Periodic Reporting for period 1 - ADJUVACCINE (Development of a marketable adjuvant candidate for vaccine applications)
Okres sprawozdawczy: 2023-01-01 do 2024-06-30
Most vaccines contain adjuvants, ingredients that help enhance the immune response induced by the vaccine. A particular saponin family derived from a Chilean soap bark tree shows high immunopotentiating activity and has been recently approved as vaccine adjuvants. However, there exist some liabilities associated to the natural source, including scarcity and difficulty in purification to homogeneity, in addition to its structural instability and dose-limiting toxicity. The ADJUVACCINE synthetic technology enables the development of stable saponin adjuvants through chemical synthesis, aiming to provide access to scalable, optimized adjuvant candidates that can be incorporated into the production pipeline for more cost-efficient and improved vaccine development. The overall objectives are to demonstrate the scalability of our innovative technology and advance the selected lead through preclinical trials for entering the vaccine market via spin-off formation, which will also involve implementation of a proper intellectual property strategy and a public/private funding roadmap plan. Moving our asset closer to the market through the creation of a spin-off company will have significant impacts at two levels, boosting the economy by promoting industrial innovation and clinical trials, as well as benefiting the healthcare system by providing access to better vaccines to improve people’s lives.
ADJUVACCINE has enabled important progress on the technical development of our synthetic adjuvant technology, yielding access to novel saponin adjuvant candidates with potent activity and no toxicity as well as validating the upscale production of a selected saponin lead compound.
We have developed synthetic saponins showing improved adjuvant potency and have carried out an extensive immunological evaluation of a key saponin candidate. These preclinical trials have confirmed no toxicity and induction of high antibody and cellular immune responses in well-established mouse vaccination models, including clinically-relevant vaccine antigens in collaboration with interested industrial partners.
Moreover, we optimized the route and have scaled-up the synthesis of a key adjuvant candidate to gram-scale, setting the stage for the upscale production of this adjuvant for potential future applications in vaccine development.
We have developed synthetic saponins showing improved adjuvant potency and have carried out an extensive immunological evaluation of a key saponin candidate. These preclinical trials have confirmed no toxicity and induction of high antibody and cellular immune responses in well-established mouse vaccination models, including clinically-relevant vaccine antigens in collaboration with interested industrial partners.
Moreover, we optimized the route and have scaled-up the synthesis of a key adjuvant candidate to gram-scale, setting the stage for the upscale production of this adjuvant for potential future applications in vaccine development.
The main results include:
1. Validation of our synthetic technology for accessing potent, non-toxic saponin adjuvants that are scalable for production in gram quantities. The impact is important as this will enable process development of such adjuvants for use in future commercial vaccines. This aspect is something that will need to be demonstrated in an industrial environment for prospective kilogram-scale production.
2. Extended preclinical evaluation of novel saponin leads in collaboration with a biotech company showed notable induction of antibody and cellular immunity, verifying its adjuvant potential in relevant settings. Yet, the establishment of a supportive regulatory framework is required for further translation. Overall, these results are impactful as they could lead to potential licensing agreements that will need to be negotiated to enable future market entry.
3. Consolidation of an optimal intellectual property rights (IPR) strategy culminating in a favorable international search report to our patent application and freedom-to-operate analysis. This places us in an optimal scenario to pursue transfer opportunities of our adjuvant assets via spin-off company formation which would have an important socioeconomic impact. Nonetheless, additional efforts in seeking investors and more public funding, which are currently underway, are needed to realize the full potential of our adjuvant technology towards future commercialization.
1. Validation of our synthetic technology for accessing potent, non-toxic saponin adjuvants that are scalable for production in gram quantities. The impact is important as this will enable process development of such adjuvants for use in future commercial vaccines. This aspect is something that will need to be demonstrated in an industrial environment for prospective kilogram-scale production.
2. Extended preclinical evaluation of novel saponin leads in collaboration with a biotech company showed notable induction of antibody and cellular immunity, verifying its adjuvant potential in relevant settings. Yet, the establishment of a supportive regulatory framework is required for further translation. Overall, these results are impactful as they could lead to potential licensing agreements that will need to be negotiated to enable future market entry.
3. Consolidation of an optimal intellectual property rights (IPR) strategy culminating in a favorable international search report to our patent application and freedom-to-operate analysis. This places us in an optimal scenario to pursue transfer opportunities of our adjuvant assets via spin-off company formation which would have an important socioeconomic impact. Nonetheless, additional efforts in seeking investors and more public funding, which are currently underway, are needed to realize the full potential of our adjuvant technology towards future commercialization.