Neon Therapeutics evaluates safety, efficacy of NEO-PV-01 in combination with KEYTRUDA and chemotherapy

Neon Therapeutics, a clinical-stage immuno-oncology company developing neoantigen-based therapeutics, today announced that it has treated the first patient in a clinical trial evaluating its proprietary personal neoantigen vaccine, NEO-PV-01, in combination with Merck's anti-PD-1 therapy, KEYTRUDA^® (pembrolizumab), along with chemotherapy. The trial is being conducted in collaboration with Merck, also known as MSD outside of the U.S. and Canada. NEO-PV-01 is Neon Therapeutics' most advanced product candidate and is a personal cancer vaccine designed specifically for each patient based on DNA mutations from that patient's tumor.

"Treating our first patient in this clinical study marks an important milestone for Neon," said Richard Gaynor, M.D., president of research and development at Neon Therapeutics. "We see a strong mechanistic rationale to explore the combination and sequence of a personal neoantigen cancer vaccine, anti-PD-1 therapy and chemotherapy. These data will help us understand the potential of NEO-PV-01 to improve durability and response rates of patients treated in combination with existing immuno-oncology drugs."

This Phase 1b clinical trial is designed to evaluate the safety, tolerability and preliminary efficacy of NEO-PV-01 in combination with KEYTRUDA and a chemotherapy regimen of pemetrexed and carboplatin in patients with untreated or advanced metastatic nonsquamous non-small cell lung cancer (NSCLC). Additionally, the trial will assess neoantigen-specific immune responses in peripheral blood and tumor tissue, and other markers of immune response. This open-label clinical trial is anticipated to enroll a total of 15 patients, with possible expansion.

Enrolled patients will undergo an initial biopsy and receive treatment with chemotherapy and KEYTRUDA. Neon Therapeutics will then manufacture a personal vaccine for each patient, based on an analysis of tumor neoantigen mutations. At week 12 of treatment, patients receive the NEO-PV-01 vaccine while continuing therapy with KEYTRUDA.