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HiberCell's HC-7366 Receives FDA Fast Track Designation for Relapsed/Refractory AML

• HiberCell's HC-7366, a GCN2-activator, has been granted Fast Track designation by the FDA for treating relapsed or refractory acute myeloid leukemia (R/R AML). • The FDA's decision highlights HC-7366's potential to address the significant unmet need in R/R AML, based on robust preclinical data. • HC-7366 is currently in Phase 1b clinical trials, evaluating its safety, tolerability, and preliminary efficacy in R/R AML or MDS AML patients. • This Fast Track designation may expedite the development of HC-7366, allowing HiberCell to work closely with the FDA during the process.

HiberCell, Inc. has announced 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 (AML). This designation aims to accelerate the development and review of therapies addressing serious conditions with unmet medical needs.
Jonathan Lanfear, President & CEO of HiberCell, stated that the Fast Track designation highlights the FDA’s recognition of the preclinical data for HC-7366 and its potential to address the unmet need in R/R AML. HC-7366 is the first GCN2-activator to enter clinical trials for AML and the only GCN2-targeting agent to receive Fast Track designation for AML treatment.

Clinical Development of HC-7366

HC-7366 is currently being investigated in Phase 1b studies in both solid and liquid tumor settings. The Phase 1b study in AML (NCT06285890) is evaluating the safety, tolerability, and preliminary efficacy of HC-7366 in patients with relapsed/refractory (R/R) AML or MDS AML. The study aims to determine the recommended Phase 2 dose (RP2D) of HC-7366 in this patient population and may include additional combination and monotherapy expansions based on dose escalation observations.

About HC-7366

HC-7366 is a first-in-class, selective, potent, small molecule activator of the general control nonderepressible 2 (GCN2) kinase. GCN2 is part of the integrated stress response (ISR) family, responding to amino acid deprivation and acting as a key metabolic stress sensor in cells. While cancer cells utilize the ISR for survival, prolonged or hyperactivation of GCN2 with HC-7366 has demonstrated antitumor and immunomodulatory activity as a monotherapy and in combination with standard of care agents in preclinical models of both solid and liquid tumors. HC-7366 is also in clinical development in a Phase 1b/2 study in clear cell renal cell carcinoma in combination with belzutifan (NCT06234605).

HiberCell's Approach to Cancer Therapy

HiberCell is focused on developing first-in-class agents that modulate adaptive stress pathways and antitumor immunity to address advanced cancer and cancer resistance. Their product candidates, including HC-5404 and HC-7366, target the stress response kinases PERK and GCN2, respectively. Odetiglucan, another product candidate, is advancing towards Phase 2 clinical development and modulates the antitumor innate immune response.
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Highlighted Clinical Trials

Phase I Study of HC-7366 for Acute Myeloid Leukemia

NCT06285890RecruitingPhase 1
M.D. Anderson Cancer Center
Posted 5/20/2024

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Reference News

[1]
HiberCell Receives FDA Fast Track Designation for HC-7366 for the Treatment of Relapsed ...
biospace.com · Oct 23, 2024

HiberCell, Inc. announces FDA Fast Track designation for HC-7366, a GCN2-activator, in treating relapsed or refractory a...

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