On July 11, 2023 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, reported the Canadian Intellectual Property Office has allowed patent number 2,876,656 titled, "Cationic Lipid Vaccine Combinations and Methods of Use," governing composition of matter and uses for Versamune (R-DOTAP) in combination with PDS0301 (Press release, PDS Biotechnology, JUL 11, 2023, View Source [SID1234633170]). The intellectual property provides broad protection for treatments utilizing Versamune based therapies, including PDS0101, in combination with PDS0301 as a potential treatment for cancer. This patent expands PDS Biotech’s market coverage and adds to the world-wide patent portfolio including the patent granted by the United States Patent and Trademark Office (USPTO), U.S. Patent No. 11,401,306, covering the combination of Versamune and cytokines including Interleukin 12 (IL-12).
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The Canadian patent will protect the capability of the composition of Versamune and PDS0301 to reduce the population of a well-documented population of cells called myeloid derived suppressor cells (MDSC) that enable the cancer to escape attack by T cells. The composition, when administered with a tumor antigen, enhances the Versamune induced anti-tumor response. Suppression of anti-tumor immune responses is a major mechanism by which tumor cells escape attack by T cells. MDSCs are reported to be the key immunosuppressive cells present in the tumor that protect the cancer’s ability to grow and are a major obstacle to effective cancer immunotherapy.
"This newly allowed patent adds to the intellectual property governing Versamune based therapies in combination with PDS0301, which we believe represent a potentially transformative treatment approach for advanced cancer patients," said Dr. Frank Bedu-Addo, CEO of PDS Biotech. "Possessing multilayered IP for our immunotherapies is an important value driver for PDS Biotech and is a key component of our business strategy. We anticipate that Canada will constitute an important market as we begin our commercialization and partnership strategies."
In December 2022, PDS Biotech provided an update on the National Cancer Institute led study of a combination of PDS0101, PDS0301 and an immune checkpoint inhibitor (ICI) in patients with various types of human papillomavirus (HPV) 16-positive cancers who had failed all prior treatments including ICI therapy. These patients have a historical median overall survival (OS) of 3-4 months on ICI therapy. This combination achieved a median overall survival of 21 months reported in 29 patients. In the patients who had not received prior ICI therapy, median OS had not yet been reached at 27 months, and an objective response rate of 88% (7/8) and complete response in 38% (3/8) of patients was reported. In similar ICI naïve patients on a combination of ICI therapy and chemotherapy, the published median OS is approximately 13 months and objective response is approximately 35%. Similar results with the combination of PDS0101, PDS0301 and an ICI were seen in all types of HPV-positive advanced cancers including anal, cervical, head and neck, vaginal and vulvar.
PDS Biotech’s exclusive rights to the combination of PDS0101 and PDS0301 permits it to design compositions and methods that overcome tumor immune suppression utilizing a different mechanism from checkpoint inhibitors.
About Versamune
Versamune is a novel investigational T cell activating platform which effectively stimulates a precise immune system response to a cancer-specific protein. Versamune based investigational immunotherapies promote a potent targeted T cell attack against cancers expressing the protein. They are given by subcutaneous injection and can be combined with standard of care treatments. Clinical data suggest that Versamune based investigational immunotherapies, such as PDS0101, demonstrate meaningful disease control by reducing and shrinking tumors, delaying disease progression and/or prolonging survival. Versamune based immunotherapies have demonstrated minimal toxicity to date that may allow them to be safely combined with other treatments. We believe Versamune based investigational immunotherapies represent a transformative treatment approach for cancer patients to provide improved efficacy, safety and tolerability.
About PDS0101
PDS0101, PDS Biotech’s lead candidate, is a novel investigational human papillomavirus (HPV)-targeted immunotherapy that stimulates a potent targeted T cell attack against HPV-positive cancers. PDS0101 is given by subcutaneous injection alone or in combination with other immunotherapies and cancer treatments. In a Phase 1 study of PDS0101 in monotherapy, the treatment demonstrated the ability to generate multifunctional HPV16-targeted CD8 and CD4 T cells with minimal toxicity. Interim data suggests PDS0101 generates clinically effective immune responses and the combination of PDS0101with other treatments can demonstrate significant disease control by reducing or shrinking tumors, delaying disease progression, and/or prolonging survival. The combination of PDS0101 with other treatments does not appear to compound the toxicity of other agents.
About PDS0301
PDS0301 is a novel investigational tumor-targeting antibody-conjugated Interleukin 12 (IL-12) that enhances the proliferation, potency and longevity of T cells in the tumor microenvironment. PDS0301 is given by a subcutaneous injection. PDS0301 is designed to improve the safety profile of IL-12 and to enhance the anti-tumor response.