C4 Therapeutics Announces 2025 Milestones Across Clinical Portfolio of Degrader Medicines Pursuing Targets of High Unmet Need in Oncology
C4 Therapeutics (CCCC) announced its 2025 milestones for its clinical portfolio of degrader medicines in oncology. The company highlighted progress across three main programs: cemsidomide for multiple myeloma and non-Hodgkin's lymphoma, CFT1946 for BRAF V600X solid tumors, and CFT8919 for non-small cell lung cancer.
Key developments include cemsidomide's promising data presented at ASH, showing a 36% overall response rate in multiple myeloma and 38% in non-Hodgkin's lymphoma. CFT1946's Phase 1 monotherapy dose escalation is expected to complete in H1 2025, with data in melanoma and colorectal cancer expected in H2 2025. The company's cash runway is expected to fund operations into 2027.
The company plans to initiate new clinical studies for cemsidomide in early 2026, including combinations with other agents for multiple myeloma and monotherapy for peripheral T-cell lymphoma. Data from CFT8919's Phase 1 study in Greater China will inform future development plans.
C4 Therapeutics (CCCC) ha annunciato i suoi obiettivi per il 2025 per il portafoglio clinico di farmaci degrader in oncologia. L'azienda ha evidenziato i progressi in tre programmi principali: cemsidomide per il mieloma multiplo e il linfoma non-Hodgkin, CFT1946 per i tumori solidi BRAF V600X e CFT8919 per il cancro polmonare non a piccole cellule.
Sviluppi chiave includono i dati promettenti di cemsidomide presentati all'ASH, che mostrano un tasso di risposta globale del 36% nel mieloma multiplo e del 38% nel linfoma non-Hodgkin. L'escalation della dose in monoterapia di CFT1946 nella Fase 1 dovrebbe concludersi nel primo semestre del 2025, con dati sul melanoma e sul cancro del colon-retto previsti nel secondo semestre del 2025. Si prevede che il capitale dell'azienda sia sufficiente a coprire le operazioni fino al 2027.
L'azienda prevede di avviare nuovi studi clinici per cemsidomide all'inizio del 2026, comprese le combinazioni con altri agenti per il mieloma multiplo e la monoterapia per il linfoma T periferico. I dati dello studio di Fase 1 di CFT8919 nella Grande Cina informeranno i futuri piani di sviluppo.
C4 Therapeutics (CCCC) anunció sus hitos para 2025 para su cartera clínica de medicamentos degradadores en oncología. La compañía destacó el progreso en tres programas principales: cemsidomide para mieloma múltiple y linfoma no Hodgkin, CFT1946 para tumores sólidos BRAF V600X, y CFT8919 para cáncer de pulmón no microcítico.
Los desarrollos clave incluyen los datos prometedores de cemsidomide presentados en ASH, que muestran una tasa de respuesta general del 36% en mieloma múltiple y del 38% en linfoma no Hodgkin. Se espera que la escalada de dosis de monoterapia de CFT1946 en la Fase 1 se complete en el primer semestre de 2025, con datos sobre melanoma y cáncer colorrectal esperados para el segundo semestre de 2025. Se espera que el capital de la compañía financie sus operaciones hasta 2027.
La empresa planea iniciar nuevos estudios clínicos para cemsidomide a principios de 2026, incluyendo combinaciones con otros agentes para mieloma múltiple y monoterapia para linfoma de células T periféricas. Los datos del estudio de Fase 1 de CFT8919 en la Gran China informarán sobre los futuros planes de desarrollo.
C4 Therapeutics (CCCC)는 암 분야의 분해제 의약품 임상 포트폴리오에 대한 2025년 목표를 발표했습니다. 회사는 다발성 골수종 및 비호지킨림프종을 위한 cemsidomide, BRAF V600X 고형종양을 위한 CFT1946, 및 비소세포 폐암을 위한 CFT8919라는 세 가지 주요 프로그램의 진행 상황을 강조했습니다.
주요 개발 사항에는 ASH에서 발표된 cemsidomide의 유망한 데이터가 포함되어 있으며, 다발성 골수종에서 36%, 비호지킨림프종에서 38%의 전체 반응률을 보여주었습니다. CFT1946의 1상 단일요법 용량 증가는 2025년 상반기 내에 완료될 것으로 예상되며, 2025년 하반기에는 멜라노마 및 대장암에 대한 데이터가 기대됩니다. 회사의 자금 운영은 2027년까지 지속될 것으로 예상됩니다.
회사는 2026년 초에 cemsidomide에 대한 새로운 임상 연구를 시작할 계획이며, 다발성 골수종 및 말초 T세포 림프종에 대한 단일요법을 포함하여 다른 약제와의 조합 연구를 포함합니다. CFT8919의 1상 연구에서 얻은 데이터는 향후 개발 계획에 정보를 제공할 것입니다.
