PDS Biotech receives patent for its novel HPV16


FLORHAM PARK, NJ, Jan. 10, 2022 (GLOBE NEWSWIRE) – PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies based on its proprietary Versamune. developed® T-Cell Activation Technology, announced today that it has received US Patent Application No. 15,724,818, entitled “Novel HPV16 Non HLA-Restricted T-cell Vaccines, Composition and Methods of Use of There,” by the United States Patent and Trademark Office (USPTO). .

The newly granted patent covers PDS0101 immunotherapy, which is a combination of the Versamune technology platform and a unique blend of short protein fragments derived from the cancer-causing virus HPV16. The composition promotes the induction of killer (CD8 +) T cells by the immune system, which recognize and attack cancers caused by infection with HPV16 regardless of the patient’s genetic makeup.

HPV16 is the most oncogenic or carcinogenic type of HPV and is by far the most common in patients with advanced HPV-associated cancers, including anal, cervical, head and neck, penile, vaginal, and vulvar cancers. According to the International Journal of Cancer, more than 40,500 patients are diagnosed with HPV16-associated cancer each year. For some of these cancers, increases in the incidence have been reported in recent years.

“We continue to appreciate the promising early efficacy and safety data from our ongoing Phase 2 clinical trials. The early clinical data, coupled with the recent grant of the PDS0101 patent, which expires in late 2037, place PDS Biotech in a strong position to advance commercialization of the product to meet a significant unmet need for more effective treatment of advanced HPV-associated patients Cover cancers, ”said Frank Bedu-Addo, chief executive officer of PDS Biotech.

In partnership with Merck & Co. PDS Biotech is evaluating a combination of PDS0101 and KEYTRUDA® in a phase 2 study (NCT04260126) for the first-line treatment of recurrent or metastatic head and neck cancer and also for the second-line treatment of recurrent or metastatic head and neck cancer in patients for whom previous therapy with checkpoint inhibitors had failed. PDS Biotech is also conducting a phase 2 clinical trial with the National Cancer Institute (NCI) for the second- and third-line treatment of several advanced HPV-associated cancers. A third phase 2 clinical trial in the first-line treatment of locally advanced cervical cancer is being conducted with the University of Texas MD Anderson Cancer Center.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company operating a growing pipeline of cancer immunotherapies based on its proprietary Versamune. developed® Technology platform for activating T cells. Our Versamune®-based products have shown that they have the potential to overcome the limitations of current immunotherapy by being in vivo, large quantities of high quality, highly potent, polyfunctional tumor-specific CD4 + helper and CD8 + killer T cells. PDS Biotech has developed several therapies based on combinations of Versamune®® and disease-specific antigens that are designed to train the immune system to better recognize diseased cells and to attack and destroy them effectively. The company’s product pipeline targets a variety of cancers, including HPV16-associated cancers (anal, cervical, head and neck) and breast, colon, lung, prostate and ovarian cancers. To learn more, please visit www.pdsbiotech.com or follow us on Twitter @PDSBiotech.

Forward-Looking Statements

This release 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) regarding PDS Biotechnology Corporation (the “Company “) And other matters. These statements may discuss goals, intentions and expectations regarding future plans, trends, events, results of operations or financial condition or otherwise based on the current beliefs of the company’s management and assumptions made by and currently available information, administration. Forward-looking statements generally include statements that are predictive in nature and depend on or relate to future events or conditions and include words such as “may”, “will”, “should”, “would”, “expect”, “expect.” “. “,“ Plan ”,“ likely ”,“ believe ”,“ estimate ”,“ project ”,“ intend ”,“ forecast ”,“ guidance ”,“ outlook ”and other similar expressions among others. 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 due to various factors including, but not limited to: the company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s expected cash runway and the Company’s current expectations for its future equity financing plans; the company’s reliance on additional funding to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising this additional capital may restrict the company’s operations or force the company to acquire rights to the technologies or product candidates Abandon company; the company’s limited operating history in the company’s current line of business that makes it difficult to assess the company’s prospects, the company’s business plan, or the likelihood of the company successfully executing such a business plan; the timing for the company or its partners to begin the planned clinical trials for PDS0101, PDS0203, and other Versamune. initiate® based products; the future success of such attempts; the successful implementation of the company’s research and development programs and collaborations, including any collaborative studies on PDS0101, PDS0203, and other Versamune® based products and the company’s interpretation of the results and insights of such programs and collaborations and whether these results are sufficient to support the future success of the company’s product candidates; the success, timing, and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements about when to begin, how fast to start, and how to complete trials (including our ability to meet our disclosed fully fund clinical trials). which does not imply any material changes to our current expected expenses), futility analysis, presentations at conferences and published data in an abstract, and receiving interim results that do not necessarily indicate the final results of the Company’s ongoing clinical trials; any statements made by the company about its understanding of the mechanisms of action of product candidates and the interpretation of preclinical and early clinical results from its clinical development programs and all collaborative studies; the market acceptance of the company’s product candidates, if approved; the timing and ability of the company to obtain and maintain US Food and Drug Administration or other regulatory agency approval or other action in relation to the Company’s product candidates; and other factors, including legislative, regulatory, political and economic developments, beyond the control of the company, including unforeseen circumstances or other disruptions to the normal course of business, arising out of or related to COVID-19. The foregoing review of important factors that could cause actual events to differ from expectations should not be considered exhaustive and should be read in conjunction with statements contained herein and elsewhere, including the risk factors discussed in annual and periodic reports of the company are included, which at. Forward-looking statements are made only as of the date of this press release and, unless required by law, the company assumes no obligation to revise or update forward-looking statements or to make other forward-looking statements, whether as a result of new information, future events or for other reasons.


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