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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, N.J.,
About this update from Pds Biotechnology Corporation
[{"type":"text","content":"PDS0203 prioritized for clinical development by PDS Biotech and Farmacore after successful meeting with Brazilian Drug Regulatory Agency\nFLORHAM PARK, N.J., Nov. 10, 2020 (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 progress on its co-development program with Farmacore Biotechnology for a Versamune®-based vaccine aimed at preventing COVID-19 infection.\n 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 lo...