Cocrystal Pharma Submits Pre-Investigational New Drug Briefing Package to the FDA for Clinical Development Guidance of CDI-45205 for COVID-19 Treatment

 

FDA’s response is expected to provide greater clarity and guidance on designing Phase 1 and Phase 2 clinical trials for CDI-45205

BOTHELL, Wash., Nov. 01, 2021 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces the submission of a pre-Investigational New Drug (IND) briefing package to the U.S. Food and Drug Administration (FDA) for its broad-spectrum protease inhibitor CDI-45205 for the treatment of patients with COVID-19.

“The pre-IND submission is a critical step to obtain the FDA’s guidance on preclinical studies, manufacturing, toxicology, and clinical development plans for CDI-45205. We look forward to our communication with the FDA and advancing toward Phase 1 and Phase 2 clinical trials to address the unmet needs of patients and to contribute to global efforts to end this pandemic,” said Sam Lee, Ph.D., Cocrystal’s co-interim CEO and President.

“As with all of our antiviral candidates, we are exploring multiple routes of administration including oral, inhalation, and injection,” added Dr. Lee. “We anticipate that CDI-45205 is best suited for intranasal/pulmonary administration based on its novel mechanism of action and pharmacokinetic profile, with this route having the advantage of direct delivery to the respiratory system, a primary infection site for SARS-CoV-2. We are also advancing preclinical studies with our novel oral COVID-19 protease inhibitors developed using our proprietary structure-based drug discovery technology, and are very excited about potential multiple treatment options for COVID-19.”

“A number of drugs are being developed as COVID-19 treatments that were originally designed for other indications. These repurposed drugs or drug candidates are a good start for humanity, but likely not the best-in-class solution that will end the pandemic,” said James Martin, Cocrystal’s co-interim CEO and CFO. “Our drug candidates are specifically designed to target the viral replication enzymes and protease, which we believe makes it possible to develop effective treatments for COVID-19 and its variants.”

About CDI-45205

CDI-45205 is among a group of protease inhibitors obtained under an exclusive license agreement with Kansas State University Research Foundation (KSURF) in 2020. CDI-45205 and several analogs showed potent in vitro activity against the SARS-CoV-2 Delta (India/B.1.617.2), Gamma (Brazil/P.1), Alpha (United Kingdom/B.1.1.7) and Beta (South African/B.1.351) variants, surpassing the activity observed with the original Wuhan strain. CDI-45205 has also shown good bioavailability in mouse and rat pharmacokinetic studies via intraperitoneal injection, and no cytotoxicity against a variety of human cell lines. Preclinical research demonstrated a strong synergistic effect with the FDA-approved COVID-19 medicine remdesivir. Additionally, a proof-of-concept animal study demonstrated that daily injection of CDI-45205 exhibited favorable in vivo efficacy in MERS-CoV-2 infected mice.

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 FDA’s response to our recent submission for CDI-45205, the ability to develop and efficacy of potential treatments against COVID-19 and advance our product candidates into clinical trials, and our strategy with respect to clinical development. 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 impact of the COVID-19 pandemic on the national and global economy, on our collaboration partners, CROs, CMOs, and on our Company, 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.

Helius Medical Technologies, Inc. to Release Third Quarter 2021 Financial Results on November 10, 2021

 

NEWTOWN, Pa., Nov. 01, 2021 (GLOBE NEWSWIRE) — Helius Medical Technologies, Inc. (NASDAQ: HSDT) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced that the Company will release its third quarter 2021 financial results on Wednesday, November 10, 2021, after the market closes.

Dane C. Andreeff, President and Chief Executive Officer, and Jeffrey S. Mathiesen, Chief Financial Officer, will host a conference call to discuss the results and provide a business update as follows:

Date:		Wednesday, November 10, 2021
Time:		5:00 p.m. Eastern Time
Toll free (U.S.):		(844) 348-4652
International:		(213) 358-0895
Conference ID:		9388362
Webcast:		https://edge.media-server.com/mmc/p/sbbrhapy

A replay of the call will be available for one week at (855) 859-2056 (U.S.) or (404) 537-3406 (international). The conference ID for the replay is 9388362. The webcast will be archived under the Newsroom section of the Company’s investor relations website.

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 promote neuroplasticity, aiming to improve the lives of people dealing with neurologic diseases.

