HiberCell, Inc., a clinical-stage biotechnology company developing therapeutics to address advanced cancer and cancer resistance, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to HC-7366 for the treatment of adult patients with relapsed or refractory acute myeloid leukemia.
The FDA’s Fast Track program aims to facilitate the development, and expedite the review, of novel potential therapies that are designed to treat serious conditions and have the potential to address significant unmet medical need.
“We are proud to announce the grant of Fast Track designation by the FDA,” said Jonathan Lanfear, President & CEO of HiberCell. Receiving Fast Track designation highlights the FDA’s recognition of the robust preclinical data generated to date for HC-7366 and the potential for HC-7366 to address the significant unmet need that exists in R/R AML.”
Mr. Lanfear continued, “HC-7366 was the first GCN2-activator to enter the clinic in AML and is the only GCN2-targeting agent to receive Fast Track designation for the treatment of AML, validating our preclinical and translational efforts. We plan to leverage the Fast-Track designation to work closely with the FDA to facilitate and, potentially accelerate the development of HC-7366 in AML.”
HC-7366 is currently under clinical investigation in both solid and liquid tumor settings. The Phase 1b study in AML (NCT06285890) will evaluate the safety, tolerability, and preliminary efficacy of HC-7366 in relapsed/refractory (R/R) AML or MDS AML. This study aims to determine the recommended Phase 2 dose (RP2D) of HC-7366 in a R/R AML population. Dependent on observations in the dose escalation portion, this study may include additional combination and monotherapy expansions.
