Descrizione del progetto
Vaccino personalizzato contro il cancro
I vaccini con neoantigeni del cancro sviluppati contro i peptidi presenti solo sulla superficie delle cellule tumorali rappresentano un nuovo approccio di medicina di precisione diretto contro i tumori in fase avanzata o metastatici. In precedenza, Takis aveva sviluppato e brevettato un metodo per la produzione di un vaccino con neoantigeni del cancro basato sul DNA specifico del paziente, con erogazione attraverso un’esclusiva tecnologia di elettroporazione. Gli studi preclinici hanno dimostrato la totale eliminazione del carcinoma polmonare umano in un modello murino umanizzato entro 60 giorni dal trattamento. Questo progetto TK-NEO, finanziato dall’UE, è volto a convalidare la fattibilità e il processo di autorizzazione per i test futuri, determinare i costi e confermare gli investimenti necessari per l’ulteriore sviluppo clinico e la commercializzazione.
Obiettivo
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.
Campo scientifico
- 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
Programma(i)
Argomento(i)
Invito a presentare proposte
Vedi altri progetti per questo bandoBando secondario
H2020-SMEInst-2018-2020-1
Meccanismo di finanziamento
SME-1 - SME instrument phase 1Coordinatore
00128 Roma
Italia
L’organizzazione si è definita una PMI (piccola e media impresa) al momento della firma dell’accordo di sovvenzione.