Avivagen CEO Kym Anthony makes a formal corporate presentation. Afterwards, he is joined by Noble Capital Markets Senior Research Analyst Joe Gomes for a Q & A session featuring questions asked by the live audience throughout the event. Research, News, and Advanced Market Data on VIVXF Information on upcoming live virtual roadshows About Avivagen Avivagen is a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications that, by safely supporting immune function, promote general health and performance. It is a public corporation traded on the TSX Venture Exchange under the symbol VIV and is headquartered in Ottawa, Canada, based in partnership facilities of the National Research Council of Canada. For more information, visit www.avivagen.com. The contents of the website are expressly not incorporated by reference in this press release.

How to Train the Body’s Own Cells to Combat Antibiotic Resistance

 

Drug-resistant superbugs have threatened human health for decades. The situation is getting worse because of the shortage of new antibiotics. But what if we changed the way we aim to treat them, and trained our cells to kill these invaders instead of relying on antibiotics to do the dirty work? This new strategy, called host-targeted defense, could help to solve antibiotic resistance problem.

Antibiotic resistance is a growing concern for global health. A recent report commissioned by the British government shows that every year globally around 700,000 people died due to infections caused by drug-resistant bacteria. The report also warned that, without action, the death toll could rise to 10 million globally and cost US$80 trillion to the global economy.

Drug resistance is a serious problem in the United States too. More than 23,000 people die every year due to multidrug-resistant pathogens and cost the country around $55 billion per year. The main culprits threatening the U.S. are methicillin-resistant Staphylococcus aureus (MRSA), carbapenem-resistant Enterobacteriaceae (CRE) and Clostridium difficile.

The CDC estimates that antibiotic-resistant pathogens cause more than 23,000 deaths annually in the United States. Source: Centers for Disease Control and Prevention. CDC webpage

The shortage of new antibacterial drugs in development to tackle the growing threat is a disturbing trend. A pathogen that is resistant to a drug reserved to treat infections when all others have failed is a particular concern. This is the case with carbapenem-resistant pathogen.

The decline in antibacterial drugs coupled with emergence of drug-resistant pathogens demands alternative approaches.

 

This article was republished with permission from The Conversation, a news site dedicated to sharing ideas from academic experts. It represents the research-based findings and opinions of Zahidul Alam, Postdoctoral Fellow, University of Pennsylvania

 

In Malay Haldar’s lab, along with other projects, my colleagues and I are studying how factors in an animal host play a role in response to infections. To test the approach, we are doing this work using a mouse model of infections. Our aim is to find novel traits or factors of the host that can be targeted to boost an individual’s immune response high enough to kill the offending microbes. The host factor we are investigating is called Spi-C, a gene found in every cell of the human body.

Targeting Host Factors

My interest in host factors arose during my graduate studies. While working on my Ph.D. research project, I learned that host factors, a variety of traits intrinsic to humans, play a significant role in bacterial infections. This inspired me to investigate how the host’s immune system fights bacteria.

New insights into the host’s defense against pathogens have led researchers to explore a new strategy called host-directed therapy (HDT), a relatively recent idea that has only been around for about a decade.

The goal of HDT is to enhance and amplify the host’s immune response to kill pathogens, rather than relying exclusively on antibacterial drugs. By targeting host factors as well as delivering antibiotic treatment, HDTs deliver a double whammy.

 

Virtual Roadshow with Avivagen CEO Kym Anthony This Virtual Road Show Replay features a formal corporate presentation from Avivagen CEO Kym Anthony. Afterwards, he is joined by Noble Capital Markets Senior Research Analyst Joe Gomes for a Q & A session featuring questions asked by the live audience throughout the event. Watch the replay, and get Noble’s research on VIVXF, as well as news and advanced market data at the link below. View All Upcoming Road Shows

 

The body naturally responds to infections with inflammation, a process in which specific populations of immune cells attack and kill the invading bacteria by either eating them or zapping them with protein weapons. However, uncontrolled inflammation triggers the production of proteins that can cause multi-organ failure and can even kill the host. Therefore, controlling inflammation is crucial to combat pathogens as well as to protect the body from hyperinflammation.

HDTs include a suite of treatments that boost the host response to pathogens and also protect the host from exaggerated immune response. HDTs include cellular therapy, in which a specific population of bone marrow cells are injected into the host body to prevent excessive immune response and tissue injury. Another HDT involves commonly used drugs for noninfectious diseases. Statins and ibuprofen, for example, calm the host response to infections. Biologics, the complex molecule drugs produced by recombinant DNA technology, do this too by neutralizing small-sized proteins and reducing tissue damage. Nutritional products, such as vitamin D3, have also been shown to cause a host’s immune cells to release antibacterial substances that enhance pathogen killing.

HDTs in conjunction to antibacterial drugs show great promise in treating various multidrug-resistant pathogens, notably against Mycobacterium tuberculosis, the pathogen which causes tuberculosis, one of the top 10 causes of death worldwide.

 

Personalizing Treatments for Infections

In the last decade, researchers have made much progress in host factor research, leading to new therapeutic strategies.

One of them is personalized medicine, in which a genomic blueprint can determine an individual’s unique susceptibilities to diseases and choose appropriate therapies.

