C4 Therapeutics and Betta Pharmaceuticals Announce Exclusive Licensing Agreement for the Development and Commercialization in Greater China of CFT8919, an Orally Bioavailable BiDAC™ Degrader of EGFR L858R for NSCLC
30 Maio 2023 - 8:00AM
C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage
biopharmaceutical company dedicated to advancing targeted protein
degradation science to develop a new generation of small-molecule
medicines and transform how disease is treated, and Betta
Pharmaceuticals Co. Ltd (Betta) (SZ300558), a leading
pharmaceutical company focusing on the development of innovative
oncology therapies in China, today announced an exclusive licensing
agreement for the development and commercialization of CFT8919 in
Greater China (including Hong Kong SAR, Macau SAR and Taiwan).
CFT8919 is an orally bioavailable BiDAC™ degrader designed to be
potent and selective against EGFR L858R for non-small cell lung
cancer (NSCLC) patients.
Under the terms of the agreement, C4T expects to receive $35
million, which includes $10 million in upfront cash as well as a
$25 million one-time equity investment, to be completed following
the receipt of required regulatory approvals and other customary
closing conditions. Additionally, C4T is eligible for up to $357
million in potential milestones and low to mid-double-digit percent
royalties on net sales in the licensed territories. Betta will be
responsible for the development, manufacturing and
commercialization of CFT8919 in the licensed territories and is
eligible to receive low single-digit percent royalties on net sales
outside of Greater China. C4T retains the right to develop and
commercialize CFT8919 in all territories outside of Greater
China.
“We are excited to partner with Betta to develop CFT8919, an
orally bioavailable allosteric EGFR L858R degrader, with the
potential to treat NSCLC patients with EGFR L858R mutations in
Greater China and beyond,” said Andrew Hirsch, president and chief
executive officer of C4 Therapeutics. “With their strong track
record of developing and commercializing NSCLC therapies in China,
we believe Betta is the ideal partner to advance CFT8919 clinical
development in a region where there is a high prevalence of lung
cancer patients with the EGFR L858R mutation.”
“The collaboration with C4T is another important collaboration
for Betta’s partnerships with top-tier biotech companies,” said
Lieming Ding, chairman and chief executive officer of Betta. “The
collaboration will further expand Betta’s product pipeline and
improve the productivity of the company's R&D, from discovery
to clinical development, and to commercialization. We will leverage
the capabilities and resources of both parties and continue
developing innovative drugs to benefit more patients.”
In preclinical studies, CFT8919 is active in in vitro and in
vivo models of EGFR L858R driven NSCLC with broad coverage of
on-target resistant mutations and intracranial activity, with the
potential to prevent or treat brain metastases in these patients.
CFT8919 has been designed to bind to an allosteric site, which is
uniquely created by the L858R activating mutation, allowing for
exquisite selectivity for this mutation. Further, CFT8919 was
designed to be effective independent of secondary EGFR mutations,
for example T790M and/or C797S. Additionally, CFT8919 demonstrated
potent anti-proliferation activity against a panel of cell lines
harboring either L858R single mutation or L858R with additional
EGFR mutations that confer resistance to approved EGFR inhibitors
such as osimertinib or erlotinib, while sparing cell lines with
wild-type EGFR.
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. Typically, these patients experience
a less durable response to approved EGFR inhibitors, including
osimertinib.
C4T is on track to submit an Investigational New Drug (IND)
application to the United States Food and Drug Administration (FDA)
for CFT8919 for the treatment of NSCLC in the first half of
2023.
MSQ Ventures served as an advisor to C4T and Goodwin Procter LLP
served as legal counsel to C4T. Han Kun Law Offices served as legal
counsel to Betta.
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,
CFT8919 retains full activity against additional EGFR mutations
that confer resistance against approved EGFR inhibitors including
L858R-C797S, L858R-T790M, and L858R-T790M-C797S.
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.
About Betta PharmaceuticalsBetta
Pharmaceuticals Co., Ltd. (SZ300558) is a commercial-staged
pharmaceutical company dedicated to the development of innovative
oncology products to meet high unmet medical needs. With about
2,000 employees in Hangzhou and Beijing, Betta's integrated R&D
platform ranges from small-molecule to biologics discovery,
clinical development, manufacturing, sales and marketing. Betta's
leading product – icotinib (Conmana®), the first innovative
oncology product domestically developed and launched in China – is
one of the top selling targeted therapies for patients with
non-small cell lung cancer, having achieved more than 13 billion
RMB accumulated sales since launched and benefited more than
500,000 patients in China. Betta currently has 3 marketed products,
15 programs in clinical development and 2 molecules under NDA
review by the NMPA. Throughout the years, Betta has set up
strategic partnerships with Xcovery LLC., Merus N.V., Agenus Inc.
and other top-tier biotech companies, with the ultimate objective
to deliver innovative health solutions around the world. For more
information, please
visit http://www.bettapharma.com/en.php.
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
preclinical studies and 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 and foreign
countries; our ability to fund our future operations; our ability
to realize development and commercialization milestones and receive
royalties on the commercial sale of our product candidates; our
ability to realize the anticipated benefits of this collaboration;
and our ability to complete the contemplated sale of equity
securities. 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.
C4T Contacts:Investors: Courtney
SolbergSenior Manager, Investor
RelationsCSolberg@c4therapeutics.com
Media: Loraine Spreen Director, Corporate
Communications & Patient
Advocacy LSpreen@c4therapeutics.com
Betta Pharmaceuticals Contact:Jianhao Shen
Director, Securities AffairsJianhao.shen@bettapharma.com
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