NEW YORK, Sept. 08, 2021 (GLOBE NEWSWIRE) — 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.
A Fast Track designation from the FDA provides several benefits for HiberCell’s HC-5404-FU PERKi therapeutic, including more frequent meetings with the FDA to discuss the drug development plan, additional written communications from the FDA regarding the design of the proposed clinical trials, the use of biomarkers, and Rolling Review, which means HiberCell can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until all sections of the NDA are completed. Additionally, with this designation, HC-5404-FU will automatically be considered for Accelerated Approval and Priority Review. Accelerated Approval is based on a surrogate endpoint reasonably likely to predict clinical benefit; Priority Review shortens the FDA review process from ten months to six.
“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.”
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 deep insights that connect these data to clinical outcomes. Leveraging these data HiberCell identifies and validates the causal features of 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.
Wed, September 8, 2021,