The U.S. Food and Drug Administration (FDA) approved the company’s application requesting a Phase 1/2a trial, which could open by mid-year.
“With FDA clearance achieved, we are on track to advance CFT7455 into the clinic in the first half of 2021,” Andrew Hirsch, president and CEO of C4 Therapeutics, said in a press release.
CFT7455 is an oral therapy belonging to the class of monofunctional degradation activating compound (MonoDACs), commonly known as “glue degraders.” By binding to E3 ligase, an enzyme that flags proteins for degradation, MonoDACs increase the binding of E3 to target proteins, causing the degradation of factors essential to the growth of cancer cells.
C4 Therapeutics’s degrader molecules were discovered using the company’s TORPEDO platform. CFT7455, in particular, is designed to increase the degradation of IKZF1/3, whose mutations often lead to treatment resistance in myeloma and lymphoma.
“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,” Hirsch added.
C4 Therapeutics’ upcoming open-label Phase 1/2 trial will evaluate CFT7455 in multiple blood cancers, and will be conducted in two parts.
In a first part, researchers will evaluate CFT7455 as a single agent in treating people with relapsed or refractory multiple myeloma or non-Hodgkin’s lymphomas. The therapy will also be evaluated in combination with dexamethasone in patients with relapsed or refractory multiple myeloma.
After an optimal dose is determined in this part, the study’s Phase 2 will evaluate the safety, tolerability, pharmacokinetics (the movement of a compound into, through, and out of the body)and pharmacodynamics (the effects of a drug on the body). Evidence of CFT7455’s anti-tumor activity, alone or in combination with dexamethasone, in multiple myeloma patients will also be assessed.
Continued treatment effects, as a single agent, will also be examined in people with mantle cell lymphoma and peripheral T-cell lymphoma, two types of non-Hodgkin’s lymphoma.
“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,” Hirsch said.
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