GlaxoSmithKline Biologicals SA

LEXINGTON, Mass.--(BUSINESS WIRE)-- Agenus subsidiary, SaponiQx, a leader in saponin-based adjuvant discovery and production, announces a pivotal advancement in vaccine research and production with the availability of cGMP (current good manufacturing practice) STIMULON™ cultured plant cell (cpc) QS-21. STIMULON cpcQS-21 is a sustainable and cost-efficient alternative to conventionally extracted QS-21 from bark extract, used in high-performance vaccines such as SHINGRIX and AREXVY. Key Highlights: SaponiQx's STIMULON cpcQS-21 offers a groundbreaking alternative to traditional sources, eliminating need for tree bark, ensuring consistent, economical availability of this critical vaccine component. Enhanced Scalability and Availability: With the capability to produce kilograms of material at scale, the SaponiQx platform has the potential to significantly bolster the global vaccine supply chain by making pandemic quantity vaccines more accessible. Innovation in Adjuvant Discovery: Merging synthetic biology with Generative AI-enabled molecular design, SaponiQx is targeting new saponin adjuvants intended to create bespoke pairing of adjuvant and antigens for fine-tuned vaccine efficacy. "SaponiQx is delivering an innovative process that reduces reliance on nature, streamlining a complex supply chain and resulting in a significant reduction in the costs of this vital product,” said SaponiQx's President and Chief Operating Officer, Chandresh Harjivan. About SaponiQx SaponiQx, a subsidiary of Agenus Inc., is a biopharmaceutical company at the forefront of saponin-based adjuvant discovery and manufacturing for vaccine developers. Established in 2021, SaponiQx is dedicated to expanding access to cost-effective and scalable vaccine adjuvants as part of its mission to safeguard the health of global populations. Adjuvants play a vital role in enhancing immune responses, thereby improving vaccine efficacy, safety, and durability. Their flagship adjuvant QS-21 plays a crucial role in the AS01 adjuvant found in several leading vaccines. For more information visit . Note: STIMULON is a registered trademark of SaponiQx Inc. SHINGRIX and AREXVY are trademarks of GlaxoSmithKline Biologicals, S.A. Forward Looking Statements This press release contains forward-looking statements, which are subject to certain risks and uncertainties regarding the future developments of vaccines and adjuvants. For a comprehensive understanding of these risks, we recommend referring to the Risk Factors section in Agenus’ latest Quarterly or Annual Report filed with the SEC.

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 LEXINGTON, Mass.--(BUSINESS WIRE)-- 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 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.

