ImmuPharma plc (LSE AIM: IMM), the specialist drug discovery and development company, is pleased to announce that, following a competitive tender process, it has selected Kymos Germany/Prolytic (“Kymos Group”), a GLP-certified, GCP-compliant and FDA-inspected European contract research organisation (“CRO”), as bioanalytical CRO partner for its Kapiglucagon program.
The selection of Kymos Group represents a further important milestone in the progression of Kapiglucagon and is expected to support the bioanalytical work required for the program’s non-clinical and clinical development.
Kymos Group will support the development and validation of regulated bioanalytical methods for Kapiglucagon, including subsequent analysis of samples generated during the nonclinical and Phase 1 clinical programs.
This development follows ImmuPharma’s recent announcements regarding the appointment of Thermo Fisher as CMC partner and Bachem AG as API manufacturing partner for the Kapiglucagon program. The Kapiglucagon program is being advanced through a streamlined development strategy, with ImmuPharma evaluating a 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.
Dr Sébastien Goudreau, Chief Scientific Officer of ImmuPharma, said:
“We are pleased to appoint Kymos Group as bioanalytical CRO partner for the Kapiglucagon program. Kymos brings relevant peptide bioanalysis expertise and the capabilities required to support the program through its nonclinical and early clinical development. This appointment represents another important step in building the development infrastructure required to advance Kapiglucagon towards the clinic.”
Joan Puig de Dou, Chief Executive Officer of Kymos Group, said:
“We are proud to support ImmuPharma in the development of Kapiglucagon, bringing our expertise in peptide bioanalysis to this promising program. Our company and team are fully committed to early-stage projects, empowering start-ups and biotech’s with tailor-made support of the highest quality standards, as they advance through pre-clinical and clinical stages.”
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