FDA Grants Orphan Drug Designation to CFT7455 for Multiple Myeloma

The FDA has granted orphan drug designation to CFT7455 for the treatment of multiple myeloma, according to a press release from manufacturer C4 Therapeutics.

“We are pleased to receive FDA’s orphan drug designation for CFT7455 in multiple myeloma and believe this designation highlights the potential of CFT7455 to improve clinical outcomes for patients with multiple myeloma who face an incurable disease,” said Adam Crystal, MD, PhD, chief medical officer of C4 Therapeutics, in the press release. “With far too many patients relapsing on numerous lines of therapy and succumbing to multiple myeloma, we are focused on advancing our Phase 1/2 trial to bring this new treatment option to patients.”

According to the press release, CFT7455 is an orally bioavailable MonoDAC™ degrader targeting IKZF1/3 for the treatment of multiple myeloma and non-Hodgkin lymphomas, such as peripheral T-cell lymphoma and mantle cell lymphoma. A phase 1/2 clinical trial was initiated in June 2021 to further investigate safety, tolerability, and anti-tumor activity, with secondary and exploratory objectives to classify the pharmacokinetic and pharmacodynamic profile of CFT7455. C4T plans to enroll approximately 160 patients in the phase 1/2 trial.

REFERENCE

C4 Therapeutics Announces FDA Orphan Drug Designation for CFT7455 for the Treatment of Multiple Myeloma. C4 Therapeutics. August 11, 2021. Accessed August 17, 2021. https://ir.c4therapeutics.com/news-releases/news-release-details/c4-therapeutics-announces-fda-orphan-drug-designation-cft7455