C4 Therapeutics (CCCC) a annoncé ses objectifs pour 2025 concernant son portefeuille clinique de médicaments dégradateurs en oncologie. L'entreprise a mis en avant des progrès dans trois programmes principaux : cemsidomide pour le myélome multiple et le lymphome non hodgkinien, CFT1946 pour les tumeurs solides BRAF V600X, et CFT8919 pour le cancer du poumon non à petites cellules.
Les développements clés incluent les données prometteuses de cemsidomide présentées à l'ASH, montrant un taux de réponse global de 36 % dans le myélome multiple et de 38 % dans le lymphome non hodgkinien. L'escalade de dose en monothérapie de CFT1946 en Phase 1 devrait se terminer au premier semestre 2025, avec des données sur le mélanome et le cancer colorectal attendues au second semestre 2025. Les ressources financières de l'entreprise devraient permettre de financer les opérations jusqu'en 2027.
L'entreprise prévoit de lancer de nouvelles études cliniques pour cemsidomide début 2026, y compris des combinaisons avec d'autres agents pour le myélome multiple et une monothérapie pour le lymphome T périphérique. Les données de l'étude de Phase 1 de CFT8919 en Grande Chine informeront les futurs plans de développement.
C4 Therapeutics (CCCC) hat seine Meilensteine für 2025 hinsichtlich seines klinischen Portfolios von Degrader-Medikamenten in der Onkologie bekannt gegeben. Das Unternehmen hob die Fortschritte in drei Hauptprogrammen hervor: cemsidomide für multiples Myelom und Non-Hodgkin-Lymphom, CFT1946 für BRAF V600X solide Tumoren und CFT8919 für nicht-kleinzelliges Lungenkarzinom.
Wichtige Entwicklungen umfassen die vielversprechenden Daten von cemsidomide, die auf dem ASH präsentiert wurden und eine allgemeine Ansprechrate von 36 % bei multiplem Myelom und 38 % bei Non-Hodgkin-Lymphom zeigen. Die Dosissteigerung von CFT1946 in der Phase 1 der Monotherapie wird voraussichtlich im ersten Halbjahr 2025 abgeschlossen sein, wobei Daten zu Melanom und kolorektalem Krebs für das zweite Halbjahr 2025 erwartet werden. Der finanzielle Spielraum des Unternehmens sollte die Betriebsführung bis 2027 sichern.
Das Unternehmen plant, Anfang 2026 neue klinische Studien für cemsidomide zu starten, einschließlich Kombinationen mit anderen Wirkstoffen für multiples Myelom und Monotherapie für peripheres T-Zell-Lymphom. Daten aus der Phase 1-Studie von CFT8919 in Großchina werden zukünftige Entwicklungspläne informieren.
- Cemsidomide showed 36% overall response rate in multiple myeloma and 38% in non-Hodgkin's lymphoma
- Cash runway extended into 2027
- Successful delivery of two development candidates to collaborator Biogen
- New collaboration established with Merck KGaA
- Maximum tolerated dose not yet reached for cemsidomide
- New clinical studies delayed until early 2026
Insights
The 2025 milestones announcement from C4 Therapeutics outlines significant progress in their degrader medicine portfolio. Cemsidomide demonstrated promising results with a
The CFT1946 BRAF V600 degrader program's advancement to completion of monotherapy dose escalation in H1 2025, coupled with planned data readouts in melanoma and colorectal cancer, represents a strategic expansion into solid tumors. The blood-brain barrier penetration data (Kpu,u 0.34-0.88) suggests potential applications in brain metastases.
The company's strong financial position, with runway into 2027, provides adequate support for these clinical initiatives. The multiple data readouts expected in H2 2025 across their pipeline could serve as significant catalysts for the company's valuation.
The clinical development strategy across C4T's portfolio shows thoughtful positioning in areas of high unmet need. Cemsidomide's dual activity against IKZF1/3 in both multiple myeloma and non-Hodgkin's lymphoma demonstrates versatility in hematologic malignancies. The
The expansion of CFT1946 into combination strategies with cetuximab for colorectal cancer and trametinib for melanoma shows understanding of resistance mechanisms in BRAF-mutated cancers. This approach could potentially address the limitations of current BRAF inhibitors.
The partnership with Betta Pharmaceuticals for CFT8919 in EGFR L858R mutant NSCLC represents a strategic approach to development in the Chinese market, where this mutation is more prevalent. The data from this study will be important for global development decisions.
