Ilya Pharma is planning to submit an Investigational New Drug Application (IND) for a Phase 1/2a safety and dose finding clinical study of ILP100-Oral, the company’s investigational immunotherapy being developed for patients with immune mediated enterocolitis resulting from cancer treatment with checkpoint inhibitors.
“Immune checkpoint inhibitors (ICI’s) have provided a welcome 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 – will 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,” says CEO and Co-Founder Evelina Vågesjö.
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-cells of the Peyer’s Patches – lymphoid tissue in the distal part of the small intestine sampling the luminal content through dendrites that acts as gate keeper to the colon.
“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 October 2021 and we look forward to following up with the full MOA and key translational data of the ILP100 during this year. In the meantime, we have successfully completed the GLP-toxicity program for ILP100 Oral and have started the planning to further assess the safety and efficacy of ILP100-Oral in a Phase 1/2a trial. This also represents an important stage in Ilya’s overall growth by demonstrating the ability of our proprietary ILP-technology platform to generate multiple novel drug candiates across a range of indications,” says Vågesjö.
Photo of Evelina Vågesjö: Jenny Öhman