HiberCell Initiates its Phase 1a/b Clinical Trial in Patients With Advanced Solid Tumors

HiberCell has recently initiated a Phase 1a/b clinical trial of HC-7366, a first-in-class selective, orally bioavailable modulator of General Control Nonderepressible 2 (GNC2) for the treatment of patients with advanced solid tumors. The first clinical trial site opened January 2022 with Sarah Cannon Research Institute at Tennessee Oncology in Nashville, TN.

“We are pleased to announce that HC-7366, our first in-human GCN2 modulator, is now being tested in cancer patients with advanced solid tumors. Importantly, we designed HC-7366 to provide both potent anti-tumor activity as well as immunomodulatory activity in cancer patients whose tumors leverage the integrated stress response pathway to drive therapeutic resistance to current therapies that can lead to cancer relapse,” said Alan Rigby, PhD, Chief Executive Officer at HiberCell. “Initiation of the Phase 1 clinical trial is an important step forward for HC-7366 and further supports our mission of addressing the foundational barriers that have historically prevented cancer patients from living longer, cancer-free lives.”

This first-in-human, multicenter, open-label, Phase 1a/b clinical trial (NCT05121948) is designed to establish the maximum tolerated dose, while evaluating safety and tolerability, and to establish the recommended Phase 2 dose for HC-7366 in patients with advanced solid tumors, including but not limited to, head and neck squamous cell carcinoma, colorectal cancer, non-small cell lung cancer, transitional cell carcinoma of the bladder, and other advanced solid tumors. This is HiberCell’s first clinical trial for HC-7366 and the company believes this is an important part of the larger strategic plan for HC-7366 that includes the exploration as a potential treatment for hematological malignancies through targeting and modulation of the integrated stress response. HiberCell submitted an IND application for HC-7366 on September 28, 2021.

HiberCell is a clinical-stage biotechnology company dedicated to the advancement of novel therapeutics that overcome the foundational molecular barriers that prevent patients from living longer, cancer-free lives. HiberCell’s approach utilizes AI/ML to integrate multi-omic and phenotypic profiles of tumors to generate insights that connect this information to clinical outcomes. By leveraging these data, HiberCell seeks to identify and validate the causal features of cancer that can potentially be targeted with their novel therapeutic candidates with the goal of addressing the most common causes of cancer mortality: resistance, relapse and metastasis. To that end, HiberCell is developing therapeutics that resolve the stress-mediated adaptive response that is essential for cancer cell survival. For more information, visit www.HiberCell.com.