ImmuPharma Selects Thermo Fisher Scientific as CDMO for Kapiglucagon Diabetes Drug Development

Thermo Fisher Partnership Bolsters Kapiglucagon Manufacturing Capabilities

ImmuPharma’s selection of Thermo Fisher Scientific as drug product CDMO validates the Kapiglucagon development program and underscores the company’s commitment to securing top-tier manufacturing partnerships. Thermo Fisher’s Patheon pharma services is a leading global pharmaceutical development and manufacturing organisation experienced in supporting projects from early development through commercial supply. The appointment followed a competitive tender, reflecting ImmuPharma’s thorough evaluation of multiple CDMOs to identify the best partner for advancing the drug product workstream.

This partnership complements ImmuPharma’s recent appointment of Bachem AG as the API manufacturer for Kapiglucagon, establishing a comprehensive CMC foundation with both upstream (API) and downstream (drug product) manufacturing capabilities. Dr Sébastien Goudreau, Chief Scientific Officer at ImmuPharma, described the selection as "an important step in strengthening the CMC foundation of the program as we continue to advance Kapiglucagon toward clinical development." Jennifer Cannon, President of Commercial Biopharma Services at Thermo Fisher Scientific, affirmed their commitment to providing the expertise necessary to efficiently progress the program through key milestones.

Kapiglucagon Tackles Glucagon Formulation Challenges in Diabetes Care

Kapiglucagon is a proprietary water-soluble glucagon prodrug engineered to resolve pharmaceutical limitations of native glucagon, which suffers from poor solubility and rapid aggregation in aqueous solutions, causing fibril formation and instability. These issues have constrained native glucagon’s use in advanced diabetes treatments. Kapiglucagon maintains high stability in aqueous solutions and regenerates native glucagon in vivo after subcutaneous administration, enabling clean, saline-based formulations that avoid clogging pump delivery systems.

Its improved physicochemical properties make Kapiglucagon ideal for continuous or intermittent delivery systems in next-generation artificial pancreas technologies and other glucagon-based therapies. ImmuPharma’s development focuses on Type 1 diabetes, particularly dual-hormone artificial pancreas systems requiring stable glucagon formulations. By combining native glucagon’s therapeutic effects with enhanced formulation stability, Kapiglucagon aims to provide more reliable automated glucose control for Type 1 diabetes patients, potentially reducing long-term complications from poor blood glucose management.

Accelerated 505(b)(2) Regulatory Pathway Could Cut Development Time and Costs

ImmuPharma is exploring a streamlined 505(b)(2) regulatory pathway in the US for Kapiglucagon, subject to FDA confirmation. This pathway permits approval of a modified existing drug by leveraging FDA-held data on the reference product—in this case, an approved glucagon brand. Positioned between a full NDA and generic pathways, 505(b)(2) may significantly reduce development duration, expenses, and clinical study requirements compared to a traditional 505(b)(1) NDA.

Kapiglucagon has a robust scientific rationale supported by growing CMC and preclinical data, forming a strong basis for further development. The initial regulatory step is a Pre-IND meeting with the FDA to align on the regulatory approach and required CMC, preclinical, and clinical programs. Post-meeting, ImmuPharma plans to progress IND-enabling activities aiming for focused clinical studies to generate safety, pharmacokinetic, and pharmacodynamic data. Additionally, a Patent Term Extension (PTE) of up to five years may extend Kapiglucagon’s patent protection to 2043.

Kapiglucagon as Strategic Growth Asset Alongside Lead Candidate P140

ImmuPharma considers Kapiglucagon a key strategic asset complementing its lead candidate, P140. The company has announced plans for accelerated Kapiglucagon development backed by recently approved funding to support advancement over the next two years. This dual-asset approach diversifies ImmuPharma’s pipeline, balancing autoimmune disease applications (P140) with Type 1 diabetes innovation (Kapiglucagon).

Securing manufacturing partners for Kapiglucagon demonstrates ImmuPharma’s confidence in its commercial potential and commitment to efficient development. The company’s portfolio includes novel peptide therapeutics across multiple areas, positioning it within the specialty pharmaceutical sector focused on peptide drug discovery and development. Partnerships with established CDMOs like Thermo Fisher and API manufacturers like Bachem provide the operational infrastructure to advance Kapiglucagon from preclinical and CMC stages to clinical trials and regulatory submissions.

