Ocugen Provides Business Update and Third Quarter 2021 Financial Results

 

Conference Call and Webcast Today at 8:30 a.m. ET

• Emergency Use Authorization application filed with the U.S. FDA for the COVID-19 vaccine candidate, COVAXIN™ (BBV152), for children aged 2 – 18 years
• Investigational New Drug application filed with the U.S. FDA for COVAXIN™ (BBV152)
• Investigational New Drug application filed with the U.S. FDA for breakthrough modifier gene therapy candidate, OCU400
• Collaboration with CanSinoBIO expanded to include OCU410 for chemistry, manufacturing, and controls development and manufacturing

MALVERN, Pa. , Nov. 09, 2021 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), 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, today reported third quarter 2021 financial results along with a general business update.

“We’ve been relentless in our efforts to launch our innovative medicines onto regulatory pathways here in the United States. The submission of COVAXIN for Emergency Use Authorization for pediatrics is another example of Ocugen contributing to public health efforts to curb the pandemic, giving parents another option for protecting their children. Two Investigational New Drug submissions within a span of two weeks is a phenomenal achievement resulting from the work of international teams aligned around serving people with serious diseases. Our capabilities in the areas of R&D, clinical development, manufacturing, and commercial continue to expand with our workforce nearly doubling since the last quarter to deliver for the future. I’m really proud of the teams for their commitment to meeting our mission,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder of Ocugen.

Business Highlights

FORWARD MOMENTUM FOR COVAXIN™ AND OPHTHALMIC PIPELINE

• The Company filed an Emergency Use Authorization (EUA) application with the U.S. Food and Drug Administration (FDA) for the use of the COVID-19 vaccine candidate, COVAXIN™ (BBV152), for children aged 2 – 18 years. The Company believes its vaccine candidate has the potential to fulfill an unmet need in the national arsenal of COVID-19 vaccines. The inactivated virus platform has been used for decades in vaccines for pediatric populations.
• The Company also filed an Investigational New Drug (IND) application with the FDA to initiate a Phase 3 clinical trial evaluating COVAXIN™ (BBV152) in support of an upcoming Biologics License Application (BLA) submission. The observer-blind, immuno-bridging study of the whole-virion, inactivated SARS-CoV-2 vaccine candidate in healthy adults, if allowed to proceed, will help demonstrate that the Phase 3 data from the studies conducted by Bharat Biotech International Limited (Bharat Biotech) in India will be applicable to the U.S. population. Under the IND, the Company will also initiate a safety-bridging study, if required.
• The Company filed an IND application with the FDA for OCU400 for the Phase 1/2 study to assess the safety of OCU400 (NR2E3) in patients with a mutation in NR2E3 and RHO mutation-associated retinal degeneration. If allowed to proceed, the Company is planning to initiate this clinical trial in the United States around the end of 2021.
• In September 2021, the Company entered into a Development and Commercial Supply Agreement with Bharat Biotech, pursuant to which Bharat Biotech will supply the Company with clinical trial materials and commercial supplies of COVAXIN™ finished drug product prior to the completion of the Company’s technology transfer to Jubilant HollisterStier.

• In September 2021, the Company and CanSino Biologics, Inc. (“CanSinoBIO”) expanded their current collaboration on the development of OCU400 to now include OCU410. With that, CanSinoBIO will be responsible for the chemistry, manufacturing, and controls (CMC) development and manufacture of clinical supplies of both products and be responsible for the costs associated with such activities.
  

Third Quarter 2021 Financial Results

• Ocugen’s cash, cash equivalents, and restricted cash totaled $107.5 million as of September 30, 2021, compared to $24.2 million as of December 31, 2020. Ocugen had 198.9 million shares of common stock outstanding as of September 30, 2021.
• Research and development expenses for the three months ended September 30, 2021 were $6.3 million compared to $1.5 million for the three months ended September 30, 2020. General and administrative expenses for the three months ended September 30, 2021 were $4.5 million compared to $1.7 million for the three months ended September 30, 2020. Ocugen reported a $0.05 net loss per share for the three months ended September 30, 2021 compared to a $0.07 net loss per share for the three months ended September 30, 2020, which includes the in-process research and development expense of $7.0 million related to the reduction of the carrying value of an asset that was previously recorded as held for sale.

Conference Call and Webcast Details

Ocugen has scheduled a conference call and webcast for 8:30 a.m. eastern time today to discuss the financial results and recent business highlights. Ocugen’s senior management team will host the call, which will be open to all listeners. There will also be a question-and-answer session following the prepared remarks.

The call can be accessed by dialing (844) 873-7330 (U.S.) or (602) 563-8473 (international) and providing the conference ID 8198297. To access a live audio webcast of the call on the “Investors” section of the Ocugen website, please click here. A replay of the webcast will be archived on Ocugen’s website for approximately 45 days following the call.

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.

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 with respect to our belief that COVAXIN™ has the potential to fulfill an unmet need in the national arsenal of COVID-19 vaccines, our plans to initiate the Phase 1/2 study for OCU400, if authorized to proceed, near the end of 2021, and our belief that the results from the Phase 3 study for COVAXIN™, if allowed to proceed, will help demonstrate that the Phase 3 data from the studies conducted by Bharat Biotech Bharat Biotech in India will be applicable to the U.S. population. 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, including whether the FDA will authorize COVAXIN™ for administration as a vaccine for pediatric uses against COVID-19 pursuant to the EUA we submitted with the FDA and the timing and scope of any such authorization, as well as 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 or IND submissions, as applicable; whether the FDA will accept our IND submissions without any changes, or if we are required to submit additional information to the FDA in support of our IND submissions, the extent and significance of any such changes; 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 for COVAXIN™; any additional CMC 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

(tables to follow)

OCUGEN, INC.

