Project description
Personalised cancer vaccine
Neoantigen cancer vaccines developed against peptides found only on the surface of cancer cells represent a novel precision medicine approach directed against advanced or metastatic cancers. Takis had previously developed and patented a method for the production of patient-specific DNA-based neoantigen cancer vaccine with delivery through an exclusive electroporation technology. The pre-clinical studies demonstrated total elimination of human lung cancer in a humanised mouse model within 60 days of treatment. This EU-funded TK-NEO project aims to validate the feasibility and the authorisation process for future tests, and determine the cost and confirm investments required for further clinical development and commercialisation.
Objective
TK-NEO is a DNA-based Neoantigen Cancer Vaccine (NCV), for use as therapeutic vaccination in patients with locally advanced or metastatic solid tumours. NCVs are a new form of precision medicine and are a perfect clinical approach for highly heterogeneous tumors in patients with metastatic disease. Takis has developed and patented a unique method for production of patient-specific NCVs based on a 6-week process, from sequencing the specific tumour DNA, synthesis of the right DNA sequence for the specific tumour, delivery through a specific Electroporation (EP) technology used under exclusive license. The solution was proven at pre-clinical stage to reduce to zero a human lung cancer in humanized mice in 60 days and to increase the efficacy several fold with respect to alternative RNA and DNA based NCVs in protecting relapse and boosting immune responses as required for the maintenance of long-term anti-tumor immunity.
The strategy to reach the market for TK-NEO is to license the IP of TK-NEO to a large pharma company, after completion of clinical validation trials to demonstrate the applicability and safety of the approach: phase I clinical trials in melanoma are targeted during SME Instrument project, while implementation of a GMP manufacturing to carry out phase II clinical trials and the implementation of the trials will require additional 5M investment. The Total Available Market is constituted by melanoma patients who underwent surgery and first chemotherapeutic treatment, who are estimated in the order of 30.000 patients per year combining EU and US.
The objectives of the feasibility study are: 1) to validate the feasibility and the authorization process for the release tests, 2) to confirm investment, cost and pricing for TK-NEO, 3) to define a MoU with VC or with the final client (pharma) for the co-financing of the clinical development of customized TK-NEO and for future licensing.
Fields of science
- natural sciencesbiological sciencesgeneticsDNA
- medical and health sciencesclinical medicineoncologylung cancer
- medical and health sciencesclinical medicineoncologyskin cancermelanoma
- medical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugsvaccines
- medical and health sciencesbasic medicineimmunologyimmunotherapy
Programme(s)
Funding Scheme
SME-1 - SME instrument phase 1Coordinator
00128 Roma
Italy
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.