HiberCell Doses First Patient in Phase 1b AML Trial of HC-7366 with Venetoclax and Azacitidine

On May 28, 2024, HiberCell, Inc., an innovative biotechnology firm focused on addressing advanced cancer and its resistance mechanisms, proudly announced the dosing of the first patient in a groundbreaking clinical trial. This study investigates the efficacy of their novel therapeutic agent, HC-7366, in conjunction with established treatments venetoclax and azacitidine, targeting advanced acute myeloid leukemia (AML).

"We are thrilled to commence patient dosing in this significant trial," said HiberCell's President and CEO, Jonathan Lanfear. He highlighted that the study builds on robust preclinical data, previously shared at notable scientific gatherings, including the 2023 ASH Annual Meeting and Exposition. These findings support the potential benefits of combining HC-7366 with venetoclax and azacitidine for AML patients who face significant treatment challenges.

The principal investigator for this study is Dr. Abhishek Maiti, an assistant professor specializing in Leukemia at The University of Texas MD Anderson Cancer Center. Lanfear further emphasized that this trial, alongside another recent study involving HC-7366 in clear cell renal cell carcinoma, marks significant progress for HiberCell. These pioneering combination studies of HC-7366 aim to address large, underserved patient populations effectively, with results expected to emerge throughout 2024 and 2025.

This newly launched Phase 1b study (NCT06285890) will assess the safety, tolerability, and initial efficacy of HC-7366 when combined with standard dosages of venetoclax and azacitidine in patients with relapsed or refractory (R/R) AML or MDS AML. The primary objective is to establish the recommended Phase 2 dose (RP2D) of HC-7366 for this patient group, with an enrollment target of up to 18 participants.

HC-7366 represents a first-in-class, first-in-human, selective, and potent small molecule that activates the general control nonderepressible 2 (GCN2) kinase. GCN2 is a crucial component of the integrated stress response (ISR) family of kinases, which reacts to amino acid deprivation and serves as a vital metabolic stress sensor within cells. While cancer cells often exploit the ISR for survival, sustained or excessive activation of GCN2 via HC-7366 has demonstrated antitumor and immunomodulatory effects both as a standalone treatment and in combination with standard of care (SOC) agents across various tumor models.

Currently, HC-7366 is being evaluated in clinical trials including a Phase 1b/2 study focusing on clear cell renal cell carcinoma in combination with belzutifan (NCT06234605), and the Phase 1b study in AML with azacitidine and venetoclax (NCT06285890).

HiberCell is dedicated to advancing its pipeline of first-in-class oncology agents that leverage novel mechanisms of action (MOA) to modulate adaptive stress pathways and enhance antitumor immunity. The company’s product candidates, including HC-5404 and HC-7366, which have concluded Phase 1a trials, target the stress response kinases PERK and GCN2, respectively. Additionally, their candidate odetiglucan is progressing towards Phase 2 development, focusing on modulating the antitumor innate immune response.

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