CONSOLIDATED BALANCE SHEETS

(in thousands)

(Unaudited)

OCUGEN, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except share and per share amounts)

(Unaudited)

 

Ocugen Provides Business Update and Third Quarter 2021 Financial Results

 

Conference Call and Webcast Today at 8:30 a.m. ET

• Emergency Use Authorization application filed with the U.S. FDA for the COVID-19 vaccine candidate, COVAXIN™ (BBV152), for children aged 2 – 18 years
• Investigational New Drug application filed with the U.S. FDA for COVAXIN™ (BBV152)
• Investigational New Drug application filed with the U.S. FDA for breakthrough modifier gene therapy candidate, OCU400
• Collaboration with CanSinoBIO expanded to include OCU410 for chemistry, manufacturing, and controls development and manufacturing

MALVERN, Pa. , Nov. 09, 2021 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), 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, today reported third quarter 2021 financial results along with a general business update.

“We’ve been relentless in our efforts to launch our innovative medicines onto regulatory pathways here in the United States. The submission of COVAXIN for Emergency Use Authorization for pediatrics is another example of Ocugen contributing to public health efforts to curb the pandemic, giving parents another option for protecting their children. Two Investigational New Drug submissions within a span of two weeks is a phenomenal achievement resulting from the work of international teams aligned around serving people with serious diseases. Our capabilities in the areas of R&D, clinical development, manufacturing, and commercial continue to expand with our workforce nearly doubling since the last quarter to deliver for the future. I’m really proud of the teams for their commitment to meeting our mission,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder of Ocugen.

Business Highlights

FORWARD MOMENTUM FOR COVAXIN™ AND OPHTHALMIC PIPELINE

• The Company filed an Emergency Use Authorization (EUA) application with the U.S. Food and Drug Administration (FDA) for the use of the COVID-19 vaccine candidate, COVAXIN™ (BBV152), for children aged 2 – 18 years. The Company believes its vaccine candidate has the potential to fulfill an unmet need in the national arsenal of COVID-19 vaccines. The inactivated virus platform has been used for decades in vaccines for pediatric populations.
• The Company also filed an Investigational New Drug (IND) application with the FDA to initiate a Phase 3 clinical trial evaluating COVAXIN™ (BBV152) in support of an upcoming Biologics License Application (BLA) submission. The observer-blind, immuno-bridging study of the whole-virion, inactivated SARS-CoV-2 vaccine candidate in healthy adults, if allowed to proceed, will help demonstrate that the Phase 3 data from the studies conducted by Bharat Biotech International Limited (Bharat Biotech) in India will be applicable to the U.S. population. Under the IND, the Company will also initiate a safety-bridging study, if required.
• The Company filed an IND application with the FDA for OCU400 for the Phase 1/2 study to assess the safety of OCU400 (NR2E3) in patients with a mutation in NR2E3 and RHO mutation-associated retinal degeneration. If allowed to proceed, the Company is planning to initiate this clinical trial in the United States around the end of 2021.
• In September 2021, the Company entered into a Development and Commercial Supply Agreement with Bharat Biotech, pursuant to which Bharat Biotech will supply the Company with clinical trial materials and commercial supplies of COVAXIN™ finished drug product prior to the completion of the Company’s technology transfer to Jubilant HollisterStier.

• In September 2021, the Company and CanSino Biologics, Inc. (“CanSinoBIO”) expanded their current collaboration on the development of OCU400 to now include OCU410. With that, CanSinoBIO will be responsible for the chemistry, manufacturing, and controls (CMC) development and manufacture of clinical supplies of both products and be responsible for the costs associated with such activities.
  

Third Quarter 2021 Financial Results

• Ocugen’s cash, cash equivalents, and restricted cash totaled $107.5 million as of September 30, 2021, compared to $24.2 million as of December 31, 2020. Ocugen had 198.9 million shares of common stock outstanding as of September 30, 2021.
• Research and development expenses for the three months ended September 30, 2021 were $6.3 million compared to $1.5 million for the three months ended September 30, 2020. General and administrative expenses for the three months ended September 30, 2021 were $4.5 million compared to $1.7 million for the three months ended September 30, 2020. Ocugen reported a $0.05 net loss per share for the three months ended September 30, 2021 compared to a $0.07 net loss per share for the three months ended September 30, 2020, which includes the in-process research and development expense of $7.0 million related to the reduction of the carrying value of an asset that was previously recorded as held for sale.

Conference Call and Webcast Details

Ocugen has scheduled a conference call and webcast for 8:30 a.m. eastern time today to discuss the financial results and recent business highlights. Ocugen’s senior management team will host the call, which will be open to all listeners. There will also be a question-and-answer session following the prepared remarks.

The call can be accessed by dialing (844) 873-7330 (U.S.) or (602) 563-8473 (international) and providing the conference ID 8198297. To access a live audio webcast of the call on the “Investors” section of the Ocugen website, please click here. A replay of the webcast will be archived on Ocugen’s website for approximately 45 days following the call.

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.

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 with respect to our belief that COVAXIN™ has the potential to fulfill an unmet need in the national arsenal of COVID-19 vaccines, our plans to initiate the Phase 1/2 study for OCU400, if authorized to proceed, near the end of 2021, and our belief that the results from the Phase 3 study for COVAXIN™, if allowed to proceed, will help demonstrate that the Phase 3 data from the studies conducted by Bharat Biotech Bharat Biotech in India will be applicable to the U.S. population. 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, including whether the FDA will authorize COVAXIN™ for administration as a vaccine for pediatric uses against COVID-19 pursuant to the EUA we submitted with the FDA and the timing and scope of any such authorization, as well as 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 or IND submissions, as applicable; whether the FDA will accept our IND submissions without any changes, or if we are required to submit additional information to the FDA in support of our IND submissions, the extent and significance of any such changes; 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 for COVAXIN™; any additional CMC 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

(tables to follow)

OCUGEN, INC.

