C4 Therapeutics Announces FDA Clearance of Investigational New Drug Application for CFT8919, an Orally Bioavailable BiDAC™ Degrader Targeting EGFR L858R for Non-Small Cell Lung Cancer
05 Juillet 2023 - 1:00PM
C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage
biopharmaceutical company dedicated to advancing targeted protein
degradation (TPD) science to develop a new generation of
small-molecule medicines and transform how disease is treated,
today announced that the U.S. Food and Drug Administration (FDA)
has cleared the company’s investigational new drug (IND)
application for CFT8919, an orally bioavailable BiDAC™ degrader
designed to be potent and selective against EGFR L858R for
non-small cell lung cancer (NSCLC) patients.
This milestone marks C4T’s fourth IND clearance from its
proprietary TORPEDO® platform. In May 2023, C4T and Betta
Pharmaceuticals entered into an exclusive licensing agreement for
the development and commercialization of CFT8919 in Greater China,
including Hong Kong SAR, Macau SAR and Taiwan. In China,
approximately 693,000 patients were diagnosed with NSCLC in 2020
and approximately 40% of these cases are driven by the EGFR
mutation. The L858R mutation is the second most common EGFR
mutation, found in approximately 40% of NSCLC patients with EGFR
mutations in China. Betta Pharmaceuticals is responsible for
preparing and submitting a Clinical Trial Application to the
National Medical Products Administration in China and plans to
commence a first-in-human clinical trial of CFT8919 in China. C4T
expects to initiate clinical trial activities outside Greater China
following the completion of Betta Pharmaceuticals’ Phase 1 dose
escalation study in Greater China.
About CFT8919CFT8919 is an orally bioavailable
allosteric BiDAC™ degrader that is designed to be potent and
selective against EGFR bearing an oncogenic L858R mutation. In
preclinical studies, CFT8919 is active in in vitro and in vivo
models of L858R driven non-small cell lung cancer. Importantly, in
preclinical studies, CFT8919 retains full activity against
additional EGFR mutations that confer resistance against approved
EGFR inhibitors including L858R-C797S, L858R-T790M,
and L858R-T790M-C797S. In 2023, C4T and Betta Pharmaceuticals
entered into an exclusive licensing agreement for the development
and commercialization of CFT8919 in Greater China, including Hong
Kong SAR, Macau SAR and Taiwan.
About C4 TherapeuticsC4 Therapeutics (C4T)
(Nasdaq: CCCC) is a clinical-stage biopharmaceutical company
dedicated to delivering on the promise of targeted protein
degradation science to create a new generation of medicines that
transforms patients’ lives. C4T is leveraging its
TORPEDO® platform to efficiently design and optimize
small-molecule medicines that harness the body’s natural protein
recycling system to rapidly degrade disease-causing proteins,
offering the potential to overcome drug resistance, drug
undruggable targets and improve patient outcomes. C4T is advancing
multiple targeted oncology programs to the clinic and expanding its
research platform to deliver the next wave of medicines for
difficult-to-treat diseases. For more information, please
visit www.c4therapeutics.com.
Forward-Looking StatementsThis press release
contains “forward-looking statements” of C4 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 develop potential therapies for patients; the design and
potential efficacy of our therapeutic approaches; the predictive
capability of our TORPEDO® platform in the development of
novel, selective, orally bioavailable BiDAC™ and MonoDAC™
degraders; the potential timing, design and advancement of our or
our partner’s clinical trials, including the potential timing for
and receipt of regulatory authorization related to clinical trials
and other clinical development activities including clinical trial
commencement; 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, Greater China and
other foreign countries; our ability to fund our future operations;
and our ability to realize the anticipated benefits of our
collaboration with Betta Pharmaceuticals. 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, advancement and conduct of
preclinical and clinical studies and other development requirements
for our product candidates; the risk that any one or more of our
product candidates will cost more to develop or may not be
successfully developed and commercialized; and the risk that the
results of preclinical studies and/or clinical trials will or will
not be predictive of results in connection with future studies or
trials. For a discussion of these and other risks and
uncertainties, and other important factors, any of which could
cause our actual results to differ from those contained in the
forward-looking statements, see the section entitled “Risk Factors”
in C4 Therapeutics’ most recent Annual Report on Form 10-K and/or
Quarterly Report on Form 10-Q, as filed with the Securities and
Exchange Commission. All information in this press release is as of
the date of the release, and C4 Therapeutics undertakes no duty to
update this information unless required by law.
Contacts:Investors: Courtney SolbergSenior
Manager, Investor RelationsCSolberg@c4therapeutics.com
Media: Loraine Spreen Director, Corporate
Communications & Patient
Advocacy LSpreen@c4therapeutics.com
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