Neon Therapeutics and Apexigen start Phase IIb combination trial for melanoma


Immuno-oncology firm Neon Therapeutics has partnered with biopharmaceutical company Apexigen to investigate its NEO-PV-01 in combination with APX005M in a Phase IIb trial to treat patients with metastatic melanoma.

NEO-PV-01 is Neon Therapeutics’ fully personalised neoantigen vaccine that is formulated based on DNA mutations obtained from individual tumours of the patients.

Based on research by the Broad Institute of MIT and Harvard and Dana-Farber Cancer Institute, NEO-PV-01 is currently being studied in several trials.

APX005M is a humanised monoclonal agonist antibody of CD40 developed by Apexigen to activate the immune system’s antigen-presenting cells (APCs) for triggering an anti-tumour immune response in the tumour microenvironment.

APX005M was previously reported to have showed immune stimulation in solid tumour patients evaluated in a Phase I clinical trial.

"This clinical combination builds upon robust preclinical evidence suggesting potential synergy between a CD40 agonist and a neoantigen-based cancer vaccine."

Neon Therapeutics research and development president Richard Gaynor said: “This clinical combination builds upon robust preclinical evidence suggesting potential synergy between a CD40 agonist and a neoantigen-based cancer vaccine.”

Funded by Neon Therapeutics, the Phase IIb trial will initially assess the safety, tolerability and preliminary efficacy of NEO-PV-01 and APX005M combination with additional immuno-oncology agents.

Apexigen chief medical officer Ovid Trifan said: “We are excited to explore the combination of NEO-PV-01 and APX005M, because the scientific rationale indicates promise for this new combination approach to generate anti-tumour efficacy for patients with solid tumours.”

The Phase IIb trial will also monitor neoantigen-specific immune responses and other immune response markers in peripheral blood and tumour tissue.