CONSOLIDATED BALANCE SHEETS

(in thousands)

(Unaudited)

OCUGEN, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except share and per share amounts)

(Unaudited)

 

Monday, November 08, 2021

Helius Medical Technologies (HSDT)(HSM:CA)
PoNS Market Authorization in Australia

Helius Medical Technologies is a neurotech company focused on neurological wellness. The Company’s purpose is to develop, license and acquire unique and non-invasive platform technologies that amplify the brain’s ability to heal itself. The Company’s first commercial product is the Portable Neuromodulation Stimulator (PoNSTM). For more information, visit www.heliusmedical.com.

Joe Gomes, Senior Research Analyst, Noble Capital Markets, Inc.

Gregory Aurand, Senior Research Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Australia Approval. Late last week, Helius announced it had received authorization from the Australian Therapeutic Goods Administration (TGA) for the sale of PoNS as a Class IIa (low-to-medium risk) medical device. Notably the authorization is for all indications, opening a much bigger market opportunity for the Company. In fact, the Australian market could be larger than the more populous Canadian market due to the Australian authorization.


Next Steps.  Helius is working with the TGA to finalize the exact scope of the authorization, which is expected to cover the use of PoNS to improve balance and gait when used as an adjunct to a therapeutic exercise program. Helius will begin evaluating the pathway toward commercialization in Australia once the scope of the authorization is finalized …

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary.  Proper due diligence is required before making any investment decision. 

Monday, November 08, 2021

Ocugen (OCGN)
Covaxin Pediatric Application Filed, Listed for Emergency Use

Ocugen Inc is a clinical stage biopharmaceutical company. It is focused on discovering, developing and commercializing a pipeline of innovative therapies that address rare and underserved eye diseases. Ocugen offers a diversified ophthalmology portfolio that includes novel gene therapies, biologics, and small molecules and targets a broad range of high-need retinal and ocular surface diseases.

Robert LeBoyer, Senior Research Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Emergency Pediatric Use Application Filed. Ocugen announced that it has filed an Emergency Pediatric Use application for Covaxin in children from age 2 to 18 year of age. The data for the application was from the Phase 2/3 study conducted by Bharat Biotech that included 529 children in its total enrollment of 25,800 patients. Separately, the World Health Organization (WHO) has issued an Emergency Use Listing for Covaxin.


WHO Listing Followed Clinical Data Assessment.  Covaxin was reviewed by the WHO’s Strategic Advisory Group of Experts on immunization (SAGE), the advisory group that makes WHO vaccination policy. SAGE evaluated the Phase 2 and Phase 3 clinical data for safety and efficacy. It determined that Covaxin meets WHO standards and endorsed its use for vaccination programs worldwide …

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary.  Proper due diligence is required before making any investment decision. 

Cocrystal Pharma’s SARS-CoV-2 Main Protease Inhibitors Demonstrate Pan-viral Activity against Human Common Coronaviruses, Noroviruses, Rhinoviruses, and Enteroviruses

 

BOTHELL, Wash., Nov. 08, 2021 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces that its SARS-CoV-2 main protease inhibitors showed potent in vitro pan-viral activity against human common coronaviruses, rhinoviruses, and respiratory enteroviruses that frequently cause the common cold, as well as against noroviruses that can cause symptoms of acute gastroenteritis. These protease inhibitors were discovered using the company’s proprietary structure-based drug discovery technology and are currently being advanced by Cocrystal toward clinical development to combat SARS-CoV-2 and its variants.

“It is exciting and compelling to see the pan-viral activity of our SARS-CoV-2 main protease inhibitors against these clinically important viruses that cause illness among millions of people worldwide each year,” said Sam Lee, Ph.D., Cocrystal’s President and interim co-CEO. “As we have observed the importance of repurposed broad-spectrum antiviral drugs during the COVID-19 pandemic, it is extremely important to design and rapidly develop new drug candidates as potent and safe pan-antivirals. This could be a gamechanger for antiviral drug discovery paradigms and treatments.

“Our current focus is on advancing these SARS-CoV-2 main protease inhibitors toward clinical development as a potential oral treatment for patients with COVID-19,” he added. “We now have additional opportunities with these same protease inhibitors for future programs that target other areas of high unmet medical need.”

About Human Common Coronaviruses
Common human coronaviruses, not to be confused with SARS-CoV-2, usually cause mild to moderate upper-respiratory tract illnesses, like the common cold. Most people become infected with one or more of these viruses at some point in their lives. In the U.S., people usually become infected with common human coronaviruses in the fall and winter although these people can become infected any time of the year. Young children are most likely to get infected and people can have multiple infections in their lifetime. For further information, please visit: https://www.cdc.gov/coronavirus/types.html

About Human Rhinoviruses and Respiratory Enteroviruses
Human rhinoviruses are responsible for more than one-half of cold-like illnesses and cost billions of dollars annually in direct medical care and missed days of work. Along with respiratory enteroviruses, rhinoviruses are the leading cause of upper respiratory tract infections and are among the most frequent infectious agents that affect humans worldwide. However, the lack of efficient antiviral treatments or vaccines against these highly prevalent and contagious pathogens prevents effective management of related diseases. For more information, please visit: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4728576/

