09.08.21 | news
HiberCell Receives Fast Track Designation from FDA for First-in-Human Studies of PERK Inhibitor (PERKi) HC-5404-FU
HC-5404-FU PERKi Program is Currently in a Phase 1a Clinical Trial for the Treatment of Solid Tumors
NEW YORK, September 8, 2021—HiberCell, a clinical stage biotechnology company developing therapeutics to treat cancer relapse and metastasis, announced today that the U.S. Food and Drug Administration (FDA) has granted the company Fast Track designation for HC-5404-FU, an orally administered PERK inhibitor (PERKi) for patients with solid tumors. As reported in June 2021, the company initiated a first-in-human, Phase 1a clinical trial for HC-5404-FU in select solid tumors, filed their Investigational New Drug (IND) application and received FDA authorization to begin clinical studies in late 2020.
“The Fast Track designation is an important step as HiberCell focuses on advancing this first-in-class clinical asset,” said Alan Rigby, PhD, chief executive officer at HiberCell. “Importantly, this designation will allow us to work closely with the FDA to quickly move HC-5404-FU through our ongoing clinical trial, HC-404-FCP-2011.” The trial is a first in-human, Phase 1a, multi-center, open-label study to establish the maximum tolerated dose (MTD) and evaluate the safety and tolerability following oral dosing of HC-5404-FU in a dose-escalating fashion. Up to 24 qualified subjects at five US sites, who have specific solid tumors, including renal cell carcinoma (RCC), gastric cancer (GC), and other solid tumors are planned for enrollment in this study. This Phase 1a study will be expanded into a Phase 1b/2a through a protocol amendment with the dose and tumor type(s) identified in Phase 1a as the most appropriate for further clinical development.
For more information about HiberCell’s clinical trials, visit the website at www.HiberCell.com
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 a patient’s cancer, generating deep insights that connect these data to clinical outcomes. Leveraging these data HiberCell identifies and validates causal features of an individuals’ cancer that can be targeted with their novel therapies with a focus on addressing the most common cause of cancer mortality: resistance, relapse and metastasis. To that end, HiberCell is developing therapeutics that resolve ‘stress’ through mechanisms that involve stimulating innate and adaptive immunity to reprogram an immunosuppressive tumor immune microenvironment or modulating the stress-mediated adaptive response that is essential for cancer cell survival.