• Successful production of STIMULON™ cpcQS-21, a cultured plant cell adjuvant with confirmed biochemical comparability to traditional bark extract-derived adjuvant
• Submission of Master File (MF) for STIMULON cpcQS-21 to the U.S. FDA for reference by partners as part of regulatory submissions
• Ongoing collaboration with Ginkgo Bioworks to drive innovation in SaponiQx's adjuvant pipeline through generative molecular design

SaponiQx, the adjuvant subsidiary of Agenus Inc. (NASDAQ: AGEN), specializing in saponin-based adjuvant discovery and manufacturing, has achieved a milestone in scaling the production of its STIMULON cultured plant cell (cpc) QS-21 adjuvant, designed to amplify the efficiency and endurance of vaccines. This cultured plant cell adjuvant is building upon SaponiQx’s expertise with its proprietary adjuvant STIMULON QS-21, a critical component of effective vaccines, including GSK’s Shingrix (Zoster Vaccine Recombinant, Adjuvanted) and Arexvy (Respiratory Syncytial Virus, Adjuvanted).

"SaponiQx is furthering its trailblazing work in adjuvant and vaccine discovery, as well as mass manufacturing," said Chandresh Harjivan, SaponiQx's President and Chief Operating Officer. "Building on Agenus’ vast experience with STIMULON, SaponiQx aims to achieve global-scale manufacturing, creating a consistent and sustainable supply by employing advanced plant and engineered cell-production techniques. Additionally, we are developing a diverse range of next-generation saponin-based adjuvants to meet the demands of existing and emerging infectious diseases."

Progress Highlights:

Breakthrough in Production: SaponiQx has successfully manufactured STIMULON cpcQS-21, showing biochemical comparability to traditional bark extract-derived adjuvants. This method eliminates the need for extraction from the Chilean soap tree bark, enabling scalable and cost-effective production. This innovation also promises consistent quality and resolves potential supply issues.

Regulatory Compliance: SaponiQx is manufacturing STIMULON cpcQS-21 in accordance with Good Manufacturing Practice (GMP) standards and has submitted a master file to the U.S. FDA to enable Investigational New Drug (IND) sponsors to reference the data as part of their regulatory submissions.

Ongoing Collaboration: Partnering with Ginkgo Bioworks, SaponiQx is developing a collection of new saponin-based adjuvants, employing generative molecular design and artificial intelligence. This alliance aims to deliver tailored, potent adjuvants cost-effectively and at a scale suitable for global vaccination programs.

About SaponiQx

Founded in 2021, SaponiQx, a subsidiary of Agenus Inc., stands at the forefront of saponin-based adjuvant discovery and manufacturing. Its mission is to provide scalable and affordable vaccine adjuvants to enhance global health. Its proprietary adjuvant, STIMULON QS-21, forms an integral part of the AS01 adjuvant used in several leading vaccines.

STIMULON is a trademark of Agenus Inc., the parent company of SaponiQx Inc. Shingrix and Arexvy are trademarks of GlaxoSmithKline Biologicals, S.A.

Forward-Looking Statements

This press release includes forward-looking statements, subject to risks and uncertainties, concerning the development of vaccines and adjuvants. Refer to the Risk Factors in Agenus’ latest Quarterly Report on Form 10-Q or Annual Report on Form 10-K filed with the SEC for a detailed discussion of these risks.

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