About Human Noroviruses
Noroviruses are global public health problem and the leading cause of vomiting and diarrhea from acute gastroenteritis among people of all ages in the U.S. and a Noroviruses are notorious for their common occurrence in hospitals, nursing homes, childcare facilities, schools, and cruise ships. In the U.S. alone, the Centers for Diseases Control and Prevention (CDC) estimates that noroviruses to cause up to 21 million illnesses, contribute to more than 100,000 hospitalizations and 900 deaths, and are responsible for nearly 1 million pediatric medical care visits annually. For more information, please visit: https://www.cdc.gov/norovirus/trends-outbreaks/burden-US.html

About Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of coronaviruses (including SARS-CoV-2), influenza viruses, hepatitis C virus, and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the potential of the company’s main protease inhibitors as a COVID-19 oral treatment and the potential to treat other viruses. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks and uncertainties arising from the delays in furthering research due to the supply chain impact including manufacturing and research delays arising from raw material and test animal shortages and other supply chain disruptions, potential delays related to the FDA’s review of our submissions, receipt of regulatory approvals, the results of any future clinical trials, general risks arising from clinical trials, regulatory changes, and development of effective treatments and/or vaccines by competitors, including as part of the programs financed by the U.S. government. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2020. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Investor Contact:
LHA Investor Relations
Jody Cain
310-691-7100
jcain@lhai.com

Source: Cocrystal Pharma, Inc.

PDS Biotechnology Licenses Protein for the Treatment of Acute Myeloid Leukemia, Prostate and Breast Cancers from National Cancer Institute

 

Advances Next Phase of Versamune^® Oncology Pipeline

FLORHAM PARK, N.J., Nov. 08, 2021 (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 a licensing agreement with the National Cancer Institute (NCI) for intellectual property related to the NCI’s proprietary tumor-associated and immunologically active T-cell receptor gamma alternate reading frame protein (TARP).

Approximately 470,000 patients are diagnosed annually with TARP-associated cancers, including acute myeloid leukemia (AML), prostate, and breast cancer according to the National Cancer Institute. In preclinical studies performed by PDS Biotech, the administration of PDS0102, the Versamune^®-TARP tumor antigen combination, led to the induction of large numbers of tumor targeted killer T-cells. It is important to note, the TARP tumor antigen alone has already been studied at the NCI in men with prostate cancer and been shown to be safe, immunogenic, and associated with slowing tumor growth rates (NCT00972309).
  
“The highly promising proof-of-concept data presented earlier this year in the advanced HPV cancer trial solidifies our confidence in the Versamune^® technology to rapidly advance our pipeline into other types of debilitating cancers,” said Dr. Lauren V. Wood, PDS Biotech’s Chief Medical Officer. “We are excited about the potential of PDS0102, which leverages the Versamune^® platform to improve on the results reported in humans with the NCI’s TARP antigen alone.”

The worldwide, non-exclusive license secures rights for the proprietary TARP antigen from the NCI with patent protection through 2034.

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 breast, colon, lung, prostate and ovarian cancers.   To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

About PDS0102

PDS0102 combines the utility of the Versamune^® platform with the proprietary T-cell receptor gamma alternate reading frame protein (TARP), a tumor antigen identified by the National Cancer Institute (NCI) which is strongly associated with acute myeloid leukemia (AML), breast and prostate cancers. Approximately 470,000 patients are projected to be diagnosed with AML, prostate, or breast cancer this year, most of which are associated with TARP.

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.

Media & Investor Relations Contact:

Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: mailto:drandolph@pdsbiotech.com

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

PDS Biotechnology Licenses Protein for the Treatment of Acute Myeloid Leukemia, Prostate and Breast Cancers from National Cancer Institute

 

Advances Next Phase of Versamune^® Oncology Pipeline

FLORHAM PARK, N.J., Nov. 08, 2021 (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 a licensing agreement with the National Cancer Institute (NCI) for intellectual property related to the NCI’s proprietary tumor-associated and immunologically active T-cell receptor gamma alternate reading frame protein (TARP).

Approximately 470,000 patients are diagnosed annually with TARP-associated cancers, including acute myeloid leukemia (AML), prostate, and breast cancer according to the National Cancer Institute. In preclinical studies performed by PDS Biotech, the administration of PDS0102, the Versamune^®-TARP tumor antigen combination, led to the induction of large numbers of tumor targeted killer T-cells. It is important to note, the TARP tumor antigen alone has already been studied at the NCI in men with prostate cancer and been shown to be safe, immunogenic, and associated with slowing tumor growth rates (NCT00972309).
  
“The highly promising proof-of-concept data presented earlier this year in the advanced HPV cancer trial solidifies our confidence in the Versamune^® technology to rapidly advance our pipeline into other types of debilitating cancers,” said Dr. Lauren V. Wood, PDS Biotech’s Chief Medical Officer. “We are excited about the potential of PDS0102, which leverages the Versamune^® platform to improve on the results reported in humans with the NCI’s TARP antigen alone.”

The worldwide, non-exclusive license secures rights for the proprietary TARP antigen from the NCI with patent protection through 2034.

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 breast, colon, lung, prostate and ovarian cancers.   To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

About PDS0102

PDS0102 combines the utility of the Versamune^® platform with the proprietary T-cell receptor gamma alternate reading frame protein (TARP), a tumor antigen identified by the National Cancer Institute (NCI) which is strongly associated with acute myeloid leukemia (AML), breast and prostate cancers. Approximately 470,000 patients are projected to be diagnosed with AML, prostate, or breast cancer this year, most of which are associated with TARP.

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.

