ImmuPharma Signs Kymos Group as Bioanalytical CRO Partner for Kapiglucagon Peptide Program

ImmuPharma's Kapiglucagon build-out is taking shape as a textbook case in modular outsourcing: the company has added Kymos Group as its bioanalytical CRO partner, completing a three-vendor development stack alongside Thermo Fisher Scientific (CMC) and Bachem AG (API manufacturing). For QA directors and regulatory leads tracking early-stage peptide programs, the configuration signals how small biotechs are distributing technical risk across GLP-certified, FDA-inspected partners before a single clinical sample is drawn.

Kymos Germany/Prolytic, operating as Kymos Group, is a GLP-certified, GCP-compliant, FDA-inspected European CRO with documented peptide bioanalysis capability. Under the agreement, Kymos will develop and validate regulated bioanalytical methods for Kapiglucagon, then conduct sample analysis across both the nonclinical program and the planned Phase 1 clinical study. The scope covers the full regulated bioanalytical lifecycle, from method development through to study sample analysis, consistent with expectations under 21 CFR Part 58 for nonclinical work and applicable ICH M10 guidance for clinical bioanalysis.

Kapiglucagon is a proprietary glucagon prodrug targeting Type 1 diabetes, engineered to address the solubility and formulation stability limitations of native glucagon. ImmuPharma is evaluating a 505(b)(2) regulatory pathway in the United States, intending to leverage existing data on native glucagon, subject to FDA confirmation. That pathway choice has direct implications for the bioanalytical strategy: method bridging and cross-reference to existing glucagon pharmacokinetic data will need to satisfy FDA's evidentiary standards for a hybrid application.

The partner selection followed a competitive tender process, according to ImmuPharma. Chief Scientific Officer Dr Sébastien Goudreau described the appointment as a step in building the development infrastructure required to advance Kapiglucagon toward the clinic. ImmuPharma has previously indicated that a recently approved funding initiative will support the program over the next two years, providing the financial runway for the nonclinical-to-Phase 1 transition.

For plant heads and CMC leads, the Thermo Fisher, Bachem, Kymos configuration illustrates a deliberate separation of drug product manufacturing, API supply, and bioanalytical oversight into distinct, independently qualified vendor relationships, a structure that distributes audit burden but demands rigorous data-transfer and chain-of-custody governance across sites and jurisdictions.

The validated bioanalytical methods Kymos delivers will serve as a foundational data package for any eventual IND submission and will set the quantitative baseline against which Phase 1 pharmacokinetic endpoints are measured.

Source: ImmuPharma PLC via company announcement, 10 August 2026.