CDMOs and the cell and gene therapy sector need to evolve to support the increasing number of innovative therapies entering trials, says Ilya Pharma.

Ilya CEO Evelina Vågesjö made the comments about innovative therapy manufacturing after the Sweden-based biotech released first-in-human (FIH) trial data indicating ILP100 – a bacteria-based therapeutic candidate designed to treat chronic wounds – shortens healing time by six days.

“We have evaluated multiple CMOs [contract manufacturing organizations] for clinical material production and commercial supply already and see the whole industry evolve together with the increasing number of clinical trials within the cell and gene therapy field,” she said.

Image: iStock/EtiAmmos

Like Ilya’s other candidates, ILP100 is a bacterium engineered to express chemokines and other immunomodulatory proteins.

When applied to a wound, ILP100 produces the cytokine CXCL12, which induces a “functional shift in the local immune cells that produce more TGF-beta and this accelerates the haling and reduces scaring” according to the firm.

Manufacturing

For the FIH trial, ILP100 was supplied in two glass vials; one vial with the lyophilized drug product and one vial with a buffer. At the time of use the buffer is mixed with the lyophilized product which resolves and rehydrates.

Vågesjö told us “The bacterial strain we use in our lead candidate, ILP100, has been characterised by a group of scientists, including Stefan Roos co-founder of Ilya Pharma. So, large parts of the CMC development have been performed or coordinated from Ilya Pharma.

“At the moment we use contractors for the GxP activities including the manufacturing. We will continue to keep all know-how and development of the products in house.”

She added, “We are lucky to be located in Uppsala where Cytiva have a Test Center – a co-working area with equipment used by GMP CMOs globally – and we have tested our clinical material manufacturing process in identical scale to build own data and de-risk the scaling and tech transfer of each process.”

Formulations

The ILP100-topical formulation is a monoseptic product that is aseptically manufactured in a closed system to ensure that it is free of any contaminants using single use components. Ilya is also working on other versions of the product according to Vågesjö.

“We are also working with the ILP100 and ILP101 as an oral formulation where the lyophilized product will be supplied in capsules for indications in the gastrointestinal tract – healing wounds in the intestine. We have outlined a new multimodal MOA in the intestine and have a grant from Bio-X for the early development activities, next up is the GLP-repeated dose testing in Q3.

“Our current plan for this project is to start the first clinical trial in 2022/23. Aseptic manufacturing is not required for manufacturing of an oral product and we are currently looking for a partner that can on this project accelerating the developments to clinical validation.”