Media & Investor Relations Contact:

Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: mailto:drandolph@pdsbiotech.com

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

Cocrystal Pharma’s SARS-CoV-2 Main Protease Inhibitors Demonstrate Pan-viral Activity against Human Common Coronaviruses, Noroviruses, Rhinoviruses, and Enteroviruses

 

BOTHELL, Wash., Nov. 08, 2021 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces that its SARS-CoV-2 main protease inhibitors showed potent in vitro pan-viral activity against human common coronaviruses, rhinoviruses, and respiratory enteroviruses that frequently cause the common cold, as well as against noroviruses that can cause symptoms of acute gastroenteritis. These protease inhibitors were discovered using the company’s proprietary structure-based drug discovery technology and are currently being advanced by Cocrystal toward clinical development to combat SARS-CoV-2 and its variants.

“It is exciting and compelling to see the pan-viral activity of our SARS-CoV-2 main protease inhibitors against these clinically important viruses that cause illness among millions of people worldwide each year,” said Sam Lee, Ph.D., Cocrystal’s President and interim co-CEO. “As we have observed the importance of repurposed broad-spectrum antiviral drugs during the COVID-19 pandemic, it is extremely important to design and rapidly develop new drug candidates as potent and safe pan-antivirals. This could be a gamechanger for antiviral drug discovery paradigms and treatments.

“Our current focus is on advancing these SARS-CoV-2 main protease inhibitors toward clinical development as a potential oral treatment for patients with COVID-19,” he added. “We now have additional opportunities with these same protease inhibitors for future programs that target other areas of high unmet medical need.”

About Human Common Coronaviruses
Common human coronaviruses, not to be confused with SARS-CoV-2, usually cause mild to moderate upper-respiratory tract illnesses, like the common cold. Most people become infected with one or more of these viruses at some point in their lives. In the U.S., people usually become infected with common human coronaviruses in the fall and winter although these people can become infected any time of the year. Young children are most likely to get infected and people can have multiple infections in their lifetime. For further information, please visit: https://www.cdc.gov/coronavirus/types.html

About Human Rhinoviruses and Respiratory Enteroviruses
Human rhinoviruses are responsible for more than one-half of cold-like illnesses and cost billions of dollars annually in direct medical care and missed days of work. Along with respiratory enteroviruses, rhinoviruses are the leading cause of upper respiratory tract infections and are among the most frequent infectious agents that affect humans worldwide. However, the lack of efficient antiviral treatments or vaccines against these highly prevalent and contagious pathogens prevents effective management of related diseases. For more information, please visit: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4728576/

About Human Noroviruses
Noroviruses are global public health problem and the leading cause of vomiting and diarrhea from acute gastroenteritis among people of all ages in the U.S. and a Noroviruses are notorious for their common occurrence in hospitals, nursing homes, childcare facilities, schools, and cruise ships. In the U.S. alone, the Centers for Diseases Control and Prevention (CDC) estimates that noroviruses to cause up to 21 million illnesses, contribute to more than 100,000 hospitalizations and 900 deaths, and are responsible for nearly 1 million pediatric medical care visits annually. For more information, please visit: https://www.cdc.gov/norovirus/trends-outbreaks/burden-US.html

About Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of coronaviruses (including SARS-CoV-2), influenza viruses, hepatitis C virus, and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the potential of the company’s main protease inhibitors as a COVID-19 oral treatment and the potential to treat other viruses. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks and uncertainties arising from the delays in furthering research due to the supply chain impact including manufacturing and research delays arising from raw material and test animal shortages and other supply chain disruptions, potential delays related to the FDA’s review of our submissions, receipt of regulatory approvals, the results of any future clinical trials, general risks arising from clinical trials, regulatory changes, and development of effective treatments and/or vaccines by competitors, including as part of the programs financed by the U.S. government. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2020. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Investor Contact:
LHA Investor Relations
Jody Cain
310-691-7100
jcain@lhai.com

Source: Cocrystal Pharma, Inc.

Monday, November 08, 2021

Ocugen (OCGN)
Covaxin Pediatric Application Filed, Listed for Emergency Use

Ocugen Inc is a clinical stage biopharmaceutical company. It is focused on discovering, developing and commercializing a pipeline of innovative therapies that address rare and underserved eye diseases. Ocugen offers a diversified ophthalmology portfolio that includes novel gene therapies, biologics, and small molecules and targets a broad range of high-need retinal and ocular surface diseases.

Robert LeBoyer, Senior Research Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Emergency Pediatric Use Application Filed. Ocugen announced that it has filed an Emergency Pediatric Use application for Covaxin in children from age 2 to 18 year of age. The data for the application was from the Phase 2/3 study conducted by Bharat Biotech that included 529 children in its total enrollment of 25,800 patients. Separately, the World Health Organization (WHO) has issued an Emergency Use Listing for Covaxin.


WHO Listing Followed Clinical Data Assessment.  Covaxin was reviewed by the WHO’s Strategic Advisory Group of Experts on immunization (SAGE), the advisory group that makes WHO vaccination policy. SAGE evaluated the Phase 2 and Phase 3 clinical data for safety and efficacy. It determined that Covaxin meets WHO standards and endorsed its use for vaccination programs worldwide …

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary.  Proper due diligence is required before making any investment decision. 

Ocugen, Inc. Announces Submission of Emergency Use Authorization Request to the US FDA for Investigational COVID-19 Vaccine COVAXIN™ (BBV152) for Children Ages 2-18 Years

 

• COVAXIN™ (BBV152) was recently awarded Emergency Use Listing by the World Health Organization
  
• Pediatric EUA submission based on immuno-bridging clinical trial in children, ages 2-18, demonstrating comparable neutralizing antibody response as seen in a large adult Phase 3 clinical trial conducted in India
• COVAXIN™ (BBV152) uses same Vero Cell manufacturing platform as other childhood vaccines, including the inactivated polio vaccine
• COVAXIN™ (BBV152) elicited antibody titers against multiple antigens (S1, RBD, and N); and provided durable immunity against COVID-19 in Phase 3 adult trial in India
• No serious adverse events or hospitalizations were observed in Phase 2/3 pediatric study of COVAXIN™ (BBV152), including no events of special interest such as Guillain-Barre Syndrome, anaphylactic reactions, myocarditis, pericarditis, and vaccine-induced thrombotic thrombocytopenia.
  