This concept is applied in noninfectious diseases like cancer. However, the application of the concept in infectious disease is very recent. Nonetheless, personalized medicine leads us to speculate why some individuals are more prone to infections than others. My colleagues and I believe that such differences may be caused by subtle differences in the DNA of the host factor genes. By connecting these differences, called polymorphisms, to the level of individuals’ vulnerability to infections, we hope that our research will contribute to the precision medicine of bacterial infections.

Our Quest for a Novel Host Factor

My colleagues in the Haldar lab and I are exploring the role of Spi-C in bacterial infection. Spi-C is essential for the development of a specific type of population of cells in the spleen that regulate the iron  storage in the body. Iron is essential for transporting oxygen in red blood cells.

But, during infections, bacteria also require iron. They need it for growth, and they compete with the host to get it. Hence, if we could alter the activity of the Spi-C gene, we might be able to deprive bacteria of this vital nutrient and thus stop the infections without harming the host.

In a recent paper, we summarized the effect of iron in host cells and its interactions with host factors in the presence or absence of infections.

In mice, we tested the role of host factor, Spi-C, as a way to defend the host. In this study we injected a chemical that is a component of the bacteria into the mice. We wanted to trigger changes that occur in the animal during a real bacterial infection.

Our preliminary results showed that the host factor is active in various organs of the mice treated with the chemical. We believe this activation plays a role in host-defense. And, indeed, we found that losing Spi-C activity increased the release of small-sized proteins that facilitate the host defense against pathogens compared to the cells that have normal Spi-C activity. We believe this change in small-sized proteins might protect the host from hyperinflammation in response to infection.

We believe that shifting of our thinking from pathogen-targeted therapy to host-directed therapy ushers in a new avenue of precision medicine, which could help to end the drug resistance crisis.

 

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PDS Biotechnology Announces Conference Call and Webcast to Present Second Quarter 2021 Financial Results

 

FLORHAM PARK, N.J., July 28, 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, announced today that its management team will present at several investor conferences listed below during the third quarter of 2021. 

At the recent American Society of Clinical Oncology (ASCO) 2021 Annual Meeting, interim data was presented in an oral session on PDS Biotech’s lead asset, PDS0101, in combination with two investigational immune-modulating agents being studied in two groups of advanced cancer patients. In the first group of patients who had failed treatment with chemotherapy and radiation, tumor reduction (objective response) was seen in 83% (5 of 6) of patients. In the second group, patients who in addition had failed treatment with checkpoint inhibitors, tumor reduction was seen in 58% (7 of 12) patients.

PDS0101 (Versamune^®-HPV16) is an investigational immunotherapy candidate designed to treat cancers caused by infection with HPV16 (HPV16-positive cancers) by activating the immune system to produce in vivo CD8+ (killer) T-cells to target and kill tumors that are HPV16-positive. Analyses of immune responses and other immune correlates are ongoing. 

The upcoming investor conferences will offer leadership the opportunity to provide an update on both ongoing PDS0101 Phase 2 clinical trials, as well as preparations to move two other investigational compounds PDS0102 (Versamune^®-TARP) and PDS0103 (Versamune^®-MUC1) into human testing. The conference details are as follows:

BTIG Investor Conference
Date: Tuesday, August 10, 2021

HC Wainwright 23^rd Annual Global Investment Conference
Date: Tuesday, September 14, 2021

Cantor Healthcare Conference
Date: Monday, September 27, 2021

AGP Fall Virtual Biotech & Specialty Pharma Conference
Date: Wednesday, October 13, 2021

A separate press release will be issued once presentation times become available. 

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 PDS0101

PDS Biotech’s lead candidate, PDS0101, combines the utility of the Versamune^® platform with targeted antigens in HPV-expressing cancers. In partnership with Merck & Co., PDS Biotech is evaluating a combination of PDS0101 and KEYTRUDA® in a Phase 2 study in first-line treatment of recurrent or metastatic head and neck cancer. PDS Biotech is also conducting two additional Phase 2 studies in advanced HPV-associated cancers and advanced localized cervical cancer with the National Cancer Institute (NCI) and The University of Texas MD Anderson Cancer Center, respectively.

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 Contacts

Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: [email protected]

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: [email protected]

PDS Biotechnology Announces Conference Call and Webcast to Present Second Quarter 2021 Financial Results

 

FLORHAM PARK, N.J., July 28, 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, announced today that its management team will present at several investor conferences listed below during the third quarter of 2021. 

At the recent American Society of Clinical Oncology (ASCO) 2021 Annual Meeting, interim data was presented in an oral session on PDS Biotech’s lead asset, PDS0101, in combination with two investigational immune-modulating agents being studied in two groups of advanced cancer patients. In the first group of patients who had failed treatment with chemotherapy and radiation, tumor reduction (objective response) was seen in 83% (5 of 6) of patients. In the second group, patients who in addition had failed treatment with checkpoint inhibitors, tumor reduction was seen in 58% (7 of 12) patients.

PDS0101 (Versamune^®-HPV16) is an investigational immunotherapy candidate designed to treat cancers caused by infection with HPV16 (HPV16-positive cancers) by activating the immune system to produce in vivo CD8+ (killer) T-cells to target and kill tumors that are HPV16-positive. Analyses of immune responses and other immune correlates are ongoing. 

