Neon Therapeutics has entered a clinical trial collaboration with Merck to carry out a Phase lb trial of NEO-PV-01 in combination with Keytruda and chemotherapy to treat patients with untreated advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC).
The trial also aims to evaluate the safety, tolerability and preliminary efficacy of NEO-PV-01 in combination with KEYTRUDA, pemetrexed and carboplatin in patients with NSCLC.
It will further examine neoantigen-specific immune responses in peripheral blood and tumour tissue, and other markers of immune response.
Neon Therapeutics’ NEO-PV-01 will be used in the proposed Phase lb trial and is a personal neoantigen vaccine based on DNA mutations from each patients’ tumour, while Merck’s Keytruda (pembrolizumab) is an anti-PD-1 therapy.
Neon Therapeutics Research and Development president MD Richard Gaynor said: “We believe there is a strong mechanistic rationale to explore the combination of a personal neoantigen cancer vaccine, anti-PD-1 therapy and chemotherapy.
“Together with a growing set of clinical collaborators, we are working to amass a diverse set of clinical data to understand the potential of NEO-PV-01 to improve durability and response rates in combination with multiple immuno-oncology targets.”
In July, Neon Therapeutics announced a partnership to evaluate NEO-PV-01 in combination with Apexigen’s CD40 agonist antibody, APX005M, for the treatment of patients with metastatic melanoma.
Under the immuno-oncology clinical trial collaboration, the companies expect to initially partner in a Phase 1b trial sponsored by Neon Therapeutics.
The trial will evaluate the safety, tolerability and preliminary efficacy of NEO-PV-01 in combination with APX005M, as well as other immuno-oncology agents to treat metastatic melanoma.
Neoantigen-specific immune responses in peripheral blood and tumour tissue will also be examined.