Neon Therapeutics and Apexigen Announce First Patient Dosed in Neon’s NT-003 Phase 1b Combination Trial of NEO-PV-01 in Met...
December 06 2018 - 7:00AM
Neon Therapeutics, Inc. (Nasdaq: NTGN), a clinical-stage
immuno-oncology company developing neoantigen-based therapeutics,
and Apexigen, Inc., a clinical-stage biopharmaceutical
company, today announced that patient dosing has begun in
NT-003, Neon’s Phase 1b combination trial of NEO-PV-01 in
metastatic melanoma. NEO-PV-01 is a personal neoantigen vaccine
custom-designed and manufactured based on the unique mutational
fingerprint of each individual patient.
The Phase 1b trial is evaluating NEO-PV-01 and nivolumab in
combination with other agents in first-line patients with advanced
or metastatic melanoma. One arm of the multi-arm study will
evaluate the vaccine and nivolumab in combination with Apexigen's
APX005M, an investigational CD40 agonist. Another will evaluate
NEO-PV-01 and nivolumab in combination with ipilimumab.
“We believe that there is very strong scientific rationale for
treating patients with these additional agents as they may enhance
neoantigen immune responses induced by NEO-PV-01 with the potential
to drive additional clinical benefit,” said Richard Gaynor, M.D.,
President of Research and Development at Neon Therapeutics.
“CD40 agonists such as APX005M have been shown to enhance
antigen presentation, resulting in improved magnitude and quality
of T cell responses and we share the enthusiasm of the team at Neon
to conduct this clinical trial,” said Ovid Trifan, M.D., Ph.D.,
Chief Medical Officer of Apexigen.
James P. Allison, Ph.D., a Nobel Prize winner, developer of the
first FDA-approved checkpoint inhibitor (ipilimumab) and one of
Neon’s founders, commented, “Both preclinical and clinical work
have demonstrated that CTLA-4 antagonism enhances the priming
of de novo immune responses and increases T cell
infiltration into the tumor. These findings provide clear rationale
for combining a checkpoint inhibitor such as ipilimumab with
NEO-PV-01 to augment the immune response and potentially transform
how we treat cancer.”
About NT-003
NT-003 is a Phase 1b, open-label, multicenter clinical study of
NEO-PV-01 with nivolumab, in combination either with APX005M or low
dose ipilimumab, for the treatment of advanced or metastatic
melanoma. APX005M or ipilimumab will only be dosed during the
vaccination period.
More information regarding NT-003 can be found here.
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 cancer by directing the
immune system towards neoantigens. Neon is using its neoantigen
platform to develop both vaccine and T cell therapies, including
NEO-PV-01, a clinical-stage neoantigen vaccine for the treatment of
metastatic melanoma, non-small cell lung cancer, and bladder
cancer; NEO-PTC-01, a neoantigen T cell therapy for the treatment
of solid tumors; and NEO-SV-01, a neoantigen vaccine for the
treatment of a subset of estrogen-receptor-positive breast cancer.
For more information, please
visit www.neontherapeutics.com.
About Apexigen
Apexigen is a clinical-stage biopharmaceutical company
discovering and developing a new generation of antibody
therapeutics for oncology, with an emphasis on new immuno-oncology
agents that could harness the patient’s immune system to combat and
eradicate cancer. The Company’s lead immuno-oncology therapeutic
APX005M, a CD40 agonist, is currently being evaluated in seven
Phase 2 and two Phase 1 clinical trials for the treatment of
patients with solid tumors. APX005M and the additional preclinical
programs were discovered using APXiMAB™, Apexigen’s proprietary
product discovery platform. For more information, please visit
www.apexigen.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 ability to obtain and maintain regulatory approval of
our product candidates; the potential timing and advancement of our
preclinical studies and clinical trials; the design and potential
efficacy of our therapeutic approaches; the ability and willingness
of our third-party research institution collaborators to continue
research and development activities relating to our product
candidates; our ability and the potential to successfully
manufacture and supply our product candidates for clinical trials;
our ability to replicate results achieved in our preclinical
studies or clinical trials in any future studies or trials;
regulatory developments in the United States and foreign countries;
our expectations regarding our ability to obtain and maintain
intellectual property protection for our product candidates; and
our expectations regarding our uses of capital, expenses, future
accumulated deficit and other financial results. 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: uncertainties
related to the initiation and conduct of studies and other
development requirements for our product candidates; 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 will be predictive of
future results in connection with future studies or trials; the
risk that Neon’s collaborations will not continue or will not be
successful; risks related to our ability to protect and maintain
our intellectual property position; 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 most recent Quarterly Report on Form 10-Q, as filed with
the Securities and Exchange Commission, 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.
Media Contact:Stephanie Simon, Ten Bridge
Communicationsstephanie@tenbridgecommunications.com
617-581-9333
Investor Contact:Will O’Connor, Stern Investor
Relationswill@sternir.com212-362-1200
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