The upcoming investor conferences will offer leadership the opportunity to provide an update on both ongoing PDS0101 Phase 2 clinical trials, as well as preparations to move two other investigational compounds PDS0102 (Versamune^®-TARP) and PDS0103 (Versamune^®-MUC1) into human testing. The conference details are as follows:

BTIG Investor Conference
Date: Tuesday, August 10, 2021

HC Wainwright 23^rd Annual Global Investment Conference
Date: Tuesday, September 14, 2021

Cantor Healthcare Conference
Date: Monday, September 27, 2021

AGP Fall Virtual Biotech & Specialty Pharma Conference
Date: Wednesday, October 13, 2021

A separate press release will be issued once presentation times become available. 

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 PDS0101

PDS Biotech’s lead candidate, PDS0101, combines the utility of the Versamune^® platform with targeted antigens in HPV-expressing cancers. In partnership with Merck & Co., PDS Biotech is evaluating a combination of PDS0101 and KEYTRUDA® in a Phase 2 study in first-line treatment of recurrent or metastatic head and neck cancer. PDS Biotech is also conducting two additional Phase 2 studies in advanced HPV-associated cancers and advanced localized cervical cancer with the National Cancer Institute (NCI) and The University of Texas MD Anderson Cancer Center, respectively.

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 Contacts

Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: [email protected]

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: [email protected]

electroCore Announces Issuance of New Patent for Migraine Treatment using Smartphones

 

ROCKAWAY, NJ, July 27, 2021 (GLOBE NEWSWIRE) —  
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced that the United States Patent and Trademark Office (USPTO) has issued 
U.S. Patent No. 11,065,444 to electroCore, relating to the use of a mobile phone for stimulating the trigeminal nerve to treat disorders.

The newly issued patent includes descriptions of devices and methods that allow a patient to self-treat a medical condition, such as migraine headache, by non-invasive electrical stimulation of nerves of the head, particularly supraorbital, supratrochlear, infraorbital, and mental nerves in the vicinity of their foramen or notch. The system comprises a handheld mobile device, such as a smartphone, that is applied to the surface of the patient’s head. One or more electrodes apply electrical impulses through the patient’s skin modulating a targeted nerve to treat the medical condition. The system is designed to address problems that arise particularly during self-treatment, when a medical professional is not present.

This newly allowed patent is owned by electroCore and is the latest 
U.S. patent to issue in connection with the company’s non-invasive development program for pain.

“We are pleased with the continued advancement of electroCore’s non-invasive approaches to treating patients,” commented JP Errico, a founder, board member and investor of electroCore, who was also an inventor of the new patent. “These new developments expand the breadth and ease of use by which electroCore’s therapy may be deployed, enabling even more patients worldwide to receive much needed relief at home.”

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 and the acute treatment of migraine and episodic cluster headache.

For more information, visit www.electrocore.com.

About gammaCoreTM
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:

• 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; its pipeline or potential markets for its technologies; the timing, outcome and impact of regulatory, clinical and commercial developments; the availability and impact of payer coverage, 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 CockrellCG Capital
404-736-3838
[email protected]

or

Media Contact:
Jackie Dorsky
electroCore
908-313-6331
[email protected]

electroCore Announces Issuance of New Patent for Migraine Treatment using Smartphones

 

ROCKAWAY, NJ, July 27, 2021 (GLOBE NEWSWIRE) —  
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced that the United States Patent and Trademark Office (USPTO) has issued 
U.S. Patent No. 11,065,444 to electroCore, relating to the use of a mobile phone for stimulating the trigeminal nerve to treat disorders.

The newly issued patent includes descriptions of devices and methods that allow a patient to self-treat a medical condition, such as migraine headache, by non-invasive electrical stimulation of nerves of the head, particularly supraorbital, supratrochlear, infraorbital, and mental nerves in the vicinity of their foramen or notch. The system comprises a handheld mobile device, such as a smartphone, that is applied to the surface of the patient’s head. One or more electrodes apply electrical impulses through the patient’s skin modulating a targeted nerve to treat the medical condition. The system is designed to address problems that arise particularly during self-treatment, when a medical professional is not present.

This newly allowed patent is owned by electroCore and is the latest 
U.S. patent to issue in connection with the company’s non-invasive development program for pain.

“We are pleased with the continued advancement of electroCore’s non-invasive approaches to treating patients,” commented JP Errico, a founder, board member and investor of electroCore, who was also an inventor of the new patent. “These new developments expand the breadth and ease of use by which electroCore’s therapy may be deployed, enabling even more patients worldwide to receive much needed relief at home.”

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 and the acute treatment of migraine and episodic cluster headache.

For more information, visit www.electrocore.com.

About gammaCoreTM
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:

• 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; its pipeline or potential markets for its technologies; the timing, outcome and impact of regulatory, clinical and commercial developments; the availability and impact of payer coverage, 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 CockrellCG Capital
404-736-3838
[email protected]

or

Media Contact:
Jackie Dorsky
electroCore
908-313-6331
[email protected]

PDS Biotechnology Announces Conference Call and Webcast to Present Second Quarter 2021 Financial Results

 

FLORHAM PARK, N.J., July 26, 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, will release financial results for the second quarter of 2021 on Thursday, August 12, 2021, before the market opens. Following the release, management will host a conference call to review the company’s financial results and provide a business update.