MALVERN, Pa., Nov. 05, 2021 (GLOBE NEWSWIRE) —  Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing novel therapeutics and vaccines, announced today that it has submitted a request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of Ocugen’s COVID-19 vaccine candidate BBV152, known as COVAXIN™ outside of the U.S., for pediatric use. The vaccine candidate was developed by the company’s partner, Bharat Biotech, and was studied in an immuno-bridging clinical trial conducted in India with children 2-18 years of age.

COVAXIN™ (BBV152) is a whole-virion, inactivated vaccine, manufactured using a Vero Cell manufacturing platform, as has been used in the production of the inactivated polio vaccine for the past 35 years, as well as of other traditional childhood vaccines.

The submission is based on results of a Phase 2/3 pediatric clinical trial conducted by Bharat Biotech in India with 526 children 2-18 years of age, which bridged immunogenicity data to a large, Phase 3 safety and efficacy clinical trial in nearly 25,800 adults in India.

About the Data to Support the EUA
A Phase 2/3, open-label, multicenter study was conducted in India from May 2021 to July 2021, to evaluate the safety, reactogenicity and immunogenicity, of the whole-virion inactivated SARS-CoV-2 Vaccine (COVAXIN™ BBV152) in healthy volunteers 2-18 years of age.

COVAXIN™ (BBV152) was evaluated in three age groups: 2-6 years, 6-12 years and 12-18 years. All participants received two doses of the whole virion inactivated SARS-CoV-2 virus vaccine 28 days apart.

The neutralizing antibody responses against wild-type strain in the pediatric age group of 2-18 years were equivalent to those seen in adults, ages 18+ years, in Bharat Biotech’s large Phase 3 efficacy and safety trial. More than 90 percent of the seroconversion rates were observed for antibody titers against S1, RBD, N proteins and wild-type neutralizing antibodies. These results suggest similar protection in children, ages 2-18, to that demonstrated in adults older than 18 years.

Among the 526 study subjects in the pediatric clinical trial, no serious adverse effects, such as deaths, hospitalizations, myocarditis, pericarditis, Guillain-Barre syndrome, vaccine-induced thrombotic thrombocytopenia or anaphylactic reactions were reported in the study. These were also not observed in the surveillance data collected in India following the administration of over 59 million doses of COVAXIN™ (BBV152) in adults. All other adverse events were mild or moderate in nature and were generally resolved within 24 hours.

“Filing for Emergency Use Authorization in the U.S. for pediatric use is a significant step toward our hope to make our vaccine candidate available here and help combat the COVID-19 pandemic,” said Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and Co-Founder of Ocugen. “Our research suggests that people are seeking more choices when selecting a vaccine, especially for their children. Having a new type of vaccine available will enable people to discuss with their child’s physician the best approach for them to lower their child’s risk of contracting COVID-19. The inactivated virus platform has been used for decades in vaccines for the pediatric population and, if authorized, we hope to offer another vaccine option to protect children as young as 2 years.”

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™ is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform.

With more than 100 million doses having been administered to adults outside the U.S., COVAXIN™ 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™ to its list of vaccines authorized for emergency use. 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. For more information, please visit www.ocugen.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 with respect to our hope that COVAXIN™, if authorized under the EUA, would be available to children as young as two years of age. 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, including whether the FDA will authorize COVAXIN™ for administration as a vaccine for pediatric uses against COVID-19 pursuant to the EUA we submitted with the FDA and the timing and scope of any such authorization, as well as 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; 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
ken.inchausti@ocugen.com 

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

Ocugen, Inc. Announces Submission of Emergency Use Authorization Request to the US FDA for Investigational COVID-19 Vaccine COVAXIN™ (BBV152) for Children Ages 2-18 Years

 

• COVAXIN™ (BBV152) was recently awarded Emergency Use Listing by the World Health Organization
  
• Pediatric EUA submission based on immuno-bridging clinical trial in children, ages 2-18, demonstrating comparable neutralizing antibody response as seen in a large adult Phase 3 clinical trial conducted in India
• COVAXIN™ (BBV152) uses same Vero Cell manufacturing platform as other childhood vaccines, including the inactivated polio vaccine
• COVAXIN™ (BBV152) elicited antibody titers against multiple antigens (S1, RBD, and N); and provided durable immunity against COVID-19 in Phase 3 adult trial in India
• No serious adverse events or hospitalizations were observed in Phase 2/3 pediatric study of COVAXIN™ (BBV152), including no events of special interest such as Guillain-Barre Syndrome, anaphylactic reactions, myocarditis, pericarditis, and vaccine-induced thrombotic thrombocytopenia.
  

MALVERN, Pa., Nov. 05, 2021 (GLOBE NEWSWIRE) —  Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing novel therapeutics and vaccines, announced today that it has submitted a request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of Ocugen’s COVID-19 vaccine candidate BBV152, known as COVAXIN™ outside of the U.S., for pediatric use. The vaccine candidate was developed by the company’s partner, Bharat Biotech, and was studied in an immuno-bridging clinical trial conducted in India with children 2-18 years of age.

COVAXIN™ (BBV152) is a whole-virion, inactivated vaccine, manufactured using a Vero Cell manufacturing platform, as has been used in the production of the inactivated polio vaccine for the past 35 years, as well as of other traditional childhood vaccines.

