ImmuPharma (AIM: IMM) has appointed Thermo Fisher Scientific to develop and manufacture the finished drug form of Kapiglucagon, its experimental diabetes treatment.
Thermo Fisher was selected following a competitive tender process, with its Patheon pharma services business taking responsibility for the drug product workstream.
The appointment follows the recent selection of Swiss group Bachem to manufacture the active pharmaceutical ingredient.
ImmuPharma said the two appointments complete the main manufacturing partnerships for the Kapiglucagon programme.
Kapiglucagon is a prodrug version of glucagon, the hormone used to raise blood sugar levels, and is being developed for Type 1 diabetes.
The prodrug approach is designed to address the poor solubility and instability issues associated with native glucagon once mixed into a formulation.
ImmuPharma is targeting dual-hormone artificial pancreas systems, which deliver both insulin to lower blood sugar and glucagon to raise it.
The company is also evaluating a 505(b)(2) regulatory pathway in the US, which may allow it to rely partly on existing safety data for approved glucagon.
That pathway remains subject to confirmation by the US Food and Drug Administration.
Chief scientific officer Sébastien Goudreau said Thermo Fisher’s appointment strengthens the manufacturing and quality foundation of the programme as it moves towards clinical development.
The next stage will involve preparing an investigational new drug application, which is required before human testing can begin in the US.
ImmuPharma has described Kapiglucagon as a strategic opportunity alongside P140, its lead candidate for lupus. The programme is supported by a recently approved funding package intended to advance the asset over the next two years.
