On April 30, 2018 Provectus Biopharmaceuticals, Inc. (OTCQB: PVCT, www.provectusbio.com), ("Provectus" or the "Company"), a clinical-stage biotechnology company developing PV-10 as the first small molecule oncolytic immunotherapy for solid tumor cancers, reported that the open-access journal PLOS ONE published results from an H. Lee Moffitt Cancer Center and Research Institute ("Moffitt") study investigating cancer combination therapy with intralesional ("IL") PV-10 and immune checkpoint blockade (anti-CTLA-4, anti-PD-1 and anti-PD-L1 antibodies) in murine melanoma models.1,2 The authors also examined the role of specific immune cell populations in eliciting and controlling tumor-specific response (Press release, Provectus Pharmaceuticals, APR 30, 2018, View Source [SID1234525865]).
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The Moffitt authors noted, "In this study, we have shown the impact of combining systemic checkpoint blockade (PD-1, PD-L1) with the tumor-specific immune response induced by IL PV-10. Treatment with IL PV-10 and anti-PD-1 antibody resulted in a delay in tumor growth and enhanced T cell activation in the M05 tumor model. Similar effects were observed with IL PV-10 and anti-PD-L1 antibody in the B16 tumor model. The effect of combination therapy with IL PV-10 and PD-1 blockade is mediated by CD8+ T cells, and depletion of either CD4+ T cells or CD4+CD25+ Tregs enhances anti-tumor immunity in the M05 melanoma model. Together these results support further development of clinical trials to assess safety and anti-tumor T cell responses in patients after IL injection of PV-10 in combination with checkpoint blockade."
Dominic Rodrigues, Vice Chair of the Company’s Board of Directors, said, "We are grateful to our research collaborators, like those at Moffitt, who continue to independently establish PV-10 as an oncolytic immunotherapy in both monotherapy and combination therapy settings."
Mr. Rodrigues added, "This PLOS ONE work established the rational clinical foundation for our ongoing Phase 1b/2 study PV-10 in combination with anti-PD-1 drug KEYTRUDA for patients with Stage IV melanoma. Moffit’s work also builds on the foundation for future combinations of PV-10 and anti-PD-L1 agents as well as other potential combinations and permutations of cancer therapies that include PV-10 as a key element."
About our Phase 1b/2 Study of PV-10 + KEYTRUDA for Stage IV Melanoma
The Phase 1b portion of the study continues to enroll patients with metastatic melanoma at clinical sites in the U.S. (NCT02557321). Stage IV patients with at least one injectable lesion who are candidates for KEYTRUDA are eligible. A total of up to 24 patients would receive the combination of IL PV-10 and KEYTRUDA every three weeks for five cycles (i.e., for up to 12 weeks, with no further PV-10 administered after week 12), followed by only KEYTRUDA every three weeks for up to 24 months. The primary endpoint for the Phase 1b trial is safety and tolerability; objective response rate and progression-free survival are key secondary endpoints (both assessed via RECIST 1.1 after five treatment cycles, and then every 12 weeks thereafter).
About PV-10
Provectus’ lead investigational oncology drug product, PV-10, the first small molecule oncolytic immunotherapy, can induce immunogenic cell death. PV-10 is undergoing clinical study for adult solid tumor cancers, like melanoma and cancers of the liver, and preclinical study for pediatric cancers.