Periodic Reporting for period 1 - TrojanDC (TrojanDC - A BREAKTHROUGH DEEP-TECH INNOVATION FOR CANCER IMMUNOTHERAPY)
Periodo di rendicontazione: 2023-07-01 al 2024-06-30
Cancer remains one of the major challenges to modern medicine affecting one-in-three people in Europe. Available immunotherapies are effective in a limited number of patients and often lose their efficacy due to heterogeneity and lack of tumor-antigen presentation. Despite these shortcomings, the global immune-oncology market is one of the fastest growing therapeutics markets. Large players like Merck, Pfizer, and Novartis have shown to be keen on acquisitions of high-potential technologies. There is thus an urgent need and high demand for innovative cost-effective immunotherapies consistently effective in a broader range of cancer patients.
Asgard Therapeutics is a pre-clinical start-up company developing innovative cancer immunotherapies based in in-vivo cell reprogramming. The company is led by the scientific co-founder and CEO Cristiana Pires who, together with her co-founders, pioneered direct reprogramming to induce antigen-presenting dendritic cells. Asgard raised a € 6M seed round of funding to generate proof-of-concept for its lead candidate TrojanDC, a paradigm-shifting immunotherapy that reprograms cancer cells into antigen-presenting dendritic cells, allowing the presentation of their tumor antigens to the immune system, thereby eliciting potent anti-cancer immunity. TrojanDC has the potential to overcome challenges with current immunotherapies by reinstating cancer immunogenicity. The Women TechEU grant will allow defining a clear roadmap for the IND-enabling studies and FIH clinical trials and creating a comprehensive business plan required to raise Series A funding in Q4 2023.
With strong proof-of-concept data already obtained, an exceptional team of high-performing scientists and a strong syndicate of seasoned VCs, Asgard Therapeutics is in a unique position to develop first-in-class cancer immunotherapy based in in-vivo reprogramming.
Asgard Therapeutics is a pre-clinical start-up company developing innovative cancer immunotherapies based in in-vivo cell reprogramming. The company is led by the scientific co-founder and CEO Cristiana Pires who, together with her co-founders, pioneered direct reprogramming to induce antigen-presenting dendritic cells. Asgard raised a € 6M seed round of funding to generate proof-of-concept for its lead candidate TrojanDC, a paradigm-shifting immunotherapy that reprograms cancer cells into antigen-presenting dendritic cells, allowing the presentation of their tumor antigens to the immune system, thereby eliciting potent anti-cancer immunity. TrojanDC has the potential to overcome challenges with current immunotherapies by reinstating cancer immunogenicity. The Women TechEU grant will allow defining a clear roadmap for the IND-enabling studies and FIH clinical trials and creating a comprehensive business plan required to raise Series A funding in Q4 2023.
With strong proof-of-concept data already obtained, an exceptional team of high-performing scientists and a strong syndicate of seasoned VCs, Asgard Therapeutics is in a unique position to develop first-in-class cancer immunotherapy based in in-vivo reprogramming.
1. Define a Clear Roadmap for Late Preclinical Development
We mapped and selected a CDMO partner for gene therapy product process development and manufacturing. Additionally, we established a robust, regulatory-compliant upstream and downstream process and planned engineering runs and GMP production to prepare for IND submission. In the realm of toxicology and pharmacokinetics, we designed studies based on FDA and EMA guidelines, conducted non-GLP and GLP studies to assess tolerability, biodistribution, and immunostimulation effects, and finalized a CRO partner after a comprehensive selection process. We also engaged early with regulatory agencies to align on non-clinical and clinical packages and planned for PRIME scheme and RMAT designation to expedite market entry.
2. Define a Roadmap for FIH Clinical Studies
We refined the clinical trial design in collaboration with Scientific Advisory Board members, resulting in a Phase I trial that includes dose escalation and expansion parts. The trial focuses on evaluating safety, tolerability, pharmacodynamics, and preliminary efficacy, with five dose levels planned and extensive pharmacodynamic investigations. The prioritized indications are microsatellite stable colorectal cancer (MSS-CRC) and head and neck squamous cell carcinoma (HNSCC) PD-L1 negative.
3. Update and Consolidate Business Plan in Preparation for Series A
We updated and consolidated the business plan, featuring a competitive analysis that demonstrated strong positioning in antigen presentation approaches and clinical indications. The unique advantages of TrojanDC over other immunotherapies and cancer vaccines were highlighted, along with its competitive edge in direct in vivo cell reprogramming for cancer immunotherapy.
