HiberCell Announces First Patient Dosed in Clinical Collaboration with Merck, Evaluating HC-7366 in Combination with WELIREG® (belzutifan) in patients with advanced ccRCC
May 01 2024 - 5:00PM
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.
Dr. Motzer has financial interests related to Merck.
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
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.
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