PDS Biotechnology Announces Publication Supporting Novel Mechanisms of Action of its Proprietary Versamune® Platform in Cancer Immunotherapy

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BERKELEY HEIGHTS, N.J., May 15, 2019 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (“PDS Biotechnology”) (Nasdaq: PDSB), a clinical-stage immuno-oncology company pioneering the development of multifunctional immunotherapeutic products, today announced a peer-reviewed publication supporting the novel mechanisms of action of its proprietary Versamune platform in cancer immunotherapy. The article was published online on May 3, 2019 in the Journal of Immunology, and describes the way PDS’ Versamune platform recruits and activates killer T-cells to recognize and effectively attack cancer cells while simultaneously making cancer cells more susceptible to T-cell attack. The article will appear in print in the June 2019 issue of the Journal.

Dr. Lauren V. Wood, MD, PDS Biotechnology’s Chief Medical Officer, commented: "As a cancer immunologist who has spent the last decade performing translational and clinical research in immuno-oncology at the National Cancer Institute, the versatility of PDS’ Versamune technology, and the strength of this recently published data, demonstrates Versamune’s potential to provide significant advancements in the treatment of various cancers and debilitating diseases. With respect to our lead therapeutic candidate, PDS0101 (a combination of Versamune nanoparticles plus proprietary human papillomavirus (HPV)-16 E6 and E7 antigens), the Journal of Immunology article details Versamune’s ability to overcome the critical mechanisms associated with ineffective immune responses mediated by HPV16 and cancer cells, therefore leading to a superior anti-tumor effect. PDS is seeking to confirm this activity in upcoming clinical studies of PDS0101, which we plan to initiate by the end of this year. These studies include; a planned phase 2 combination study to evaluate PDS0101 in combination with Keytruda in the treatment of head and neck cancer, a phase 2 study to evaluate PDS0101 in advanced HPV-associated cancers, and an anticipated registration trial to evaluate PDS0101 monotherapy in the treatment of high-grade cervical dysplasia”.

The preclinical study detailed in the Journal of Immunology article examined the immunological activity of lipids, including the novel and proprietary cationic lipid enantiomer R-1,2-dioleoyl-3-trimethyl-ammonium-propane (R-DOTAP, a component of Versamune nanoparticles). The study was independently performed at the University of Kentucky School of Medicine in the laboratory of Professor Jerold Woodward and sponsored by PDS. Professor Woodward’s study corroborated the results of multiple earlier related preclinical studies, including those by Professor Leaf Huang, at UNC Chapel Hill and Dr. Samir Khleif at the National Cancer Institute (U.S. Patent No. 10,286,064).

These preclinical studies confirm the ability of the Versamune nanotechnology to promote antigen presentation via both the MHC Class I and Class II pathways, while simultaneously stimulating production of type 1 interferons. Together, both mechanisms appear to promote a powerful antigen-specific and multi-cytokine inducing (polyfunctional) killer T-cell (CD8+) response with strong potential for superior anti-tumor efficacy. In a tumor regression study performed with the HPV-tumor model system (TC-1), a single subcutaneous injection of tumor-bearing mice with a PDS0101 prototype uniquely induced complete regression of established tumors, and was associated with a dramatic increase in the ratio of HPV-specific killer T cells to immune suppressive regulatory T-cells within the tumor microenvironment prior to regression.

Versamune-based immunotherapies have been demonstrated to alter the tumor micro-environment in preclinical mechanism of action studies, thus further enhancing the ability of Versamune-induced T-cells to effectively kill tumor cells. Versamune is now being applied to the development of multiple clinical-stage cancer products, including those intended to address both early and late-stage cancer indications as monotherapies, as well as in combinations with other successful immuno-oncology approaches such as checkpoint inhibitors.

PDS Biotechnology’s lead product candidate, PDS0101 (Versamune-HPV) is a proprietary clinical stage immunotherapeutic administered by subcutaneous injection being developed to treat HPV-associated cancers such as head and neck cancers and anal cancers, both of which are widely reported to be increasing in frequency over the last decade, as well as cervical, penile, vaginal and vulvar cancers and their pre-cancerous conditions. In a human Phase 1/2a clinical study, PDS0101 monotherapy demonstrated potent induction of the critical phenotype of tumor-attacking killer (CD8) T-cells, and induction of memory T-cells. No dose-limiting toxicities were observed in this study, suggesting potential for a rare combination of potency and safety among immune-oncology therapeutics.

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Globe Newswire: 13:30 GMT Wednesday 15th May 2019

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