C4 Therapeutics Announces FDA Clearance of Investigational New Drug Application for CFT7455, an Orally Bioavailable MonoDAC for Hematologic Malignancies
- Category: Small Molecules
- Published on Wednesday, 20 January 2021 10:51
- Hits: 663
– Phase 1/2 Clinical Study of CFT7455 Expected to Initiate in 1H 2021 –
WATERTOWN, MA, USA I January 19, 2021 I C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a biopharmaceutical company pioneering a new class of small-molecule medicines that selectively destroy disease-causing proteins through degradation, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s investigational new drug (IND) application for its lead product candidate, CFT7455, an orally bioavailable MonoDAC (Monofunctional Degradation Activating Compound) targeting IKZF1/3 for the treatment of hematologic malignancies such as multiple myeloma and non-Hodgkin lymphomas, including peripheral T cell lymphoma and mantle cell lymphoma. The FDA has completed its 30-day safety review and granted approval for the company to proceed with the proposed Phase 1/2 clinical trial for CFT7455.
“The clearance of our first IND is an important milestone for the company, moving us closer to our goal of transforming the treatment of cancer with novel medicines that destroy, rather than inhibit, disease causing proteins,” said Andrew Hirsch, president and chief executive officer of C4 Therapeutics. “With FDA clearance achieved, we are on track to advance CFT7455 into the clinic in the first half of 2021 and we look forward to replicating the impressive efficacy we saw pre-clinically in patients with multiple myeloma and non-Hodgkin lymphomas. This is the first of the four programs that we expect to put into the clinic by the end of 2022, each of which was developed through our TORPEDO™ platform.”
The Phase 1/2 clinical trial will be an open-label, two-part dose-escalation and expansion study evaluating CFT7455 across multiple hematologic malignancies. The Phase 1 portion of the trial will explore CFT7455 as a single agent in patients with relapsed or refractory (R/R) multiple myeloma (MM) and non-Hodgkin lymphomas (NHL), and in parallel in combination with dexamethasone in R/R MM patients. Following the identification of an optimal dose, the Phase 2 expansion portion of the trial will enroll additional investigational arms including patients with MM, as single agent and in combination with dexamethasone, and as single agent in patients with mantle cell lymphoma and peripheral T-cell lymphoma, two subtypes of NHL. The trial will primarily investigate safety and tolerability, with key secondary objectives to characterize the pharmacokinetic and pharmacodynamic profile and anti-tumor activity of CFT7455.
About C4 Therapeutics
C4 Therapeutics (C4T) is a biopharmaceutical company focused on harnessing the body’s natural regulation of protein levels to develop novel therapeutic candidates to target and destroy disease-causing proteins for the treatment of cancer, neurodegenerative conditions and other diseases. This targeted protein degradation approach offers advantages over traditional therapies, including the potential to treat a wider range of diseases, reduce drug resistance, achieve higher potency, and decrease side effects through greater selectivity. To learn more about C4 Therapeutics, visit www.C4Therapeutics.com.
SOURCE: C4 Theapeutics