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.

About HC-7366

HC-7366 is a first-in-class, first-in-human, selective, potent, small molecule activator of the general control nonderepressible 2 (GCN2) kinase. GCN2 is one of the kinases of the integrated stress response (ISR) family, which responds to amino acid deprivation and is a key metabolic stress sensor in cells. While cancer cells utilize the ISR for survival, prolonged or hyperactivation of GCN2 with HC-7366 has been shown to have antitumor and immunomodulatory activity as a monotherapy and in combination with standard of care agents in both solid and liquid tumor models. HC-7366 is currently under clinical development in a Phase 1b/2 study in clear cell renal cell carcinoma in combination with belzutifan (NCT06234605) and in a Phase 1b study in R/R AML (NCT06285890).

About HiberCell

HiberCell is a clinical stage oncology company, dedicated to the advancement of first-in-class agents with the novel MOA of modulation of adaptive stress pathways and antitumor immunity. We believe that therapeutic modulation of these mechanisms allows us to address advanced cancer and cancer resistance. Our product candidates HC-5404 and HC-7366, both having completed Phase 1a clinical trials, target the stress response kinases PERK and GCN2, respectively, while our product candidate odetiglucan, currently advancing towards Phase 2 clinical development, modulates the antitumor innate immune response. For more information about HiberCell, please visit hibercell.com.

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IR@hibercell.com