The project is carried out in collaboration between Neomatrix srl (Coordinator), Sapienza S. Andrea University and IRCCS Regina Elena National Cancer Institute.

The development of new precision cancer therapies based on advanced technologies such as genomics offers new therapeutic perspectives. The information thus acquired is used to generate a personalized vaccine that can educate the patient's immune system to recognize the tumor and fight it.

This is an interactive process that generates an evolution of the tumor also subjected to the selective pressure of the different pharmacological therapies. A critical point in the design of a personalized vaccine is to be able to intercept the evolutionary trajectories of the tumor in order to incorporate those relevant mutations into the vaccine therapy. To answer this question, liquid biopsy can be used, which studies tumor mutations in peripheral blood.

The collaboration of the biotech company Neomatrix srl with IFO-IRE and Sapienza aims to develop a vaccine based on synthetic DNA that incorporates liquid biopsy into the prediction algorithm of tumor targets. The main objectives of the project are two:

1. Characterize synthetic DNA-based vaccines in order to produce the data necessary for EMA authorization for phase I-II clinical trials. The studies will be divided into basic studies such as the analysis of the quality and quantity of immune responses induced by synthetic DNA compared to that induced by classical plasmid DNAs and their antitumor effects. While regulatory studies will be carried out in a GLP environment in collaboration with external CROs. These studies will be the subject of the documents (IMPD and IB) necessary to obtain EMA authorisation for the phase I-II clinical trial.
2. Evaluation of the feasibility in the clinical context of the vaccine generation process using liquid biopsy. This goal is actually twofold, it pertains to the feasibility of the process in the real world of the clinic and involves improving the accuracy of the vaccine by incorporating information from the liquid biopsy.

In the field of genetic vaccines, the project aims to bring to the clinic an innovative system based on the use of linear synthetic DNA in the clinic, with the production of a personalized vaccine that will be patented. The results of the project will be the subject of one or more scientific publications aimed at demonstrating the feasibility of the personalized vaccine and identifying the evolutionary trajectories of neoantigens during different anticancer therapies.