HC-5404-FU

May 28, 2024 -- HiberCell, Inc., a clinical-stage biotechnology company developing therapeutics to address advanced cancer and cancer resistance, is pleased to announce the first patient dosed in a clinical trial evaluating HC-7366 in combination with standard of care agents venetoclax and azacitidine for advanced acute myeloid leukemia (AML). "We are excited to announce the first patient dosed in this study," said Jonathan Lanfear, President & CEO of HiberCell. "This study builds on the preclinical data we have presented at recent conferences, including the 2023 ASH Annual Meeting and Exposition, which support evaluation of HC-7366 in combination with venetoclax and azacitidine in AML patients with significant unmet need." The study’s principal investigator is Dr. Abhishek Maiti, assistant professor of Leukemia at The University of Texas MD Anderson Cancer Center. Mr. Lanfear continued, "The initiation of this study along with our recently announced study of HC-7366 in clear cell renal cell carcinoma marks the continued advancement of HC-7366 and HiberCell. These are seminal combinatorial studies of HC-7366 with the potential to address large, targeted, and underserved patient populations. We look forward to seeing data for these studies throughout 2024 and 2025." The newly announced Phase 1b study (NCT06285890) will evaluate the safety, tolerability, and preliminary efficacy of HC-7366 in combination with standard dosing of venetoclax and azacitidine 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 combination with venetoclax and azacitidine in a R/R AML population. The study will enroll up to 18 patients. HC-7366 is a first-in-class, first-in-human, selective, potent, small molecule activator of the general control nonderepressible 2 (GCN2) kinase. GCN2 is one of the kinases of the integrated stress response (ISR) family, which responds to amino acid deprivation and is a key metabolic stress sensor in cells. While cancer cells utilize the ISR for survival, prolonged or hyperactivation of GCN2 with HC-7366 has been shown to have antitumor and immunomodulatory activity as a monotherapy and in combination with SOC agents in both solid and liquid tumor models. HC-7366 is currently under clinical development in a Phase 1b/2 study in clear cell renal cell renal cell carcinoma in combination with belzutifan (NCT06234605) and in a Phase 1b study in AML in combination with azacitidine and venetoclax (NCT06285890). HiberCell is a clinical stage oncology company, dedicated to the advancement of first-in-class agents with the novel MOA of modulation of adaptive stress pathways and antitumor immunity. We believe that therapeutic modulation of these mechanisms allows us to address advanced cancer and cancer resistance. Our product candidates HC-5404 and HC-7366, both having completed Phase 1a clinical trials, target the stress response kinases PERK and GCN2, respectively, while our product candidate odetiglucan, currently advancing towards Phase 2 clinical development, modulates the antitumor innate immune response. For more information about HiberCell, please visit hibercell.com. The content above comes from the network. if any infringement, please contact us to modify.

May 01, 2024 -- HiberCell, Inc., a clinical-stage biotechnology company developing therapeutics to address cancer relapse, metastasis, and resistance, is pleased to announce the dosing of the first patient in a Phase 1b study evaluating HC-7366, an activator of integrated stress response (ISR) Kinase GCN2, in combination with Merck’s oral hypoxia-inducible factor-2α (HIF-2α) inhibitor WELIREG® (belzutifan) for the treatment of advanced clear cell renal cell carcinoma (ccRCC). The Phase 1b study (NCT06234605) will evaluate the safety, tolerability, and preliminary efficacy of HC-7366 in combination with belzutifan in patients with advanced ccRCC. This trial will also determine a recommended Phase 2 dose (RP2D) of HC-7366 in combination with fixed-dose belzutifan, 120 mg po qd. Dose escalation of HC-7366 in the combination, followed by an expansion phase will optimize dose evaluation. An independent HC-7366 monotherapy cohort is being evaluated in parallel. The study will enroll up to 80 patients at clinical sites across the US. Robert J. Motzer, MD., Section Head, Kidney Cancer, Genitourinary Oncology Service at Memorial Sloan Kettering Cancer Center (MSK) will be the lead Principal Investigator (PI) for the clinical trial. "The first patient dosed in this trial marks the beginning of an exciting new chapter in the clinical development of HC-7366," stated Cherry Thomas, M.D., Chief Medical Officer. "The combination of HC-7366 with belzutifan, a key agent for the treatment of clear cell renal cell carcinoma, offers a potentially promising novel and differentiated treatment in a setting with major unmet need and limited treatment options for patients. We recently presented key aspects of the significant preclinical data in support of the combination at the 2024 American Association for Cancer Research Annual Conference." WELIREG® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. HC-7366 is a first-in-class, first-in-human, selective, potent, small molecule activator of the general control nonderepressible 2 (GCN2) kinase. GCN2 is one of the kinases of the integrated stress response (ISR) family, which responds to amino acid deprivation and is a key metabolic stress sensor in cells. While cancer cells utilize the ISR for survival, prolonged or hyperactivation of GCN2 with HC-7366 has been shown to have antitumor and immunomodulatory activity as a monotherapy and in combination with SOC agents in preclinical models of both solid and liquid tumors. HC-7366 is currently under clinical development in a Phase 1b study in clear cell renal cell carcinoma in combination with belzutifan. HiberCell is a clinical stage oncology company, dedicated to the advancement of first-in-class agents with the novel MOA of modulation of adaptive stress pathways and antitumor immunity. We believe that therapeutic modulation of these mechanisms allows us to address tumor metastasis, treatment resistance, and cancer relapse; all significant drivers of cancer-related deaths. Our product candidates HC-5404 and HC-7366, both having completed Phase 1a clinical trials, target the stress response kinases PERK and GCN2, respectively, while our product candidate odetiglucan, currently advancing towards Phase 2 clinical development, modulates the antitumor innate immune response. For more information about HiberCell, please visit hibercell.com. The content above comes from the network. if any infringement, please contact us to modify.