- C4 Therapeutics, Inc. ( NASDAQ: CCCC ) added ~7% pre-market Thursday after the clinical-stage biotech announced that the FDA issued a Study May Proceed Letter to start a Phase 1/2 trial for its oral solid tumor candidate CFT1946.
- CFT1946 is designed to target the BRAF-V600 mutant solid tumors, including lung, colorectal, or melanoma, and the trial is expected to primarily assess its safety, tolerability, and anti-tumor activity.
- Noting that BRAF-V600 mutant solid tumors make up about 50,000 cancer cases annually, CCCC Chief Executive Andrew Hirsch said that CFT1946 would address some limitations of BRAF inhibitor treatments.
- The company expects to begin the trial with an initial arm designed to evaluate the candidate as a single agent for BRAF-V600 mutant solid tumors.
- In August, CCCC said that a Phase 1 trial for CFT1946 will start in 2H 2022, targeting BRAF-V600 mutant melanoma, colorectal and non-small cell lung cancer.
For further details see:
C4 Therapeutics wins FDA nod to study cancer candidate in solid tumors