ImmuPharma appoints Bachem for Kapiglucagon API
ImmuPharma PLC has appointed Bachem AG as the manufacturing partner for the active pharmaceutical ingredient of its Kapiglucagon program, a significant Chemistry, Manufacturing and Controls milestone expected to advance the drug's development for Type 1 diabetes. This partnership with a leading peptide and oligonucleotide manufacturer is crucial for the next stage of pharmaceutical development and Investigational New Drug (IND)-enabling preparations for Kapiglucagon, a proprietary glucagon prodrug designed to improve solubility and formulation stability for potential use in artificial pancreas systems. The company also plans to select a drug product manufacturing partner and continue advancing its regulatory strategy, including interactions with the FDA and progression towards IND submission.
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ImmuPharma plc (LSE AIM: IMM), the specialist drug discovery and development company, is pleased to announce that, following a competitive tender process, it has appointed Bachem AG ("Bachem") as manufacturing partner for the active pharmaceutical ingredient ("API") for its Kapiglucagon program.
Bachem is a leading global peptide and oligonucleotide development and manufacturing partner, supporting pharmaceutical and biotechnology companies from early-stage development through to commercial supply.
The appointment represents an important Chemistry, Manufacturing and Controls ("CMC") milestone and is expected to support the next stage of pharmaceutical development and IND-enabling preparation for Kapiglucagon.
About Kapiglucagon
Kapiglucagon is a proprietary glucagon prodrug being developed for Type 1 diabetes ("T1D") applications, with a focus on overcoming the inherent physicochemical limitations of native glucagon. The program is designed to improve solubility and formulation stability, with potential application in dual-hormone artificial pancreas systems and other glucagon-based therapeutic settings.
ImmuPharma believes Kapiglucagon represents an important strategic opportunity alongside its lead asset, P140. The Company has previously stated that it intends to evaluate a 505(b)(2) regulatory pathway in the United States, leveraging existing data on native glucagon, subject to FDA confirmation.
Next steps
The immediate CMC focus will be the API workstream with Bachem, followed by the selection and appointment of a drug product ("DP") manufacturing partner to support formulation, manufacturing and broader IND-enabling activities.
In parallel, ImmuPharma will continue to advance the regulatory and development strategy for Kapiglucagon, including future regulatory interactions and, subject to alignment with health authorities, progression towards IND submission and first-in-human studies.
Dr Sébastien Goudreau, Chief Scientific Officer of ImmuPharma, said:
"We are pleased to appoint Bachem as API manufacturing partner for Kapiglucagon. This is an important CMC step for the program and strengthens the foundation for its further development toward the clinic."
About 505(b)(2) regulatory approval
About Bachem
Bachem is a leading global partner for peptide and oligonucleotide development and manufacturing, supporting pharmaceutical and biotechnology companies from early-stage research through to commercial supply.
With headquarters in Switzerland, Bachem operates internationally through sites in Switzerland, the UK and the US.
Core capabilities include:
- Development services for peptide and oligonucleotide APIs
- GMP manufacturing and commercial API supply, including glucagon
- Project management and related services for pharmaceutical and biotechnology partners
For more information, please visit www.bachem.com.
Glossary
CMC Chemistry, Manufacturing and Controls
FDA U.S. Food and Drug Administration
IND Investigational New Drug
NDA New Drug Application
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