On December 6, 2018 Neon Therapeutics, Inc. (Nasdaq: NTGN), a clinical-stage immuno-oncology company developing neoantigen-based therapeutics, and Apexigen, Inc., a clinical-stage biopharmaceutical company, reported that patient dosing has begun in NT-003, Neon’s Phase 1b combination trial of NEO-PV-01 in metastatic melanoma (Press release, Apexigen, DEC 6, 2018, View Source [SID1234591000]). NEO-PV-01 is a personal neoantigen vaccine custom-designed and manufactured based on the unique mutational fingerprint of each individual patient.
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The Phase 1b trial is evaluating NEO-PV-01 and nivolumab in combination with other agents in first-line patients with advanced or metastatic melanoma. One arm of the multi-arm study will evaluate the vaccine and nivolumab in combination with Apexigen’s APX005M, an investigational CD40 agonist. Another will evaluate NEO-PV-01 and nivolumab in combination with ipilimumab.
"We believe that there is very strong scientific rationale for treating patients with these additional agents as they may enhance neoantigen immune responses induced by NEO-PV-01 with the potential to drive additional clinical benefit," said Richard Gaynor, M.D., President of Research and Development at Neon Therapeutics.
"CD40 agonists such as APX005M have been shown to enhance antigen presentation, resulting in improved magnitude and quality of T cell responses and we share the enthusiasm of the team at Neon to conduct this clinical trial," said Ovid Trifan, M.D., Ph.D., Chief Medical Officer of Apexigen.
James P. Allison, Ph.D., a Nobel Prize winner, developer of the first FDA-approved checkpoint inhibitor (ipilimumab) and one of Neon’s founders, commented, "Both preclinical and clinical work have demonstrated that CTLA-4 antagonism enhances the priming of de novo immune responses and increases T cell infiltration into the tumor. These findings provide clear rationale for combining a checkpoint inhibitor such as ipilimumab with NEO-PV-01 to augment the immune response and potentially transform how we treat cancer."
About NT-003
NT-003 is a Phase 1b, open-label, multicenter clinical study of NEO-PV-01 with nivolumab, in combination either with APX005M or low dose ipilimumab, for the treatment of advanced or metastatic melanoma. APX005M or ipilimumab will only be dosed during the vaccination period.
More information regarding NT-003 can be found here.