On June 14, 2021 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company pioneering a new class of small-molecule medicines that selectively destroy disease-causing proteins through degradation, reported that the first patient has been dosed in the Company’s clinical trial of CFT7455, an orally bioavailable MonoDAC targeting IKZF1/3 for the treatment of multiple myeloma and non-Hodgkin’s lymphomas, including peripheral T-cell lymphoma and mantle cell lymphoma (Press release, C4 Therapeutics, JUN 14, 2021, View Source [SID1234583950]).
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"Initiating enrollment in the CFT4755 Phase 1/2 trial is a significant milestone in the clinical development of this innovative treatment for hematologic malignancies and reflects C4T’s focus on advancing programs in our portfolio that have the potential to improve outcomes for patients with cancer," said Andrew Hirsch, chief executive officer of C4 Therapeutics. "We are excited to learn more about the safety and efficacy of CFT7455 in the current clinical trial and expect to share data from this study in 2022."
The Phase 1/2 trial will primarily investigate safety, tolerability, and anti-tumor activity, with secondary and exploratory objectives to characterize the pharmacokinetic and pharmacodynamic profile of CFT7455. The Phase 1 portion of this study will explore CFT7455 as a single agent in patients with relapsed or refractory (R/R) multiple myeloma (MM) and non-Hodgkin’s lymphomas (NHL), and in combination with dexamethasone in R/R MM patients. Following identification of recommended dosage, the Phase 2 portion of the trial is expected to expand to four investigational arms: (1) relapsed/refractory MM, single agent CFT7455; (2) relapsed/refractory MM, CFT7455 combined with dexamethasone; (3) peripheral T-cell lymphoma, single agent CFT7455; and (4) mantle cell lymphoma, single agent CFT7455. Across the Phase 1/2 trial, C4T plans to enroll a total of approximately 160 patients.
"Dosing our first patient with CFT7455 is a pivotal event for C4T that demonstrates the progress we have made to efficiently design highly potent degrader medicines with our TORPEDO platform," said Marc Cohen, executive chairman and co-founder of C4 Therapeutics. "With our first program now in the clinic, we look forward to leveraging our expertise across discovery and clinical development to advance our pipeline and reach the goal of having four programs in the clinic by year-end 2022."
About CFT7455
CFT7455 is an orally bioavailable MonoDAC (Monofunctional Degradation Activating Compound) designed to bind with high affinity to the E3 ligase adapter protein, cereblon, to target and degrade IKZF1/3 for the treatment of multiple myeloma (MM) and non-Hodgkin’s lymphomas (NHLs), including peripheral T cell lymphoma (PTCL) and mantle cell lymphoma (MCL). In preclinical studies, CFT7455 has demonstrated potent and selective protein degradation with favorable pharmacological properties. C4T submitted an IND for CFT7455 in December 2020, for which the Company received clearance from the U.S. Food and Drug Administration in January 2021. The Company initiated a Phase 1/2 clinical trial for CFT7455 in June 2021. More information about this trial may be accessed at www.clinicaltrials.gov (identifier: NCT04756726).