Clinical trial builds upon encouraging patient response and translational data from a previous study investigating odetiglucan in combination with pembrolizumab in metastatic TNBC

NEW YORK, Dec. 14, 2021 — HiberCell, a clinical-stage biotechnology company developing therapeutics to address therapeutic resistance, cancer relapse and metastasis, today announced a clinical trial collaboration with Merck, known as MSD outside of the United States and Canada. This metastatic breast cancer clinical trial evaluates KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with HiberCell’s odetiglucan (Imprime PGG), a Dectin-1, pattern recognition receptor agonist.

Odetiglucan, a novel intravenously-administered innate immune activator, has been previously investigated in combination with pembrolizumab in immune checkpoint inhibitor-naive TNBC, as well as non-small cell lung carcinoma in combination with other immune checkpoint inhibitors, anti-angiogenic antibodies, and tumor-targeting antibodies. Under this collaboration with Merck, the phase 2 single arm, open-label clinical trial is anticipated to enroll up to 50 patients with metastatic breast cancer who have progressed through prior hormone therapy with at least one CDK4/6 inhibitor in sites across the United States. Merck will provide KEYTRUDA® for the planned clinical trials.

“We are pleased to continue the important work that we began five years ago, with a focus on improving outcomes for cancer patients who suffer from treatment-mediated resistance,” said Alan Rigby, Ph.D., chief executive officer at HiberCell. “This clinical trial is expected to build upon encouraging clinical and translational data from our prior collaborative studies with the team at Merck, which investigated odetiglucan in combination with pembrolizumab in metastatic TNBC. The data-driven decision to establish a new clinical trial represents an expansion of our odetiglucan clinical development program and highlights our continued priority of combining odetiglucan with other therapies in an effort to develop new treatment options.”

For more information about HiberCell’s odetiglucan, visit the company’s website at https://www.hibercell.com/programs/#science.

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About Odetiglucan
Odetiglucan is a Dectin-1, pattern recognition receptor agonist that drives a coordinated innate and adaptive anti-cancer immune cell response in metastatic cancers including TNBC, melanoma, and non-small cell lung carcinoma. Phase 2 clinical studies of odetiglucan in combination with immune checkpoint inhibitors have demonstrated mechanistic proof-of-concept data including the activation of innate and adaptive immunity that has resulted in clinical benefit for patients.

About HiberCell
HiberCell is a clinical-stage biotechnology company dedicated to the advancement of novel therapeutics that overcome the foundational molecular barriers that prevent patients from living longer, cancer-free lives. HiberCell’s approach utilizes AI/ML to integrate multi-omic and phenotypic profiles of tumors to generate deep insights that connect these data to clinical outcomes. Leveraging these data, HiberCell seeks to identify and validate the causal features of cancer that can potentially be targeted with their novel therapeutic candidates with the goal of addressing the most common causes of cancer mortality: resistance, relapse and metastasis. To that end, HiberCell is developing therapeutics that resolve ‘stress’ through mechanisms that involve stimulating innate and adaptive immunity to reprogram an immunosuppressive tumor immune microenvironment or modulating the stress-mediated adaptive response that is essential for cancer cell survival.

Contacts

Investor Contact:
Westwicke, an ICR Company
Stephanie Carrington
stephanie.carrington@westwicke.com
+1 646-277-1282

Media Contact:
Westwicke, an ICR Company
Terri Clevenger
Terri.clevenger@westwicke.com
+1 203-856-4326