Granted Composition of Matter Patent for Versamune® Platform by the United States Patent and Trademark Office
PRINCETON, N.J., March 05, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immuno-oncology company developing multiple therapies based on the Company’s proprietary Versamune® T-cell activating technology, today announced that it has been granted U.S. Patent No. 15/702,063 titled “Stimulation of an Immune Response by Enantiomers of Cationic Lipids” by the United States Patent and Trademark Office (USPTO).
“The expansion of our international patent portfolio furthers protects our novel Versamune® platform and the development of our robust pipeline,” commented Dr. Frank Bedu-Addo, CEO of PDS Biotech. "As we advance our lead program, PDS0101 towards three Phase 2 studies this year with leaders in the field of immuno-oncology, we believe that our Versamune® platform holds the potential to significantly improve clinical outcomes for patients.”
The U.S. Patent No. 15/702,063 titled “Stimulation of an Immune Response by Enantiomers of Cationic Lipids” provides protection for compositions of matter for the Versamune® platform including its chemical design and methods of delivery including oral, injectable and topical. The patent covers immune activating compositions containing the immunologically active enantiomer of the cationic lipid 1,2-dioleoyl-3-trimethyl-ammonium-propane (R-DOTAP) and a specific antigen. This patent has also been issued in several other countries including the European Union, Japan, Canada and Australia. The PDS Versamune® patent portfolio also includes broader cationic lipid compositions that activate the immune system. The combination of Versamune® with various antigens forms the basis for PDS Biotech’s broad immuno-oncology pipeline, including its lead candidate PDS0101 for the treatment of advanced human papillomavirus (HPV) related cancers.
About PDS Biotechnology
PDS Biotech is a clinical-stage immuno-oncology company developing multiple therapies based on the Company’s proprietary Versamune® T-cell activating technology platform. The Versamune® platform effectively delivers tumor-specific antigens for in vivo uptake and processing, while also activating a critical immunological pathway, the type 1 interferon pathway, thus resulting in the production of potent tumor-specific killer T-cells. Using Versamune®, PDS Biotech is engineering therapies designed to better recognize cancer cells and break down their defense systems to effectively attack and destroy tumors. PDS Biotech’s pipeline combines the Versamune® technology with tumor-specific antigens across several cancer types. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.
About PDS0101
PDS Biotech’s lead candidate, PDS0101, combines the utility of the Versamune® platform with targeted antigens in HPV-expressing cancers. In partnership with Merck, PDS Biotech is advancing a combination of PDS0101 and KEYTRUDA® to a Phase 2 study in first line treatment of recurrent or metastatic head and neck cancer. In partnership with the National Cancer Institute (NCI), PDS Biotech is also advancing a combination of PDS0101 and two clinical stage immunotherapies to a Phase 2 study in advanced HPV-associated cancers. A third phase 2 study is to be performed in advanced localized cervical cancer combining PDS0101 with the chemoradiotherapy, which is the standard of care.
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 Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the timing for the Company or its partners to initiate the planned clinical trials for its lead asset, PDS0101; the Company’s interpretation of the results of its Phase 1 trial for PDS0101 and whether such results are sufficient to support additional trials or the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101 and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the acceptance by the market of the Company’s product candidates, if approved; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company’s product candidates; 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:
Deanne Randolph
PDS Biotech
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Tram Bui / Alexander Lobo
The Ruth Group
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