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.