Cemsidomide Data Presented at American Society of Hematology (ASH) Annual Meeting Support Best-in-Class Profile; Program Advancing to Next Phase of Clinical Development in Multiple Myeloma and Non-Hodgkin’s Lymphoma
CFT1946 Phase 1 Trial Continues to Progress in BRAF V600X Solid Tumors With Monotherapy Dose Escalation Expected to Complete in 1H 2025; Data in Melanoma and Colorectal Cancer Expected in Second Half of 2025
CFT8919 Progressing Through Phase 1 Dose Escalation in Greater China; Phase 1 Data Will Inform Future Development Plans Outside of China
Cash Runway Expected to Fund Operations Into 2027
WATERTOWN, Mass., Jan. 14, 2025 (GLOBE NEWSWIRE) -- C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, today announced its anticipated 2025 milestones as it continues its evolution into becoming a fully integrated biotechnology company focused on orally bioavailable degraders.
“Stellar execution in 2024 has set up 2025 to be a pivotal year for the company as we work to generate important data that will position us to advance programs and bring degrader medicines to patients searching for new therapeutic options,” said Andrew Hirsch, president and chief executive officer of C4 Therapeutics. “The cemsidomide data presented at the ASH Annual Meeting in December support a potentially best-in-class profile and we are preparing for the next phase of development of this molecule. We continue to progress the CFT1946 Phase 1/2 study and will leverage data from the tumor specific cohorts to determine the development path for this program. In addition, we expect data from the CFT8919 Phase 1 dose escalation study run by our partner Betta Pharmaceuticals in China, which will define its potential for non-small cell lung cancer patients with the EGFR L858R mutation. We are excited about the degrader rationale for these programs, which we believe have the potential to deliver value for patients, caregivers, physicians and shareholders.”
ANTICIPATED 2025 MILESTONES
Cemsidomide: Cemsidomide is an oral degrader of IKZF1/3 for the potential treatment of relapsed/refractory (R/R) multiple myeloma (MM) and R/R non-Hodgkin’s lymphoma (NHL).
Multiple Myeloma
- Enable initiation of the next phase of clinical development to investigate cemsidomide in combination with dexamethasone in the late-line setting, and in combination with other MM agents for earlier lines of treatment. These new studies are expected to initiate in early 2026.
- Complete Phase 1 dose escalation and present data in the second half of 2025.
Non-Hodgkin’s Lymphoma
- Complete Phase 1 dose escalation and present data in the second half of 2025.
- Open expansion cohort(s) of the current Phase 1/2 trial in patients with peripheral T-cell lymphoma (PTCL) in the second half of 2025.
- Enable initiation of the next phase of clinical development to investigate cemsidomide monotherapy in later lines of therapy in PTCL. This new study is expected to initiate in early 2026.
CFT1946: CFT1946 is an oral degrader targeting BRAF V600 mutations for the potential treatment of solid tumors including colorectal cancer (CRC), melanoma and other malignancies with V600 mutations.
- Complete monotherapy Phase 1 dose escalation in BRAF V600 mutant solid tumors in the first half of 2025.
- Generate data from the Phase 1 cohorts exploring monotherapy CFT1946 in melanoma, CFT1946 in combination with cetuximab in CRC and CFT1946 in combination with trametinib in melanoma. Data from these cohorts will define and enable the next phase of development.
- Present Phase 1 data in the second half of 2025. These presentations will include: (1) monotherapy in BRAF V600 mutant solid tumors, (2) monotherapy expansion cohorts in melanoma, and (3) in combination with cetuximab in CRC.
CFT8919: CFT8919 is an oral degrader targeting EGFR bearing an oncogenic L858R mutation for the potential treatment of non-small cell lung cancer (NSCLC).
- Evaluate data from the Phase 1 dose escalation study in Greater China, which is led by partner Betta Pharmaceuticals, in patients with locally or advanced metastatic NSCLC harboring an EGFR L858R mutation. These data will be used to determine the next phase of development.
Discovery: C4T will continue to utilize its TORPEDO® platform to develop orally bioavailable degraders for oncology and non-oncology targets for internal research and collaboration programs. To further highlight its deep expertise in drug discovery, C4T plans to:
- Present and publish preclinical work from its internal pipeline and TORPEDO® platform.
- Advance internal and collaboration programs to key milestones.
2024 ACCOMPLISHMENTS
Cemsidomide: C4T advanced the Phase 1/2 clinical trial and delivered data reinforcing the potential of cemsidomide to become a backbone therapy of choice in MM and NHL where IKZF1/3 degradation is warranted.
Multiple Myeloma
- At ASH, presented data on cemsidomide in combination with dexamethasone. As of the data cutoff date of October 11, 2024, the dose level exploring 75 µg once daily (QD) achieved an overall response rate (ORR) of 36 percent. Cemsidomide was well-tolerated across all dose levels.
