EIF2AK4

BOSTON, Oct. 23, 2024 (GLOBE NEWSWIRE) -- HiberCell, Inc., a clinical-stage biotechnology company developing therapeutics to address advanced cancer and cancer resistance, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to HC-7366 for the treatment of adult patients with relapsed or refractory acute myeloid leukemia. The FDA’s Fast Track program aims to facilitate the development, and expedite the review, of novel potential therapies that are designed to treat serious conditions and have the potential to address significant unmet medical need. “We are proud to announce the grant of Fast Track designation by the FDA,” said Jonathan Lanfear, President & CEO of HiberCell. Receiving Fast Track designation highlights the FDA’s recognition of the robust preclinical data generated to date for HC-7366 and the potential for HC-7366 to address the significant unmet need that exists in R/R AML.” Mr. Lanfear continued, “HC-7366 was the first GCN2-activator to enter the clinic in AML and is the only GCN2-targeting agent to receive Fast Track designation for the treatment of AML, validating our preclinical and translational efforts. We plan to leverage the Fast-Track designation to work closely with the FDA to facilitate and, potentially accelerate the development of HC-7366 in AML.” HC-7366 is currently under clinical investigation in both solid and liquid tumor settings. The Phase 1b study in AML (NCT06285890) will evaluate the safety, tolerability, and preliminary efficacy of HC-7366 in relapsed/refractory (R/R) AML or MDS AML. This study aims to determine the recommended Phase 2 dose (RP2D) of HC-7366 in a R/R AML population. Dependent on observations in the dose escalation portion, this study may include additional combination and monotherapy expansions. About HC-7366 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 standard of care 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 carcinoma in combination with belzutifan (NCT06234605) and in a Phase 1b study in R/R AML (NCT06285890). About HiberCell 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. For Media/Investor Inquiries: IR@hibercell.com

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.

NEW YORK, April 05, 2024 (GLOBE NEWSWIRE) -- HiberCell, Inc., a clinical-stage biotechnology company developing therapeutics to address cancer relapse, metastasis, and resistance, today announced the publication of “Discovery of HC-7366: An Orally Bioavailable and Efficacious GCN2 Kinase Activator” in the Journal of Medicinal Chemistry along with two poster presentations on this same molecule which will be highlighted at the American Association for Cancer Research (AACR) Annual Meeting 2024, taking place in San Diego, California. This publication and abstracts are now available online and on the AACR website, respectively. “The acceptance of these publications and presentations in top journals and at prestigious conferences are recognition of the strong scientific foundation that is the backbone of our clinical studies,” said Jonathan Lanfear, President & CEO of HiberCell. “In particular, our publication in the Journal of Medicinal Chemistry illustrates that that HC-7366 is a refined GCN2 activator with a superior PK/PD profile, enhanced selectivity, and robust preclinical efficacy.” Mr. Lanfear continued “We also look forward to presenting two posters highlighting key preclinical data for HC-7366 in two distinct combinations with important SOC agents at the upcoming AACR meeting. Our first poster features the remarkable preclinical activity of HC-7366 as monotherapy and in combination with belzutifan in clear cell renal cell carcinoma models (ccRCC). This work was foundational to our ongoing Phase 1b study in ccRCC in combination with belzutifan, which was announced earlier this year. Our second presentation details preclinical data demonstrating the ability of HC-7366 to augment osimertinib therapy to counteract resistance mechanisms in models of EGFR mutant NSCLC.” HiberCell is seeking partners to further develop the combination of HC-7366 and EGFR-TKIs, and other EGFR pathway inhibitors. Poster Presentations: Abstract Title: HC-7366, a potent GCN2 activator, complements belzutifan, a HIF-2⍺ antagonist, by providing combination benefit in belzutifan-sensitive models and monotherapy activity in belzutifan-resistant models Poster/Abstract Number: 4615 Session Date and Time: Tuesday Apr 9, 2024 9:00 AM - 12:30 PM Abstract Title: HC-7366, a potent GCN2 kinase activator, augments osimertinib therapy to delay resistance in EGFR mutant NSCLC models. Poster/Abstract Number: 4666 Session Date and Time: Tuesday Apr 9, 2024 9:00 AM - 12:30 PM About HC-7366 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 models of both solid and liquid tumors. HC-7366 is currently under clinical development in a Phase 1b study in clear cell renal cell renal cell carcinoma in combination with Merck’s oral hypoxia-inducible factor-2α (HIF-2α) inhibitor WELIREG® (belzutifan) (NCT06234605). WELIREG® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. About HiberCell 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. For Media/Investor Inquiries: IR@hibercell.com