The conference call is scheduled to begin at 8:00 am ET on Thursday, August 12, 2021. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and mention PDS Biotechnology. A live webcast of the conference call will also be available on the investor relations page of the Company’s corporate website at www.pdsbiotech.com.

After the live webcast, the event will be archived on PDS Biotech’s website for 6 months. In addition, a telephonic replay of the call will be available for 6 months. The replay can be accessed by dialing 877-660-6853 (United States) or 201-612-7415 (International) with confirmation code 13721612.

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 capable of targeting and killing tumors. Our immuno-oncology product candidates are initially being studied in combination therapy to potentially enhance efficacy without compounding toxicity across a range of cancer types. The company’s lead investigational cancer immunotherapy product PDS0101 is currently in three (3) Phase 2 clinical studies in HPV-associated cancers. Interim data for the company’s most advanced Phase 2 trial was reported in an oral presentation at the recent American Society of Clinical Oncology (ASCO) on June 7, 2021. The interim results demonstrated strong efficacy in treating the cancer in patients with advanced, treatment-resistant HPV16-positive anal, cervical, head and neck, vaginal and vulvar cancers. 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.

CONTACT: Media & Investor Relations Contact:
Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: [email protected]

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: [email protected]

Monday, July 26, 2021

Ocugen (OCGN)
Initiating Coverage Based on Covaxin and Novel Gene Therapy Platform

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.

Ocugen is developing products from two technology platforms.  The company has in-licensed Covaxin, a whole-virion vaccine for COVID-19 that has advantages over the the current vaccines in use today. Its gene therapy programs are based on delivering “master control” genes that regulate other genes that function in downstream pathways of disease.


Covaxin Has Advantages Over Current Vaccines Covaxin uses a whole-virus technology that stimulates immunity to many regions of the virus.  Its clinical trials included over 25,800 patients in Phase 3, with data for patients from ages 12 to 91. The clinical trial data shown efficacy against several new variant strains, included the Delta strain that associated with recent breakthrough cases …

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. 

PDS Biotechnology Announces Conference Call and Webcast to Present Second Quarter 2021 Financial Results

 

FLORHAM PARK, N.J., July 26, 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, will release financial results for the second quarter of 2021 on Thursday, August 12, 2021, before the market opens. Following the release, management will host a conference call to review the company’s financial results and provide a business update.

The conference call is scheduled to begin at 8:00 am ET on Thursday, August 12, 2021. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and mention PDS Biotechnology. A live webcast of the conference call will also be available on the investor relations page of the Company’s corporate website at www.pdsbiotech.com.

After the live webcast, the event will be archived on PDS Biotech’s website for 6 months. In addition, a telephonic replay of the call will be available for 6 months. The replay can be accessed by dialing 877-660-6853 (United States) or 201-612-7415 (International) with confirmation code 13721612.

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 capable of targeting and killing tumors. Our immuno-oncology product candidates are initially being studied in combination therapy to potentially enhance efficacy without compounding toxicity across a range of cancer types. The company’s lead investigational cancer immunotherapy product PDS0101 is currently in three (3) Phase 2 clinical studies in HPV-associated cancers. Interim data for the company’s most advanced Phase 2 trial was reported in an oral presentation at the recent American Society of Clinical Oncology (ASCO) on June 7, 2021. The interim results demonstrated strong efficacy in treating the cancer in patients with advanced, treatment-resistant HPV16-positive anal, cervical, head and neck, vaginal and vulvar cancers. 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.

CONTACT: Media & Investor Relations Contact:
Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: [email protected]

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: [email protected]

Avivagen Announces Strategic Changes to Support Growth in Asia and South America

 

• Addition of Mr. Lesley Nernberg brings technical sales and marketing expertise to Asia expansion efforts
• Termination of distribution agreement with São Paulo-based Look Chemicals creates opportunity for accelerated adoption of OxC-betaTM Livestock in Brazil

Ottawa, ON /Business Wire/ July 22, 2021/ Avivagen Inc. (TSXV:VIV, OTCQB:VIVXF) (“Avivagen”), a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications that safely enhances feed intake and supports immune function, thereby supporting general health and performance, has announced new strategic measures to support continued growth in Asia and Brazil.

Avivagen has retained the services of Mr. Lesley Nernberg as a technical sales and marketing consultant, focused on accelerating the adoption of OxC-betaTM Livestock in Asia. He has held important technical sales and operation management positions with multiple well-known multinational animal nutrition companies such as ADM, Diamond V and Biomin, with a focus on marketing feed additives and complete feed across Asia. Based in Thailand, Mr. Nernberg holds a graduate degree in animal science and nutrition from the University of Manitoba and has established himself as an expert in the livestock feed additive industry in Asia over the past nine years. In particular, Mr. Nernberg will focus primarily on Vietnam, Indonesia and South Korea.

Avivagen also today announced the termination of its Brazilian OxC-betaTM Livestock distribution agreement with São Paulo-based Look Chemicals Importacao E Exportacao LTDA. Advanced discussions with potential new distribution partners are currently underway in order to support the company’s growth ambitions in the world’s third-largest feed production market.

