Periodic Reporting for period 1 - AIDA (AIDA: Allergy Immunotherapy based on Designed Allergens)
Periodo di rendicontazione: 2023-04-01 al 2024-09-30
The AIDA project is pioneering a novel mRNA-based allergy immunotherapy using consensus allergens (CAs) to provide broad-spectrum protection against multiple allergens. Unlike conventional allergen immunotherapy (AIT), which targets single allergens and requires years of treatment, this approach aims to enhance efficacy, safety, and patient adherence by shortening treatment duration and reducing side effects.
Preliminary results show that CAs elicit cross-reactive antibodies against both food and pollen allergens without inducing allergen-specific IgE, making them a safer alternative to traditional treatments. In vitro studies further demonstrate that CAs promote Th1 polarization, shifting the immune response away from allergic inflammation.
To validate its effectiveness, AIDA is collaborating with Dr. Mayorga’s group at IBIMA (Malaga, Spain) to assess whether mRNA consensus allergens protect against anaphylaxis in an animal model. Larger preclinical and translational studies will follow to prepare for clinical trials and regulatory approval.
The project has also filed a patent covering Australia, the U.S. the EU, Canada, and Japan, with ongoing efforts to secure funding for IP protection and expand commercialization strategies. Engagement with regulatory agencies (EMA, FDA) is underway, and discussions with venture capital firms (Thia Ventures, Hummingbird, Reinforced Ventures) are progressing, with investments contingent on successful completion of the animal model validation.
AIDA is setting the stage for a next-generation allergy immunotherapy, with strong potential for scientific, clinical, and commercial impact in transforming allergy treatment.
Preliminary results show that CAs elicit cross-reactive antibodies against both food and pollen allergens without inducing allergen-specific IgE, making them a safer alternative to traditional treatments. In vitro studies further demonstrate that CAs promote Th1 polarization, shifting the immune response away from allergic inflammation.
To validate its effectiveness, AIDA is collaborating with Dr. Mayorga’s group at IBIMA (Malaga, Spain) to assess whether mRNA consensus allergens protect against anaphylaxis in an animal model. Larger preclinical and translational studies will follow to prepare for clinical trials and regulatory approval.
The project has also filed a patent covering Australia, the U.S. the EU, Canada, and Japan, with ongoing efforts to secure funding for IP protection and expand commercialization strategies. Engagement with regulatory agencies (EMA, FDA) is underway, and discussions with venture capital firms (Thia Ventures, Hummingbird, Reinforced Ventures) are progressing, with investments contingent on successful completion of the animal model validation.
AIDA is setting the stage for a next-generation allergy immunotherapy, with strong potential for scientific, clinical, and commercial impact in transforming allergy treatment.
The AIDA project successfully established proof of concept for a novel mRNA-based allergy immunotherapy using CAs to treat LTP-related allergies. A consensus allergen was computationally designed and optimized to enhance cross-reactivity across multiple LTP allergens while preserving key epitopes.
In vivo prophylactic assays were conducted to compare the immune response induced by the consensus allergen, Pru p 3, and Par j 2 in a mouse model. The results demonstrated that mice immunized with the consensus allergen developed broad-spectrum antibodies capable of binding allergens from both food and pollen sources, whereas Pru p 3 and Par j 2 immunizations produced antibodies specific to food and pollen allergens, respectively. Additionally, both mRNA and protein formulations of the consensus allergen induced a strong immune response.
To further validate these findings, an in vitro model using patient-derived samples was developed. Peripheral blood monocytes were successfully differentiated into dendritic cells (DCs) and treated with the mRNA-consensus allergen before co-culturing with autologous T cells. Preliminary results showed that T cells were polarized towards a Th1 response, rather than a Th2 allergic response, suggesting that the consensus allergen may reduce allergic inflammation and promote immune tolerance.
These findings highlight the potential of consensus allergen-based mRNA immunotherapy as a next-generation treatment for multiple allergies, offering broad protection, improved safety, and a reduction in IgE-mediated allergic responses.
