22 March 2023 | Wednesday | News
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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."