“We have experienced considerable success in a number of Asian markets to date, and the addition of an accomplished, respected and connected expert like Mr. Nernberg will help us further establish OxC-betaTM as a leading health-promoting option for producers throughout the region,” says Kym Anthony, CEO of Avivagen Inc. “We’re also very excited about the potential for new agreements to support our continued and accelerated growth in Brazil. We thank Look Chemicals for their support during our entry into this important production market.”

About OxC-beta™ Technology and OxC-beta™ Livestock
Avivagen’s OxC-beta™ technology is derived from Avivagen discoveries about ?-carotene and other carotenoids, compounds that give certain fruits and vegetables their bright colours. Through support of immune function, the technology provides a non-antibiotic means of promoting health and growth. OxC-beta™ Livestock is a proprietary product shown to be an effective and economic alternative to the antibiotics commonly added to livestock feeds. The product is currently available for sale in the United States, Philippines, Mexico, Taiwan, New Zealand, Thailand, Brazil, Australia and Malaysia.

Avivagen’s OxC-beta™ Livestock product is safe, effective and could fulfill the global mandate to remove all in-feed antibiotics as growth promoters. Numerous international livestock trials with poultry and swine using OxC-beta™ Livestock have proven that the product performs as well as, and, sometimes, in some aspects, better than in-feed antibiotics.

About Avivagen
Avivagen is a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications that, by safely supporting immune function, promote general health and performance. It is a public corporation traded on the TSX Venture Exchange under the symbol VIV and is headquartered in Ottawa, Canada, based in partnership facilities of the National Research Council of Canada. For more information, visit www.avivagen.com. The contents of the website are expressly not incorporated by reference in this press release.

Forward Looking Statements
This news release includes certain forward-looking statements that are based upon the current expectations of management. Forward-looking statements involve risks and uncertainties associated with the business of Avivagen Inc. and the environment in which the business operates. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking, including those identified by the expressions “aim”, “anticipate”, “appear”, “believe”, “consider”, “could”, “estimate”, “expect”, “if”, “intend”, “goal”, “hope”, “likely”, “may”, “plan”, “possibly”, “potentially”, “pursue”, “seem”, “should”, “whether”, “will”, “would” and similar expressions.

Statements set out in this news release relating to discussions with potential new distribution partners in Brazil, new agreements that might arise from such discussions and the possibility for continued and accelerated growth in Brazil as well as the possibility for OxC-beta™ Livestock to replace antibiotics in livestock feeds as growth promoters are forward-looking statements. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results or events to differ materially from current expectations. For instance, discussions with potential new distribution partners may not result in an agreement, any new agreement with a distribution partner in Brazil may not result in growth for Avivagen in Brazil, Avivagen’s products may not gain market acceptance or regulatory approval in new jurisdictions or for new applications and may not be widely accepted as a replacement for antibiotics as growth promoters in livestock feeds due to many factors, many of which are outside of Avivagen’s control. Readers are referred to the risk factors associated with the business of Avivagen set out in Avivagen’s most recent management’s discussion and analysis of financial condition available at www.SEDAR.com. Except as required by law, Avivagen assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those reflected in the forward-looking statements.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

For more information:
Avivagen Inc.
Drew Basek
Director of Investor Relations
100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6 Phone: 416-540-0733
E-mail: [email protected]

Kym Anthony
Chief Executive Officer
100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6 Head Office Phone: 613-949-8164
Website: www.avivagen.com
Copyright © 2021 Avivagen Inc. OxC-beta™ is a trademark of Avivagen Inc.

Thursday, July 22, 2021

Item 9 Labs Corp (INLB)
Pairing Award Winning Brands and an Asset Light Franchising Model to Cannabis

Item 9 Labs Corp. (OTCQX: INLB) is a vertically integrated cannabis operator and dispensary franchisor delivering premium products from its large-scale cultivation and production facilities in the United States. The award-winning Item 9 Labs brand specializes in best-in-class products and user experience across several cannabis categories. The company also offers a unique dispensary franchise model through the national Unity Rd. retail brand. Easing barriers to entry, the franchise provides an opportunity for both new and existing dispensary owners to leverage the knowledge, resources, and ongoing support needed to thrive in their state compliantly and successfully. Item 9 Labs brings the best industry practices to markets nationwide through distinctive retail experience, cultivation capabilities, and product innovation. The veteran management team combines a diverse skill set with deep experience in the cannabis sector, franchising, and the capital markets to lead a new generation of public cannabis companies that provide transparency, consistency, and well-being. Headquartered in Arizona, the company is currently expanding its operations space by 650,000+ square feet on its 50-acre site, one of the largest properties in Arizona zoned to grow and cultivate flower. For additional information, visit item9labscorp.com.

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

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

Initiating Coverage. We are initiating research coverage on Item 9 Labs Corp. Item 9 is combining a traditional cannabis cultivation operation with an asset light franchise dispensary model to expand across the nation. We believe the combination creates a differentiated business model that offers premium products and distribution through an expanding network of dispensary franchises.


