Remedium Bio, a biotechnology company developing a lead candidate disease modifying treatment for Osteoarthritis (OA), and Exothera S.A., a full-service CDMO specialized in gene therapy, vaccines, and oncolytic viruses, entered a collaboration agreement 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, according to the company. Remedium’s recent development progress demonstrated strong safety and efficacy potential in a translatable preclinical model.

Exothera is a highly experienced viral vector manufacturer, with demonstrated capabilities in large-scale AAV production, achieving state-of-the art titers and quality.

With an existing 160,000 sq.-ft. high-tech manufacturing center of excellence in Jumet, Belgium, Exothera is in a position to supply Remedium’s lead candidate for clinical studies and at commercial scale.

Exothera 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 said: “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 said: “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.”