4. Increase Our Partner Network
We utilized Women TechEU funds to identify and engage with potential investors and established relationships with other women entrepreneurs, leveraging Women TechEU network opportunities. These efforts successfully secured €30 million in Series A funding, ensuring financial support for continued development.
At the end of the project, we successfully achieved all milestones. We established a clear roadmap for late preclinical development, including process development, CDMO selection, IND-enabling studies, and a regulatory pathway. We defined the roadmap for First-in-Human (FIH) clinical trials, refined the trial synopsis, and drafted a detailed protocol, with the FIH clinical trial set to commence in Europe and plans for US expansion. We also completed a detailed business plan incorporating all project findings and an updated competitive landscape analysis. Most importantly, these achievements culminated in the successful €30 million Series A fundraising, significantly supporting continued development and progress.
We mapped and selected a CDMO partner for gene therapy product process development and manufacturing. Additionally, we established a robust, regulatory-compliant upstream and downstream process and planned engineering runs and GMP production to prepare for IND submission. In the realm of toxicology and pharmacokinetics, we designed studies based on FDA and EMA guidelines, conducted non-GLP and GLP studies to assess tolerability, biodistribution, and immunostimulation effects, and finalized a CRO partner after a comprehensive selection process. We also engaged early with regulatory agencies to align on non-clinical and clinical packages and planned for PRIME scheme and RMAT designation to expedite market entry.
2. Define a Roadmap for FIH Clinical Studies
We refined the clinical trial design in collaboration with Scientific Advisory Board members, resulting in a Phase I trial that includes dose escalation and expansion parts. The trial focuses on evaluating safety, tolerability, pharmacodynamics, and preliminary efficacy, with five dose levels planned and extensive pharmacodynamic investigations. The prioritized indications are microsatellite stable colorectal cancer (MSS-CRC) and head and neck squamous cell carcinoma (HNSCC) PD-L1 negative.
3. Update and Consolidate Business Plan in Preparation for Series A
We updated and consolidated the business plan, featuring a competitive analysis that demonstrated strong positioning in antigen presentation approaches and clinical indications. The unique advantages of TrojanDC over other immunotherapies and cancer vaccines were highlighted, along with its competitive edge in direct in vivo cell reprogramming for cancer immunotherapy.
4. Increase Our Partner Network
We utilized Women TechEU funds to identify and engage with potential investors and established relationships with other women entrepreneurs, leveraging Women TechEU network opportunities. These efforts successfully secured €30 million in Series A funding, ensuring financial support for continued development.
At the end of the project, we successfully achieved all milestones. We established a clear roadmap for late preclinical development, including process development, CDMO selection, IND-enabling studies, and a regulatory pathway. We defined the roadmap for First-in-Human (FIH) clinical trials, refined the trial synopsis, and drafted a detailed protocol, with the FIH clinical trial set to commence in Europe and plans for US expansion. We also completed a detailed business plan incorporating all project findings and an updated competitive landscape analysis. Most importantly, these achievements culminated in the successful €30 million Series A fundraising, significantly supporting continued development and progress.
The project's innovative approach and outcomes hold significant potential to advance the field of gene therapy and cancer immunotherapy. The key impacts include: enhanced efficacy of cancer treatments; accelerated drug development, and strengthened competitive position.
To ensure the continued success and uptake of these innovative outcomes, continued progression through preclinical to Phase I clinical trials, followed by Phase II and III, is essential to validate safety, efficacy, and overall benefit.
The project has successfully achieved several groundbreaking results in terms of preclincial development, regulatory and clinical strategy as well as business plan. These accomplishments lay a solid foundation for the continued development and eventual commercialisation of TrojanDC, positioning it to make a significant impact on the field of cancer immunotherapy.
To ensure the continued success and uptake of these innovative outcomes, continued progression through preclinical to Phase I clinical trials, followed by Phase II and III, is essential to validate safety, efficacy, and overall benefit.
The project has successfully achieved several groundbreaking results in terms of preclincial development, regulatory and clinical strategy as well as business plan. These accomplishments lay a solid foundation for the continued development and eventual commercialisation of TrojanDC, positioning it to make a significant impact on the field of cancer immunotherapy.