Precision-Panc Team Launches PRIMUS-006 Study on IMM-101, Gemcitabine, and Pembrolizumab Combination

The University of Glasgow's Precision-Panc team, alongside NHS Greater Glasgow & Clyde, announced the commencement of the Phase II PRIMUS-006 clinical trial. This study focuses on assessing a unique treatment combination for patients with metastatic pancreatic cancer. The combination includes IMM-101, an immunomodulatory agent derived from heat-killed, whole cell Mycobacterium obuense, gemcitabine, and pembrolizumab. This trial is a segment of the Precision-Panc Platform master protocol program, co-sponsored by NHS Greater Glasgow & Clyde and the University of Glasgow, and managed by the Glasgow Oncology Clinical Trials Unit. Cancer Research UK has endorsed the PRIMUS-006 study, and it is financially supported by Merck Sharp & Dohme LLC and Immodulon Therapeutics Ltd.

Professor David Chang, the principal investigator, and Professor of Surgical Oncology at the University of Glasgow, emphasizes the significance of this study in seeking new treatments for pancreatic cancer. Professor Jeff Evans, also from the University of Glasgow, highlighted the potential of IMM-101 to boost anti-tumor activity when combined with gemcitabine and pembrolizumab.

Pancreatic ductal adenocarcinoma (PDAC) is a particularly challenging form of cancer due to its poor immunogenicity and highly immunosuppressive micro-environment, which hampers the activation of cytotoxic T lymphocytes. Gemcitabine, known for its ability to enhance antigen presentation, combined with IMM-101 and pembrolizumab, holds promise for improving anti-tumor efficacy in first-line pancreatic cancer treatments.

Dr. Josefine Roemmler-Zehrer, Chief Medical Officer of Immodulon, expressed optimism about the study's potential to establish IMM-101 as a fundamental therapy in treating immunologically cold tumors. The collaboration with NHS Greater Glasgow & Clyde, the University of Glasgow, and other partners aims to advance the availability of IMM-101 to patients with pancreatic cancer and similar conditions.

The Phase II PRIMUS-006 study is a single-arm trial evaluating the combination of IMM-101, gemcitabine, and pembrolizumab as a first-line treatment for metastatic pancreatic cancer patients who are not fit for multi-agent cytotoxic treatments. The primary goal is to enhance the anti-tumor response, with key secondary goals including safety, tolerability, progression-free survival, disease control rate, and overall survival. The study plans to include up to 50 patients across 15-20 sites in the UK.

Pancreatic ductal adenocarcinoma (PDAC) is a leading cause of cancer mortality. About half of the patients present with metastatic disease, and those with resectable or locally advanced inoperable disease often progress to metastatic disease. Current treatments offer limited survival benefits, and many patients are not fit for aggressive combination therapies. Hence, there is a critical need for new therapeutic approaches.

IMM-101, used in the study, is an immunomodulator capable of inducing a broad immune response. Previous studies, such as the Phase II IMAGE-1 Study, indicate that IMM-101 combined with gemcitabine is well-tolerated and can prolong progression-free survival in advanced PDAC patients compared to gemcitabine alone. Immodulon is prioritizing further studies on IMM-101 in PDAC and other similar tumors.

Precision-Panc aims to create a framework for recruiting and screening pancreatic cancer patients, enabling molecular profiling and biomarker analysis, and facilitating enrollment in clinical trials. The platform strives to accelerate the development of targeted therapies through an integrated approach of pre-clinical work, clinical trials, and discovery.