The Phase II study will evaluate a new drug combination – gemcitabine (a chemotherapy agent), pembrolizumab (a T-cell checkpoint inhibitor) and IMM-101, a broad-spectrum immunomodulatory agent containing heat-killed, whole cell Mycobacterium obuense – as first-line treatment in patients with metastatic pancreatic cancer.

PRIMUS-006, which is co-sponsored by NHS Greater Glasgow & Clyde and the University of Glasgow, and co-ordinated by the Glasgow Oncology Clinical Trials Unit, will evaluate the new combination therapy in patients diagnosed with metastatic pancreatic cancer who might not able to receive current combination chemotherapy. As part of the study, up to 50 patients with metastatic pancreatic ductal adenocarcinoma will be recruited and treated from 15-20 hospital sites in the United Kingdom.

Pancreatic ductal adenocarcinoma (PDAC) is often fatal, as it is commonly found too late and does not respond well to treatments. The new triple drug combination trialled in PRIMUS-006 has the potential to offer new hope to patients who cannot be given existing treatment options.

Professor David Chang, the Chief Investigator and Professor of Surgical Oncology & honorary consultant pancreatic surgeon, Wolfson Wohl Cancer Research Centre, University of Glasgow and Glasgow Royal Infirmary, said: “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.”

Precision-Panc is an ambitious therapeutic development programme that seeks to uncover the molecular profile of individual patients with pancreatic cancer, to learn more about the disease and to pave the way for patients entering clinical trials in a way that matches their tumour biology to the type of treatment.

It is composed of a network of clinical trials, aimed to find the right trial for the patient, matching patients to treatments most likely to work for their type of pancreatic cancer. It is designed to be comprehensive, with a faster turnaround time than traditional clinical trials, while also advancing discovery through science and ultimately changing the outcome of patients with this disease.

Professor Jeff Evans, University of Glasgow, and Honorary Consultant in Medical Oncology at the Beatson West of Scotland Cancer Centre, said: “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.”

Josefine Roemmler-Zehrer, MD, Associate Professor, and Chief Medical Officer of Immodulon, said: “This is an exciting opportunity to be part of a high calibre 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.

“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.”

PRIMUS-006 is endorsed by Cancer Research UK (CRUK Reference: A3105) The study is funded by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA, 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.

First published: 19 June 2024

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