SaponiQx Announces Breakthrough in Scaling Up of STIMULON™ Cultured Plant Cell Adjuvant
August 09 2023 - 8:30AM
Business Wire
- 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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