05.23.23 | news
HiberCell Doses First Patient in Phase 1b Study Exploring Novel Combination of Odetiglucan and CD40 Agonistic Monoclonal Antibody (CDX-1140) in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) in the Maintenance Setting
BOSTON, May 22, 2023 (GLOBE NEWSWIRE) — HiberCell, a clinical-stage biotechnology company developing therapeutics to address cancer relapse, metastasis, and resistance, today announced dosing of the first patient in a Phase 1b clinical trial investigating the effects of odetiglucan, a first-in-class immunomodulatory agent, in combination with the CD40 agonistic monoclonal antibody, CDX-1140, in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) in the maintenance setting. Odetiglucan is a systemically administered Dectin-1 agonist that has been observed to modulate both the innate and adaptive immune systems. CDX-1140 is a potent CD40 agonist antibody developed by Celldex Therapeutics specifically designed to balance good systemic exposure and safety with potent biological activity.
“The dosing of the first patient in this Phase 1b study marks an important milestone for HiberCell as we continue to advance our portfolio of first-in-class therapeutic agents targeting critical pathways that tumor and immune cells leverage to allow cancer cells to survive and become resistant to treatment,” said Jonathan Lanfear, President and Chief Executive Officer at HiberCell. “Odetiglucan is a Dectin-1 myeloid agonist that mediates anti-tumor activity by modulating tumor-immune interactions in the tumor microenvironment. We are excited to advance this novel combination of two myeloid agonists, odetiglucan with CDX-1140, in metastatic PDAC, an area of very high unmet medical need, and for which myeloid cell-mediated immune suppression is a critical challenge. We expect to report interim clinical data in in the second half of 2023.”
The Phase 1b, multi-site, open-label trial is a two-part study evaluating the safety, tolerability, and efficacy of odetiglucan in combination with CDX-1140 in metastatic PDAC patients with prior evidence of objective response or stable disease following a minimum of 16, and maximum of 32 weeks, of chemotherapy. The primary objectives of the study include identifying the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D), while evaluating the safety, tolerability, and dose-limiting toxicities (DLTs) of odetiglucan in combination with CDX-1140. Key secondary objectives will evaluate duration of response (DOR), overall response rate (ORR), median progression free survival (PFS) and median overall survival (OS), although the study is not powered for statistical significance for these endpoints.
HiberCell will highlight additional information on this study with a poster presentation at the 2023 American Society of Clinical Oncology (ASCO) Meeting. This abstract is now available on the ASCO website. Information about the clinical trial can also be found on clinicaltrials.gov, identifier number: NCT 05484011.
Poster Presentation Detail:
Abstract Title: A phase 1b, open-label, two-part safety, tolerability, and efficacy study of a soluble beta-glucan (odetiglucan) in combination with a CD40 agonistic monoclonal antibody (CDX-1140) in patients with metastatic pancreatic adenocarcinoma whose disease did not progress during first-line (1L) chemotherapy
Abstract/Poster Number: TPS4201/ 507a
Presentation Time: Monday, June 5, 2023, 8:00 AM – 11:00 AM
About Metastatic Pancreatic ductal adenocarcinoma (PDAC)
Based on published literature, PDAC is one of the most aggressive forms of cancer with a 5 year survival rate of 10.8%, making it the third most common cause of cancer-related death in men and women. For patients with metastatic disease, the overall survival is approximately 10-12 months with standard of care therapies. While many patients respond to chemotherapy, there are currently no approved therapies available for non-BRCA mutation patients who cannot tolerate further chemotherapy. In this setting, patients typically experience rapid cancer progression with significant worsening in health-related quality of life resulting in a high unmet medical need for novel and effective therapeutic options.
Odetiglucan is a systemically administered, Dectin-1, pattern recognition receptor agonist shown to drive a coordinated innate and adaptive anti-cancer immune response. A Phase 2 clinical study of odetiglucan in combination with an anti-PD1 immune checkpoint inhibitor (pembrolizumab) provided mechanistic proof-of-concept (including activation of an innate and adaptive anti-cancer immune response) along with a generally well tolerated profile and initial signs of clinical activity.
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 in Phase 2 clinical development, modulates the anti-tumor innate immune response.
Stern Investor Relations, Inc.