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.”
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