Ilya Pharma has designed a drug delivery technology to accelerate the healing process in chronic wounds, which could save limbs and improve quality of life for patients.
“We also aim to dramatically reduce total cost for wound care, use of antibiotics, and limit the spread of antibiotic resistance,” according to CEO Evelina Vågesjö.
In addition, the biotech was one of the first to spend time in the Testa BioProcess Center in Uppsala, Sweden – opened by GE Healthcare and the Swedish government earlier this year – which enabled ILP-100 production methods to be verified in an authentic setting.
Biopharma-Reporter (BPR) asked Vågesjö (EV) exactly what the biologics delivery process entails, how it compares to available wound healing technologies, and when we should expect to see ILP-100 hit the market.
BPR: How does ILP-100 work?
EV: ILP-100 works by delivering human therapeutic proteins on-site, for example in skin wounds or in the colon of the intestine, via living lactic acid bacteria acting like small bioreactors. In order to do this, we use a freeze-dried formulation with good stability, and the lactic acid bacteria are revived immediately prior to use, by adding a small volume of water.
After application, the therapeutic protein is continuously delivered to the wound surface for about one hour.
BPR: How does ILP-100 compare to other wound healing offerings on the market?
EV: Today, the wound care market is dominated by different types of dressings and other technology classified as medical devices. There is considerable room for improvement in terms of clinical evidence, especially in the active wound care segment. However, ILP-100 has been classified as a medical product, and this is a trend we see in many pipeline products for wound care.
Compared to traditional biologics, e.g. recombinant proteins, the innovative technology in ILP-100 offers a very cost-effective way of delivering biologics locally and continuous delivery increases the efficacy of accelerated wound healing significantly.
BPR: Is it expensive to produce?
EV: Cost of goods in commercial manufacturing of ILP-100 is estimated to be lower than the cost of goods for traditional biologics. The main cost driver is the type of container used – we are currently testing the compatibility of different two-compartment syringes, as well as other containers for medical products, in parallel with our dosing studies to determine the minimal dose required.
Since we work with bacteria, the dose is in log-scale. Therefore, reducing the dose one log gives ten times as many vials per batch, so this is a very important part of product development.
BPR: Which patient population is Ilya Pharma targeting with ILP-100?
EV: Ilya Pharma is [targeting] accelerated healing and reduced infection rates in large and chronic wounds, which is especially problematic for people with diabetes. We are also exploring indications in the gastrointestinal tract, such as inflammatory bowel disease.
Our goal is to accelerate the healing process by at least 80% in chronic wounds to save limbs and significantly improve quality of life for patients and their relatives. We also aim to dramatically reduce total cost for wound care, use of antibiotics, and limit the spread of antibiotic resistance.
BPR: Which geographies is Ilya targeting?
EV: The large markets are Europe, the US and some parts of Asia, where health care is advanced. It takes time developing pharmaceuticals, especially when they are based on a novel technology. The long-term goal is to make a cost-efficient product that can reach the bulk of patients.
BPR: What development stage is Ilya at with ILP-100? What should we expect over the next few months?
EV: We have just finished the preclinical tox-program, which resulted in a successful safety and efficacy profile of ILP-100. The next, larger milestone is a Phase I clinical study and you will hear about the first treated research subject in a few months.
BPR: Where is funding coming from for this project?
EV: Ilya Pharma is financed by a mixture of research and innovation grants, as well as private funding. Up until now, we have raised €4.5m ($5.1m) in grant funding and €3.5m in private funding in two issues.
The largest grant is a Horizon 2020 SME Instrument Phase II grant of €3m, that covers activities until the end of 2018, at which stage Phase I clinical data will be obtained and a Phase II study ready to start. A mid-financing/Series A round of €20-30m is planned and we will open this in the spring of 2019.
This funding will take the project through a Phase II clinical trial to partnering. There is interest already and we are looking specifically for investors experienced in biopharma that can help accelerate the project through Phase II and commercial partnering.
BPR: When did Ilya work at the Testa Center?
EV: Ilya Pharma was the first company which, following a competitive selection process, was provided the opportunity to access the resources at the Testa Center at GE Healthcare. The work at Testa Center was carried out in September 2018, when we both verified our manufacturing process in full scale and built up valuable data and knowledge regarding the industrialisation process.
BPR: How did working at the Testa Center benefit the development of ILP-100?
EV: The timing of the opening of Testa Center in Uppsala was perfect. We could run our manufacturing in full scale multiple times before our contract manufacturing organisation produced a GMP-batch.
This has meant significant risk minimisation in the project, during this critical period, and also that we have had the opportunity to test steps that will be needed for commercial manufacturing. We now have a large data set on the bioprocess together with substantial data from the product specifications.
Having this amount of data from full scale batches, as well as keeping the ‘know how’ in the company, is very rare in projects at this stage of development and really strengthens both our case for commercialisation and overall position.
Evelina Vågesjö is CEO and co-founder of Ilya Pharma. She holds a PhD in physiology and has developed methods to steer immune cell function to accelerate healing and blood flow regulation at Uppsala University.