Remedium Bio, a biotechnology company developing a lead candidate disease modifying treatment for Osteoarthritis (OA), and Exothera S.A., a full-service Contract Development and Manufacturing Organization (CDMO) specialized in gene therapy, vaccines, and oncolytic viruses, reached an agreement for a collaboration to demonstrate the industrialization potential of Remedium’s AAV2-FGF18.

Remedium’s lead candidate is the only disease modifying gene therapy based on the clinically proven regenerative mechanism of FGF18. OA is the largest unmet clinical need in rheumatology, with no currently approved disease modifying treatments and an estimated 300-500 million patients around the globe. Remedium’s recent development progress, demonstrating strong safety and efficacy potential in a translatable preclinical model, was recently presented at the 2023 Orthopaedic Research Society meeting, 2023 OARSI World Congress, and the 2022 American Society for Bone and Mineral Research meeting.

Exothera is a highly experienced viral vector manufacturer, with demonstrated capabilities in large-scale AAV production, achieving state-of-the art titers and quality. Boasting an existing 160,000 sq. ft. high-tech manufacturing centre of excellence in Jumet, Belgium, Exothera is well-positioned to supply Remedium's lead candidate for clinical studies and at commercial scale. Exothera can count on state-of-the-art technology and an extensive set of experts in AAV-based viral vector production. The CDMO will execute a proof of concept for transient expression of Remedium’s AAV2-FGF18 with suspension culture, based on a HEK-293 cell line. Exothera will focus on identifying a high yield production process and reduce cost of goods for the manufacturing process of Remedium’s AAV2-FGF18.

Hanna Lesch, Chief Technology Officer at Exothera: “It is wonderful to engage in a new challenge to apply the exoREADY™ platform to a first-in-class gene therapy for Osteoarthritis. We have already achieved promising results with other AAV-based gene therapies, and we are confident that we can play our part in making a better life for patients”.

Frank Luppino, President, and CEO of Remedium: “With several recently approved cell and gene therapy products advancing to the market, gene therapy is transcending the realm of rare monogenic disorders to enable treatment of large unmet clinical needs like Osteoarthritis. Remedium’s recently published preclinical results uniquely position the company to advance this transformative therapy to the clinic. We are very excited to be able to partner with Exothera on this project to advance our lead candidate through preclinical toxicology studies and eventually human clinical trials.”

About Remedium

Remedium Bio, Inc. is a preclinical-stage biotechnology company developing novel gene therapies for a broad range of highly debilitating diseases. The company's R&D approach focuses on modularly combining proven technologies to treat well-characterized disease pathology, thereby streamlining elements of the product development process. Remedium's pipeline includes a lead candidate first-in-class, single-injection, potentially disease-modifying gene therapy for the treatment of Osteoarthritis and treatments for the management of Diabetes and Stroke.

Website: https://remedium-bio.com/

About Exothera SA

Exothera is a viral vector CDMO using standard and innovative bioproduction platforms to rapidly deliver affordable viral vector-based vaccines and cell and gene therapies. As a Univercells company, Exothera capitalizes on novel manufacturing technologies and best-in-class bioprocessing expertise to provide custom-made process optimization and GMP clinical and commercial production of viral vectors. Based on its extensive technology expertise, Exothera selects technologies to optimally answer customer needs for cost-effective and agile viral vector manufacturing and provides QC services and analytical development.

Website: www.exothera.world