HiberCell Announces First Patients Dosed in Phase 2 Clinical Trial of Odetiglucan in Combination with KEYTRUDA in Adult Patients With Metastatic, Hormone-Refractory Breast Cancer

HiberCell recently announced the first patients have been dosed in a Phase 2 clinical trial of odetiglucan plus KEYTRUDA (pembrolizumab) for the treatment of metastatic, hormone-refractory breast cancer in adults. This clinical trial, being conducted under the previously announced collaboration with Merck (known as MSD outside of the US and Canada), evaluates KEYTRUDA, Merck’s anti-programmed death receptor-1, or anti-PD-1, therapy, in combination with HiberCell’s odetiglucan (Imprime PGG), a Dectin-1, pattern recognition receptor agonist.

The open-label study anticipates enrolling up to 65 adult metastatic, hormone-refractory breast cancer patients who have progressed through prior hormone therapy with at least one CDK4/6 inhibitor and up to two lines of chemotherapy. The primary objective of the study is overall response rate (ORR) per RECIST v1.1; key secondary objectives include median overall survival (mOS), progression-free survival (PFS) and median PFS by RECIST v1.1, and safety. The study will also evaluate pharmacodynamic markers to further elucidate the anti-cancer immune activity associated with odetiglucan.

Odetiglucan, a novel intravenously administered investigational innate and adaptive immune modulator, has previously been investigated in combination with pembrolizumab in immune checkpoint inhibitor-naive metastatic triple negative breast cancer (mTNBC) patients.

“The first patients dosed clinical milestone is a significant step forward in the development of odetiglucan that builds on these prior clinical trials. Importantly, this study continues our patient-centric, patient-first approach that leverages our differentiated therapeutic pipeline to address metastatic disease,” said Alan Rigby, PhD, President and Chief Executive Officer at HiberCell.

“New treatments to overcome tumor resistance to immunotherapies remain a serious unmet medical need. The fact that the first patients have been dosed with odetiglucan is a positive step forward in our clinical development program. We anticipate that this trial will provide important clinical data to support our understanding of the potential benefits of odetiglucan in combination with pembrolizumab,” added Dr. Alison Stopeck, Chief of the Division of Hematology/Oncology, Associate Director of Clinical and Translational Research at the Stony Brook University Cancer Center and chair of the trial steering committee.

More information about the clinical trial can be found on clinicaltrials.gov, identifier number: NCT05159778.

HiberCell is a clinical-stage biotechnology company dedicated to the advancement of novel therapeutic candidates 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 insights that connect this information to clinical outcomes. By 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 intended to resolve the stress-mediated adaptive response that is essential for cancer cell survival.