Neon Therapeutics Announces First Patient Treated in Clinical Trial Evaluating Personal Cancer Vaccine NEO-PV-01 in Combination with KEYTRUDA® (pembrolizumab) and Chemotherapy

CAMBRIDGE, MA, USA I May 08, 2018 I 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.

“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.”

“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. More information about the trial is available at www.clinicaltrials.gov.

About Neon Therapeutics
Neon Therapeutics is a clinical-stage immuno-oncology company and a leader in the field of neoantigen-targeted therapies, dedicated to transforming the treatment of each patient’s cancer by directing the immune system towards neoantigens. We have pioneered a proprietary neoantigen platform to develop neoantigen-targeted therapies using two distinct approaches. In NEON / ONE, these neoantigens are specific to each individual. In NEON / SELECT, these neoantigens are shared across subsets of patients and tumor types. By leveraging both vaccines and T cell therapies, we hope to offer a new level of patient and tumor specificity that will drive a strong risk-benefit profile to improve patient outcomes.

For more information, please visit www.neontherapeutics.com.

SOURCE: Neon Therapeutics

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