ImmuPharma appoints Bachem for Kapiglucagon API
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This announcement contains inside information for the purposes of the UK Market Abuse Regulations ('UK MAR'). Upon publication of this announcement, this inside information (as defined in UK MAR) is now considered to be in the public domain. The person responsible for arranging the release of this announcement on behalf of the Company is tim mccarthy, Chief Executive Officer.
25 June 2026
ImmuPharma PLC
("ImmuPharma" or the "Company")
ImmuPharma appoints Bachem as API manufacturing partner for Kapiglucagon
ImmuPharma plc (LSE AIM: IMM), the specialist drug discovery and development company, is pleased to announce that, following a competitive tender process, it has appointed Bachem AG ("Bachem") as manufacturing partner for the active pharmaceutical ingredient ("API") for its Kapiglucagon program.
Bachem is a leading global peptide and oligonucleotide development and manufacturing partner, supporting pharmaceutical and biotechnology companies from early-stage development through to commercial supply.
The appointment represents an important Chemistry, Manufacturing and Controls ("CMC") milestone and is expected to support the next stage of pharmaceutical development and IND-enabling preparation for Kapiglucagon.
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 evaluate a 505(b)(2) regulatory pathway in the United States, leveraging existing data on native glucagon, subject to FDA confirmation.
Next steps
The immediate CMC focus will be the API workstream with Bachem, followed by the selection and appointment of a drug product ("DP") manufacturing partner to support formulation, manufacturing and broader IND-enabling activities.
In parallel, ImmuPharma will continue to advance 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 appoint Bachem as API manufacturing partner for Kapiglucagon. This is an important CMC step for the program and strengthens the foundation for its further development toward the clinic."
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Notes to Editors
About ImmuPharma PLC
ImmuPharma PLC (LSE AIM: IMM) is a specialty biopharmaceutical company that discovers and develops peptide-based therapeutics. The Company's portfolio includes novel peptide therapeutics for autoimmune diseases and anti-infectives.
For additional information about ImmuPharma please visit www.immupharma.co.uk.
ImmuPharma's LEI (Legal Entity Identifier) code: 213800VZKGHXC7VUS895.
Kapiglucagon: A Stable Next-Generation Glucagon Prodrug for Diabetes
Kapiglucagon has been developed to address the key pharmaceutical limitations associated with native glucagon. It is a water-soluble glucagon prodrug designed to maintain high stability in aqueous solution while regenerating native glucagon in vivo following subcutaneous administration. Unlike native glucagon, which rapidly aggregates and forms fibrils in solution, Kapiglucagon demonstrates excellent solubility and formulation stability, enabling the development of clean, saline-based formulations that do not clog pump-based delivery systems. This improved physicochemical profile makes Kapiglucagon particularly well suited for continuous or intermittent delivery in advanced diabetes technologies, including next-generation artificial pancreas systems. By combining the therapeutic activity of native glucagon with a formulation that overcomes its inherent instability, Kapiglucagon has the potential to provide more reliable and practical dual-hormone automated glucose control solutions for patients with Type 1 Diabetes and avoid the long-term health complications of inadequate blood glucose control.
ImmuPharma's vision is to position Kapiglucagon as a key enabling solution for next-generation artificial pancreas technologies. By overcoming the long-standing instability of native glucagon in aqueous formulations, Kapiglucagon offers the potential to deliver a stable, pump-compatible glucagon source, allowing dual-hormone closed-loop systems to operate safely and effectively. Through this innovation, ImmuPharma aims to contribute to a new generation of diabetes care in which artificial pancreas systems can significantly reduce the daily burden of disease while improving metabolic control and patient quality of life.
About 505(b)(2) regulatory approval
A 505(b)(2) is a U.S. FDA drug approval pathway that sits between a full NDA and a generic. The 505(b)(2) approval route allows a company to obtain approval for a modified version of an existing drug by relying partly on data which the FDA already has for the reference product, in this case a glucagon brand. The timeframe, cost and clinical study requirements for completing such a program may be considerably reduced compared to a normal NDA (new drug application) that follows a full 505(b)(1) NDA development pathway. A (PTE) Patent Term Extension of 5 years may also be applied to the existing patent life of Kapiglucagon which could result in a patent expiry extension to 2043.
Kapiglucagon has established a strong scientific rationale and a growing body of supporting CMC and preclinical data, which the Company believes provides a solid foundation for further development. The first step is expected to be a Pre-IND meeting with the FDA to align on the proposed regulatory pathway and the scope of the required CMC, preclinical and clinical program. Following this interaction, the Company intends to advance the remaining development activities, including IND-enabling work, with the objective of entering a focused clinical study designed to generate safety, pharmacokinetic and pharmacodynamic data to support the next stage of value creation for Kapiglucagon.
About Bachem
Bachem is a leading global partner for peptide and oligonucleotide development and manufacturing, supporting pharmaceutical and biotechnology companies from early-stage research through to commercial supply.
With headquarters in Switzerland, Bachem operates internationally through sites in Switzerland, the UK and the US.
Core capabilities include:
· Development services for peptide and oligonucleotide APIs
· GMP manufacturing and commercial API supply, including glucagon
· Project management and related services for pharmaceutical and biotechnology partners
For more information, please visit www.bachem.com.
Glossary
CMC Chemistry, Manufacturing and Controls
FDA U.S. Food and Drug Administration
IND Investigational New Drug
NDA New Drug Application
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