Periodic Reporting for period 1 - ADJU-PLATFORM (MINIMAL SAPONIN-BASED ADJUVANT VACCINE PLATFORM)
Okres sprawozdawczy: 2024-03-01 do 2025-08-31
Adjuvants are added to vaccines to increase antigen immunogenicity, enhancing and boosting the immune response. The ADJU-PLATFORM project has validated preclinically a previously developed synthetic technology, offering streamlined access to cost-effective saponin-based conjugates with commercial utility in vaccine development. We have executed an intellectual property strategy leading to an international patent application that has entered national phases. The project has also established a commercialization roadmap for accelerated market entry of our adjuvant platform via out-licensing, with the goal of enabling the future development of new vaccine solutions.
Most vaccines utilize adjuvants, substances that enhance the immunogenicity of the antigen and stimulate the immune system, thereby promoting a stronger and more prolonged immune response. Despite the promise of adjuvants based on naturally occurring saponins extracted from plants, there exist some inherent limitations associated to the natural product, including scarcity, heterogeneity, chemical instability and toxicity. The ADJU-PLATFORM project builds upon a saponin synthetic technology that enables access to a streamlined, structurally defined adjuvant candidates for conjugation of a range of homogeneous antigens towards the development of chemically pure, non-toxic self-adjuvanting vaccines. The high purity, chemical control and exquisite structural definition of our adjuvant platform are key features of our technology, making it a potentially superior alternative to existing vaccine modalities with more heterogeneity and costlier timelines. The overall objectives involved validation of our platform both at the synthetic/scale up and preclinical levels, as well as demonstration of its innovative potential by advancing intellectual property positions and commercialization opportunities of the technology. Facilitating technology transfer of our results via out-licensing to interested industrial partners represents a viable go-to-market strategy for our asset and will have significant socioeconomic impact on two fronts, fuelling innovation of the European pharmaceutical landscape for further clinical development, while benefiting the health care system and ultimately patients in need for improved vaccine solutions.
Most vaccines utilize adjuvants, substances that enhance the immunogenicity of the antigen and stimulate the immune system, thereby promoting a stronger and more prolonged immune response. Despite the promise of adjuvants based on naturally occurring saponins extracted from plants, there exist some inherent limitations associated to the natural product, including scarcity, heterogeneity, chemical instability and toxicity. The ADJU-PLATFORM project builds upon a saponin synthetic technology that enables access to a streamlined, structurally defined adjuvant candidates for conjugation of a range of homogeneous antigens towards the development of chemically pure, non-toxic self-adjuvanting vaccines. The high purity, chemical control and exquisite structural definition of our adjuvant platform are key features of our technology, making it a potentially superior alternative to existing vaccine modalities with more heterogeneity and costlier timelines. The overall objectives involved validation of our platform both at the synthetic/scale up and preclinical levels, as well as demonstration of its innovative potential by advancing intellectual property positions and commercialization opportunities of the technology. Facilitating technology transfer of our results via out-licensing to interested industrial partners represents a viable go-to-market strategy for our asset and will have significant socioeconomic impact on two fronts, fuelling innovation of the European pharmaceutical landscape for further clinical development, while benefiting the health care system and ultimately patients in need for improved vaccine solutions.
ADJU-PLATFORM has led to significant advances on the technical development of our synthetic adjuvant technology, providing scalable adjuvant/vaccine candidates with potent activity and no toxicity. These have been validated in extensive preclinical settings inducing strong humoral and cellular immune responses in mouse vaccinations models.
Moreover, we have advanced in our intellectual property rights strategy, obtaining a positive assessment of our PCT application that has enabled moving into the corresponding national phases. Likewise, we have attracted the attention of pharma companies potentially interested in licensing our adjuvant platform, a prospect that we are currently seeking for further clinical advancement of our asset in anticipation to market entry.
Moreover, we have advanced in our intellectual property rights strategy, obtaining a positive assessment of our PCT application that has enabled moving into the corresponding national phases. Likewise, we have attracted the attention of pharma companies potentially interested in licensing our adjuvant platform, a prospect that we are currently seeking for further clinical advancement of our asset in anticipation to market entry.
The main results include:
1. Validation of our synthetic platform for accessing streamlined saponin leads and saponin–antigen conjugates as self-adjuvanting vaccine candidates amenable to scale up. The impact is important as this will facilitate multi-gram production of such synthetic constructs before process development can be demonstrated at kilogram scale in a future industrial context.
2. Preclinical evaluation of novel saponin-based adjuvants and self-adjuvanting vaccines in relevant collaborative settings, which showed their ability to elicit robust humoral and cellular immunity. This validation confirmed their immunological potential for further development into future clinical trials, although a proper regulatory framework needs to be implemented before this transition
3. Consolidation of an optimal intellectual property rights (IPR) strategy culminating in a favorable international report to our patent application and subsequent entering into national phases. Together with the preclinical testing results above, this solid IPR position represents an important step forward that support our approach to define potential licensing agreements with interested companies. These efforts, which are currently underway and will need to be negotiated in due time, are being complemented with an active search for public funding, with the goal of realizing the full promise of our adjuvant platform towards future commercialization.
1. Validation of our synthetic platform for accessing streamlined saponin leads and saponin–antigen conjugates as self-adjuvanting vaccine candidates amenable to scale up. The impact is important as this will facilitate multi-gram production of such synthetic constructs before process development can be demonstrated at kilogram scale in a future industrial context.
2. Preclinical evaluation of novel saponin-based adjuvants and self-adjuvanting vaccines in relevant collaborative settings, which showed their ability to elicit robust humoral and cellular immunity. This validation confirmed their immunological potential for further development into future clinical trials, although a proper regulatory framework needs to be implemented before this transition
3. Consolidation of an optimal intellectual property rights (IPR) strategy culminating in a favorable international report to our patent application and subsequent entering into national phases. Together with the preclinical testing results above, this solid IPR position represents an important step forward that support our approach to define potential licensing agreements with interested companies. These efforts, which are currently underway and will need to be negotiated in due time, are being complemented with an active search for public funding, with the goal of realizing the full promise of our adjuvant platform towards future commercialization.