PDS Biotech and Farmacore Announce Updates to Co-Development of Versamune®-Based COVID-19 Vaccine

PDS0203 prioritized for clinical development by PDS Biotech and Farmacore after successful meeting with Brazilian Drug Regulatory Agency

FLORHAM PARK, NJ, USA I November 10, 2020 I 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 progress on its co-development program with Farmacore Biotechnology for a Versamune®-based vaccine aimed at preventing COVID-19 infection.

Based on promising and robust preclinical data with PDS0203, and in the interest of rapid development, PDS Biotech and Farmacore have jointly prioritized advancement of PDS0203 to human clinical trials. PDS Biotech had previously announced the parallel development of two Versamune®-based COVID-19 vaccines PDS0203 and PDS0204 each containing different SARS-CoV-2 proteins. The decision to jointly develop PDS0203 was made with the support of the Agência Nacional de Vigilância Sanitária (ANVISA) following a successful pre-investigational new drug meeting on November 06, 2020. ANVISA and Farmacore reviewed the PDS0203 data and agreed on the path forward for official submission of a final data package and the phase 1/2 human clinical trial protocol. Farmacore is in discussions with specific agencies of the government to extend the preclinical funding to cover the upcoming human clinical trial anticipated to begin during the first half of 2021.

As previously disclosed, PDS Biotech has generated robust preclinical data demonstrating that PDS0203 elicits a 30-45 fold increase in the induction of highly active and potent virus-specific T-cells within 14 days of treatment compared to the vaccine without Versamune®. Importantly, the study also demonstrated induction of the long-lasting virus-specific memory T-cells necessary for longer term protection. The vaccine has also demonstrated strong and long-lasting induction of neutralizing antibodies. The PDS0203 subunit vaccine is based on recombinant proteins and does not require the use of inactivated viruses, traditional adjuvants, DNA or RNA to induce robust protective immune responses.

“PDS0203 may present strong potential to provide the breadth and level of immune responses necessary for a safe and effective vaccine with long-term protection against COVID-19," said Dr. Greg Conn, Chief Scientific Officer of PDS Biotechnology.

“PDS Biotech and Farmacore are now one step closer to advancing our Versamune®-based COVID-19 vaccine into the clinic,” said Dr. Frank Bedu-Addo, Chief Executive Officer of PDS Biotech. “The preclinical results of PDS0203 demonstrate its potential to induce a robust and broad immune response. We look forward to evaluating our next-generation vaccine in planned human clinical trials in partnership with Farmacore and to advance our understanding of the potential of novel Versamune®-based vaccines like PDS0203 to provide long-term protection against infection with viruses such as SARS-CoV-2.”

“In this global pandemic, it is incumbent upon the scientific community to be flexible and to ensure we are prioritizing the vaccine with the most clinical potential and that we can progress most quickly,” said Helena Faccioli, CEO of Farmacore. “We are excited to continue advancing the partnership with PDS Biotech, and we are thrilled to have the support of ANVISA to provide the opportunity to develop a treatment in Brazil in the fight against this pandemic.”

The companies plan to utilize multiple research and development sites in the United States and Brazil to progress preclinical and clinical development PDS0203.  Farmacore will lead the regulatory and clinical trial efforts in Brazil while PDS Biotech will continue to contribute scientific expertise and operational support.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune® T-cell activating technology platform. Versamune® effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has engineered multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

About Farmacore

Farmacore is a biotechnology company, founded in 2005 as a startup, focusing on R&D of innovative immunobiological products for use in the human and veterinary health sectors. It is a technology-based company that conducts research and development of biotechnological products and processes for the human and veterinary sectors. It develops innovative biotechnological and immunobiological products and adds value to them in all stages of development, from project design to biomolecule production www.farmacore.com.br.

About PDS0203

PDS0203 is an investigational vaccine designed for the prevention of COVID-19 being jointly developed by PDS Biotech and Farmacore. PDS0203 combines the utility of PDS Biotech’s Versamune® platform with a recombinant native Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) protein recognizable by our immune system (antigen). The Versamune® platform, due to its unique ability to induce both antibody and T-cell responses is being utilized to develop a next generation vaccine that may more effectively prevent COVID-19.

SOURCE: PDS Biotech

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