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 provide treatment of gait deficit. 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 as a class II, non-implantable, medical device intended as a short-term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from MS, and chronic balance deficit due to mild-to-moderate traumatic brain injury (“mmTBI”) and is to be used in conjunction with physical therapy. The PoNS^® is an investigational medical device in Australia (“AUS”) and is currently under premarket review by the AUS Therapeutic Goods Administration.

Investor Relations Contact:

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

PDS Biotech Announces Agreement with University of Georgia to License Novel Proteins for Versamune-based Universal Flu Vaccine

 

FLORHAM PARK, N.J., Nov. 01, 2021 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune^® T-cell activating technology, today announced an agreement to license COBRA (Computationally Optimized Broadly Reactive Antigen) antigens from the University of Georgia initially for use in the clinical development of its infectious disease immunotherapy pipeline, PDS0202, a universal flu vaccine candidate.

“Our new agreement with the University of Georgia demonstrates the versatility and potential of our Versamune^® platform and advances our infectious disease pipeline,” commented PDS Biotech CEO, Frank Bedu-Addo. “There are four types of seasonal influenza viruses, and a universal flu vaccine would eliminate the need to manufacture a new seasonal flu vaccine each year by providing robust, long-lasting protection against multiple subtypes of flu. We believe this is the next step in the advancement of novel infectious disease vaccines to address the nearly one billion cases of influenza worldwide annually.”

Designed by renowned influenza expert, Dr. Ted Ross at the University of Georgia, the novel COBRA antigens are to be used in combination with Versamune^® for PDS0202 for the universal prevention of infection by multiple strains of influenza virus. The antigens were selected following successful pre-clinical development work completed under a contract from the National Institute of Allergy and Infectious Diseases (NIAID), Collaborative Influenza Vaccine Innovation Centers (CIVICs) program to progress PDS0202 development. PDS0202 leverages Versamune^®’s ability to induce the immune system to generate high levels of flu-specific neutralizing antibodies, CD4 helper and CD8 killer T-cells, as well as long-acting memory T-cells to potentially provide broad and long-term protection against multiple influenza strains. Influenza is estimated to result in about 3 to 5 million cases of severe illness and about 290,000 to 650,000 respiratory deaths globally each year.

“The preclinical results of the combination of COBRA antigens and Versamune^® were impressive, especially given the unique problem in developing a universal flu vaccine,” added Dr. Ross. “Designing a vaccine that works for many influenza strains is the goal. We are excited to see how the PDS0202 – COBRA vaccine performs in human trials.” 

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.

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 or monitoring committees’ or other third parties’ 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, significance of milestones, 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: drandolph@pdsbiotech.com

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

PDS Biotech Announces Agreement with University of Georgia to License Novel Proteins for Versamune-based Universal Flu Vaccine

 

FLORHAM PARK, N.J., Nov. 01, 2021 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune^® T-cell activating technology, today announced an agreement to license COBRA (Computationally Optimized Broadly Reactive Antigen) antigens from the University of Georgia initially for use in the clinical development of its infectious disease immunotherapy pipeline, PDS0202, a universal flu vaccine candidate.

“Our new agreement with the University of Georgia demonstrates the versatility and potential of our Versamune^® platform and advances our infectious disease pipeline,” commented PDS Biotech CEO, Frank Bedu-Addo. “There are four types of seasonal influenza viruses, and a universal flu vaccine would eliminate the need to manufacture a new seasonal flu vaccine each year by providing robust, long-lasting protection against multiple subtypes of flu. We believe this is the next step in the advancement of novel infectious disease vaccines to address the nearly one billion cases of influenza worldwide annually.”

Designed by renowned influenza expert, Dr. Ted Ross at the University of Georgia, the novel COBRA antigens are to be used in combination with Versamune^® for PDS0202 for the universal prevention of infection by multiple strains of influenza virus. The antigens were selected following successful pre-clinical development work completed under a contract from the National Institute of Allergy and Infectious Diseases (NIAID), Collaborative Influenza Vaccine Innovation Centers (CIVICs) program to progress PDS0202 development. PDS0202 leverages Versamune^®’s ability to induce the immune system to generate high levels of flu-specific neutralizing antibodies, CD4 helper and CD8 killer T-cells, as well as long-acting memory T-cells to potentially provide broad and long-term protection against multiple influenza strains. Influenza is estimated to result in about 3 to 5 million cases of severe illness and about 290,000 to 650,000 respiratory deaths globally each year.

