ImmuPharma Selects Thermo Fisher for Kapiglucagon

ImmuPharma announce that, following a competitive tender process, it has selected Thermo Fisher Scientific, as its drug product (“DP”) and contract development and manufacturing organisation (“CDMO”) for its Kapiglucagon program.

Thermo Fisher’s Patheon pharma services is a global pharmaceutical development and manufacturing organization, supporting pharmaceutical and biotechnology companies from early-stage development through to commercial supply.

The selection of Thermo Fisher represents an important Chemistry, Manufacturing and Controls (“CMC”) milestone for the Kapiglucagon program and is expected to support the next stages of pharmaceutical development and IND-enabling preparation.

This development follows the Company’s recent announcement regarding the appointment of Bachem AG as API manufacturing partner for the Kapiglucagon program. The program is being advanced through a streamlined development strategy, with ImmuPharma evaluating a potential 505(b)(2) regulatory pathway in the United States, leveraging existing data on native glucagon, subject to FDA confirmation.

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 pursue an accelerated development plan for Kapiglucagon, including evaluation of a 505(b)(2) regulatory pathway, and that the program is supported by the recently approved funding initiative intended to advance the asset over the next two years.

Next steps

The selection of Thermo Fisher is expected to support the DP workstream of the Kapiglucagon CMC program. In parallel, ImmuPharma intends to continue advancing 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 select Thermo Fisher as DP CDMO for the Kapiglucagon program. This represents an important step in strengthening the CMC foundation of the program as we continue to advance Kapiglucagon toward clinical development.”

Jennifer Cannon, President, Commercial, Biopharma Services, Thermo Fisher Scientific, said:

“We are pleased to collaborate with ImmuPharma on the Kapiglucagon program. Our team is committed to helping customers advance innovative therapies by providing the development and manufacturing expertise needed to advance programs efficiently through key development milestones. We look forward to supporting ImmuPharma as the program progresses.”

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