Immodulon announces allowability of claims for key European patent application related to lead drug candidate, IMM-101, in combination with immune checkpoint inhibitors

Claims cover IMM-101 in combination with any anti-PD-L1, anti-PD1 or anti-CLTA-4 monoclonal antibody as a treatment for cancer

Patent grant will further bolster Company’s IP position around IMM-101 ahead of planned pivotal trial start in first quarter of 2022

Uxbridge, UK, 8 June 2021 – – Immodulon, the immuno-oncology company, today announced that it has received an indication of allowability from the European Patent Office for the claims in Immodulon’s patent application No. EP3082956. This patent application relates to combining IMM101, the Company’s investigational treatment comprising heat-killed Mycobacterium obuense, with various classes of immune checkpoint inhibitors (CPIs) for the treatment of any tumour type. Upon grant, this patent is expected to expire in 2034. This indication of allowance follows the Company’s announcement in March 2021 of the Notice of Intention to Grant European patent application EP3319635, which more narrowly claims IMM-101 in combination with specifically named immune checkpoint inhibitors – pembrolizumab, atezolizumab or tremelimumab – for the treatment of any cancer. These antibodies are leading examples, respectively, of the anti-PD-1, anti-PD-L1 and anti-CTLA-4 classes of immune checkpoint inhibitors.

Dr. Jaap Kampinga, Chief Executive Officer of Immodulon, commented:
“We are pleased to have received this indication of allowability of the claims for this key European Patent Application that will bolster our IP position around IMM-101, our lead drug candidate, in combination with immune checkpoint inhibitors as a treatment for cancer. IMM-101 has a unique mechanism of action – principally activating dendritic cells of the human immune system via the TollLike receptor 2. Studies to date suggest that IMM-101 is synergistic to the effects of the main classes of checkpoint inhibitors and presents no added safety burden.

“IMM-101 has been tested in a number of clinical studies with clinical proof of concept established in a Phase 2 metastatic pancreatic cancer trial, the results of which have been published in a peerreviewed journal. Immodulon is now planning to commence a potentially pivotal study in the first quarter of 2022 in a large and growing subgroup of metastatic pancreatic ductal adenocarcinoma patients that are not eligible for treatment with the current best standard-of-care, a market we estimate could be worth $1.6 billion alone. Results from the company’s phase 1/2 study in patients with advanced melanoma using IMM-101 in combination with the anti-PD-1 nivolumab are expected towards the end of 2021. Additionally, the company has an open IND in the US for IMM-101 in sarcoma and the drug candidate has Orphan Drug Designation in the EU and US for pancreatic cancer.”

About Immodulon Therapeutics
Immodulon Therapeutics Ltd. (London, UK) is a privately-owned, clinical-stage, immuno-oncology company primarily focused on the development of safe, effective and novel treatments for cancer. Its lead drug candidate, IMM-101, has shown promise in early clinical trials, demonstrating potential fo rthe platform. It contains heat-killed whole cell Mycobacterium obuense which activates dendritic cells and other cells of the innate immune system predominantly via Toll-like receptor 2. It is Immodulon’s vision that IMM-101 will become a backbone immunotherapy across multiple tumour types. Its unique mechanism of action should not only make this product applicable to a range of cancers but, in combination with immune checkpoint inhibitors and any other standard-of-care treatment of the four major pillars of cancer therapy – immunotherapy, chemotherapy, radio/ablation therapy and surgery – it is also expected to increase their efficacy without compromising on the patient’s safety and quality of life. For more information about Immodulon, please visit www.immodulon.com.

Media contact:
Immodulon
Dr. Jaap Kampinga, CEO
info@immodulon.com
T: +44 (0)20 3137 6346

FTI Consulting
Simon Conway / George Kendrick
ImmodulonTherapeutics@fticonsulting.com
T: +44 (0) 20 3727 1000