LimmaTech in-licenses Shigella bioconjugate vaccine from GSK to continue its clinical development; Phase I/II study completion and results are expected in 2023 Currently, there are no vaccines to help prevent shigellosis, a disease which causes 600,000 deaths each year. With the pathogen developing resistance to the antibiotics used to treat it, there is an urgent need for a vaccine to prevent the disease. SCHLIEREN, Switzerland--(BUSINESS WIRE)-- LimmaTech Biologics AG (“LimmaTech Bio”), a clinical-stage biotech company developing vaccines for the prevention of life-threatening diseases, signed an in-license agreement with GlaxoSmithKline Biologicals SA (LSE/NYSE: GSK) enabling LimmaTech Bio to further develop and commercialize a quadrivalent bioconjugate vaccine candidate for shigellosis that GSK added to its infectious disease pipeline when LimmaTech Bio’s predecessor company, GlycoVaxyn, was acquired by GSK in 2015. This press release features multimedia. View the full release here: Shigellosis is a serious diarrheal infection and global health threat with a major impact in low- and middle-income countries where mortality and morbidity are high. The multivalent vaccine candidate being developed is composed of antigens from the four most epidemiologically relevant Shigella bacterial strains and is being tested in an ongoing Phase I/II dose-finding and age-descending (adults-children-infants) double-blind study to evaluate its safety and immunogenicity in the 9-month-old infants target population. “LimmaTech Bio has remained committed to developing our Shigella vaccine candidate and this agreement with GSK has its roots in our successful ongoing partnerships with them. We have been a part of the Shigella vaccine program’s journey together with GSK and the Wellcome Trust and the agreement recognizes and validates our in-house expertise in vaccine development as well as our capabilities to move the program forward rapidly,” said Patricia Martin, PhD, Managing Director and Vice President of Clinical and Regulatory Affairs at LimmaTech Bio. “Based on the promising results of the monovalent version, we are looking forward to the data from the 4-valent form of the vaccine, which we expect in 2023. It is now more than ever critical to have a vaccine against a pathogen that is increasingly becoming resistant to antibiotics and represents a high unmet need, especially in young children.” LimmaTech Bio is an independently owned Swiss biotechnology company that spun out from GlycoVaxyn after its acquisition by GSK in 2015. LimmaTech Bio signed a research collaboration agreement with GSK to develop novel bioconjugate antigen-based vaccines including a monovalent Shigella vaccine in cooperation with the Wellcome Trust. Following positive results from the proof-of-concept human challenge clinical trial with the monovalent Shigella vaccine, LimmaTech initiated the development of a multivalent Shigella vaccine in 2018 with a Wellcome Trust grant received by GSK for the new program. The results from the Phase I/II study with this multivalent vaccine are expected in 2023. A positive outcome for safety and immunogenicity will support the further development of the vaccine with pivotal efficacy trials in the target pediatric population as well as travelers and military personnel traveling to Shigella endemic countries. Thomas Breuer, Chief Global Health Officer at GSK, added, “At GSK, we’re committed to changing the trajectory of high-burden infectious diseases that disproportionately affect underserved people in lower-income countries. Partnering with the team at LimmaTech Bio to further the development of this Shigella vaccine candidate is a great example of how we can do that. LimmaTech will give this candidate vaccine the greatest chance of success, while GSK continues to use its expertise to progress another vaccine in clinical development using a GSK proprietary vaccine platform technology called GMMA. Having more than one vaccine could improve supply security and enable countries to implement the one that best suits their particular needs. Together, we can get ahead of Shigella.” Shigellosis is a global health threat caused by any one of four Gram-negative Shigella spp. bacteria, including S. dysenteriae, S. sonnei, S. flexneri, and S. boydii. It is estimated that about 188 million infections are due to Shigella of which 62.3 million cases occur in children younger than 5 years. Diarrheal infection is one of the major causes of morbidity and mortality in numerous countries as well as in travelers and deployed military personnel in endemic regions. There are 600,000 deaths attributed to Shigella each year and it is the second leading cause for diarrheal deaths. The standard treatment for shigellosis is oral rehydration and antibiotic therapy, however, the bacteria have acquired resistance to many antibiotics with numerous reports of outbreaks of multidrug-resistant strains, which makes treatment extremely difficult. Currently, no licensed Shigella vaccine is available. About LimmaTech Biologics AG LimmaTech Biologics AG is applying its deep know-how of engineering complex carbohydrate molecules to develop next-generation vaccines to prevent life-threatening diseases. Spun out from GlycoVaxyn after that company’s acquisition by GSK, LimmaTech Bio is advancing its own proprietary clinical pipeline to halt the increasing threat of global infections due to emerging antimicrobial resistance and sexually transmitted infections such as gonorrhea, alongside partnered programs with GSK. LimmaTech is committed to translating novel scientific concepts into commercially available vaccines that benefit humanity. For more information, please visit . View source version on businesswire.com: Contacts LimmaTech Biologics Paul Wolfrom, CFO E-Mail: media@lmtbio.com For media inquiries Gretchen Schweitzer or Alexander Siebert Trophic Communications Phone: +49 1511 0619 905 Email: limmatech@trophic.eu Source: LimmaTech Biologics View this news release online at: