ImmuPharma (AIM:IMM) has selected Thermo Fisher Scientific as its drug product manufacturer and contract development and manufacturing organisation (CDMO) for the Kapiglucagon programme, following a competitive tender.
The AIM-listed drug discovery and development company said the appointment marks an important chemistry, manufacturing and controls (CMC) milestone, supporting the next stage of pharmaceutical development ahead of a planned investigational new drug (IND) submission.
Kapiglucagon is a water-soluble glucagon prodrug designed to overcome the instability of native glucagon in solution, aimed at use in next-generation dual-hormone artificial pancreas systems for Type 1 diabetes.
The Thermo Fisher appointment follows ImmuPharma's recent selection of Bachem as its active pharmaceutical ingredient (API) manufacturing partner for the same programme.
ImmuPharma is evaluating a 505(b)(2) regulatory pathway in the United States, a route that would let it lean on existing FDA data for glucagon reference products rather than pursuing a full new drug application.
"We are pleased to select Thermo Fisher as DP CDMO for the Kapiglucagon program," said Dr Sébastien Goudreau, ImmuPharma's chief scientific officer.
The company expects its next step to be a pre-IND meeting with the FDA to confirm the regulatory pathway and the scope of required CMC, preclinical and clinical work, ahead of a planned first-in-human study.
News Intelligence what this means for the company
ImmuPharma has appointed Thermo Fisher Scientific's Patheon unit as the drug product manufacturer and CDMO for Kapiglucagon, its water-soluble glucagon prodrug for Type 1 diabetes artificial pancreas systems, following a competitive tender. This is a manufacturing milestone that clears the way for a pre-IND meeting with the FDA to confirm the 505(b)(2) regulatory pathway and scope of required work ahead of a planned first-in-human study. The appointment follows ImmuPharma's earlier selection of Bachem as the active pharmaceutical ingredient (API) manufacturing partner for the same programme.
The selection of established manufacturing partners (Bachem for API, Thermo Fisher for drug product) de-risks the CMC pathway for Kapiglucagon and moves the programme toward IND-enabling work. However, as a pre-revenue clinical-stage company, ImmuPharma remains dependent on successful FDA engagement and clinical advancement; manufacturing appointments alone do not validate the therapeutic approach or market opportunity.
Insights assembled by AI. Editor-reviewed and grounded in tickstock’s coverage and proprietary knowledge graph.
Content is for informational purposes only, not financial advice.
