Initiating inflammasome inhibitor development

GENEVA & DURHAM, N.C.—Selexis SA and KBI Biopharma, Inc. have announced a new collaboration with ZyVersa Therapeutics to advance development of ZyVersa’s lead inflammasome inhibitor, IC 100, for the treatment of multiple inflammatory conditions.

Under the collaboration, ZyVersa will use Selexis’ innovative cell line expression technologies in combination with KBI Biopharma’s contract development manufacturing services to advance IC 100 into the clinic. The collaboration includes a commercial license agreement between Selexis and IC 100’s licensor, InflamaCORE, LLC.

“ZyVersa’s approach to inflammasome inhibition is unique and has the potential to more effectively reduce the inflammation that occurs in patients with inflammatory diseases than product candidates in development that are targeting NLRP3,” said Igor Fisch, Ph.D., CEO, Selexis SA.

Inflammasomes play a critical role in innate immunity, the body’s first line of defense against foreign infectious organisms and cell damage. But overactivation of inflammasomes leads to chronic debilitating inflammatory diseases such as multiple sclerosis and diabetic kidney disease.

ZyVersa’s IC 100 is a monoclonal antibody that uniquely inhibits the adaptor ASC (apoptosis-associated speck-like protein containing a caspase recruitment domain) component of multiple inflammasomes. IC 100 disrupts ASC Speck structure and function, blocking inflammasome formation and initiation of the inflammatory cascade, thereby inhibiting perpetuation of the inflammatory response. ZyVersa expects IC 100 to significantly reduce inflammation contributing to a broad group of inflammatory disorders.

“The signed commercial license agreement between Selexis and InflamaCORE, and our intent to leverage Selexis and KBI’s capabilities, are important steps toward advancing IC 100 to human trials. IC 100 has the potential to transform treatment of debilitating inflammatory diseases by inhibiting ASC, which is a component of multiple types of inflammasomes. This is an important differentiator for IC 100 since activation of multiple types of inflammasomes, not just the NLRP3 inflammasome, is pathogenic in numerous chronic inflammatory diseases,” stated Stephen Glover, co-founder, CEO and president of ZyVersa Therapeutics.

Selexis’ expertise in mammalian cell line generation, along with KBI Biopharma’s proven strengths in process development and analytics, are part of the development approach. This platform starts with DNA transfection and ends with GMP drug substance in as little as nine months, allowing predictable delivery of material to partners for clinical study and achieving faster time-to-market with lower manufacturing costs.

“We are excited to partner with ZyVersa on their innovative IC 100 program,” added Tim Kelly, Ph.D., president and CEO, KBI Biopharma. “It’s an ideal opportunity to leverage our fully integrated offering to advance IC 100 into clinical studies while delivering a robust, scalable process and a thoroughly characterized, stable and potent product. Together, Selexis and KBI provide a truly unique solution for ZyVersa and all biopharma companies who are bringing the next generation of therapies to patients.”