In vivo prophylactic assays were conducted to compare the immune response induced by the consensus allergen, Pru p 3, and Par j 2 in a mouse model. The results demonstrated that mice immunized with the consensus allergen developed broad-spectrum antibodies capable of binding allergens from both food and pollen sources, whereas Pru p 3 and Par j 2 immunizations produced antibodies specific to food and pollen allergens, respectively. Additionally, both mRNA and protein formulations of the consensus allergen induced a strong immune response.
To further validate these findings, an in vitro model using patient-derived samples was developed. Peripheral blood monocytes were successfully differentiated into dendritic cells (DCs) and treated with the mRNA-consensus allergen before co-culturing with autologous T cells. Preliminary results showed that T cells were polarized towards a Th1 response, rather than a Th2 allergic response, suggesting that the consensus allergen may reduce allergic inflammation and promote immune tolerance.
These findings highlight the potential of consensus allergen-based mRNA immunotherapy as a next-generation treatment for multiple allergies, offering broad protection, improved safety, and a reduction in IgE-mediated allergic responses.
The AIDA project has introduced a novel mRNA-based allergy immunotherapy using consensus allergens (CAs) to address multiple allergies simultaneously. Unlike conventional allergen immunotherapy (AIT), which targets single allergens and requires long treatment durations, CAs provide broad-spectrum protection by inducing cross-reactive antibodies against both food and pollen allergens. Preliminary in vitro studies suggest that CAs promote Th1 polarization, shifting the immune response away from allergic inflammation, a key step toward long-term immune tolerance.
To validate these findings, preclinical testing is underway in collaboration with Dr. Mayorga’s group at IBIMA (Malaga, Spain), where the mRNA consensus allergen will be evaluated in an animal model of anaphylaxis to determine its protective effects. Further preclinical and clinical studies will be necessary to confirm its safety and efficacy, particularly in larger patient cohorts.
For successful market adoption, key steps include regulatory engagement, securing financial investment, and ensuring GMP-compliant production. The project has filed a patent, now in the national phase in Australia, the U.S. the EU, Canada, and Japan, with ongoing efforts to secure funding for IP protection. Engagement with regulatory agencies (EMA, FDA) is in progress, and discussions with venture capital firms are advancing to support the transition from preclinical research to clinical trials.
Future success will depend on further research, commercialization strategies, and industry partnerships to facilitate international market entry and standardization. By leveraging mRNA technology, AIDA has the potential to shorten treatment duration, improve safety, and enhance immune modulation, positioning itself as a next-generation allergy immunotherapy with scientific, clinical, and commercial impact.
In pursuit of funding, we are already in discussions with several venture capital (VC) firms, including Thia Ventures, Hummingbird, and Reinforced Ventures, all of which have expressed interest in our technology. These firms are ready to invest once we successfully complete the animal disease model, marking an important milestone in the commercial development of next-generation allergy immunotherapy.
To validate these findings, preclinical testing is underway in collaboration with Dr. Mayorga’s group at IBIMA (Malaga, Spain), where the mRNA consensus allergen will be evaluated in an animal model of anaphylaxis to determine its protective effects. Further preclinical and clinical studies will be necessary to confirm its safety and efficacy, particularly in larger patient cohorts.
For successful market adoption, key steps include regulatory engagement, securing financial investment, and ensuring GMP-compliant production. The project has filed a patent, now in the national phase in Australia, the U.S. the EU, Canada, and Japan, with ongoing efforts to secure funding for IP protection. Engagement with regulatory agencies (EMA, FDA) is in progress, and discussions with venture capital firms are advancing to support the transition from preclinical research to clinical trials.
Future success will depend on further research, commercialization strategies, and industry partnerships to facilitate international market entry and standardization. By leveraging mRNA technology, AIDA has the potential to shorten treatment duration, improve safety, and enhance immune modulation, positioning itself as a next-generation allergy immunotherapy with scientific, clinical, and commercial impact.
In pursuit of funding, we are already in discussions with several venture capital (VC) firms, including Thia Ventures, Hummingbird, and Reinforced Ventures, all of which have expressed interest in our technology. These firms are ready to invest once we successfully complete the animal disease model, marking an important milestone in the commercial development of next-generation allergy immunotherapy.