Exothera Partners with Remedium to Scale-Up Manufacturing of Gene Therapy Drug Candidate

Exothera, a Belgium-based contract development and manufacturing organization (CDMO), and Remedium Bio, a US-based biotechnology company, have entered into an agreement under which the two companies will collaborate to scale-up manufacturing and demonstrate the industrialization potential of Remedium’s lead gene therapy drug candidate, AAV2-FGF18, the companies announced on March 22, 2023.

Remedium’s lead candidate is a disease-modifying gene therapy that is based on the clinically proven regenerative mechanism of fibroblast growth factor 18 (FGF18), according to Remedium in a company press release. The company is developing the gene therapy to treat osteoarthritis, a sector of rheumatology that has the largest unmet clinical need and which currently has no approved disease-modifying treatments, according to the press release.

With a 160,000-ft² manufacturing center of excellence in Jumet, Belgium, Exothera, is well-positioned to supply clinical- and commercial-scale supplies of AAV2-FGF18, the company stated in the release. The CDMO will execute a proof-of-concept demonstration for transient expression of AAV2-FGF18 with suspension culture using a human embryonic kidney cells 293 cell line. Exothera aims to identify a high yield production process and reduce cost-of-goods for the lead candidate’s manufacturing process.