ZyVersa Therapeutics to Advance Development of Its Lead Inflammasome Inhibitor with Selexis and KBI Biopharma’s Integrated Development Platform

Geneva, Switzerland, and Durham, NC, September 5, 2019 – JSR Life Sciences Companies 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 leverage Selexis’ innovative cell line expression technologies in combination with KBI Biopharma’s best-in-class 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.

Inflammasomes are important signaling complexes that play a critical role in innate immunity, the body’s first line of defense against foreign infectious organisms and cell damage. However, overactivation of inflammasomes lead 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. By inhibiting ASC, IC 100 blocks inflammasome formation and initiation of the inflammatory cascade. By inhibiting the ASC component of ASC Specks, IC 100 disrupts ASC Speck structure and function, thereby inhibiting perpetuation of the massive inflammatory response. Via these mechanisms of action, IC 100 is expected to significantly reduce inflammation contributing to a broad group of inflammatory disorders.

"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, PhD, CEO, Selexis SA.

Added Tim Kelly, PhD, president and CEO, KBI Biopharma, “We are excited to partner with ZyVersa on their innovative IC 100 program. 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.”

Selexis’ expertise in mammalian cell line generation along with KBI Biopharma’s proven strengths in process development and analytics fuel their integrated development approach. This unparalleled 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.

“The signed commercial license agreement between Selexis and InflamaCORE, LLC, and our intent to leverage Selexis and KBI’s capabilities are important steps toward advancing IC 100 to human trials,” stated Stephen Glover, co-founder, chief executive officer, and president of ZyVersa Therapeutics. “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.”

ZyVersa is a clinical stage specialty biopharmaceutical company leveraging advanced, proprietary technologies to develop first-in-class drugs. Our focus is on patients with inflammatory or renal diseases who have significant unmet medical needs. Our clinical pipeline includes a phase 2a-ready asset, VAR 200, a cholesterol efflux mediator for treatment of focal segmental glomerulosclerosis (FSGS), and a novel inflammasome inhibitor with potential for multiple inflammatory diseases. For more information, please visit www.zyversa.com.

Selexis SA, a JSR Life Sciences Company, is the global leader in cell line development with best-in-class modular technology and highly specialized solutions that enable the life sciences industry to rapidly discover, develop and commercialize innovative medicines and vaccines. Our global partners are utilizing Selexis technologies to advance more than 120 drug products in clinical development and the manufacture of five commercial products. As part of a comprehensive drug development process, the Company’s technologies shorten development timelines and reduce manufacturing risks. More information is available at www.selexis.com.

KBI Biopharma is an award-winning biopharmaceutical contract services organization providing fully-integrated, accelerated drug development and biomanufacturing services to pharmaceutical and biotechnology companies globally. With each of our 300+ client partners, we have worked closely to personalize and rapidly accelerate their drug development programs. Built upon a foundation of world-class analytical capabilities, we deliver efficient process development and clinical and commercial cGMP manufacturing services for mammalian, microbial, and cell therapy programs. We have locations in Durham and Research Triangle Park (NC), Boulder and Louisville (CO), The Woodlands (TX), San Diego (CA), and Leuven, Belgium.