“The preclinical results of the combination of COBRA antigens and Versamune^® were impressive, especially given the unique problem in developing a universal flu vaccine,” added Dr. Ross. “Designing a vaccine that works for many influenza strains is the goal. We are excited to see how the PDS0202 – COBRA vaccine performs in human trials.” 

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.

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 or monitoring committees’ or other third parties’ 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, significance of milestones, 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: drandolph@pdsbiotech.com

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

Helius Medical Technologies, Inc. to Release Third Quarter 2021 Financial Results on November 10, 2021

 

NEWTOWN, Pa., Nov. 01, 2021 (GLOBE NEWSWIRE) — Helius Medical Technologies, Inc. (NASDAQ: HSDT) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced that the Company will release its third quarter 2021 financial results on Wednesday, November 10, 2021, after the market closes.

Dane C. Andreeff, President and Chief Executive Officer, and Jeffrey S. Mathiesen, Chief Financial Officer, will host a conference call to discuss the results and provide a business update as follows:

Date:		Wednesday, November 10, 2021
Time:		5:00 p.m. Eastern Time
Toll free (U.S.):		(844) 348-4652
International:		(213) 358-0895
Conference ID:		9388362
Webcast:		https://edge.media-server.com/mmc/p/sbbrhapy

A replay of the call will be available for one week at (855) 859-2056 (U.S.) or (404) 537-3406 (international). The conference ID for the replay is 9388362. The webcast will be archived under the Newsroom section of the Company’s investor relations website.

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 promote neuroplasticity, aiming to improve the lives of people dealing with neurologic diseases.

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 provide treatment of gait deficit. 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 as a class II, non-implantable, medical device intended as a short-term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from MS, and chronic balance deficit due to mild-to-moderate traumatic brain injury (“mmTBI”) and is to be used in conjunction with physical therapy. The PoNS^® is an investigational medical device in Australia (“AUS”) and is currently under premarket review by the AUS Therapeutic Goods Administration.

Investor Relations Contact:

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

Cocrystal Pharma Submits Pre-Investigational New Drug Briefing Package to the FDA for Clinical Development Guidance of CDI-45205 for COVID-19 Treatment

 

FDA’s response is expected to provide greater clarity and guidance on designing Phase 1 and Phase 2 clinical trials for CDI-45205

BOTHELL, Wash., Nov. 01, 2021 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces the submission of a pre-Investigational New Drug (IND) briefing package to the U.S. Food and Drug Administration (FDA) for its broad-spectrum protease inhibitor CDI-45205 for the treatment of patients with COVID-19.

“The pre-IND submission is a critical step to obtain the FDA’s guidance on preclinical studies, manufacturing, toxicology, and clinical development plans for CDI-45205. We look forward to our communication with the FDA and advancing toward Phase 1 and Phase 2 clinical trials to address the unmet needs of patients and to contribute to global efforts to end this pandemic,” said Sam Lee, Ph.D., Cocrystal’s co-interim CEO and President.

“As with all of our antiviral candidates, we are exploring multiple routes of administration including oral, inhalation, and injection,” added Dr. Lee. “We anticipate that CDI-45205 is best suited for intranasal/pulmonary administration based on its novel mechanism of action and pharmacokinetic profile, with this route having the advantage of direct delivery to the respiratory system, a primary infection site for SARS-CoV-2. We are also advancing preclinical studies with our novel oral COVID-19 protease inhibitors developed using our proprietary structure-based drug discovery technology, and are very excited about potential multiple treatment options for COVID-19.”

“A number of drugs are being developed as COVID-19 treatments that were originally designed for other indications. These repurposed drugs or drug candidates are a good start for humanity, but likely not the best-in-class solution that will end the pandemic,” said James Martin, Cocrystal’s co-interim CEO and CFO. “Our drug candidates are specifically designed to target the viral replication enzymes and protease, which we believe makes it possible to develop effective treatments for COVID-19 and its variants.”

About CDI-45205

CDI-45205 is among a group of protease inhibitors obtained under an exclusive license agreement with Kansas State University Research Foundation (KSURF) in 2020. CDI-45205 and several analogs showed potent in vitro activity against the SARS-CoV-2 Delta (India/B.1.617.2), Gamma (Brazil/P.1), Alpha (United Kingdom/B.1.1.7) and Beta (South African/B.1.351) variants, surpassing the activity observed with the original Wuhan strain. CDI-45205 has also shown good bioavailability in mouse and rat pharmacokinetic studies via intraperitoneal injection, and no cytotoxicity against a variety of human cell lines. Preclinical research demonstrated a strong synergistic effect with the FDA-approved COVID-19 medicine remdesivir. Additionally, a proof-of-concept animal study demonstrated that daily injection of CDI-45205 exhibited favorable in vivo efficacy in MERS-CoV-2 infected mice.