Unity Road.  The March acquisition of ONE Cannabis Group and its Unity Rd. cannabis dispensary franchise business enables Item 9 to provide solutions to cannabis industry challenges commonly faced by existing business owners, prospective entrepreneurs, and consumers. The Company recently opened the first franchised location in Colorado and is working with 15 other groups to open an additional …

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. 

Avivagen Announces Strategic Changes to Support Growth in Asia and South America

 

• Addition of Mr. Lesley Nernberg brings technical sales and marketing expertise to Asia expansion efforts
• Termination of distribution agreement with São Paulo-based Look Chemicals creates opportunity for accelerated adoption of OxC-betaTM Livestock in Brazil

Ottawa, ON /Business Wire/ July 22, 2021/ Avivagen Inc. (TSXV:VIV, OTCQB:VIVXF) (“Avivagen”), a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications that safely enhances feed intake and supports immune function, thereby supporting general health and performance, has announced new strategic measures to support continued growth in Asia and Brazil.

Avivagen has retained the services of Mr. Lesley Nernberg as a technical sales and marketing consultant, focused on accelerating the adoption of OxC-betaTM Livestock in Asia. He has held important technical sales and operation management positions with multiple well-known multinational animal nutrition companies such as ADM, Diamond V and Biomin, with a focus on marketing feed additives and complete feed across Asia. Based in Thailand, Mr. Nernberg holds a graduate degree in animal science and nutrition from the University of Manitoba and has established himself as an expert in the livestock feed additive industry in Asia over the past nine years. In particular, Mr. Nernberg will focus primarily on Vietnam, Indonesia and South Korea.

Avivagen also today announced the termination of its Brazilian OxC-betaTM Livestock distribution agreement with São Paulo-based Look Chemicals Importacao E Exportacao LTDA. Advanced discussions with potential new distribution partners are currently underway in order to support the company’s growth ambitions in the world’s third-largest feed production market.

“We have experienced considerable success in a number of Asian markets to date, and the addition of an accomplished, respected and connected expert like Mr. Nernberg will help us further establish OxC-betaTM as a leading health-promoting option for producers throughout the region,” says Kym Anthony, CEO of Avivagen Inc. “We’re also very excited about the potential for new agreements to support our continued and accelerated growth in Brazil. We thank Look Chemicals for their support during our entry into this important production market.”

About OxC-beta™ Technology and OxC-beta™ Livestock
Avivagen’s OxC-beta™ technology is derived from Avivagen discoveries about ?-carotene and other carotenoids, compounds that give certain fruits and vegetables their bright colours. Through support of immune function, the technology provides a non-antibiotic means of promoting health and growth. OxC-beta™ Livestock is a proprietary product shown to be an effective and economic alternative to the antibiotics commonly added to livestock feeds. The product is currently available for sale in the United States, Philippines, Mexico, Taiwan, New Zealand, Thailand, Brazil, Australia and Malaysia.

Avivagen’s OxC-beta™ Livestock product is safe, effective and could fulfill the global mandate to remove all in-feed antibiotics as growth promoters. Numerous international livestock trials with poultry and swine using OxC-beta™ Livestock have proven that the product performs as well as, and, sometimes, in some aspects, better than in-feed antibiotics.

About Avivagen
Avivagen is a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications that, by safely supporting immune function, promote general health and performance. It is a public corporation traded on the TSX Venture Exchange under the symbol VIV and is headquartered in Ottawa, Canada, based in partnership facilities of the National Research Council of Canada. For more information, visit www.avivagen.com. The contents of the website are expressly not incorporated by reference in this press release.

Forward Looking Statements
This news release includes certain forward-looking statements that are based upon the current expectations of management. Forward-looking statements involve risks and uncertainties associated with the business of Avivagen Inc. and the environment in which the business operates. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking, including those identified by the expressions “aim”, “anticipate”, “appear”, “believe”, “consider”, “could”, “estimate”, “expect”, “if”, “intend”, “goal”, “hope”, “likely”, “may”, “plan”, “possibly”, “potentially”, “pursue”, “seem”, “should”, “whether”, “will”, “would” and similar expressions.

Statements set out in this news release relating to discussions with potential new distribution partners in Brazil, new agreements that might arise from such discussions and the possibility for continued and accelerated growth in Brazil as well as the possibility for OxC-beta™ Livestock to replace antibiotics in livestock feeds as growth promoters are forward-looking statements. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results or events to differ materially from current expectations. For instance, discussions with potential new distribution partners may not result in an agreement, any new agreement with a distribution partner in Brazil may not result in growth for Avivagen in Brazil, Avivagen’s products may not gain market acceptance or regulatory approval in new jurisdictions or for new applications and may not be widely accepted as a replacement for antibiotics as growth promoters in livestock feeds due to many factors, many of which are outside of Avivagen’s control. Readers are referred to the risk factors associated with the business of Avivagen set out in Avivagen’s most recent management’s discussion and analysis of financial condition available at www.SEDAR.com. Except as required by law, Avivagen assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those reflected in the forward-looking statements.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

For more information:
Avivagen Inc.
Drew Basek
Director of Investor Relations
100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6 Phone: 416-540-0733
E-mail: [email protected]

Kym Anthony
Chief Executive Officer
100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6 Head Office Phone: 613-949-8164
Website: www.avivagen.com
Copyright © 2021 Avivagen Inc. OxC-beta™ is a trademark of Avivagen Inc.

