Developing off-the-shelf immunotherapies
to treat wounds in skin and mucosa
Developing off-the-shelf immunotherapies
to treat wounds in skin and mucosa
Ilya Pharma, being a clinical stage biopharmaceutical development company is currently pursuing three projects with drug candidates from its proprietary ILP-technology platform to clinical proof of concept and validation.
Well known, but instable, human therapeutic proteins are produced at the actual wound site by live lactic acid bacteria acting as mini-bioreactors. This provides a new and cost-effective way to deliver biological drugs and enables use of a wide range of proteins, not suited to be developed as biologics.
The drug candidates are classified as ATMP and gene therapies by the EMA and FDA and the projects are fully compliant.
The innovation stems from cutting edge medical research in immunophysiology and applied microbiology at Uppsala University and the Swedish University of Agricultural Sciences. The treatments target the function of tissue-resident immune cells. The mechanism of action for the first project of accelerated healing in skin wounds was published in PNAS 2018.
Unmet clinical needs targeted are treatment of wounds in skin and mucosa.
For the lead candidate ILP100 in a topical formulation, a first-in-human clinical trial (WHILYAS1, EudraCT No. 2019000680-24) have been successfully completed Q4 2020. With this milestone the Company have significantly de-risked the projects in regulatory, CMC and clinical for ILP-drug candidates.
The clinical phase II program have been outlined in pre-submissionmeetings with FDA and national regulators in Europe. A phase IIa study (WHILYAS2) in patients with diabetes and chronic wounds, funded by the EIC Accelerator is planned with first dosing in Q2 2021.
For wound healing, the objectives are to deliver clinical value by providing cost efficient biological treatments substantially cheaper than traditional biologicals and with better efficacy than medical devices.
For treatment of active relapse in inflammatory bowel disease the, majority of patients are not responding to treatment with the available biologics. The company are currently performing IND-enabling studies and expect to be able to enter clinical testing in 18-24 months.
Ilya Pharma is today financed by a mix of grants and private funding. The company received a H2020 SME Instrument phase II grant 2018 of 3 MEUR and EIC Accelerator 2020 of 5.3 MEUR. The company is currently raising for the continued clinical development in phase IIs and IND enabling studies in IBD from suitable investors and potential partners with proven track record in cell- and gene therapy and therapeutics.
