ImmuPharma Appoints Bachem as API Manufacturing Partner for Kapiglucagon Glucagon Prodrug Program

A critical CMC milestone for ImmuPharma's Kapiglucagon program now has a named manufacturing partner: Bachem AG, selected following a competitive tender to supply the active pharmaceutical ingredient for the proprietary glucagon prodrug. For QA directors and regulatory leads tracking IND-enabling timelines, the appointment signals that the CMC workstream is sufficiently mature to engage a specialist peptide CDMO at the API stage.

Kapiglucagon is a glucagon prodrug engineered to address the physicochemical limitations of native glucagon, specifically solubility and formulation stability, with intended application in dual-hormone artificial pancreas systems and glucagon-based therapeutics for Type 1 diabetes. ImmuPharma has indicated it intends to pursue a 505(b)(2) regulatory pathway in the United States, contingent on FDA confirmation, leveraging the existing data package on native glucagon to support the development dossier.

Bachem's role is currently scoped to the API workstream. ImmuPharma has stated that selection of a drug product manufacturing partner remains a discrete next step, covering formulation development and broader IND-enabling activities. That sequencing reflects standard CMC gating logic: API process definition and characterisation precede formulation work, and both must reach sufficient maturity before regulatory interactions can anchor an IND submission timeline.

The 505(b)(2) angle carries specific implications for CMC documentation. Bridging studies linking Kapiglucagon's physicochemical profile to the native glucagon reference will need to satisfy 21 CFR Part 314 requirements, and the API manufacturing process established with Bachem will form the foundation of the chemistry section of any future NDA or IND filing. Process validation scope, impurity profiling, and specification-setting at this stage will directly shape the regulatory package.

ImmuPharma's CSO Dr Sébastien Goudreau described the appointment as strengthening the foundation for progression toward the clinic, a characterisation consistent with the company's stated intent to advance toward first-in-human studies subject to health authority alignment.

The measurable next checkpoint is the appointment of a drug product manufacturing partner, which will determine how quickly formulation development and IND-enabling studies can be initiated in parallel with ongoing regulatory strategy work.

Source: ImmuPharma PLC via company announcement, 25 June 2026.