ImmuPharma (AIM:IMM), the AIM-listed specialist drug discovery and development company, has selected Kymos Group as bioanalytical contract research organisation (CRO) partner for its Kapiglucagon program following a competitive tender.
Kymos Germany/Prolytic is GLP-certified, GCP-compliant and FDA-inspected, and will develop and validate regulated bioanalytical methods for Kapiglucagon, including analysis of samples from the nonclinical and Phase 1 clinical programs.
The appointment follows ImmuPharma's recent selection of Thermo Fisher as chemistry, manufacturing and controls (CMC) partner and Bachem as active pharmaceutical ingredient manufacturer for the same program, building out the development infrastructure ahead of clinical work.
ImmuPharma is evaluating a 505(b)(2) regulatory pathway in the United States for Kapiglucagon, a route that would let it lean on existing data for native glucagon rather than pursue a full new drug application, subject to FDA confirmation.
Kapiglucagon is designed as a stable, water-soluble glucagon prodrug intended to overcome the aggregation and fibril formation that limit native glucagon in solution, positioning it for use in dual-hormone artificial pancreas systems for Type 1 diabetes.
"This appointment represents another important step in building the development infrastructure required to advance Kapiglucagon towards the clinic", said Dr Sébastien Goudreau, ImmuPharma's Chief Scientific Officer.
The company expects a Pre-IND meeting with the FDA as the next step, to align on the regulatory pathway and the scope of the required CMC, preclinical and clinical program.