The submission is based on results of a Phase 2/3 pediatric clinical trial conducted by Bharat Biotech in India with 526 children 2-18 years of age, which bridged immunogenicity data to a large, Phase 3 safety and efficacy clinical trial in nearly 25,800 adults in India.

About the Data to Support the EUA
A Phase 2/3, open-label, multicenter study was conducted in India from May 2021 to July 2021, to evaluate the safety, reactogenicity and immunogenicity, of the whole-virion inactivated SARS-CoV-2 Vaccine (COVAXIN™ BBV152) in healthy volunteers 2-18 years of age.

COVAXIN™ (BBV152) was evaluated in three age groups: 2-6 years, 6-12 years and 12-18 years. All participants received two doses of the whole virion inactivated SARS-CoV-2 virus vaccine 28 days apart.

The neutralizing antibody responses against wild-type strain in the pediatric age group of 2-18 years were equivalent to those seen in adults, ages 18+ years, in Bharat Biotech’s large Phase 3 efficacy and safety trial. More than 90 percent of the seroconversion rates were observed for antibody titers against S1, RBD, N proteins and wild-type neutralizing antibodies. These results suggest similar protection in children, ages 2-18, to that demonstrated in adults older than 18 years.

Among the 526 study subjects in the pediatric clinical trial, no serious adverse effects, such as deaths, hospitalizations, myocarditis, pericarditis, Guillain-Barre syndrome, vaccine-induced thrombotic thrombocytopenia or anaphylactic reactions were reported in the study. These were also not observed in the surveillance data collected in India following the administration of over 59 million doses of COVAXIN™ (BBV152) in adults. All other adverse events were mild or moderate in nature and were generally resolved within 24 hours.

“Filing for Emergency Use Authorization in the U.S. for pediatric use is a significant step toward our hope to make our vaccine candidate available here and help combat the COVID-19 pandemic,” said Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and Co-Founder of Ocugen. “Our research suggests that people are seeking more choices when selecting a vaccine, especially for their children. Having a new type of vaccine available will enable people to discuss with their child’s physician the best approach for them to lower their child’s risk of contracting COVID-19. The inactivated virus platform has been used for decades in vaccines for the pediatric population and, if authorized, we hope to offer another vaccine option to protect children as young as 2 years.”

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™ is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform.

With more than 100 million doses having been administered to adults outside the U.S., COVAXIN™ 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™ to its list of vaccines authorized for emergency use. 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. For more information, please visit www.ocugen.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 with respect to our hope that COVAXIN™, if authorized under the EUA, would be available to children as young as two years of age. 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, including whether the FDA will authorize COVAXIN™ for administration as a vaccine for pediatric uses against COVID-19 pursuant to the EUA we submitted with the FDA and the timing and scope of any such authorization, as well as 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; 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
ken.inchausti@ocugen.com 

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

Helius Medical Technologies, Inc. Receives PoNS® Market Authorization in Australia

 

NEWTOWN, Pa., Nov. 04, 2021 (GLOBE NEWSWIRE) — Helius Medical Technologies, Inc. (Nasdaq:HSDT) (Helius or the Company), a neurotech company focused on neurological wellness, today announced it received market authorization from the Australian Therapeutic Goods Administration (TGA) for the sale of PoNS as a Class IIa medical device. The Company’s representative in Australia is working with the TGA to finalize the exact scope of the authorization, which is expected to cover the use of PoNS to improve balance and gait when used as an adjunct to a therapeutic exercise program.

“We are thrilled that we will be able to introduce this groundbreaking therapy for patients in Australia needing to improve their balance and gait,” said Dane C. Andreeff, President and Chief Executive Officer of Helius. “This marks the third country in which PoNS is authorized and further validates the effectiveness of our innovative PoNS therapy. We will begin evaluating the pathway toward commercialization in Australia once the scope of the authorization is finalized.”

About Helius Medical Technologies, Inc.

Helius Medical Technologies is a leading neurotech company in the medical device field focused on neurologic deficits using non-implantable platform technologies that amplify the brain’s ability to compensate and promotes neuroplasticity, aiming to improve the lives of people needing to improve their balance and gait. The Company’s first commercial product is the Portable Neuromodulation Stimulator (PoNS^®). For more information, visit www.heliusmedical.com.

About the PoNS Device and PoNS Therapy

The Portable Neuromodulation Stimulator (PoNS) is an innovative non-surgical device, inclusive of a controller and mouthpiece, which delivers electrical stimulation to the surface of the tongue to improve balance and gait. The PoNS device is indicated for use in the United States as a short-term treatment of gait deficit due to mild-to-moderate symptoms from multiple sclerosis (“MS”) and is to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over by prescription only. It is authorized for sale in Canada for two indications: (i) PoNS is authorized for use as a short term treatment (14 weeks) of chronic balance deficit due to mild-to-moderate traumatic brain injury (“mmTBI”) and is to be used in conjunction with physical therapy; and (ii) PoNS is authorized for use as a short term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from MS and is to be used in conjunction with physical therapy.

Cautionary Disclaimer Statement

Certain statements in this news release are not based on historical facts and constitute forward-looking statements or forward-looking information within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Canadian securities laws. All statements other than statements of historical fact included in this news release are forward-looking statements that involve risks and uncertainties. Forward-looking statements are often identified by terms such as “believe,” “continue,” “expect,” “will,” “goal,” “aim to” and similar expressions. Such forward-looking statements include, among others, statements regarding finalizing the exact scope of approval in Australia and the Company’s plans to begin evaluating the pathway toward commercialization in Australia.

