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Selecta Biosciences, Inc. (NASDAQ:SELB), a biotechnology company leveraging its clinically validated ImmTOR™ platform to develop tolerogenic therapies for autoimmune diseases and gene therapies, today announced that it has entered into an agreement to transition the manufacturing and development rights and remaining clinical operations of ImmTOR for SEL-212 to its development and commercialization partner, Swedish Orphan Biovitrum AB (publ.) (Sobi). As of November 6, 2023, Sobi will assume responsibility for the manufacturing and commercial supply of ImmTOR for SEL-212. SEL-212, a combination of Selecta's ImmTOR immune tolerance platform and a therapeutic uricase enzyme (pegadricase), is in development for the treatment of chronic refractory gout. A Biologics License Application (BLA) submission for SEL-212 remains on track for the first half of 2024.
In connection with this transition, 15 Selecta employees currently supporting ImmTOR manufacturing and clinical development activities for SEL-212 are expected to become employees of Sobi. In addition, Peter G. Traber, M.D., Chief Medical Officer of Selecta, will begin serving as a consultant to Sobi, helping to oversee the clinical and regulatory activities associated with SEL-212. Dr. Traber will also continue to serve in his role as Chief Medical Officer at Selecta on a part-time basis.
"We believe transitioning our manufacturing operations to Sobi will further streamline our organization, consistent with our announced strategic objective to optimize the value of our SEL-212 royalty stream for stockholders," said Carsten Brunn, Ph.D., President and Chief Executive Officer of Selecta. "Leveraging ImmTOR, the only immune tolerance platform with positive Phase 3 data, we firmly believe that SEL-212 has strong potential to address this significant unmet need and exceed $700 million in peak sales in the U.S."
Sobi licensed SEL-212 from Selecta in June 2020 and is responsible for development, regulatory and commercial activities in all markets outside of China. Selecta was originally responsible for ImmTOR manufacturing. Selecta is eligible to receive up to $615.0 million in remaining regulatory and commercial milestone payments and tiered double-digit royalties on net sales of SEL-212.
Posted In: SELB
