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

Cambridge, Mass., May 8, 2018 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.  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.

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth N.J., USA.

Media Contact:

Stephanie Simon, Ten Bridge Communications
stephanie@tenbridgecommunications.com
617-581-9333