C4 Therapeutics Presents New Preclinical Data for CFT1946 Highlighting Superior Activity as a Single Agent to Clinically Approved BRAF Inhibitor Standard of Care Combinations at the American Association for Cancer Research Annual Meeting 2024
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Insights
The advancement of CFT1946 by C4 Therapeutics represents a noteworthy stride in the oncology field, particularly for targeted protein degradation approaches. The preclinical data suggesting efficacy in multiple cancer models, especially those resistant to current BRAF inhibitors, is a promising development. The ability to degrade mutant proteins and potentially overcome resistance mechanisms is a significant leap, potentially addressing a key challenge in targeted cancer therapy. The improved brain penetration and CNS activity could be a game-changer for patients with metastatic diseases, especially considering the limitations of existing treatments in crossing the blood-brain barrier.
However, it is critical to remain cautiously optimistic. The transition from preclinical to clinical efficacy is fraught with uncertainty and many compounds fail to replicate preclinical success in human trials. The upcoming clinical trial results will be pivotal in determining the compound's future. Stakeholders should monitor the Phase 1/2 trial progression closely, as positive data could lead to increased investment and partnership opportunities, while failure could impact the company's valuation significantly.
The pharmaceutical industry is closely watching the development of novel therapies like CFT1946. The preclinical success of CFT1946 in various models, including BRAF inhibitor-resistant ones, indicates a potential to fill a significant unmet medical need. This could translate into a substantial market opportunity for C4 Therapeutics. The company's focus on BRAF V600X mutant cancers, which are prevalent in a subset of melanoma and lung cancer patients, suggests a targeted approach that may benefit from expedited regulatory pathways and orphan drug designations.
From a market perspective, the success of CFT1946 could disrupt the current standard of care and shift treatment paradigms. As the only BRAF V600X degrader in clinical trials, C4 Therapeutics could capture a first-mover advantage in this niche market. However, the long-term market impact will depend on clinical trial outcomes, pricing strategies and the ability to secure reimbursement from payers. Investors should look for signals of clinical efficacy and safety in the upcoming trial data releases to gauge the potential commercial viability of CFT1946.
In the biotech industry, intellectual property (IP) is a critical asset and the development of CFT1946 by C4 Therapeutics likely involves a complex IP strategy. The novelty of a BiDAC™ degrader that selectively targets the BRAF V600X mutant protein could be protected by a robust patent portfolio, which would be essential for securing market exclusivity upon approval. This exclusivity would provide a competitive edge and could justify substantial R&D investments.
For stakeholders, the strength and breadth of the patent estate surrounding CFT1946 are crucial. It not only protects the company's market position but also could attract potential licensing deals or collaborations. However, the legal landscape of biotech patents is intricate and any future litigation or challenges to the patents could pose risks to the company's market position. Hence, monitoring the IP developments in tandem with the clinical progress is vital for a comprehensive assessment of the drug's commercial prospects.
WATERTOWN, Mass., April 08, 2024 (GLOBE NEWSWIRE) -- C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, presented a poster today at the American Association for Cancer Research (AACR) Annual Meeting 2024 highlighting new preclinical data for CFT1946 across multiple models of BRAF V600X mutant colorectal cancer (CRC) and non-small cell lung cancer (NSCLC), additional BRAF inhibitor (BRAFi)-resistant melanoma models, and an intracranial model of BRAF V600E metastatic melanoma.
CFT1946 is an orally bioavailable BiDAC™ degrader that selectively degrades the BRAF V600X mutant protein and prevents RAF dimer-mediated resistance. While currently approved BRAF inhibitors are also selective for BRAF V600X mutant proteins, their activity is limited by primary or acquired resistance often mediated by mechanisms that promote RAF dimerization. Further, in a significant number of patients with BRAF V600X melanoma and NSCLC, the disease metastasizes to the brain. BRAF inhibitors have limited brain penetration, while CFT1946 demonstrates CNS activity in preclinical models.
Key findings include:
- Promising activity of CFT1946 as a single agent in a broad range of BRAF V600X preclinical models, including models of BRAFi resistance.
- CFT1946 as a single agent and in combination with cetuximab demonstrates superior activity to the standard of care combination, BRAFi with cetuximab, in all CRC models tested to date, further supporting the potential of a degrader advantage in this setting.
- CFT1946 demonstrates superior prolongation of survival when compared to encorafenib in an intracranial model of metastatic melanoma.
Collectively, these data support the ongoing clinical evaluation of CFT1946, which is the only BRAF V600X degrader in the clinic to date. The CFT1946 Phase 1/2 trial continues to progress and data from the Phase 1 monotherapy dose escalation portion of the trial are expected to be presented in the second half of this year.
Details of the poster are as follows:
Title: CFT1946, a potent, selective BRAF V600X mutant-specific degrader demonstrates superior activity as a single agent to clinically approved BRAF inhibitors and standard of care combinations in preclinical models of BRAF V600X melanoma, CRC, NSCLC, and brain metastasis
Abstract Number: 1658
Session Date and Time: Monday April 8, 2024 9:00 AM - 12:30 PM PT
Location: Poster Section 14
Session Title: Cell Signaling Components as Therapeutic Targets
Presenter: Bridget Kreger, Ph.D., principal scientist, biology
The poster will be made available after the presentation under the scientific presentations and publications page of the company’s website at www.c4therapeutics.com.
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 CFT1946
CFT1946 is an orally bioavailable BiDAC™ degrader designed to be potent and selective against BRAF V600X mutant targets. In preclinical studies, CFT1946 is active in vivo and in vitro in models with BRAF V600E driven disease and in models resistant to BRAF inhibitors. CFT1946 is currently in a Phase 1 dose escalation study in BRAF V600X mutant solid tumors including colorectal cancer, non-small cell lung cancer and melanoma. More information about this trial may be accessed at www.clinicaltrials.gov (identifier: NCT05668585).
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; and the predictive capability of our TORPEDO® platform in the development of novel, selective, orally bioavailable BiDAC™ and MonoDAC™ degraders. 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. For a discussion of the 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
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