Cyxone, a biotech company specializing in autoimmune diseases, in collaboration with its CDMO partner, has streamlined part of the manufacturing process for its drug candidate Rabeximod, which is under development for the treatment of rheumatoid arthritis (RA).

As part of the continued development of Rabeximod, Cyxone is now, in collaboration with its CDMO, working on the development of creating a scalable manufacturing process for the late development phases as well as the commercialization of Rabeximod.

Rabeximod is produced by chemical synthesis through several intermediate steps to make up the final active pharmaceutical ingredient (API). In the recent process development efforts one of the major time-consuming steps was significantly improved, which opens for a much more streamlined manufacturing process going forward.

“With the transition from an early-stage manufacturing process to a large-scale process for late-stage development and commercial, there are always scale up challenges often not encountered at early-stage development at smaller scale despite various design and robustness tests,” said Laurens van Pinxteren, CMC responsible for Cyxone. “We have now streamlined one of the process steps applicable to several intermediate steps that will result in shorter manufacturing times and in the end higher yields.”

Erika Samuelsson, chief development officer, Cyxone, said: “We are very happy with this improvement of the manufacturing process, which has the potential to create significant value for Cyxone both in our upcoming clinical studies beyond Phase 2b and in the future commercialization of Rabeximod.”

Rabeximod is a well-tolerated, orally available Phase 2 candidate drug with a unique mechanism of action. Rabeximod selectively targets the inflammatory macrophage, a type of white blood cell which is the central orchestrator of the inflammatory process that causes tissue destruction and clinical symptoms in RA.

Combined with the convenience of oral administration and a beneficial tolerability profile, this opens up for treatment in the early, as well as later stages of the disease. It is believed to be particularly effective at onset and relapses of RA, with good potential to prevent joint destruction and progression of the disease.