Heidelberg site to lead GMP development of lactoperoxidase and glucose oxidase for Phase II clinical trials

AGC Biologics Heidelberg site

Microbial projects are underway at AGC Biologics’ Heidelberg facility.

HEIDELBERG, Germany, Sept. 24, 2026 (GLOBE NEWSWIRE) -- Belgian biopharmaceutical company Flen Health has selected AGC Biologics as their CDMO partner to provide process development, scale-up, and GMP manufacturing services for a new and improved wound and skin healing product.

Manufacturing Services to Support Regulatory Submissions, Clinical Trials

With cell line development from myBIOS complete, AGC Biologics’ Heidelberg, Germany facility will partner for the next stage of development and clinical-scale manufacturing of two recombinant proteins, lactoperoxidase and glucose oxidase, the enzymatic components at the core of the wound treatment’s novel mechanism of action. Following the technology transfer, AGC Biologics will conduct microbial manufacturing at 100-liter and 1,000-liter scale using the Pichia pastoris expression system, in support of Flen Health’s planned Investigational New Drug submission and Phase II clinical trials.

A Novel Combination Product

Flaminal® has been used clinically for 25 years in European markets as a topical enzyme-alginate gel for difficult-to-heal wounds. Classified as a medical device, the therapeutic approach combines a recombinant enzyme system within an alginate matrix to accelerate wound healing.

Flen Health is now advancing an improved, recombinant version of the product as part of its strategic entry into the U.S. market, which has seen limited changes to the chronic and acute wound care sector in recent years.

Addressing a Serious Diabetes Complication

Diabetic foot ulcers remain one of the most undertreated complications in chronic wound care, affecting up to 25% of diabetic patients in their lifetime with an annual cost of $13 billion to the US healthcare system. Diabetic foot ulcers are the leading cause of lower extremity amputations among people with diabetes, accounting for about 85% of such procedures. Globally, 10.2% of the population are living with diabetes and the prevalence of the disease continues to rise, increasing the risk of non-healing foot ulcers and further straining healthcare systems. Effective wound repair in DFUs is challenged by disrupted cell communication, impaired inflammatory responses, and a hostile healing environment.

The Next Chapter for Enzyme-based Wound Therapies

While Flen Health’s Phase 0 human study will utilize current food-grade enzyme formulations, the strategic transition to AGC Biologics’ pharma-grade recombinant enzymes will occur ahead of Phase II clinical trials, applying deep expertise in a world-class GMP facility in preparation for U.S. regulatory submissions.

“Patients with diabetic foot ulcers need better treatment options,” said Georges Sollie, CEO of Flen Health. “By combining our novel recombinant enzyme platform with AGC Biologics’ manufacturing expertise, we are accelerating the development of a promising new therapeutic approach.”

“As we now advance into full GMP development and manufacturing, we are building on a successful feasibility program we initiated with Flen Health in July 2025. That is exactly the pattern we pride ourselves on, building trust and mutual collaboration with our customers,” said Dieter Kramer, Managing Director, AGC Biologics Heidelberg. “We’re thankful Flen Health has entrusted us with this next chapter.”

In addition to the Heidelberg location, AGC Biologics’ global microbial manufacturing network includes facilities in Copenhagen, Denmark; Seattle, USA; and Chiba, Japan.

Frequently Asked Questions (FAQs):

Will the recombinant LPO/GOX product require a traditional IND, a device submission, or some other regulatory coordination with the FDA?

Flen Health participated in an INTERACT meeting with the FDA in January 2026 to receive feedback on their Chemistry, Manufacturing, and Controls development plan. This enables them to prepare for an IND submission.

How does the new recombinant version differ from the current Flaminal product?

The current Flaminal product on the market utilizes food-grade enzymes within an alginate environment to effectively treat difficult-to-heal wounds and accelerate the healing process. With the new recombinant version, AGC Biologics will manufacture the lactoperoxidase and glucose oxidase drug substances to GMP and pharma-grade standards to support classification of the product as a biologic in the United States.

Does AGC Biologics provide strain development?

AGC Biologics offers full strain development for Escherichia coli expression systems. For this program, Flen Health partnered with myBIOS to provide Pichia pastoris strain cell line development. myBIOS specializes in methanol-free, inducible recombinant protein production using P. pastoris, enabling safer, more sustainable, and cost-efficient manufacturing. myBIOS supports customers in strain engineering and early-stage process development, while its myPICHIA® platform provides a comprehensive toolbox for in-house protein production.

AGC Biologics has experience working with partners to provide process development for multiple expression system host cells (E. coli, P. pastoris with or without methanol induction, Pseudomonas fluorescens, Bacillus, and Lactobacillus casei).

What did the feasibility program launched in July 2025 include: strain screening, cell-line development, fermentation, purification, formulation, analytics, or all of these?

The feasibility stage conducted at the AGC Biologics site in Heidelberg for Flen Health included comprehensive process transfer, upstream and downstream process development, analytical method implementation, and dedicated project management for recombinant lactoperoxidase and glucose oxidase programs. By focusing on optimizing fermentation, purification, and analytical frameworks, this strategic partnership lays a solid groundwork for future wound and skin healing solutions.

Will AGC Biologics support CMC documentation for the IND, including process descriptions, analytical methods, specifications, validation plans, and stability data?

Similar to other customer programs, AGC Biologics will support all required regulatory documentation for the IND submission, building on best practices developed through other submissions and providing our regulatory expertise at every stage.

What is the regulatory history of the AGC Biologics Heidelberg site?

AGC Biologics has a strong regulatory track record. The 100+ successful audits and inspections conducted at AGC Biologics help the CDMO continuously hone its quality and compliance culture and systems.

The AGC Biologics Heidelberg site has received regulatory approvals from agencies such as the FDA, EMA, and PMDA. Heidelberg’s inspection history over the last ten years includes routine inspections from the FDA and Germany’s Regierungspräsidium Tübingen, all with no critical or major findings.

About Flen Health

Flen Health is a biopharmaceutical company dedicated to developing innovative therapies for unmet needs in wound care. Founded in 2000 and headquartered in Kontich, Belgium, the company has more than 25 years of experience delivering trusted wound and skin healing solutions across Europe and in more than 40 countries worldwide. Flen Health is now leveraging this expertise to bring its novel therapeutics to the U.S. market. For more information, visit www.flenhealth.com.

About AGC Biologics

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, to provide friendly and expert services. We provide world-class development and manufacturing of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with locations in Seattle, Washington; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba and Yokohama, Japan. AGC Biologics is a part of AGC Inc.’s Life Science Business. The Life Science Business runs eight facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. To learn more, visit www.agcbio.com.

A photo accompanying this announcement is available at: https://www.globenewswire.com/NewsRoom/AttachmentNg/58ab4572-76b2-4b34-b01d-5beb7d246c44

CONTACT: Flen Health media contact: julie.kerckhof@flenhealth.com

AGC Inc. corporate contact: info-pr@agc.com

AGC Biologics media contact: kati.sills@agc.com