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Ilya Pharma publishes novel mechanism of action & preclinical proof of concept

Evelina Vågesjö Photo Jenny Öhman Nordic Life Science

Ilya Pharma has announced that its preclinical data for ILP100 in an oral formulation have been published in American Journal pf Physiology, Gastrointestinal and Liver Physiology.

ILP100-Oral, the company’s investigational immunotherapy is being developed as first-line-treatment for patients with immune mediated enterocolitis resulting from cancer treatment with checkpoint inhibitors.

This is the indication where local treatment is vital, allowing the immune cells to attack the tumors but leave the gut alone.”

“Immune checkpoint inhibitors (ICI’s) have provided a welcomed new front line range of treatments for advanced cancers, including melanoma, urothelial and renal cell carcinoma, and non-small cell lung cancer. However, many patients treated with ICIs – particularly those on combination regimes –  develop immune-mediated adverse events, especially enteropathies including colitis. This oral formulation of ILP100 is designed to treat the estimated one-third who develop immune-mediated enterocolitis, characterized by abdominal pain, diarrhea, ulcerations and in worst cases perforations of the tissue leading to sepsis, which negatively affects patients lives and leads to discontinuation of ICI treatment in a significant number of patients. This is the indication where local treatment is vital, allowing the immune cells to attack the tumors but leave the gut alone. Current treatments are all systemic, include steroids and biologics that counteracts the ICI-effects,” says CEO and Co-Founder Evelina Vågesjö.

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ILP100 Oral

ILP100 Oral, is a Limosilactobacillus reuteri R2LC genetically modified to express human CXCL12 1a and formulated in capsules for oral administration. Both the bacteria and bacteria-derived CXCL12 interact with the B lymphocytes of the Peyer’s Patches – lymphoid tissue in the distal part of the small intestine sampling the luminal content and acting as gate keepers.

“The researchers and co-founders of Ilya published the full MOA of the R2LC strain of Limosilactobacillus reuteri  in Microbiome (Liu et al 2021 Microbiome) in 2021 and we look have now followed up with the MOA and key translational and safety data of the ILP100 in multiple animal models of colitis. Following a successful pre-IND meeting with the FDA we are compiling the IND for the planned phase 1/2a trial SITU-GUT trial where ILP100-Oral will be given as first line treatement to patients with stage 1 and 2 ICI-induced colitis,” says Vågesjö.

Ilya Pharma’s Immune Checkpoint Inhibitor project has been co-founded by and received initial EU regional funding from STUNS through the Bio-X program.

Photo of Evelina Vågesjö: Jenny Öhman/Nordic Life Science