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 FDA’s response to our recent submission for CDI-45205, the ability to develop and efficacy of potential treatments against COVID-19 and advance our product candidates into clinical trials, and our strategy with respect to clinical development. 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 impact of the COVID-19 pandemic on the national and global economy, on our collaboration partners, CROs, CMOs, and on our Company, 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.

	Image Credit: Yale Rosen (Flickr)

A New Way to Organize Cancer Mutations Could Lead to Better Treatment Matches for Patients

 

There are many types of cancer treatments. But which ones work best varies from patient to patient. Currently, doctors determine which treatment to try for a patient based on where in their DNA, or genetic code, the error that caused the cancer is located.

But a new approach that groups patients by the changes in protein structure and function caused by that error, rather than by the location of the changes in DNA, could lead to both more inclusive clinical trials and better treatment matches for patients.

 

This article was republished with permission from The Conversation, a news site dedicated to sharing ideas from academic experts.  It was written by and represents the research-based opinions of Jacqulyne Robichaux Assistant Professor of Thoracic & Head and Neck Oncology, The University of Texas MD Anderson Cancer Center

 

I am part of a team that researches targeted therapies for cancer and ways to make treatment more patient-specific. A recent study by our research team determined that grouping DNA errors by structure may better personalize cancer therapies.

Targeted Therapies
Hone in on Cancer Cells

Mutations are errors made during cell replication when the genetic material of that cell, or DNA, makes a new copy of itself. These mutations are usually harmless and caught by the cell’s proofreading machinery.

However, the proofreader occasionally fails. And on rare instances, these mutations occur in parts of the DNA called oncogenes. Under normal conditions, oncogenes are essential to normal growth and development, such as fetal organ development and general tissue repair and maintenance. But when mutations cause oncogenes to signal for unregulated growth, cancer can form.

One way to kill these tumor cells is to use targeted therapy. Cancer-targeted therapies bind specifically to the defective proteins produced by mutated oncogenes and prevent them from sending a “grow” signal.

Because targeted therapies bind directly to the cancerous protein, they spare most noncancerous cells from being harmed. This results in more specific cancer cell killing and less overall treatment toxicity. In contrast, chemotherapy attacks all actively dividing cells, which includes not just cancer but also hair follicles, the digestive tract, and other parts of the body.

To make targeted therapies more specific, scientists often study the physical or structural changes that mutations cause in proteins. They design drugs that preferentially bind to these particular changes to prevent the defective protein from causing uncontrolled growth.

However, because mutations can occur in many different areas of a protein, multiple targeted therapies are often necessary to bind all the different mutations that occur across cancer types. This leads to a difficult clinical problem: How do physicians match patients to the most effective targeted therapy for their mutations?

Traditional Treatments Use Mutation Location

To attempt to answer this question, our research team chose to focus on one oncogene in lung cancer, EGFR, or epidermal growth factor receptor. We did this for two reasons. First, lung cancer remains the No. 1 cause of cancer-related deaths worldwide. Second, EGFR mutations are among the most common forms of lung cancer – they occur in approximately a third of non-small-cell lung cancers worldwide, amounting to over 550,000 patients annually.

EGFR has many different mutations that cause unregulated growth. Multiple generations of targeted therapies are available for this population of patients.

Clinical trials and treatment options for patients with oncogene-driven lung cancer, particularly with EGFR, are currently based on the type and location of the mutation in the DNA.

However, mutation location is not the best approach to predict how well patients will respond to a drug. Because mutations change the shape of a protein, they can alter the way targeted therapies interact with the protein.

Regrouping cancer mutations

By examining the mutated structures of different EGFR proteins, our team found that they could be categorized into distinct subgroups.

For example, we found that mutations that form away from the areas of the protein that drugs target don’t noticeably affect how well the drug binds to the protein. Cells with this kind of protein mutation were thus killed by all types of EGFR inhibitors. Although these mutations occurred across many locations in the DNA, they shared the same overall structural and functional effect on proteins.

Conversely, mutations that form near typical drug target areas compress this region and prevent certain EGFR inhibitors from attaching to the protein. These mutations also occurred in several different DNA locations.

