Neon Therapeutics Announces First Patient Treated in Clinical Trial Evaluating Personal Cancer Vaccine NEO-PV-01 …


CAMBRIDGE, Mass.–()–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.



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