On January 12, 2022 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies based on the Company’s proprietary Versamune T-cell activating technology, reported that it has been granted U.S Patent Application No. 15,724,818 titled "Novel HPV16 Non HLA-Restricted T-cell Vaccines, Composition and Methods of Use Thereof" by the United States Patent and Trademark Office (USPTO) (Press release, PDS Biotechnology, JAN 12, 2022, View Source [SID1234598617]).
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The newly issued patent covers the PDS0101 immunotherapy which consists of a combination of the Versamune technology platform with a unique mixture 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 that recognize, and attack cancers caused by infection with HPV16 irrespective of the patients’ genetic makeup.
HPV16 is the most oncogenic or cancer-causing type of HPV, and is by far the most prevalent in patients with advanced HPV-associated cancers, including anal, cervical, head and neck, penile, vaginal and vulvar cancers. More than 40,500 patients are diagnosed with HPV16-associated cancers each year according to the International Journal of Cancer. Some of these cancers have been reported to be increasing in incidence over the last few years.
"We remain excited about 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 that runs into late 2037 puts PDS Biotech in a strong position to progress commercialization of the product to address a significant unmet need for more effective treatment of advanced HPV-associated cancers," stated 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) in first-line treatment of recurrent or metastatic head and neck cancer, and also in second line treatment of recurrent or metastatic head and neck cancer in patients who have failed prior checkpoint inhibitor therapy. PDS Biotech is also conducting a Phase 2 clinical study in both second- and third-line treatment of multiple advanced HPV-associated cancers with the National Cancer Institute (NCI). A third Phase 2 clinical trial in first line treatment of locally advanced cervical cancer is being performed with The University of Texas, MD Anderson Cancer Center.