iv) changes in the size and nature of our competition; (v) loss of one or more key executives or scientists; and (vi) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

¹ Top 10 Things You should Know About Heart Rhythm; Scripps Health.

² Managing Atrial Fibrillation; Lisa Eramom MA, Medical Economics Journal, February 25, 2019, Volume 96, Issue 4

Andrew Ballou
BioSig Technologies, Inc.
Vice President, Investor Relations
55 Greens Farms Road
Westport, CT 06880,
aballou@biosigtech.com
203-409-5444, x133

Source: BioSig Technologies, Inc.

BioSig to Present at the 27th Annual International AF Symposium

News and Market Data on BioSig Technologies

 

PURE EP (TM) System to be highlighted in a Spotlight Session by DJ Lakkireddy, M.D., Kansas City Heart Rhythm Institute at HCA Midwest Health

Westport, CT, Jan. 07, 2022 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”), a medical technology company commercializing an innovative signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals, today announced that the Company would be presenting at the 27th Annual International Atrial Fibrillation Symposium on January 13-15, 2022.

Clinical observations collected with BioSig’s PURE EP™ System will be presented by DJ Lakkireddy, M.D., Kansas City Heart Rhythm Institute at HCA Midwest Health during Spotlight Session: Complex AF Case Study Utilizing a New Standard in Signal Processing on January 13, 2022, from 8:30-9:30 AM ET.

“Dr. Lakkireddy is highly regarded for his passionate commitment to those suffering from complex arrhythmias and for his leadership in the field of electrophysiology, and we are thrilled to have him represent our technology at this benchmark industry event. We would like to thank the course directors, Drs. Ruskin, Mansour, Reddy, Keane, Jais, and the entire faculty for bringing the electrophysiology community together during this important industry event. We look forward to reconnecting with our physician partners and our peers as we gear up for an impactful clinical and commercial year,” commented Kenneth L. Londoner, Chairman, and CEO of BioSig Technologies, Inc.

During the event, BioSig will be exhibiting at booth 403. The Company’s executive, commercial and clinical teams will host demonstrations of the PURE EP™ System and some of its platform technology’s latest software and algorithmic features for arrhythmia care.

The conference will also be broadcast live. To register for the event and stream the live presentation, please follow this link: https://register.rcsreg.com/r2/afs2022/ga/top.html

To date, more than 73 physicians have completed over 1800 patient cases with the PURE EP™ System. The Company is in a focused commercial launch of the PURE EP™ System in the Northeast, Texas, and Florida.

Clinical data acquired by the PURE EP™ System in a multi-center study at Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Mayo Clinic Jacksonville, and Massachusetts General Hospital was recently published in the Journal of Cardiovascular Electrophysiology and is available electronically with open access via the Wiley Online Library. Study results showed 93% consensus across the blinded reviewers with a 75% overall improvement in intracardiac signal quality and confidence in interpreting PURE EP™ signals over conventional sources.

One in 18 Americans suffers from a cardiac arrhythmia. Atrial fibrillation is the most common arrhythmia type, affecting over 33 million people worldwide, including over 6 million in the U.S. The number of people suffering from atrial fibrillation is expected to reach 8-12 million by 2050¹. According to the Centers for Disease Control and Prevention (CDC), atrial fibrillation causes more than 750,000 hospitalizations in the U.S. each year, resulting in approximately $6 billion in healthcare spending annually².

About 27^7h Annual International AF Symposium
This intensive, highly focused three-day symposium brings together the world’s leading medical scientists to share in a highly interactive environment the most recent advances in the field of atrial fibrillation. The primary objective of the meeting is to provide attendees with a thorough and practical course on the current state of the art in the field of atrial fibrillation in a scholarly and collegial atmosphere, as well as an opportunity to network with colleagues and faculty between sessions. More information about the event on  www.afsymposium.com.

About BioSig Technologies


BioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals (www.biosig.com).

The Company’s first product, PURE EP™ System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording, and storing electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory.

Forward-looking Statements
This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (ii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iii) difficulties in obtaining financing on commercially reasonable terms; (iv) changes in the size and nature of our competition; (v) loss of one or more key executives or scientists; and (vi) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

¹ Top 10 Things You should Know About Heart Rhythm; Scripps Health.

² Managing Atrial Fibrillation; Lisa Eramom MA, Medical Economics Journal, February 25, 2019, Volume 96, Issue 4

Andrew Ballou
BioSig Technologies, Inc.
Vice President, Investor Relations
55 Greens Farms Road
Westport, CT 06880,
aballou@biosigtech.com
203-409-5444, x133

Source: BioSig Technologies, Inc.