ImmuPharma selects Thermo Fisher to manufacture diabetes drug

The agreement advances CMC activities as ImmuPharma prepares the diabetes therapy for regulatory interactions and potential clinical development.

ImmuPharma, a London-based drug discovery and development company, has selected Thermo Fisher Scientific, a Waltham, Massachusetts-based life sciences company and contract development and manufacturing organization (CDMO), through its Patheon pharma services business as the drug product CDMO for its investigational diabetes drug Kapiglucagon.

Thermo Fisher will support the drug product portion of the chemistry, manufacturing and controls (CMC) program while the company continues regulatory planning and development activities aimed at progressing the therapy toward an investigational new drug (IND) application and first-in-human clinical studies.

The announcement follows the company’s recent selection of Bachem AG as the active pharmaceutical ingredient (API) manufacturing partner for the program. According to the company, the program is being developed under a streamlined strategy that includes evaluating a potential 505(b)(2) regulatory pathway in the United States, subject to FDA confirmation.

Kapiglucagon is a proprietary glucagon prodrug being developed for Type 1 diabetes applications. According to ImmuPharma, the candidate is designed to address solubility and formulation stability limitations associated with native glucagon and could have applications in dual-hormone artificial pancreas systems and other glucagon-based therapies.

The announcement is the latest in a series of recent pharmaceutical manufacturing agreements involving Thermo Fisher. Earlier this month, Arcturus Therapeutics selected the company to support Phase III clinical supply and potential commercial manufacturing of its investigational cystic fibrosis therapy.

This piece was created with the help of generative AI tools and edited by our content team for clarity and accuracy.
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