FDA Grants Fast Track to HiberCell's HC-7366 for Relapsed/Refractory AML

BOSTON, Oct. 23, 2024 - HiberCell, Inc., a biotechnology company at the clinical stage focusing on therapeutics for advanced cancer and cancer resistance, recently announced that the U.S. Food and Drug Administration (FDA) has awarded Fast Track designation to HC-7366. This designation is specifically for treating adult patients with relapsed or refractory acute myeloid leukemia (AML).

The FDA's Fast Track program aims to accelerate the development and review of innovative therapies that target serious conditions with significant unmet needs. Jonathan Lanfear, President and CEO of HiberCell, expressed pride in receiving this designation, which underscores the FDA's acknowledgment of the solid preclinical data supporting HC-7366 and its potential to meet the critical needs in the treatment of relapsed or refractory AML.

Lanfear further highlighted that HC-7366 is the first GCN2-activator entered into clinical trials for AML and the only GCN2-targeting agent to be granted the Fast Track designation for AML treatment. This recognition validates their preclinical and translational research efforts. HiberCell plans to use this designation to collaborate closely with the FDA, which could potentially expedite the development of HC-7366 for AML.

Currently, HC-7366 is under clinical investigation in both solid and liquid tumors. The ongoing Phase 1b study in AML (NCT06285890) is designed to assess the safety, tolerability, and initial effectiveness of HC-7366 in patients with relapsed/refractory AML or MDS AML. The study aims to establish the recommended Phase 2 dose (RP2D) for HC-7366 in this patient population. Based on findings from the dose-escalation segment, the study may also explore additional combination and monotherapy expansions.

HC-7366 is a pioneering, first-in-human, selective, potent small molecule activator of the general control nonderepressible 2 (GCN2) kinase. GCN2 is part of the integrated stress response (ISR) kinase family, which reacts to amino acid deprivation and serves as a vital metabolic stress sensor in cells. Cancer cells exploit the ISR for survival, but prolonged or hyperactivation of GCN2 with HC-7366 has demonstrated antitumor and immunomodulatory effects both as a monotherapy and in combination with standard care treatments in solid and liquid tumor models. HC-7366 is being clinically developed in a Phase 1b/2 study for clear cell renal cell carcinoma in combination with belzutifan (NCT06234605) and in a Phase 1b study for relapsed/refractory AML (NCT06285890).

HiberCell is a clinical-stage oncology company dedicated to developing first-in-class agents that modulate adaptive stress pathways and antitumor immunity. The company believes that targeting these mechanisms can effectively address advanced cancer and cancer resistance. HiberCell's product candidates include HC-5404 and HC-7366, both of which have completed Phase 1a clinical trials, targeting the stress response kinases PERK and GCN2, respectively. Another candidate, odetiglucan, is advancing towards Phase 2 clinical development and focuses on modulating the antitumor innate immune response.

HiberCell continues to push forward in the development of innovative cancer treatments, leveraging robust scientific research and strategic clinical trials to bring new hope to patients with advanced and resistant forms of cancer.