Neon Therapeutics Provides Business Update and Outlook for 2019
January 03 2019 - 6:00AM
Neon Therapeutics, Inc. (Nasdaq: NTGN), a clinical-stage
immuno-oncology company developing neoantigen-based therapeutics,
today provided a business update and outlook for 2019.
“We have an exciting year ahead of us in 2019, with multiple
data readouts from our personal neoantigen vaccine program,
NEO-PV-01, in a variety of metastatic cancer settings using a
number of rational treatment combinations. We are also continuing
to investigate monotherapy opportunities and look forward to
sharing our plans later this year,” said Hugh O’Dowd, Neon’s Chief
Executive Officer.
“We expect the upcoming data readouts to include correlations
between mechanism of action and clinical response and enable
development of later-stage trials that will draw on treatment
combinations and target patient populations most likely to benefit
from our personal cancer vaccine,” said Richard Gaynor, M.D.,
Neon’s President of Research and Development.
Neon also continues to advance its T cell programs, including
the development of a library of high-quality TCRs. “I expect these
programs to become increasingly important in 2019, as we continue
to build a diversified clinical-stage pipeline,” Mr. O’Dowd
said.
With regard to its personal neoantigen T cell program,
NEO-PTC-01, Neon continues to build on data presented at the
Society for the Immunotherapy of Cancer 2018 Annual
Meeting. The Company plans to file a European Clinical Trial
Application (CTA) in the first half of 2019 to enable it to
initiate a first-in-human clinical study of NEO-PTC-01, which is
being developed in collaboration with the Netherlands Cancer
Institute (NKI).
“Data from our ongoing research give us added confidence that we
can reliably generate multiple enriched neoantigen-specific T cell
populations that are capable of killing tumor cells,” said Dr.
Gaynor. “We believe NEO-PTC-01 has several significant advantages
that could overcome the challenges of other cell therapies in the
solid tumor setting and we look forward to evaluating this approach
in checkpoint refractory patients.”
John Haanen, M.D., Ph.D., Professor and Head of the Medical
Oncology Division at the NKI, remarked: “We are excited to be
working with Neon to initiate the first neoantigen adoptive T-cell
clinical trial that seeks to elicit both de novo and memory T cell
responses across a range of solid tumors in patients that are
refractory to checkpoint inhibitors.”
With respect to TCRs, Neon has been leveraging its RECON®
bioinformatics engine to identify shared neoantigen epitopes and
its NEO-STIM™ induction protocol to generate neoantigen-reactive
T-cell receptors to these epitopes. Drawing on this work, Neon has
assembled libraries of high-quality TCRs against various shared
neoantigens across common HLAs.
“Our maturing T cell programs will join our vaccine programs in
developing new paradigms for the treatment of solid tumors,” said
Dr. Gaynor.
Pipeline Overview and Upcoming Milestones
NEO-PV-01
- NT-001: Phase 1b Clinical Trial of NEO-PV-01
in the Metastatic Setting
- 52-week data expected in the first half of 2019
- NT-002: Phase 1b Clinical Trial of NEO-PV-01
in Metastatic Non-Small Cell Lung Cancer
- 52-week data expected in the second half of 2019
- NT-003: Phase 1b Clinical Trial of NEO-PV-01
in Metastatic Melanoma Combinations
- Immune monitoring data expected in the first half of 2020
- NT-004: Phase 1b Clinical Trial of NEO-PV-01
in Earlier Disease Setting
- Finalizing plans for first monotherapy study
NEO-PTC-01
- NC-001: Phase 1 Clinical Trial in Solid Tumor
Setting: Neon intends to submit a European CTA for
NEO-PTC-01, a personal neoantigen T-cell therapy, for the treatment
of checkpoint refractory patients in the first half of
2019.
NEO-SV-01
- NS-001: Phase 1 Clinical Trial in Subset of
ER+ Breast Cancer: Neon expects to submit an
Investigational New Drug (IND) application to the U.S. Food
and Drug Administration (FDA) in the first half of 2019.
Financial Guidance
Based on its current operating plans, Neon now expects that its
existing cash, cash equivalents and marketable securities will
enable the Company to fund its anticipated operating expenses and
capital expenditure requirements into the second quarter of 2020.
As of September 30, 2018, Neon had $121.7 million in cash, cash
equivalents and marketable securities.
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.
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 potential timing of
data readouts from our ongoing and planned 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, timing 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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