Based on these findings, our team hypothesized that structural changes in similar protein regions, not DNA location, would cause similar changes in how well a drug works.

To test our hypothesis, we retrospectively analyzed public and hospital data on how well patients responded to cancer treatments. We sorted patients into traditional DNA location-based groups and our newly defined structure/function-based subgroups to determine whether one group had more patients who responded better than the other to different drugs.

We found that the structure/function-based subgroups identified nearly twice as many patients that benefited from a particular drug compared with the DNA location-based groups. Grouping patients by structure/function also identified which EGFR inhibitor provided the longest clinical benefit for patients.

More Inclusive Clinical Trials

In
addition to potentially matching patients to more effective treatments,
clinical trials using structure-based subgroups may lead to broader access to
therapies.

Current clinical trials exclude up to a fifth of patients with EGFR mutant non-small-cell lung cancer because each clinical trial typically focuses on only a handful of specific mutation types. Reframing clinical studies to be based on the changes that mutations cause to protein structure and function, as opposed to their location on DNA, could expand treatment options to include patients with more rare EGFR mutant cancers.

This approach provides a framework that clinical trials could use to make studies more inclusive of all types of mutations. And it may also identify previously ignored or hidden mutation subgroups that can lead to additional drug development and ultimately improve patient care.

 

Suggested Reading:

Measuring Cancer Cells to Tailor Treatments

Biologists Identify New Targets for Cancer Vaccines

Stem Cells Role in the Anti-Aging Business

Therapeutic Research Advanced by Stem Cell Science

 

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Thursday, October 28, 2021

Ocugen (OCGN)
Ocugen Files IND For Phase 3 Covaxin Trial

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.

IND Submitted To Begin Unvaccinated Patient and Booster Study Ocugen has submitted an IND to begin a Phase 3 study testing Covaxin (BBV152) as a vaccine for COVID-19.  The study will enroll unvaccinated patients and those vaccinated at least six months prior to determine if immune responses in US patients are comparable with those seen in the Phase 3 conducted in India. If successful, we expect the data to be submitted for marketing approval.


Study Design Patients will be randomized to receive two doses of either Covaxin or placebo 28 days apart.  The primary endpoint will compare blood-based samples taken from the US study with samples from patients in the Phase 3 Bharat biotech trial. The secondary endpoints test the vaccine’s immunogenic profile, safety, and tolerability. The company hopes to complete the study during …

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 Investigational New Drug Application with U.S. FDA to Initiate a Phase 3 Clinical Trial Evaluating COVID-19 Vaccine Candidate COVAXIN™ (BBV152)

 

The Phase 3 study is designed to bridge data collected from the vaccine efficacy trial conducted in India to the U.S. population

MALVERN, Pa., Oct. 27, 2021 (GLOBE NEWSWIRE) — Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing novel therapeutics and vaccines, announced that it has submitted an Investigational New Drug application (IND) with the U.S. Food and Drug Administration (FDA) to evaluate the COVID-19 vaccine candidate, BBV152, known as COVAXIN™ outside the United States.  

COVAXIN™ is a whole-virion inactivated COVID-19 investigational vaccine candidate that uses the same vero cell manufacturing platform that has been used in the production of polio vaccines for decades.

The Phase 3 trial proposed in the IND is designed to establish whether the immune response experienced by participants in a completed Phase 3 efficacy trial in India is similar to that observed in a demographically representative, healthy adult population in the U.S. who either have not been vaccinated for COVID-19 or who already received two doses of an mRNA vaccine at least six months earlier.

“We are very excited to take this next step in the development of COVAXIN™, which we hope will bring us closer to introducing a different type of COVID-19 vaccine to the American public,” said Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and Co-Founder of Ocugen. “We are hopeful that the study conducted under the IND, if allowed to proceed, will help demonstrate that the data from India will be applicable to the U.S. population.”

If the study is allowed to proceed, Ocugen’s Phase 3 immuno-bridging study, OCU-002, will seek to enroll several hundred healthy adults in the U.S. Subjects will be randomized to receive either two doses of COVAXIN™ or placebo, 28 days apart. The primary endpoint will compare blood-based samples taken from U.S. participants who received COVAXIN™ with samples of the participants in the Phase 3 efficacy trial conducted in India. The secondary endpoint involves testing the vaccine’s immunogenic profile. The study will also evaluate safety and tolerability in the U.S. population. Ocugen hopes to complete the study during H1 2022.

