Benzinga | Feb 22, 2021 08:33AM EST

PDS Biotechnology And Farmacore Biotechnology Announce Brazilian Pharmaceutical Company Blanver Has Joined Their Consortium To Develop And Commercialize A COVID-19 Vaccine In Latin America

FLORHAM PARK, N.J., Feb. 22, 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(r) T-cell activating technology, and Farmacore Biotechnology today announced that Blanver Farmoqu?mica e Farmac?utica S.A. has joined their consortium to develop and commercialize a novel COVID-19 vaccine in Latin America.



Blanver is a leading Brazilian Pharmaceutical Company focused on the development, manufacture, and commercialization of innovative pharmaceutical products. Under the terms of the agreement, S?o Paulo-based Blanver will manufacture, promote, distribute, and commercialize the Versamune(r)-based COVID-19 vaccine in Latin America. As the license holder of Versamune-CoV2-FC (PDS0203) in Latin America, Farmacore will continue to lead the regulatory and clinical trial efforts in Brazil and has selected a top clinical research organization to conduct clinical trials in Brazil. PDS Biotech will continue to contribute scientific expertise and operational support.

"Innovation is part of Blanver's DNA," commented Sergio Frangioni, Blanver Group CEO. "We are honored to join the consortium with PDS Biotech and Farmacore as our partners in Latin America to advance this innovative treatment to patients quickly in the fight against this deadly disease."

"We are delighted to have these two expert partners in Latin America, who provide a combination of scientific and manufacturing expertise in addition to local market experience to help broaden the potential reach of a Versamune(r)-based COVID-19 vaccine to patients," said Dr. Frank Bedu-Addo, CEO of PDS Biotech.

"We are excited to add Blanver's wealth of experience in development and commercialization across Latin America to this consortium as we continue in the fight against this global pandemic," said Helena Faccioli, CEO of Farmacore.

The consortium is in active discussions with specific agencies of the Brazilian government to extend the preclinical funding to cover the upcoming human clinical trials anticipated to begin during the first half of 2021.

The novel vaccine combines PDS Biotech's Versamune(r) T-cell activating technology with a SARS-CoV-2 recombinant protein antigen co-developed with Farmacore. As previously disclosed, preclinical data demonstrated that the vaccine 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 antigen without Versamune(r). The study also demonstrated induction of long-lasting virus-specific memory T-cells necessary for longer term protection. The studies also demonstrated strong, long-lasting induction of neutralizing antibodies. Notably, the vaccine contains a protein derived from the spike (S) protein that also includes the receptor binding domain (RBD) as well as other potentially non-mutating regions of the virus that can be recognized and attacked by T-cells. The vaccine is based on recombinant proteins (subunit vaccine) and does not require the use of attenuated viruses, traditional adjuvants, DNA or RNA to induce robust protective immune responses. In addition, a recent Phase I study of PDS0101, a Versamune(r)-based HPV16 subunit vaccine, demonstrated powerful T-cell responses and an attractive human safety profile with no serious or dose-limiting toxicities, presenting strong potential for an attractive safety profile for the novel Versamune(r)-based SARS-CoV-2 vaccine.