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.
About the Versamune® Cationic Lipid Platform Technology
Versamune® is a proprietary, clinical stage, synthetic lipid-based immunotherapy platform. PDS Biotechnology’s pipeline of Versamune®-based products, which are administered by subcutaneous injection, provides strong activation of type I interferon genes. The Versamune® mechanism of action also involves effective presentation of tumor antigens via the MHC Class I and Class II pathways. These two mechanisms together promote strong in-vivo induction of polyfunctional tumor-targeting CD8+ T-cells as well as antigen-specific CD4+ T cells. This result, as well as a high degree of safety, was confirmed in the PDS0101 monotherapy Phase 1/2a human clinical trial.
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.
About PDS Biotechnology
PDS Biotechnology is a clinical stage immuno-oncology company with a growing pipeline of clinical-stage immunotherapies to treat various early-stage and late-stage cancers, including head and neck cancer, cervical, anal, prostate, breast and other cancers.
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 in-vivo 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.
For additional information about PDS, please visit www.pdsbiotech.com.
Forward Looking Statements
This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” and other similar expressions among others. Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the ability of the Company to integrate Edge and PDS Biotechnology following the merger; the Company’s ability to protect its intellectual property rights; competitive responses to the completion of the merger; potential adverse reactions or changes to business relationships resulting from the completion of the merger; the Company’s ability to access capital markets, the timing for the Company to initiate two clinical trials for its lead asset, PDS0101; the successful implementation of the Company’s research and development programs and collaborations; the acceptance by the market of the Company’s product candidates, if approved; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company’s annual and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.
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PDS Biotechnology Corporation
