CFT7455 receives clearance of investigational new drug application by FDA for the treatment of multiple myeloma and non-Hodgkin lymphoma

The U.S. Food and Drug Administration (FDA) announced the clearance of the Investigational New Drug Application of CFT7455, a monofunctional degradation activating compound (monoDAC) that targets IKZF1/3.¹ This orally available compound is designed to treat multiple myeloma (MM) and non-Hodgkin lymphomas (NHLs).

CFT7455 as a monoDAC is thought to act by binding to E3 ligases and creating an improved binding surface for the target protein, causing degradation. The targets IKZF1/3, are transcription factors involved in the proliferation of MM and NHL cells.²

Having passed its 30-day safety review and achieving FDA clearance means that CFT7455 can proceed to a phase I/II clinical trial in patients with relapsed/refractory MM and NHL. The phase I portion will investigate CFT7455 alone and combined with dexamethasone. Once the optimal dose has been found, the phase II trial will be initiated with the primary endpoints of safety and tolerability. The secondary endpoints will be the characterization of the pharmacokinetic and pharmacodynamic profiles, along with the antitumor activity of CFT7455.