NEW YORK, Dec. 05, 2023 — HiberCell, Inc., a clinical-stage biotechnology company developing therapeutics to address cancer relapse, metastasis, and resistance, today announced a clinical collaboration with Merck (known as MSD outside the United States and Canada) to evaluate HC-7366, HiberCell’s first-in-class, potent and selective activator of the general control nonderepressible 2 (GCN2) kinase, in combination with WELIREG^® (belzutifan), Merck’s oral hypoxia-inducible factor-2α (HIF-2α) inhibitor, for the treatment of clear cell renal cell carcinoma (RCC).

The Phase 1b study will evaluate the safety, tolerability, and preliminary efficacy of HC-7366 in combination with WELIREG in participants with ccRCC. With a focus on determining the recommended Phase 2 dose (RP2D), the study includes a dose-escalation phase followed by a dose-expansion phase and an independent HC-7366 monotherapy cohort. The study is planned to open in Q1 2024 and will enroll up to 80 participants at clinical sites across the US. Robert J. Motzer, MD., Section Head, Kidney Cancer, Genitourinary Oncology Service at Memorial Sloan Kettering Cancer Center (MSKCC) will be the lead Principal Investigator (PI) for the clinical trial.

“We are excited to collaborate with Merck to evaluate HC-7366 in combination with belzutifan,” said Jonathan Lanfear, President & CEO of HiberCell. “We are also excited to announce that one of the scientific leaders within the RCC space, Dr. Robert Motzer, will be our lead PI for this important trial. We expect this study to build on what we have demonstrated preclinically, showing that the combination of these two therapies has the potential to significantly broaden and deepen patient responses relative to belzutifan alone. This trial will also build on the data from our ongoing Ph1a/1b monotherapy studies for HC-7366 in solid tumors. We are eager to pursue this investigational combination in a setting where additional treatment options for patients are needed.”

WELIREG^® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About Clear Cell Renal Cell Carcinoma

Clear cell renal cell carcinoma is the most common type of kidney cancer, accounting for ~70% of all cases. Current treatment options for patients include antiangiogenics and immunotherapy, however, there are limited options for patients who are refractory to these therapies. As such, new treatment strategies for patients who have failed immunotherapy and antiangiogenics are urgently needed.

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 anti-tumor 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 investigation as monotherapy in Ph1a/1b studies in advanced solid tumors (NCT05121948).

Disclosures

Dr. Motzer has financial interests related to Merck.

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 anti-tumor 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 completing 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 anti-tumor innate immune response. For more information about HiberCell, please visit hibercell.com.

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