There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those expressed or implied by such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include uncertainties associated with the regulatory submission review and approval process, the clinical development process, the Company’s capital requirements to achieve its business objectives, availability of funds, the impact of the COVID-19 pandemic, manufacturing, labor shortage and supply chain risks, the Company’s ability to train physical therapists in the supervision of the use of the PoNS Treatment, the Company’s ability to secure contracts with rehabilitation clinics, the Company’s ability to build internal commercial infrastructure, build a commercial team and build relationships with Key Opinion Leaders, neurology experts and neurorehabilitation centers, market awareness of the PoNS device, future clinical trials, the product development process, other development activities, ongoing government regulation, and other risks detailed from time to time in the “Risk Factors” section of the Company’s filings with the United States Securities and Exchange Commission and the Canadian securities regulators, which can be obtained from either at www.sec.gov or www.sedar.com.

The reader is cautioned not to place undue reliance on any forward-looking statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company assumes no obligation to update any forward-looking statement or to update the reasons why actual results could differ from such statements except to the extent required by law.

Investor Relations Contact

Lisa M. Wilson, In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com

Immunotherapy to Treat Cancer May Involve Placing Cancer Cells in the Body

 

Anne
Trafton | MIT News Office

Immunotherapy is a promising strategy to treat cancer by stimulating the body’s own immune system to destroy tumor cells, but it only works for a handful of cancers. MIT researchers have now discovered a new way to jump-start the immune system to attack tumors, which they hope could allow immunotherapy to be used against more types of cancer.

Their novel approach involves removing tumor cells from the body, treating them with chemotherapy drugs, and then placing them back in the tumor. When delivered along with drugs that activate T cells, these injured cancer cells appear to act as a distress signal that spurs the T cells into action.

“When you create cells that have DNA damage but are not killed, under certain conditions those live, injured cells can send a signal that awakens the immune system,” says Michael Yaffe, who is a David H. Koch Professor of Science, the director of the MIT Center for Precision Cancer Medicine, and a member of MIT’s Koch Institute for Integrative Cancer Research.

In mouse studies, the researchers found that this treatment could completely eliminate tumors in nearly half of the mice.

Yaffe and Darrell Irvine, who is the Underwood-Prescott Professor with appointments in MIT’s departments of Biological Engineering and Materials Science and Engineering, and an associate director of the Koch Institute, are the senior authors of the study, which appears today in Science Signaling. MIT postdoc Ganapathy Sriram and Lauren Milling PhD ’21 are the lead authors of the paper.

T Cell Activation

One class of drugs currently used for cancer immunotherapy is checkpoint blockade inhibitors, which take the brakes off of T cells that have become “exhausted” and unable to attack tumors. These drugs have shown success in treating a few types of cancer but do not work against many others.

Yaffe and his colleagues set out to try to improve the performance of these drugs by combining them with cytotoxic chemotherapy drugs, in hopes that the chemotherapy could help stimulate the immune system to kill tumor cells. This approach is based on a phenomenon known as immunogenic cell death, in which dead or dying tumor cells send signals that attract the immune system’s attention.

Several clinical trials combining chemotherapy and immunotherapy drugs are underway, but little is known so far about the best way to combine these two types of treatment.

The MIT team began by treating cancer cells with several different chemotherapy drugs, at different doses. Twenty-four hours after the treatment, the researchers added dendritic cells to each dish, followed 24 hours later by T cells. Then, they measured how well the T cells were able to kill the cancer cells. To their surprise, they found that most of the chemotherapy drugs didn’t help very much. And those that did help appeared to work best at low doses that didn’t kill many cells.

The researchers later realized why this was so: It wasn’t dead tumor cells that were stimulating the immune system; instead, the critical factor was cells that were injured by chemotherapy but still alive.

“This describes a new concept of immunogenic cell injury rather than immunogenic cell death for cancer treatment,” Yaffe says. “We showed that if you treated tumor cells in a dish, when you injected them back directly into the tumor and gave checkpoint blockade inhibitors, the live, injured cells were the ones that reawaken the immune system.”

The drugs that appear to work best with this approach are drugs that cause DNA damage. The researchers found that when DNA damage occurs in tumor cells, it activates cellular pathways that respond to stress. These pathways send out distress signals that provoke T cells to leap into action and destroy not only those injured cells but any tumor cells nearby.

“Our findings fit perfectly with the concept that ‘danger signals’ within cells can talk to the immune system, a theory pioneered by Polly Matzinger at NIH in the 1990s, though still not universally accepted,” Yaffe says.  

Tumor Elimination

In studies of mice with melanoma and breast tumors, the researchers showed that this treatment eliminated tumors completely in 40 percent of the mice. Furthermore, when the researchers injected cancer cells into these same mice several months later, their T cells recognized them and destroyed them before they could form new tumors.

The researchers also tried injecting DNA-damaging drugs directly into the tumors, instead of treating cells outside the body, but they found this was not effective because the chemotherapy drugs also harmed T cells and other immune cells near the tumor. Also, injecting the injured cells without checkpoint blockade inhibitors had little effect.

“You have to present something that can act as an immunostimulant, but then you also have to release the preexisting block on the immune cells,” Yaffe says.

Yaffe hopes to test this approach in patients whose tumors have not responded to immunotherapy, but more study is needed first to determine which drugs, and at which doses, would be most beneficial for different types of tumors. The researchers are also further investigating the details of exactly how the injured tumor cells stimulate such a strong T cell response.

Suggested Reading:

Measuring Cancer Cells to Tailor Treatments

Stem Cells Role in the Anti-Aging Business

Therapeutic Research Advanced by Stem Cell Science

Biologists Identify New Targets for Cancer Vaccines

 

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