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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.

The proceeds will support the execution of the Phase II/III trial and potential NDA submission for the Nectero EAST System, a Breakthrough Therapy for small to medium-sized AAA. TEMPE, Ariz.--(BUSINESS WIRE)-- Nectero Medical, a clinical-stage biotechnology company pioneering novel therapies to treat aneurysmal disease, today announced the closing of its $96 million Series D financing round. Financing was led by Norwest Venture Partners, with large investments from Boston Scientific Corporation, BioStar Capital, Cadence Healthcare Ventures, Aphelion Capital and other firms. Proceeds will be utilized to accelerate the execution of the Phase II/III (stAAAble) trial and to support the submission of a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for the Nectero Endovascular Aneurysm Stabilization Treatment (Nectero EAST®) System. Upon completion of the Series D financing, Dr. Zack Scott, of Norwest Venture Partners, and Dr. Alan Davis, of BioStar Capital, have joined the Nectero Medical Board of Directors. “We are pleased to have raised the funds required to complete the necessary work to bring our potentially transformative technology to market,” said Jack Springer, President & CEO, Nectero Medical. “In addition, we are fortunate to add two highly knowledgeable and extremely insightful members to our already strong and accomplished Board of Directors.” The Nectero EAST System is an investigational, single-use, endovascular system that delivers pentagalloyl glucose (PGG) locally into the aneurysmal wall, where it binds to elastin and collagen to strengthen the aortic vessel wall and to potentially reduce further degradation. The procedure takes less than an hour to complete and leaves no permanent implant behind. In January 2024, Nectero Medical initiated a Phase II/III clinical trial (stAAAble) to investigate the safety and efficacy of the Nectero EAST System in patients with infrarenal abdominal aortic aneurysms (AAAs), maximum diameter 3.5 – 5.0cm. “We are honored and excited to be the lead investor in the Series D financing to fund the efforts necessary to bring the Nectero EAST System to market,” said Dr. Zack Scott, General Partner, Norwest Venture Partners. “The Nectero EAST System has the potential to have a profound impact on the hundreds of thousands of patients living with aneurysmal disease and would represent the most significant advancement in the treatment of AAA in over 25 years.” “FDA has granted Breakthrough Therapy designation for the Nectero EAST System, acknowledging that the preliminary clinical evidence indicates that the combination product may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s),” said Dr. Alan Davis, Managing Director, BioStar Capital. “This potentially transformational treatment is a perfect addition to the BioStar’s investment portfolio centered around our deep-seated commitment to fund cutting-edge innovations that improve patients’ lives.” About the Nectero EAST® System The Nectero EAST System is a single-use, endovascular system for the treatment of infrarenal abdominal aortic aneurysm (AAA). It is estimated that >1M diagnosed Americans are living with AAA and ~60,000 undergo treatment each year; complications of AAA account for approximately 10,000 deaths in the U.S. annually. Available treatments are primarily reserved for AAAs larger than 5.0/5.5cm (female/male) in diameter, symptomatic patients, or rapidly expanding aneurysms. Smaller AAAs are traditionally monitored with serial ultrasound or CT surveillance and carry a 0.5-5% annual risk of rupture. The Nectero EAST System is comprised of a dual-balloon delivery catheter and stabilizer mixture containing pentagalloyl glucose (PGG). The system delivers PGG locally into the aneurysmal wall, where it can bind to elastin and collagen to potentially strengthen the aortic vessel wall and reduce the risk of further degradation. The procedure does not require any specialized tools for vascular surgeons trained in endovascular techniques, takes less than an hour to complete, leaves no permanent implant behind, and does not preclude any future interventions. Early clinical results from the company’s first-in-human (“FIH”) study were recently published in the Journal of Vascular Surgery. In 2023, the Nectero EAST System was granted Fast Track and Breakthrough Therapy designations to treat patients with infrarenal AAAs, maximum diameter 3.5 – 5.0cm. The safety and efficacy of the Nectero EAST System in treating patients with infrarenal AAAs is being investigated in the Nectero EAST System for Small- to Mid-sized Abdominal Aortic Aneurysms (AAA) StaBiLization: Evaluation of Efficacy (stAAAble) clinical trial. If successful, the Nectero EAST System may offer patients with smaller AAAs a first approved therapeutic option beyond surveillance. For more information, please visit . Disclaimer There is no assurance as to the results of the study described in this press release or the efficacy of the Nectero EAST System.