PDS Biotechnology and Farmacore Biotechnology Announce Co-Development of PDS0204 COVID-19 Vaccine

Brazilian government to provide initial funding support to progress development of Versamune®-based vaccine to prevent COVID-19 infection

FLORHAM PARK, NJ, USA I June 17, 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 a co-development agreement with Farmacore Biotechnology for Versamune®-CoV-2FC, a Versamune®-based vaccine aimed at preventing COVID-19 infection.

Under the collaboration, PDS Biotech and Farmacore will accelerate development of Versamune®-CoV-2FC into Phase 1 clinical testing in Brazil, with initial financial support provided by the Brazilian Ministry of Science, Technology, Innovation and Communication (MCTIC). Versamune®-CoV-2FC combines a Farmacore-developed recombinant SARS-CoV-2 protein with PDS Biotech’s Versamune® platform nanotechnology. The rapid advancement of this joint COVID-19 program expands upon a previously announced research and development collaboration between PDS Biotech and Farmacore to develop a Versamune®-based vaccine for tuberculosis.

“We are excited to expand our ongoing collaboration with Farmacore, which provides an opportunity to rapidly accelerate development of a novel COVID-19 vaccine into Phase 1 clinical testing in Brazil,” said Dr. Frank Bedu-Addo, Chief Executive Officer, PDS Biotech. “We believe that pairing PDS Biotech’s Versamune® T-cell activating vaccine technology with Farmacore’s recombinant SARS-CoV-2 protein will allow us to quickly assess the efficacy of Versamune®-CoV-2FC to potentially reduce the continuing spread of COVID-19 infections.”

“This is a global pandemic, which requires a global effort. In joining forces with our partner PDS Biotech, we believe we can substantially accelerate our development efforts to bring an effective COVID-19 vaccine, inducing a broader range of long-term protective immune responses, to people around the world,” said Helena Faccioli, Executive Director of Farmacore.

The companies plan to utilize multiple research and development sites in the United States and Brazil to progress preclinical and clinical development of Versamune®-CoV-2FC. Under the terms of the agreement, Farmacore retains commercialization rights in Latin America, and revenues from Latin America sales will be shared between the two companies. PDS Biotech retains the right of first refusal for commercialization outside of Latin America. PDS Biotech is in discussions with other governmental and non-governmental agencies regarding additional funding for a COVID-19 vaccine.

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 Versamune®-CoV-2FC

Versamune®-CoV-2FC (PDS0204) is a COVID-19 vaccine candidate that combines the immune-activating Versamune® platform with a Farmacore-developed recombinant fusion protein of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) recognizable by our immune system (antigen). The vaccine’s target profile is to provide rapid induction of neutralizing antibodies, as well as killer T-cells and memory T-cells against the SARS-CoV-2 virus, in patients vaccinated with PDS0204 to protect against COVID-19 and to prevent spread of the infection.

SOURCE: PDS Biotechnology

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