STOCK TITAN

C4 Therapeutics Announces First Patient Dosed in CFT8919 Clinical Trial

Rhea-AI Impact
(Moderate)
Rhea-AI Sentiment
(Neutral)

C4 Therapeutics (Nasdaq: CCCC) announced that its partner Betta Pharmaceuticals has dosed the first patient in a Phase 1 clinical trial of CFT8919 in Greater China. CFT8919 is an orally bioavailable allosteric degrader targeting EGFR L858R mutations in non-small cell lung cancer (NSCLC). The drug aims to overcome limitations of current EGFR tyrosine kinase inhibitors, particularly for patients with the L858R mutation. In China, where approximately 693,000 NSCLC cases are diagnosed annually, about 50% have EGFR mutations, with L858R being present in roughly 40% of EGFR-mutated cases. The collaboration with Betta Pharmaceuticals could yield up to $357 million in milestones plus royalties for C4T.

Loading...
Loading translation...

Positive

  • First patient dosed in Phase 1 trial represents clinical development milestone
  • Partnership deal worth up to $357 million plus royalties
  • Large addressable market with 693,000 annual NSCLC cases in China
  • High prevalence of target mutation (EGFR L858R) in Asian population

Negative

  • Early-stage clinical development with uncertain outcomes
  • Competitive market with existing EGFR tyrosine kinase inhibitors

News Market Reaction

-1.97%
1 alert
-1.97% News Effect

On the day this news was published, CCCC declined 1.97%, reflecting a mild negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Clinical Development Initiated in Greater China by Partner Betta Pharmaceuticals

WATERTOWN, Mass., Nov. 06, 2024 (GLOBE NEWSWIRE) -- C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, today announced its partner Betta Pharmaceuticals has dosed the first patient in the Phase 1 clinical trial of CFT8919, an orally bioavailable allosteric degrader of EGFR L858R for non-small cell lung cancer (NSCLC), in Greater China.

“We are pleased to see CFT8919, our fourth small molecule degrader to enter the clinic, begin the journey through clinical development in Greater China with our partner Betta Pharmaceuticals,” said Len Reyno, M.D., chief medical officer of C4 Therapeutics. “CFT8919 may offer an exciting advancement in treating non-small cell lung cancer driven by an EGFR mutation, which is currently treated with EGFR tyrosine kinase inhibitors (TKIs) that offer a less durable response for patients with the EGFR L858R driver mutation than those with other driver mutations. We, along with our partner Betta Pharmaceuticals, believe CFT8919 may offer a novel targeted therapy for patients and physicians searching for treatment options.”

C4T designed CFT8919 to be potent and selective against EGFR bearing an oncogenic L858R mutation and capable of overcoming common EGFR secondary mutations that render patients refractory to EGFR TKIs. The EGFR mutation is particularly common in NSCLC patients of Asian heritage. In China, where approximately 693,000 patients are diagnosed with NSCLC annually, approximately 50 percent of diagnoses are driven by the EGFR mutation. The EGFR L858R mutation is the second most common EGFR mutation, found in approximately 40 percent of patients diagnosed with an EGFR mutation in the U.S. and China.

In 2023, C4T and Betta Pharmaceuticals entered into a strategic collaboration to develop, manufacture and commercialize CFT8919 in Greater China, including Hong Kong SAR, Macau SAR and Taiwan. Under the terms of the agreement, C4T is eligible for up to $357 million in potential milestones plus royalties on net sales. C4T retains development and commercialization rights for CFT8919 in the United States, European Union and rest of the world.

About CFT8919
CFT8919 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 Therapeutics
C4 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 progressing targeted oncology programs through clinical studies and leveraging its TORPEDO® platform to efficiently design and optimize small-molecule medicines to address difficult-to-treat diseases. C4T’s degrader medicines are designed to 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. For more information, please visit www.c4therapeutics.com.

Forward-Looking Statements
This 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; our ability to achieve milestones and receive potential royalty payments from our collaboration partner, Betta Pharmaceuticals; and our ability to fund our future operations. 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 sufficient capital to fund our future operations will be available to us on acceptable terms or at the times required. 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 Solberg
Senior Manager, Investor Relations
CSolberg@c4therapeutics.com

Media:
Loraine Spreen
Senior Director, Corporate Communications & Patient Advocacy
LSpreen@c4therapeutics.com


FAQ

What is the Phase 1 trial milestone announced for C4 Therapeutics (CCCC)?

C4 Therapeutics announced that its partner Betta Pharmaceuticals has dosed the first patient in a Phase 1 clinical trial of CFT8919 for EGFR L858R mutated non-small cell lung cancer in Greater China.

How many NSCLC patients in China could potentially benefit from CFT8919 (CCCC)?

Of the 693,000 annual NSCLC cases in China, approximately 50% have EGFR mutations, with the L858R mutation present in about 40% of EGFR-mutated cases, representing a significant potential patient population.

What is the potential value of C4 Therapeutics' (CCCC) partnership with Betta Pharmaceuticals?

The partnership could yield up to $357 million in milestone payments plus royalties on net sales for C4 Therapeutics, with Betta Pharmaceuticals having rights in Greater China.
C4 Therapeutics, Inc.

NASDAQ:CCCC

CCCC Rankings

CCCC Latest News

CCCC Latest SEC Filings

CCCC Stock Data

196.74M
84.44M
9.75%
76.96%
5.31%
Biotechnology
Biological Products, (no Disgnostic Substances)
Link
United States
WATERTOWN