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.

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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.”

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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.

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