Combination of intralesional PV-10 with systemic immunomodulatory therapy to treat liver cancer granted US patent.

Tennessee-based Provectus Biopharmaceuticals has reported the company has been granted a patent for its combination of intralesional (“IL”) PV-10 with systemic immunomodulatory therapy, including anti-PD-1 and anti-PD-L1 agents, for treating melanoma and other cancers of the liver. The new patent is a continuation of USP 9,107,887, for Provectus’ first cancer combination therapy patent, granted in 2015. Pfizer, Inc., said Provectus, is a co-assignee on both patents.

PV-10 is an injectable formulation consisting of rose Bengal disodium; the development represents 10 years of work by the company to optimize the synthetic process for manufacturing the substance and its related halogenated xanthene analogs. According to the company it had recently presented preliminary results from Provectus’ ongoing Phase1b/2 study of PV-10 in combination with KEYTRUDA^® (pembrolizumab), the systemic anti-PD-1 (programmed death receptor-1) antibody agent from Merck, at the Society for Melanoma Research 2017 Congress, held in Brisbane, Australia in October. Provectus reported preliminary overall efficacy, including 10% complete response, 50% objective response and 60% receiving a clinical benefit, with the highest response, said the company observed in Stage IV M1c melanoma patients.

Chairman of Provectus’ Board of Directors, Dominic Rodrigues, noted that the patent continues the company’s work to expand the intellectual property protection of PV-10, “and to augment the potential commercial value of Provectus’ clinical development program in cancer combination therapy.” Rodrigues also explained, “Provectus’ ongoing Phase 1b study of PV-10 and KEYTRUDA is based on a rational study design for Stage IV melanoma patients with visceral disease, and provides for the investigation of the potential for small molecule oncolytic immunotherapy to demonstrate orthogonality to and synergy with checkpoint inhibition, combination therapy measures of safety and efficacy, respectively."

Concluding, Rodrigues commented: “Assuming a rational clinical basis for combination, another form of differentiation is needed to gain and protect market share for cancer combination therapy. We believe this aspect of our company’s patent estate provides for proprietary combinations with protected agents.”