Natural QS-21 is one of the leading adjuvant candidates currently under investigation and has been studied in over 100 clinical trials and administered to over 50,000 recipients. Our product pipeline is based on improving the safety database and performance characteristics of this rare natural product. Unlike the rare natural product, our pipeline is produced via biosustainable methods that enable the scalability and robust manufacturing profile that vaccine manufacturers prefer.
The core breakthrough of our synthetic process allows Adjuvance to manufacture two primary products; SAPONEX and TQL-1055. SAPONEX is commercially viable and ecologically sustainable source of synthetic QS-21 for vaccine manufacturers. SAPONEX is scalable and capable of large scale synthesis. TQL-1055, is a structural variant of QS-21 which has improved safety, efficacy and manufacturing characteristics.
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SAPONEX is Adjuvance’s synthetic version of QS-21. QS-21 is a naturally occurring saponin adjuvant isolated from the bark of a rare South American tree. QS-21 has been administered to more than 50,000 recipients and is a key component of various investigative adjuvant formulations, such as AS01, and AS02. QS-21, has been used in numerous Phase III clinical trials, and was recently approved for use in GSK’s pediatric malaria vaccine Mosquirix. SAPONEX contains the two molecules responsible for QS-21’s immunostimulatory activity (QS-21-apiose and QS-21-xylose) in high purity. SAPONEX is a clinical stage program and synthetic QS-21 has been used in a Phase I trial in the US (NCT00597272, QS-DG). SAPONEX potentially represents lower cost, equipotency, exquisite purity and improved scalability when compared to natural QS-21.
TiterQuil molecules represent novel compositions of matter that do not exist in nature. TiterQuil molecules are created by targeted molecular variations in the QS-21 molecules based upon observed structure-activity relationships. We have selected our lead asset, TiterQuil-1055(TQL1055), from a diverse array of novel TiterQuil candidates. We believe that our lead adjuvant, TiterQuil-1055, whose development was previously supported by the NIH, is a superior adjuvant that will significantly enhance the immunogenicity of commercial vaccines and provide for the emergence of new vaccines that may require an effective adjuvant. TiterQuil-1055, with its significantly improved safety, efficacy and manufacturing characteristics, has the ability to become the adjuvant of choice for early stage programs as well as to enable the development of new programs which require a powerful vaccine adjuvant that delivers efficacy, stability, and tolerability.