PDS Biotech Advances the Fight Against Cancer with its Versamune® Platform

The following post was written and/or published as a collaboration between Benzinga’s in-house sponsored content team and a financial partner of Benzinga.

PDS Biotechnology Corporation (NASDAQ: $PDSB) will be reporting preliminary Phase 2 clinical data of its lead compound PDS0101 for the treatment of advanced HPV-associated cancers in patients whose cancer has returned or progressed after treatment at the upcoming American Society of Clinical Oncology (ASCO) 2021 Annual Meeting on June 4-8.  The study is being performed under a collaboration agreement with the National Cancer Institute (NCI).

PDS Biotech’s pipeline is based on its proprietary T-cell activating Versamune® platform to overcome key limitations of immuno-oncology. Versamune® is designed to train the immune system to generate powerful tumor-targeting killer T-cells in patients to treat cancer more effectively with minimal side effects.

Preliminary Data in the Fight Against Cancer

PDS Biotech’s lead oncology asset, PDS0101, is being studied in three Phase 2 clinical trials for the treatment of multiple types of advanced HPV-associated cancers including anal, cervical, head and neck, penile, vaginal and vulvar cancers.  

Earlier this year, the company announced that the first of these Phase 2 trials, which is being led by the NCI, had reached its preliminary goal of achieving an objective anti-tumor effect (regression or shrinkage) in 3 or more of the first 8 subjects.   

Abstract 2501 from the “Phase II evaluation of the triple combination of PDS0101, M9241 and bintrafusp alfa in patients with HPV 16 positive malignancies” will be presented by Dr. Julius Strauss of the NCI during the Developmental Therapeutics - Immunotherapy session on June 7 from 3 p.m. to 6 p.m. EST.  

The planned presentation at ASCO will provide a look at more mature data from the NCI-led clinical trial, which is studying the effect of PDS0101 administered in combination with two of EMD Serono’s investigational immunotherapy agents.  

“The efficacy achievement in this NCI-led Phase 2 clinical trial strengthens the evidence of our novel Versamune® platform’s potential ability to induce high levels of tumor-specific killer T-cells that attack cancer to achieve tumor regression,” commented Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech.

“The initial data suggests that this novel combination has the potential to significantly improve clinical outcomes for patients with advanced HPV-associated cancers and limited treatment options.”

Application of Versamune® in Inducing T-Cells Against COVID-19

PDS Biotechnology’s Versamune® platform is also being evaluated in a COVID-19 vaccine. PDS0203, the company’s COVID-19 vaccine, is being developed in Brazil in partnership with Brazilian pharmaceutical companies Farmacore and Blanver.

Recently, PDS Biotech announced that its COVID-19 vaccine consortium received a commitment from The Ministry of Science, Technology and Innovation of Brazil (MCTI) to fund clinical development and commercialization of its PDS0203 with an award of up to $60 million USD.  PDS Biotech expects to move into clinical trials in Q3 of 2022 in Brazil, with the goal of commercialization in Latin America by 2023.

It was also recently reported in a leading peer-reviewed journal that Versamune® promoted superior induction of neutralizing antibodies in a COVID-19 vaccine. In addition, PDS0203 has demonstrated strong T-cell induction. T-cells are known to be an important component of an effective antiviral immune response.

It is also anticipated that PDS0203 may induce a greater breadth of protective immune responses and has the potential for enhanced long-term protection against multiple variants of the SARS-CoV-2 virus that causes COVID-19. 

The company is financially sound, ending 2020 debt-free with $28.8 million in cash on hand. 

Visit https://www.pdsbiotech.com/ for further information. 

The preceding post was written and/or published as a collaboration between Benzinga’s in-house sponsored content team and a financial partner of Benzinga. Although the piece is not and should not be construed as editorial content, the sponsored content team works to ensure that any and all information contained within is true and accurate to the best of their knowledge and research. This content is for informational purposes only and not intended to be investing advice.