– PRIMUS-006 study led by Professors David Chang and Jeff Evans of the University of Glasgow –
– Phase II study is evaluating a novel combination in first-line metastatic pancreatic cancer –

GLASGOW, United Kingdom, June 18, 2024 (GLOBE NEWSWIRE) — The Precision-Panc team at the University of Glasgow, with their Co-Sponsor,
NHS Greater Glasgow & Clyde, today announced 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. 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).
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.

About Precision-Panc

Precision-Panc aims to establish a mechanism and framework to recruit and screen patients with pancreatic cancer to perform
molecular profiling and evaluation of circulating biomarkers and to Related Links enable enrollment in clinical studies to accelerate
therapeutic development for pancreatic cancer. The PRIMUS studies are a series of clinical trials with novel design to answer specific
therapeutic questions and parallel biomarker studies. The Precision-Panc Platform is a way to accelerate stratified therapeutic
development through a combination of pre-clinical work, clinical trials, and discovery. As part of the platform there will be a suite
of clinical trials, with the aim to have a trial for each indication of pancreatic cancer in the future.
For more information, please visit www.precisionpanc.org.

Josh Rappaport and William Gramig
Precision AQ

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