- The maximum tolerated dose has not yet been reached. Patients are enrolling in the 100 µg QD cohort.
Non-Hodgkin’s Lymphoma
- At ASH, presented data on cemsidomide monotherapy. As of the data cutoff date of October 11, 2024, cemsidomide demonstrated a 38 percent ORR across all subtypes and doses studied. In PTCL, cemsidomide achieved a 44 percent ORR and a 25 percent complete metabolic response rate.
- The maximum tolerated dose has not yet been reached. Patients are enrolling in the 75 µg QD cohort.
CFT1946: C4T advanced the Phase 1/2 clinical trial across multiple arms and delivered monotherapy data demonstrating proof of mechanism and early evidence of proof of concept.
- At the European Society of Medical Oncology (ESMO) Congress, presented monotherapy data demonstrating CFT1946 is well tolerated across all dose levels and demonstrates initial signs of anti-tumor activity across all dose levels.
- At the TPD Summit, presented new preclinical data demonstrating CFT1946 has the ability to cross the blood-brain barrier, with Kpu,u values in the range of 0.34 to 0.88.
- Progressed the Phase 1 monotherapy dose escalation study. Began enrolling patients across multiple exploratory cohorts: CFT1946 monotherapy in melanoma, CFT1946 in combination with trametinib in melanoma, and CFT1946 in combination with cetuximab in CRC.
CFT8919: Betta Pharmaceuticals, with C4T support, initiated the Phase 1 clinical trial of CFT8919 in Greater China.
Discovery: C4T further validated its TORPEDO® platform and advanced key research efforts.
- Delivered two development candidates for non-oncology targets to collaborator Biogen.
- Established a new collaboration with Merck KGaA, Darmstadt, Germany focused on two critical oncogenic proteins.
- Continued to progress its internal discovery portfolio of orally bioavailable degraders.
Corporate: C4T further strengthened its leadership across its management team and Board of Directors to supports its evolution into a fully integrated biotechnology company.
- Paige Mahaney, Ph.D., was appointed chief scientific officer. Dr. Mahaney is an experienced drug developer who has helped leading pharmaceutical companies build clinical portfolios across a wide range of disease indications and treatment modalities.
- C4T continued to evolve its governance by appointing three new members to its Board of Directors who bring deep experience across drug discovery, commercialization and lifecycle management.
Cash Guidance
C4T expects that its cash, cash equivalents and marketable securities as of December 31, 2024, together with anticipated collaboration expense reimbursements, but excluding any collaboration option or milestone payments, will enable the company to fund its operating plan into 2027.
JP Morgan Presentation
C4T will present at the 43rd Annual J.P. Morgan Healthcare Conference on Wednesday, January 15, 2025 at 2:15 pm PST (5:15 pm EST). A live webcast will be available under “Events & Presentations” in the Investors section of the company’s website at www.c4therapeutics.com. A replay of the webcast will be archived on the C4T website for at least two weeks following the presentation.
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.
About Cemsidomide
Cemsidomide is an investigational, orally bioavailable small-molecule degrader designed to be a more potent and selective degrader of IKZF1/3, transcription factors that drive multiple myeloma (MM) and non-Hodgkin’s lymphomas (NHL), with unique pharmacokinetic properties. Clinical data has shown that cemsidomide is well-tolerated. In MM, cemsidomide displays evidence of anti-myeloma activity and immunomodulatory effects. In NHL, cemsidomide displays evidence of anti-lymphoma activity. More information may be accessed at www.clinicaltrials.gov (identifier: NCT04756726).
About CFT1946
CFT1946 is an investigational, orally bioavailable brain penetrant small molecule degrader of BRAF V600 mutations in solid tumors currently being evaluated in a Phase 1/2 global clinical trial in patients refractory to BRAF inhibitors. CFT1946 is designed to be potent and selective against the BRAF V600 mutant form. Initial clinical data from the Phase 1 trial demonstrate that CFT1946 has a well-tolerated safety profile, demonstrates dose-dependent bioavailability and degradation of BRAF V600E protein, and demonstrates evidence of monotherapy anti-tumor activity. CFT1946 is the only degrader of BRAF V600 mutant solid tumors in clinical trials. More information about this trial may be accessed at www.clinicaltrials.gov (identifier: NCT05668585).
About CFT8919
CFT8919 is an orally bioavailable allosteric 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.
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; 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 or cohort initiation; 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; our ability to replicate interim or early-stage results from our clinical trials in the results obtained when those clinical trials are completed or when those therapies complete later-stage clinical trials; regulatory developments in the United States and foreign countries; the anticipated timing and content of presentations of data from our clinical trials; 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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