Selecta Biosciences, a clinical stage biotechnology company developing a novel class of targeted antigen-specific immune tolerance treatments, has entered into an exclusive license with 3SBio, a biotechnology company researching, developing, manufacturing and marketing biopharmaceutical products primarily in China, for pegsiticase (Uricase PEG-20), a pegylated recombinant uricase from candida utilis.

Pegsiticase has shown the ability to efficiently reduce plasma uric acid levels in gout patients in successful U.S. phase I clinical tests. The exclusive license enables Selecta to develop pegsiticase in patients with refractory and tophaceous gout and apply its immunomodulatory Synthetic Vaccine Particle (SVP) platform to optimize the safety and efficacy profile for patients at risk of immunogenicity. SEL-212 is a novel product that combines Selecta’s proprietary SVP with 3SBio’s pegsiticase and is designed to be the first non-immunogenic version of uricase.

“Pegsiticase already has shown significant efficacy signals in gout patients and we have the opportunity to develop a novel therapeutic approach with the goal of preventing the inhibitory antibodies and other complications of immunogenicity that have been a significant barrier to the widespread use of uricase-based drugs,” said Werner Cautreels, Ph.D., president and CEO of Selecta. “With the combination of SVP and pegsiticase, we believe we can dramatically improve treatment for patients with refractory and tophaceous gout.”

Cautreels said, “Working with 3SBio, we have the potential to fulfill a key medical need expressed by physicians—the first non-immunogenic uricase. 3SBio’s strength of enzyme manufacturing combined with Selecta’s proprietary antigen-specific tolerance platform will ensure fast progress toward human proof-of-concept. If successful, Selecta’s SVP platform may unlock the full therapeutic potential of many other biologic therapies adversely affected by immunogenicity.”

Selecta will work with 3SBio to advance pegsiticase-based therapeutics as potential treatments for refractory and tophaceous gout as well as tumor lysis syndrome, with the ultimate goal of expeditiously moving toward regulatory approvals. Selecta and 3SBio have agreed to work together to achieve clinical proof-of-concept for SEL-212 and pegsiticase in human clinical trials in their territories; Selecta’s territory includes U.S. and all of Europe. Proof-of-concept clinical studies are expected to be initiated in 2015.