On June 18, 2024 Precision-Panc team at the University of Glasgow, with their Co-Sponsor, NHS Greater Glasgow & Clyde, reported the opening of the Phase II PRIMUS-006 study evaluating IMM-101, a broad-spectrum immunomodulatory agent containing heat-killed, whole cell Mycobacterium obuense, in combination with gemcitabine and pembrolizumab as first-line treatment in patients with metastatic pancreatic cancer (Press release, Immodulon Therapeutics, JUN 18, 2024, View Source [SID1234644423]). The PRIMUS-006 study is part of the Precision-Panc Platform master protocol program, which is Co-Sponsored by NHS Greater Glasgow & Clyde and the University of Glasgow and co-ordinated by the Glasgow Oncology Clinical Trials Unit. PRIMUS-006 is endorsed by Cancer Research UK (CRUK Reference: A31505).
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The study is funded by Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, U.S.A., through its investigator-initiated program with provision of study drug and financial support.The study is also funded by Immodulon Therapeutics Ltd through its investigator-initiated program with provision of study drug and financial support for the study.
"The opening of the Phase II PRIMUS-006 study is an important milestone in the pursuit to develop new treatment options to improve the overall outcomes in patients diagnosed with pancreatic cancer," said Professor David Chang, principal investigator and professor of surgical oncology & honorary consultant pancreatic surgeon, Wolfson Wohl Cancer Research Centre, University of Glasgow and Glasgow Royal Infirmary. "The selection of IMM-101 to comprise part of the triplet combination reflects its potential to enhance anti-tumour activity alongside gemcitabine and pembrolizumab in patients with first-line metastatic pancreatic cancer," said Professor Jeff Evans of the University of Glasgow and Honorary Consultant in Medical Oncology at the Beatson West of Scotland Cancer Centre, Glasgow.
Pancreatic ductal adenocarcinoma (PDAC) tends to be poorly immunogenic with diminished antigen presentation and a highly immunosuppressive tumour micro-environment that further impedes the functional activation of cytotoxic T lymphocytes. Based on the ability of gemcitabine to enhance the expression of antigen-presenting molecules, its use in combination with IMM-101, a broad-spectrum immunomodulator with potential to sensitize pancreatic cancers to immune checkpoint inhibition, and pembrolizumab, MSD’s anti-PD-1 therapy, this novel combination has the potential to enhance anti-tumour efficacy in patients with first-line pancreatic cancer.
"This is an exciting opportunity to be part of a high caliber pancreatic cancer research program and reflects the potential of IMM-101 to become a backbone therapy in immunologically cold tumours by enhancing the efficacy of existing anti-cancer treatment options, including chemotherapy and checkpoint inhibitors," said Josefine Roemmler-Zehrer, MD, Associate Professor, and Chief Medical Officer of Immodulon. "We look forward to working with the Co-Sponsors NHS Greater Glasgow & Clyde and University of Glasgow, MSD and other key collaborators to support this study and advance our efforts to bring IMM-101 closer to patients diagnosed with pancreatic cancer and other solid tumours."
The Phase II PRIMUS-006 study is a single-arm clinical study evaluating IMM-101, gemcitabine and pembrolizumab as first-line combination triplet therapy in patients diagnosed with metastatic pancreatic cancer who are deemed not sufficiently fit enough to tolerate treatment consisting of two or more cytotoxic agents. As the overall objective of the study is to enhance the anti-tumour activity of immunotherapy, the primary endpoint of the study is the objective response rate as defined by RECIST 1.1. Key secondary endpoints include safety and tolerability, evaluation of progression-free survival, disease control rate and overall survival. Up to 50 patients with metastatic pancreatic ductal adenocarcinoma will be treated in the study from approximately 15-20 hospital sites in the United Kingdom.
About Pancreatic Ductal Adenocarcinoma (PDAC)
PDAC is the third most common cause of cancer death in the developed world. Approximately 50% of patients present with metastatic disease and most of the patients who present with resectable or locally advanced inoperable disease ultimately develop metastatic disease.
Gemcitabine monotherapy has modest clinical benefit and a marginal survival advantage in patients with metastatic PDAC. Better response rates and survival can be achieved with the FOLFIRINOX regimen, and with the addition of nab-paclitaxel to gemcitabine.
Nevertheless, overall survival remains disappointing with these combination cytotoxic chemotherapy regimens.
Furthermore, many patients are not fit enough to tolerate these combination regimens, and these patients are invariably excluded from participation in clinical trials because of lower performance status. Consequently, these patients represent a significant unmet clinical need and are in urgent need of novel therapeutic approaches.
About IMM-101
IMM-101 is a systemic, broad-spectrum immunomodulator containing heat-killed, whole cell Mycobacterium obuense, capable of generating a broad systemic innate and adaptive type 1 immune response with potential to treat immunologically ‘cold’ cancers, like pancreatic cancer. In the Phase II IMAGE-1 Study of IMM-101 in combination with gemcitabine, clinical data indicate that IMM-101 is well-tolerated and effective and that it has the potential as a first-line treatment to prolong progression-free survival in patients with advanced pancreatic ductal adenocarcinoma (PDAC) when compared to gemcitabine alone. The study data also suggest a beneficial effect on survival in patients with metastatic PDAC. Immodulon is currently prioritizing the initiation of a Bayesian adaptive pivotal study for IMM-101 in PDAC that can be expanded to evaluate IMM-101 in other immunologically ‘cold’ tumours across multiple parallel arms.