US-based biotechnology company HiberCell has dosed the first patient in its Phase Ib clinical trial of the immunomodulatory agent odetiglucan combined with CDX-1140.
The combination therapy is intended to treat patients with metastatic pancreatic ductal adenocarcinoma (PDAC) in the maintenance setting.
The multi-site, open-label, two-part study will evaluate the efficacy, tolerability, dose-limiting toxicities and safety of the combined therapy in metastatic PDAC patients.
Subjects with previous evidence of objective response or stable disease after 16-32 weeks of chemotherapy have been enrolled in the study.
The trial’s primary objective is to identify the maximum tolerated dose and recommended Phase II dose.
Its secondary aims are to evaluate the duration of response and overall response rate, as well as determine median progression-free survival and median overall survival rates.
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HiberCell president and CEO Jonathan Lanfear said: “The dosing of the first patient in this Phase Ib 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.
“Odetiglucan is a Dectin-1 myeloid agonist that mediates anti-tumour activity by modulating tumour-immune interactions in the tumour 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 the second half of 2023.”
Developed by Celldex Therapeutics as a CD40 agonistic monoclonal antibody, CDX-1140 is designed to balance good systemic exposure and safety with potent biological activity.
The drug previously showed anti-tumour activity with activation of an innate and adaptive anti-cancer immune response in a Phase II study in combination with pembrolizumab, an anti-PD1 immune checkpoint inhibitor.