PDSB stock rose in pre-market trading on July 27, 2020, after the company announced pre-clinical data.

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 preclinical data for its COVID-19 vaccine candidate, Versamune-CoV-2 (PDS0203). PDS0203 pairs the Versamune® platform with a recombinant protein recognized by the human immune system that is derived from the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) virus that causes COVID-19. The protein included in PDS0203 encompasses SARS-CoV-2 sections that induce an antibody response, as well as sections that are recognized by CD8 and CD4 T-cells.

PDS Biotech has generated robust preclinical data confirming that PDS0203 elicits induction of highly active and potent virus-specific CD8 killer and CD4 helper T-cells within 14 days of treatment. Importantly, the study also demonstrated induction of the long-lasting virus-specific memory T-cells necessary for longer term protection. PDS0203 demonstrated a 30-45 fold increase in COVID-19 specific T-cells by Day 14 when compared to the vaccine without Versamune®. These preclinical studies also confirmed induction of strong anti-SARS-CoV-2 neutralizing antibodies within 14 days, with a 20-25-fold increase when compared to the vaccine without Versamune®. Lastly, these preclinical studies showed a further substantial increase in neutralizing antibody levels continuing more than 30 days after vaccination. PDS Biotech plans to submit details of the preclinical studies to a peer reviewed scientific journal.

“Recent COVID-19 research has highlighted the critical importance of developing vaccines capable of generating high levels of targeted CD8 and CD4 T-cells, in addition to neutralizing antibodies, to achieve durable protection against COVID-19 infection. Our preclinical data shows PDS0203’s ability to rapidly induce both protective antibodies and long-lasting T-cells specific for COVID-19,” commented Dr. Frank Bedu-Addo, CEO of PDS Biotech, “Due to the mechanism by which Versamune® activates a disease-specific immune response, our PDS0101 program demonstrated successful translation of T-cell induction and safety data from preclinical models to humans. We therefore believe that this encouraging PDS0203 preclinical data may similarly translate to humans. If so, then it may present unique potential to provide the breadth and level of immune responses necessary for a safe and effective vaccine with long-term protection against COVID-19.”

As previously announced, the Company has also initiated preclinical development of Versamune®-CoV-2FC (PDS0204), a COVID-19 vaccine candidate being developed in partnership with Brazil-based Farmacore Biotechnology, which combines the immune-activating Versamune® platform with a Farmacore-developed SARS-CoV-2 recombinant fusion protein.

The Versamune® technology is based on proprietary immune activating lipids that uniquely activate an important immunological signaling pathway, called the Type 1 interferon signaling pathway, known to be important in the induction of both anti-viral and anti-tumor immune responses. It also promotes efficient access of the disease-specific immunologically recognized protein (antigen) into two important immunological pathways called the Class I and II MHC pathways, therefore enabling powerful induction and activation if CD8 (Killer) and CD4 (helper) T-cells that can recognize, kill and protect against the specific disease. The technology is protected by multiple international composition and application patents.

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