Neon Therapeutics Announces Acceptance of European Clinical Trial Authorization Application for NEO-PTC-01
April 30 2020 - 7:00AM
Neon Therapeutics, Inc. (Nasdaq: NTGN) today announced the
acceptance of its Clinical Trial Authorization (CTA) from the Dutch
Health Authority (DHA) for its personal neoantigen-targeted T cell
therapy candidate, NEO-PTC-01. Neon’s initial Phase 1 clinical
trial of NEO-PTC-01 will be in patients with metastatic melanoma
who are not responsive to checkpoint inhibitors. NEO-PTC-01
is a personal neoantigen-targeted T cell therapy candidate derived
from patients’ peripheral blood mononuclear cells (PBMCs) and
consisting of multiple T cell populations targeting the most
therapeutically relevant neoantigens from each patient’s tumor.
The Phase 1 dose-finding clinical trial in
metastatic melanoma will be conducted in collaboration with
the Netherlands Cancer Institute and is expected to
begin in the third quarter of 2020, subject to the ability to
commence that trial in the Netherlands in light of the current
COVID-19 outbreak. Neon is also planning for a second indication
for NEO-PTC-01 in metastatic ovarian cancer, as well as for the
potential to both expand to other solid tumor types and pursue
clinical development in the United States.
“We are excited to be able to initiate this
first-in-human study of NEO-PTC-01 as it brings us closer to
demonstrating NEO-PTC-01’s potential to prime, activate and expand
neoantigen-targeting T cells in solid
tumors. Importantly, moving forward with this important trial
advances our goal to shift the paradigm in the treatment of cancer
patients towards an era of truly personal immuno-oncology
therapies,” said Hugh O’Dowd, Chief Executive Officer of Neon.
“We believe that NEO-PTC-01 has several key
advantages that overcome the challenges of other cell therapy
approaches. In preclinical studies, including research using
patient tumor samples, we have demonstrated the ability to produce
multiple neoantigen-specific CD8+ and CD4+ T cell
populations, including both memory and de novo T cell
responses. We have further shown that these T cell populations kill
tumor cells by targeting tumor neoantigens,” said Richard
Gaynor, M.D., President of Research and Development at Neon. “We
believe that our approach to leveraging these neoantigen targets
will provide the tumor specificity required to develop safe,
effective and durable T cell therapies for the treatment of solid
tumors. We look forward to demonstrating these potential benefits
in our Phase 1 study in checkpoint inhibitor, non-responsive
metastatic melanoma, which will commence later this year.”
About Neon Therapeutics
Neon is a biotechnology company developing novel
neoantigen-targeted T cell therapies, dedicated to transforming the
treatment of cancer by directing the immune system towards
neoantigens. Neon is using its neoantigen platform to develop both
personal and precision neoantigen-targeted T cell therapy
candidates. Neon’s most advanced program is NEO-PTC-01, its
personalized neoantigen-targeted T cell therapy candidate
consisting of multiple T cell populations targeting the most
therapeutically relevant neoantigens from each patient’s tumor.
For more information, please
visit www.neontherapeutics.com.
Forward-Looking Statements
This press release contains “forward-looking statements” of Neon
Therapeutics, Inc. within the meaning of the Private Securities
Litigation Reform Act of 1995. These forward-looking statements may
include, but may not be limited to, express or implied statements
regarding our completed and ongoing research into oncology targets;
the timing of clinical trials; the abilities of our RECON
bioinformatics platform; our ability to obtain and maintain
regulatory approval of our product candidates; the design and
potential efficacy of therapeutic approaches; financial plans and
projections; and our ability to replicate results achieved in our
preclinical studies or clinical trials in any future studies or
trials. Any forward-looking statements in this press release are
based on management’s current expectations and beliefs of future
events, and are subject to a number of risks and uncertainties that
could cause actual results to differ materially and adversely from
those set forth in or implied by such forward-looking statements.
These risks and uncertainties include, but are not limited to:
risks related to the initiation, timing and conduct of studies,
clinical trials and other research and development requirements for
our product candidates; the risk that any of our research
activities will result in a clinical application; the risk that any
one or more of our product candidates will not be successfully
developed and commercialized; the risk that the results of
preclinical studies and clinical trials may not be predictive of
future results in connection with future studies or trials; the
risk that our collaborations will not continue or will not be
successful; risks related to our ability to protect and maintain
our intellectual property position; risks related to our capital
requirements and use of capital and unexpected expenditures; and
risks related to the ability of our licensors to protect and
maintain their intellectual property position. For a discussion of
these and other risks and uncertainties, and other important
factors, any of which could cause Neon’s actual results to differ
from those contained in the forward-looking statements, see the
section entitled “Risk Factors” in Neon’s definitive proxy
statement, as filed with the Securities and Exchange Commission on
April 2, 2020, as well as discussions of potential risks,
uncertainties, and other important factors in Neon’s other filings
with the Securities and Exchange Commission. All information in
this press release is as of the date of the release, and Neon
undertakes no duty to update this information unless required by
law.
Investor Contact:Will O’Connor, Stern Investor
Relationswill@sternir.com 212-362-1200
Media Contact:Stephanie Simon, Ten Bridge
Communicationsstephanie@tenbridgecommunications.com
617-581-9333
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