Neon Therapeutics has treated the first patient in a Phase Ib clinical trial that aims to analyse NEO-PV-01 vaccine in combination with Keytruda (pembrolizumab) along with chemotherapy to treat patients with untreated or advanced metastatic nonsquamous non-small cell lung cancer (NSCLC).

Conducted in partnership with Merck, the trial seeks to investigate the safety, tolerability and preliminary efficacy of NEO-PV-01 in combination with Keytruda, as well as a chemotherapy regimen of pemetrexed and carboplatin.

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The open-label trial will also examine neoantigen-specific immune responses in peripheral blood and tumour tissue, and other markers of immune response.

The trial expects to enrol a total of 15 patients and plans to expand enrolment.

“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.”

As part of the trial, patients will undergo an initial biopsy and receive treatment with chemotherapy and Keytruda.

Neon will then manufacture a personal vaccine for each patient, depending upon an analysis of tumour neoantigen mutations.

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At week 12, patients will receive the NEO-PV-01 vaccine, along with Keytruda.

Neon Therapeutics research and development president Richard Gaynor said: “Treating our first patient in this clinical study marks an important milestone for Neon.

“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.”

NEO-PV-01 is currently under development by Neon Therapeutics as a personal cancer vaccine designed specifically for each patient based on DNA mutations from that patient’s tumour.

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