The Phase 3 study conducted in India by Ocugen’s business partner, Bharat Biotech, involved 25,798 participants receiving two doses of COVAXIN™ or placebo, 28 days apart. The primary endpoint was preventing symptomatic COVID-19 occurring at least 14 days after the second dose. Results of the trial found 93.4% efficacy against severe COVID-19 disease, 77.8% efficacy against symptomatic COVID-19 and 63.6% efficacy against asymptomatic disease. A sub-analysis of the Phase 3 study examined the presence of infections by variants of the original coronavirus strain. Overall, 90% of infections showed the presence of a variant, with 59% of those being the Delta variant. The sub-analysis revealed COVAXIN™-treated patients experienced 65.2% efficacy against the Delta variant. Adverse events reported in the trial included pain, erythema, induration, swelling, headache, pyrexia, fatigue, chills, myalgia, arthralgia, nausea and vomiting. 12.4% of subjects experienced an adverse event in both the COVAXIN™ and placebo arm. Additionally, 0.3% of subjects in the COVAXIN™ arm experienced a serious adverse event compared to 0.47% of patients in the placebo arm.

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 manufactured, COVAXIN™ is currently being administered under emergency use authorizations in 17 countries, and applications for emergency use authorization are pending in more than 60 other countries. The trade name COVAXIN™ has not been evaluated by the FDA.   

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

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

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

Cautionary Note on Forward-Looking Statements  
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such forward-looking statements include information about qualitative assessments of available data, potential benefits, expectations for clinical trials, and anticipated timing of clinical trial readouts and regulatory submissions, including with respect to our hope that the Phase 3 trial included in our Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA) for COVAXIN™, if allowed to proceed, will be completed during the first half of 2022, or that the results of any such trial may demonstrate that existing data from Bharat Biotech’s clinical trials in India for COVAXIN™ 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, 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 FDA will accept our IND submission without any changes, or if we are required to submit additional information to the FDA in support of our IND submission, the extent and significance of any such changes; whether we will be able to provide the FDA with sufficient additional information regarding the design of and results from preclinical and clinical studies of COVAXIN™, which have been conducted by Bharat Biotech in India in order for those trials to support a biologics license application (BLA); the size, scope, timing and outcome of any additional trials or studies that we may be required to conduct to support a BLA, including our planned Phase 3 clinical trial for which we have submitted an IND to the FDA; any additional chemistry, manufacturing and controls information that we may be required to submit at the time of our BLA filing; 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 Investigational New Drug Application with U.S. FDA to Initiate a Phase 3 Clinical Trial Evaluating COVID-19 Vaccine Candidate COVAXIN™ (BBV152)

 

The Phase 3 study is designed to bridge data collected from the vaccine efficacy trial conducted in India to the U.S. population

MALVERN, Pa., Oct. 27, 2021 (GLOBE NEWSWIRE) — Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing novel therapeutics and vaccines, announced that it has submitted an Investigational New Drug application (IND) with the U.S. Food and Drug Administration (FDA) to evaluate the COVID-19 vaccine candidate, BBV152, known as COVAXIN™ outside the United States.  

COVAXIN™ is a whole-virion inactivated COVID-19 investigational vaccine candidate that uses the same vero cell manufacturing platform that has been used in the production of polio vaccines for decades.

The Phase 3 trial proposed in the IND is designed to establish whether the immune response experienced by participants in a completed Phase 3 efficacy trial in India is similar to that observed in a demographically representative, healthy adult population in the U.S. who either have not been vaccinated for COVID-19 or who already received two doses of an mRNA vaccine at least six months earlier.

“We are very excited to take this next step in the development of COVAXIN™, which we hope will bring us closer to introducing a different type of COVID-19 vaccine to the American public,” said Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and Co-Founder of Ocugen. “We are hopeful that the study conducted under the IND, if allowed to proceed, will help demonstrate that the data from India will be applicable to the U.S. population.”

If the study is allowed to proceed, Ocugen’s Phase 3 immuno-bridging study, OCU-002, will seek to enroll several hundred healthy adults in the U.S. Subjects will be randomized to receive either two doses of COVAXIN™ or placebo, 28 days apart. The primary endpoint will compare blood-based samples taken from U.S. participants who received COVAXIN™ with samples of the participants in the Phase 3 efficacy trial conducted in India. The secondary endpoint involves testing the vaccine’s immunogenic profile. The study will also evaluate safety and tolerability in the U.S. population. Ocugen hopes to complete the study during H1 2022.

