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PDS Biotechnology Signs Cooperative Research and Development Agreement with National Cancer Institute to Perform a Phase 2 Clinical Study of PDS0101 in Combination with Other Immune-modulating Agents in Advanced HPV-related Cancers

May 29, 2019

BERKELEY HEIGHTS, N.J., May 29, 2019 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (“PDS Biotechnology”) (Nasdaq: PDSB), a clinical-stage immuno-oncology company pioneering the development of novel multifunctional immunotherapeutic products, today announced that it has entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) for the development of the PDS0101 HPV cancer immunotherapy in combination with other immune-modulating agents as a potential treatment for advanced HPV-related cancers.

Under the agreement, PDS will collaborate with the NCI’s Genitourinary Malignancies Branch (GMB) and Laboratory of Tumor Immunology and Biology (LTIB) with plans to conduct a Phase 2 clinical study evaluating PDS0101, a novel, nanoparticle-based immunotherapy leveraging PDS’s proprietary Versamune® platform technology in combination with novel immune-modulating agents being studied at NCI as part of CRADAs with other companies. The CRADA also involves preclinical evaluation of PDS0101 in combination with other therapeutic modalities upon the mutual agreement of both parties. Versamune® is designed to promote cross-presentation of tumor antigens into the MHC Class I pathway, as well as strong and localized activation of the type I interferon immunological pathway. Activation of these mechanisms resulted in robust in vivo induction of active tumor-specific CD8+ killer T-cells in a first-in-human clinical trial of PDS0101 monotherapy.

Under a prior collaboration agreement between PDS and NCI, LTIB conducted in vitro and in vivo preclinical studies to evaluate the PDS0101 combination studies. The combination demonstrated potent induction of active tumor-infiltrating CD8 and CD4 T-cells and resulted in superior tumor regression efficacy. Based on this strong preclinical data PDS is eager to move the combination studies into a phase 2 human study.

Dr. Jeffrey Schlom, Chief, LTIB, and Dr. James Gulley, Chief, GMB, at NCI will serve as principal investigators for the NCI, while Dr. Frank Bedu-Addo and Dr. Lauren Wood, PDS’s Chief Medical Officer, will serve as PDS’s investigators.

Dr. Bedu-Addo, Chief Executive Officer of PDS Biotechnology commented, “We believe this CRADA provides further validation of our Versamune® platform and its potential in the treatment of cancer. With HPV-associated head and neck and anal cancers reported to be on a steady rise over the last decade, and the fact that these cancers are considered difficult to treat, there is an urgent need for more effective therapies. The preclinical work done by LTIB to-date suggests that a combination of immunotherapeutics has the potential to address key limitations of current therapies, and to become the type of treatment option that could bring significant benefit to patients. We look forward to working closely with Dr. Schlom and Dr. Gulley as we continue to advance the development of PDS0101 through these and other studies.”

About PDS0101 and the Versamune® Cationic Lipid Platform TechnologyVersamune® 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 BiotechnologyPDS 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 StatementsThis 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.

Media & Investor Relations Contact:Tram Bui / Alexander LoboThe Ruth GroupPhone: +1-646-536-7035 / +1-646-536-7037Email: tbui@theruthgroup.com / alobo@theruthgroup.com

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