C4 Therapeutics Announces First Patient Dosed in CFT8919 Clinical Trial
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.
C4 Therapeutics (Nasdaq: CCCC) ha annunciato che il suo partner Betta Pharmaceuticals ha somministrato la prima dose al paziente in uno studio clinico di Fase 1 per CFT8919 nella Cina continentale. CFT8919 è un degrader alosterico bio disponibile per via orale che mira a colpire le mutazioni EGFR L858R nel cancro polmonare non a piccole cellule (NSCLC). Il farmaco si propone di superare i limiti degli attuali inibitori della tirosina chinasi EGFR, in particolare per i pazienti con la mutazione L858R. In Cina, dove circa 693.000 casi di NSCLC vengono diagnosticati annualmente, circa il 50% presenta mutazioni EGFR, con L858R presente in circa il 40% dei casi mutati. La collaborazione con Betta Pharmaceuticals potrebbe generare fino a 357 milioni di dollari in traguardi e royalties per C4T.
C4 Therapeutics (Nasdaq: CCCC) anunció que su socio Betta Pharmaceuticals ha administrado la primera dosis al paciente en un ensayo clínico de Fase 1 de CFT8919 en China continental. CFT8919 es un degradador alostérico bio disponible por vía oral que se dirige a las mutaciones EGFR L858R en el cáncer de pulmón no microcítico (NSCLC). El fármaco tiene como objetivo superar las limitaciones de los actuales inhibidores de la tirosina quinasa EGFR, especialmente para los pacientes con la mutación L858R. En China, donde aproximadamente 693,000 casos de NSCLC son diagnosticados anualmente, alrededor del 50% tiene mutaciones EGFR, siendo L858R presente en aproximadamente el 40% de los casos mutados. La colaboración con Betta Pharmaceuticals podría generar hasta 357 millones de dólares en hitos y regalías para C4T.
C4 Therapeutics (Nasdaq: CCCC)는 파트너사인 Betta Pharmaceuticals가 중국 본토에서 CFT8919의 1상 임상 시험에서 첫 환자에게 약물을 투여했다고 발표했습니다. CFT8919는 비소세포 폐암(NSCLC)에서 EGFR L858R 변이를 목표로 하는 경구 생체이용 가능성의 올로스터릭 분해제입니다. 이 약물은 특히 L858R 변이가 있는 환자들에 대해 현재의 EGFR 티로신 키나제 억제제의 한계를 극복하는 것을 목표로 합니다. 중국에서는 매년 약 693,000건의 NSCLC가 진단되고 있으며, 이 중 약 50%가 EGFR 변이를 가지고 있으며, L858R은 약 40%의 EGFR 변이 케이스에서 나타납니다. Betta Pharmaceuticals와의 협업은 C4T에 대해 최대 3억 5천7백만 달러의 마일스톤과 로열티를 발생시킬 수 있습니다.
C4 Therapeutics (Nasdaq: CCCC) a annoncé que son partenaire Betta Pharmaceuticals a administré la première dose au patient lors d'un essai clinique de phase 1 de CFT8919 en Chine continentale. CFT8919 est un dégradeur allostérique bio-disponible par voie orale ciblant les mutations EGFR L858R dans le cancer du poumon non à petites cellules (NSCLC). Le médicament vise à surmonter les limitations des inhibiteurs de la tyrosine kinase EGFR actuels, en particulier pour les patients présentant la mutation L858R. En Chine, où environ 693 000 cas de NSCLC sont diagnostiqués chaque année, environ 50 % présentent des mutations EGFR, la L858R étant présente dans environ 40 % des cas mutés. La collaboration avec Betta Pharmaceuticals pourrait générer jusqu'à 357 millions de dollars en jalons et redevances pour C4T.
C4 Therapeutics (Nasdaq: CCCC) gab bekannt, dass sein Partner Betta Pharmaceuticals den ersten Patienten in einer Phase-1-Studie zu CFT8919 in China behandelt hat. CFT8919 ist ein oral bioverfügbarer allosterischer Degrader, der auf EGFR L858R-Mutationen bei nicht-kleinzelligem Lungenkrebs (NSCLC) abzielt. Das Medikament soll die Einschränkungen der aktuellen EGFR-Tyrosinkinase-Inhibitoren überwinden, insbesondere bei Patienten mit der L858R-Mutation. In China, wo jährlich etwa 693.000 NSCLC-Fälle diagnostiziert werden, haben etwa 50% EGFR-Mutationen, wobei L858R in ungefähr 40% der EGFR-mutierten Fälle vorhanden ist. Die Zusammenarbeit mit Betta Pharmaceuticals könnte bis zu 357 Millionen Dollar an Meilensteinen und Tantiemen für C4T einbringen.
- 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
- Early-stage clinical development with uncertain outcomes
- Competitive market with existing EGFR tyrosine kinase inhibitors
Insights
The initiation of CFT8919's Phase 1 trial in Greater China marks a significant milestone in addressing a critical unmet need in NSCLC treatment. The drug's unique mechanism as an EGFR L858R degrader could potentially overcome the limitations of current TKIs, particularly relevant given the
The market opportunity is substantial, with approximately 693,000 annual NSCLC diagnoses in China alone, of which
The progression of CFT8919 into clinical trials triggers potential milestone payments from the Betta partnership, strengthening C4T's financial position. The deal structure, featuring up to
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
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
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