OpRegen® Clinical Data Continues to Demonstrate Functional and Anatomical Improvements in Patients With Dry AMD With Geographic Atrophy

 

 

CARLSBAD, Calif.–(BUSINESS WIRE)–Jul. 20, 2021– 

Lineage Cell Therapeutics, Inc.
 (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today reported updated interim results from its ongoing, 24-patient Phase 1/2a clinical study of its lead product candidate, OpRegen. OpRegen is an investigational cell therapy consisting of allogeneic retinal pigment epithelium (RPE) cells, administered one time to the subretinal space, for the treatment of dry age-related macular degeneration (AMD) with geographic atrophy (GA). These updated results include a minimum of 6 months of follow-up in all 24 patients treated with OpRegen, including all 12 patients treated in Cohort 4, which had better baseline vision and smaller areas of GA at baseline than earlier cohorts.

“I am excited about the observed changes in visual acuity that show strong trends towards sustained vision improvement in almost all of the treated eyes of Cohort 4 patients as compared to their untreated fellow eyes, which continue to show progression of atrophic AMD and decline of vision,” stated Principal Investigator 
Allen C. Ho, M.D. FACS, Wills Eye Hospital Attending Surgeon and Director of 
Retina Research, Professor of Ophthalmology, 
Thomas Jefferson University. “Based on the observed retinal changes suggestive of restoration of critical tissue in the area of atrophy, the beneficial functional visual improvements may be explained by structural changes as a result of OpRegen therapy and these changes may be durable in effect. We look forward to continuing to follow all study patients and reporting our efficacy and safety observations over time.”

“This update further reinforces our view that a suspension of OpRegen RPE cells can generate clinically meaningful anatomical and functional outcomes in patients with dry AMD with GA, particularly in those with earlier-stage atrophic disease,” stated  Brian M. Culley, Lineage CEO. “Not only has OpRegen generated the only known cases of retinal tissue restoration in previously confirmed atrophic areas in humans, but it also has provided a durable functional benefit of improved visual acuity in the majority of the twelve better vision, earlier-stage patients treated in the ongoing clinical study. As these data continue to mature, we will work with our advisors in preparation for a meeting with the FDA this year, where we intend to discuss our proposed next steps for further clinical development of OpRegen. Our belief is that RPE cell transplants can provide outcomes beyond the reach of traditional pharmaceutical approaches, which are limited to a subset of biological pathways, and which may fail to provide the maximal restorative benefit available to patients. We aim to position OpRegen RPE transplants as the best available option in the race to address the large unmet need in dry AMD with GA and establish Lineage as the pre-eminent allogeneic cell therapy company.”

Overall, 10/12 (83%) of the Cohort 4 patients’ treated eyes continued to be at or above baseline visual acuity at their last assessment, based on per protocol scheduled visits ranging from 6 months to approximately 3 years post-transplant. Improvements in best corrected visual acuity (BCVA) for Cohort 4 patients reached up to +19 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. In contrast, 10/12 (83%) of the patients’ untreated eyes were below pre-treatment baseline values at the same time points. Among the six Cohort 4 patients treated between September and 
November 2020, three (50%) continue to exhibit marked improvements in BCVA ranging from +8 to +18 letters at their last scheduled assessments of at least 6 months. Two additional Cohort 4 patients experienced a gain between +2 and +4 letters from their baseline values. One Cohort 4 patient measured 6 letters below baseline. Previously reported structural improvements in the retina, decreases in drusen density, and a trend toward slower GA progression in treated compared to untreated eyes continued to be present. Overall, OpRegen has been well tolerated with no unexpected adverse events or serious adverse events. Evidence of durable engraftment of OpRegen RPE cells has extended to more than 5 years in the earliest treated patients, supporting the potential for OpRegen to be a one-time treatment.

Three patients with evidence of retinal restoration and confirmed history of GA growth continue to demonstrate areas of retinal restoration as of their last assessment, ranging from 6 months to approximately 3 years after treatment. Notably, on Optical Coherence Tomography (OCT) analyses, the first Cohort 4 patient with evidence of retinal restoration and confirmed history of GA growth, has demonstrated zero growth in the area of atrophy (GA) almost 3 years following treatment with OpRegen. This is unprecedented due to the progressive nature of the disease. Applying the expected rate of progression based on changes from historical images to the baseline assessment, the size of the atrophic lesion at the visit would have been 4.58 mm using square root transformation (SQRT). Instead, the lesion measured at 2.8 mm SQRT, which was the same as it was at baseline, meaning there was no GA growth over almost 3 years, representing a 63.6% (1.78 mm SQRT) smaller area of GA than was expected. The area of GA in this patient’s untreated fellow eye, which was less severely impacted at baseline, progressed as expected from 3.63 mm to 4.01 mm using SQRT, an increase of 10.5% or 0.38 mm. Notably, microperimetry data collected at the Year 2 and Year 3 post-treatment study visits indicated improvements in the patient’s ability to discern different intensities of light and the patient has experienced clinically significant improvement in visual acuity for more than 2 years, at one point gaining 12 letters on an ETDRS scale. In addition to positive anatomical changes, all three patients with evidence of retinal tissue restoration had visual acuity increases above baseline levels within 9 months post-treatment and visual acuity has remained relatively stable over time compared to their fellow eyes.