The Phase 3 study conducted in India by Ocugen’s business partner, Bharat Biotech, involved 25,798 participants receiving two doses of COVAXIN™ or placebo, 28 days apart. The primary endpoint was preventing symptomatic COVID-19 occurring at least 14 days after the second dose. Results of the trial found 93.4% efficacy against severe COVID-19 disease, 77.8% efficacy against symptomatic COVID-19 and 63.6% efficacy against asymptomatic disease. A sub-analysis of the Phase 3 study examined the presence of infections by variants of the original coronavirus strain. Overall, 90% of infections showed the presence of a variant, with 59% of those being the Delta variant. The sub-analysis revealed COVAXIN™-treated patients experienced 65.2% efficacy against the Delta variant. Adverse events reported in the trial included pain, erythema, induration, swelling, headache, pyrexia, fatigue, chills, myalgia, arthralgia, nausea and vomiting. 12.4% of subjects experienced an adverse event in both the COVAXIN™ and placebo arm. Additionally, 0.3% of subjects in the COVAXIN™ arm experienced a serious adverse event compared to 0.47% of patients in the placebo arm.

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 manufactured, COVAXIN™ is currently being administered under emergency use authorizations in 17 countries, and applications for emergency use authorization are pending in more than 60 other countries. The trade name COVAXIN™ has not been evaluated by the FDA.   

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

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

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

Cautionary Note on Forward-Looking Statements  
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such forward-looking statements include information about qualitative assessments of available data, potential benefits, expectations for clinical trials, and anticipated timing of clinical trial readouts and regulatory submissions, including with respect to our hope that the Phase 3 trial included in our Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA) for COVAXIN™, if allowed to proceed, will be completed during the first half of 2022, or that the results of any such trial may demonstrate that existing data from Bharat Biotech’s clinical trials in India for COVAXIN™ 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, 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 FDA will accept our IND submission without any changes, or if we are required to submit additional information to the FDA in support of our IND submission, the extent and significance of any such changes; whether we will be able to provide the FDA with sufficient additional information regarding the design of and results from preclinical and clinical studies of COVAXIN™, which have been conducted by Bharat Biotech in India in order for those trials to support a biologics license application (BLA); the size, scope, timing and outcome of any additional trials or studies that we may be required to conduct to support a BLA, including our planned Phase 3 clinical trial for which we have submitted an IND to the FDA; any additional chemistry, manufacturing and controls information that we may be required to submit at the time of our BLA filing; 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

Wednesday, October 27, 2021

Axcella Health (AXLA)
Axcella Announces Plans For COVID-19 Long-Haulers

Axcella Health Inc. is a clinical-stage biotechnology company focused on treating complex diseases and improvinge health using endogenous metabolic modulator, or EMM, compositions. Its product candidates are comprised of multiple EMMs that are engineered in distinct combinations and ratios to simultaneously impact multiple biological pathways. The company’s pipeline includes two lead therapeutic candidates:, AXA1665 for the reduction in risk of recurrent overt hepatic encephalopathy (OHE) , and AXA1125 for the treatment of non-alcoholic steatohepatitis (NASH).

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

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

Raising Price Target Axcella Therapeutics held an R&D Day to review the company’s current Phase 2 trials and development platform.  It also announced plans for a Phase 2 clinical trial to test AXA1125 in Long COVID (Post-Acute Sequelae of COVID-19). In view of this new trial and its market potential, we are raising our price target.


Research and Development Day Reviewed Trials and Product Design The company reviewed how its products target multiple disease drivers rather than a single target in a disease pathway.  Preclinical studies showed increases in fatty acid oxidation, restoration of cellular homeostasis, and reduced inflammation. These actions improve mitochondrial function and increase energetic efficiency, resulting …

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. 

OpRegen® Data Update to Be Featured at 2021 American Academy of Ophthalmology Annual Meeting in Presentation by Michael S. Ip, M.D.

CARLSBAD, Calif.–(BUSINESS WIRE)–Oct. 26, 2021–

Lineage Cell Therapeutics, Inc.

(NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, reported today that updated interim results from a Phase 1/2a clinical study of its lead product candidate, OpRegen^®, an investigational retinal pigment epithelium cell transplant therapy currently in development for the treatment of dry age-related macular degeneration (AMD), will be featured in a presentation at the 2021 American
Academy of Ophthalmology (AAO) 125^th Annual Meeting, to be held at the
Ernest N. Morial Convention Center, New Orleans, LA (
November 12
– 15, 2021). The presentation, “OpRegen Trial: Phase 1/2a Dose
Escalation Study of Human Embryonic Stem-Cell Derived Retinal Pigment
Epithelium Cells Transplanted Subretinally in Patients with Advanced AMD,” will be presented on
November 13, 2021 at
2:38 pm EDT
as part of the Gene and Cell-Based Therapies Session, by
Michael S. Ip, M.D., Professor,
Department of Ophthalmology at the
David Geffen School of Medicine at the
University of California – Los Angeles
.

In addition to Dr. Ip’s presentation, Lineage also intends to announce updated interim results from the Phase 1/2a study next month, which will include a minimum of 12 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. OpRegen is well-positioned among product candidates in development for dry AMD as the only experimental therapy that has demonstrated an ability to halt or reverse the expansion of geographic atrophy as well as restore layers of retinal tissue in three patients to date. Specifically, outer retinal layer restoration was observed via optical coherence tomography (OCT) and was evidenced by the presence of new areas of retinal pigment epithelium (RPE) monolayer with overlying ellipsoid zone, external limiting membrane, and outer nuclear layer, all of which were not present at the time of baseline assessment. These findings are suggestive of integration of the new RPE cells with functional photoreceptors in areas that previously showed no presence of any of these cells.

The
American Academy of Ophthalmology is the world’s largest association of eye physicians and surgeons. The mission of the
American Academy of Ophthalmology is to protect sight and empower lives by serving as an advocate for patients and the public, leading ophthalmic education, and advancing the profession of ophthalmology. For more information, please visit https://www.aao.org/ or follow the association on Twitter @aao_ophth.

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 geographic atrophy (GA). The study enrolled 24 patients into 4 cohorts. The first 3 cohorts enrolled only legally blind patients with Best Corrected Visual Acuity (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 is a registered trademark of
Cell Cure Neurosciences Ltd., a majority-owned subsidiary of
Lineage Cell Therapeutics, Inc.

About
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 retinal pigmented epithelium, 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, 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,” ‘suggest,” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to the projected timing of future announcements or presentations of updated or additional data from the Phase 1/2a clinical study of OpRegen, 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, Lineage’s plans to meet with the FDA to discuss OpRegen’s clinical development, the potential utilization of OCT imaging to measure efficacy in a pivotal clinical trial of OpRegen for the treatment of dry AMD with GA, and the potential for Lineage’s investigational allogeneic cell therapies to provide safe and effective treatment for multiple, diverse serious or life threatening conditions. 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.

View source version on businesswire.com:
https://www.businesswire.com/news/home/20211026005496/en/

Lineage Cell Therapeutics, Inc. IR Ioana C. Hone (
ir@lineagecell.com)
(442) 287-8963

Solebury
Trout IR Mike Biega (
Mbiega@soleburytrout.com)

(617) 221-9660

Russo
Partners – Media Relations Nic Johnson or David Schull Nic.johnson@russopartnersllc.com

David.schull@russopartnersllc.com

(212) 845-4242

Source:
Lineage Cell Therapeutics, Inc.

Friday, October 22, 2021

PDS Biotechnology Corp (PDSB)
Phase 2 Treatment Continues As New Patient Recruitment Is Delayed

PDS Biotechnology Corp operates as a clinical stage biotechnology company, principally involved in drug discovery in the United States. It is primarily engaged in the treatment of various early-stage and late-stage cancers, including head and neck cancer, prostate cancer, breast cancer, cervical cancer, anal cancer, and other cancers. Its products are based on the proprietary Versamune platform technology, which activates and directs the human immune system to unleash a powerful and targeted attack against cancer cells.

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

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

Current Patients Unaffected As Recruitment Is Suspended.  POn Oct 21, PDSB announced that recruitment of new patients for the National Cancer Institute (NCI)-led Phase 2 clinical trial (NCT04287868) has been suspended. In a conversation with management, we learned that the action was related to updates to the informed consent document used by the NCI, which the company referred to as administrative purposes. Patients previously enrolled in the trial are not affected and continue to receive treatment.


Only One of Three Trials Is Affected. The trial impacted is the Phase 2 evaluating PDS0101 (Versamune-HPV16) in a triple combination for advanced HPV cancers . The trial is sponsored by the National Cancer Institute and is testing PDS0101 with two other…

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.