Ilya Pharma has secured the IP position for ILP100 – a candidate immunotherapy for various skin and mucosal disease – with patents in India, China, Australia, and the US.

The patents mean the company’s method for using modified bacteria for treatment of both mucosal and cutaneous wounds in humans and animals has patent protection in all major markets according to CEO Evelina Vågesjö.

She told BioProcess Insider “all commercial activities are covered,” explaining that the patents cover the general use of lactic acid bacteria transformed with a plasmid capable of expressing the wound healing protein CXCL12 in Lactobacillus reuteri, as well as pharmaceutical products and medical devices.

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“These claims protect inventions which are central to the Company’s programs for treating human and animal medical problems where tissues are damaged.”

The new patents come months after Ilya moved to secure its manufacturing supply chain for the products by buying Nordic Bioanalysis.

Vågesjö said “The ILP-drug candidates – being local immunotherapies- are manufactured from a master cell bank through bioreactor fermentation and lyophilization.

“The two drug candidates in development ILP100-Topical and ILP100-Oral have the same Drug Substance (DS) but different Drug Product (DP).”

She added that “Ilya Pharma has done most of the development work for bioprocess and bioanalytics inhouse, but we use contract manufacturers (CMOs) for GMP manufacturing of its batches for clinical development.”

Next steps

Ilya is currently developing a portfolio of three versions of the drug for skin and mucosal diseases.

ILP100-Topical is for surgical wounds in diabetic, pre-diabetic and obese patients especially at risk. The US FDA OKed a Phase II trial earlier in the year and study start on-gong according to Vågesjö.

A topical formulation of ILP100 is also being developed for the treatment diabetic ulcers. The drug is currently being examined in a Phase 2a trial in Sweden.

And an oral version ILP100 is being developed for patients with immune mediated enterocolitis resulting from cancer treatment with checkpoint inhibitors. Vågesjö told us the firm plans to file an IND for this indication next year.