Competitive CDMO Selection Highlights Program Maturity

The competitive tender process for selecting the drug product CDMO indicates Kapiglucagon’s development maturity and ability to attract multiple world-class manufacturing organisations. Such competitive bidding is standard in biopharma, enabling evaluation based on technical capabilities, capacity, timelines, regulatory expertise, and commercial terms. ImmuPharma’s process reflects progress in developing the CMC package and readiness to formalise manufacturing partnerships.

Thermo Fisher Scientific’s selection underscores its recognised pharmaceutical development and manufacturing expertise. Patheon pharma services operates a global network with experience across therapeutic areas and product formats. Their track record in supporting development, regulatory milestones, and commercial manufacturing aligns with ImmuPharma’s goal to advance Kapiglucagon efficiently toward IND submission and clinical trials. The partnership will support the drug product workstream and facilitate regulatory alignment through Pre-IND meetings and strategy discussions.

Upcoming Development Milestones and Regulatory Timeline

ImmuPharma has outlined milestones to progress Kapiglucagon from preclinical and CMC stages to clinical testing. The Thermo Fisher partnership focuses on the drug product workstream alongside advancing regulatory strategy. The company plans ongoing regulatory engagement aiming for IND submission and first-in-human studies, pending regulatory alignment.

The Pre-IND meeting with the FDA is a critical milestone to present the regulatory pathway, CMC strategy, preclinical data, and clinical design for FDA feedback. Following this, ImmuPharma will refine its development plan and advance IND-enabling work. Timelines depend on FDA review, CMC progress by Thermo Fisher and Bachem, preclinical completion, and resource allocation. Approved funding for two years supports these activities. Specific dates for Pre-IND, IND submission, or clinical study start were not disclosed.

ImmuPharma’s Peptide Therapeutics Focus in a Competitive Biopharma Market

ImmuPharma is a specialty biopharmaceutical company focused on discovering and developing peptide-based therapeutics for autoimmune diseases and anti-infectives. Peptide therapeutics are gaining prominence due to their specificity, favorable pharmacology, and broad therapeutic applications.

Kapiglucagon development showcases ImmuPharma’s expertise in peptide chemistry and prodrug engineering to overcome pharmaceutical challenges. This expands the company’s focus into diabetes, a significant market opportunity. Partnerships with leading CDMOs and API manufacturers demonstrate ImmuPharma’s credibility in pharmaceutical development. The industry trend toward outsourcing enables companies like ImmuPharma to access world-class manufacturing without heavy internal infrastructure investment.

Financial and Operational Impact of Thermo Fisher CDMO Partnership

While specific contract values and payment terms were not disclosed, the Thermo Fisher CDMO engagement involves development fees, clinical supply manufacturing costs, and potentially milestone payments. Kapiglucagon development is funded for the next two years, covering partnership expenses.

Operationally, the partnership grants ImmuPharma access to Thermo Fisher’s technical, regulatory, and manufacturing capabilities without building proprietary facilities. This outsourced model reduces capital expenditures and accelerates development. Working with Bachem for API and Thermo Fisher for drug product creates a distributed manufacturing model requiring coordination but offering specialized expertise at each stage. No immediate share price impact was evident at announcement.

Artificial Pancreas Technology Drives Demand for Advanced Glucagon Therapeutics

Kapiglucagon’s role in next-generation artificial pancreas systems represents a major growth opportunity in diabetes care technology. Artificial pancreas systems, or closed-loop glucose control systems, integrate continuous glucose monitoring, algorithmic insulin delivery, and increasingly dual-hormone delivery combining insulin and glucagon to better prevent hypoglycemia.

Dual-hormone systems need stable, soluble glucagon formulations compatible with infusion pumps. Native glucagon’s instability has limited dual-hormone adoption, creating demand for improved formulations. ImmuPharma positions Kapiglucagon as "a key enabling solution for next-generation artificial pancreas technologies." As these technologies gain clinical and market traction, demand for stable glucagon formulations like Kapiglucagon is expected to rise, presenting significant commercial potential upon regulatory approval and clinical adoption.