Outer retinal layer restoration, which was observed using clinical high-resolution OCT, was evidenced by the presence of new areas of RPE monolayer with overlying ellipsoid zone, external limiting membrane, and outer nuclear layer, which were not present at the time of baseline assessment. These findings suggest integration of the new RPE cells with functional photoreceptors in areas that previously showed no presence of these cells. These effects were most prominent in the transitional areas around the primary area of GA.

These findings of retinal restoration have been confirmed utilizing multiple imaging technologies. The use of multiple imaging modalities differs from traditional assessment of GA progression, which employs only fundus autofluorescence (FAF) to assess changes in the total surface area of the apparent GA over time. Using only FAF may fail to identify structural changes that can be observed only with the addition of OCT imaging. The use of OCT allows for a more precise determination of changes in retinal thickness, organization, and overall health of the retina in areas of potential atrophy, benefits which are possible with cell transplant therapy.

The loss of RPE cells over time creates progressively larger areas of atrophy in the adult retina, leading to impaired vision or complete blindness, a condition known as atrophic AMD. Humans lack the innate ability to regenerate retinal tissue and replace lost retina cells, which led to a presumption that progression of GA may someday be slowed or halted but could not be reversed. The unique findings from the ongoing OpRegen clinical study support a different view, in which an RPE cell transplant can potentially replace or rescue retinal cells in patients who suffer from retinal lesions or degeneration. The totality of these findings supports the view that atrophic AMD is not an irreversible, degenerative condition and that some portion of diseased retinal tissue may be recoverable.

Improvements in Visual Acuity Observed with OpRegen RPE Transplant. The graph represents the mean changes in Best Corrected Visual Acuity (BCVA) for Cohort 4 patients’ treated eye when compared to their fellow eye over a period of 12 months.

About OpRegen

OpRegen is currently being evaluated in a Phase 1/2a open-label, dose escalation safety and efficacy study of a single injection of human retinal pigment epithelium cells derived from an established pluripotent cell line and transplanted subretinally in patients with advanced dry AMD with GA. The study enrolled 24 patients into 4 cohorts. The first 3 cohorts enrolled only legally blind patients with BCVA of 20/200 or worse. The fourth cohort enrolled 12 better vision patients (BCVA from 20/65 to 20/250 with smaller mean areas of GA). Cohort 4 also included patients treated with a new “thaw-and-inject” formulation of OpRegen, which can be shipped directly to sites and used immediately upon thawing, removing the complications and logistics of having to use a dose preparation facility. The primary objective of the study is to evaluate the safety and tolerability of OpRegen as assessed by the incidence and frequency of treatment emergent adverse events. Secondary objectives are to evaluate the preliminary efficacy of OpRegen treatment by assessing the changes in ophthalmological parameters measured by various methods of primary clinical relevance. OpRegen has been well tolerated to date and there have been no new, unexpected ocular or systemic adverse events or serious adverse events that have not been previously reported. OpRegen is a registered trademark of 
Cell Cure Neurosciences Ltd., a majority-owned subsidiary of 
Lineage Cell Therapeutics, Inc.

About Age-Related Macular Degeneration

Age-related macular degeneration (AMD) is an eye disease that can blur the sharp, central vision in patients and is the leading cause of vision loss in people over the age of 60. There are two forms of AMD: dry (atrophic) AMD and wet (neovascular) AMD. Dry (atrophic) AMD is the more common of the two forms, accounting for approximately 85-90% of all cases. In atrophic AMD, parts of the macula get thinner with age and accumulations of extracellular material between Bruch’s membrane and the RPE, known as drusen, increase in number and volume, leading to a progressive loss of central vision, typically in both eyes. Global sales of the two leading wet AMD therapies were in excess of 
$10 billion in 2019. Nearly all cases of wet AMD eventually will develop the underlying atrophic AMD if the newly formed blood vessels are treated correctly. There are currently no 
U.S. Food and Drug Administration (FDA), or 
European Medicines Agency, approved treatment options available for patients with atrophic AMD.

About Lineage Cell Therapeutics, Inc. 

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include three allogeneic (“off-the-shelf”) product candidates: (i) OpRegen^®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC2, an allogeneic dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

Forward-Looking Statements

Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “can,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “tend to,” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to the potential benefits of treatment with OpRegen in dry AMD patients with GA, the significance of clinical data reported to date from the ongoing Phase 1/2a study of OpRegen, including the findings of retinal tissue restoration, plans to meet with the FDA in 2021 to discuss OpRegen’s clinical development, and Lineage’s potential to become the pre-eminent allogeneic cell therapy company. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineage’s business and other risks in Lineage’s filings with the 
Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the 
SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the 
SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
([email protected])
(442) 287-8963

Solebury Trout IR
Gitanjali Jain Ogawa
([email protected])
(646) 378-2949

Russo Partners – Media Relations
Nic Johnson or  David Schull
[email protected]
[email protected]
(212) 845-4242

Source: 
Lineage Cell Therapeutics, Inc.