Adoptive T cell therapy utilizing high-precision neoantigen targeting is a promising concept for the treatment of solid tumors. NEOGAP has developed a personalised adoptive T cell therapy for treating solid tumours based on two proprietary technologies: PIOR® machine learning software and EpiTCer®. PIOR® is used to identify tumour-specific mutations that give rise to neoantigens, i.e. proteins exclusively expressed in the tumour, and to select and design neoantigens that can be targeted by T cells. EpiTCer® enables efficient delivery of neoantigens and activation of neoantigen specific T cells. Our cancer immunotherapy consists of personalised Tumour Trained Lymphocytes (pTTL), which are autologous T-cells harvested from regional lymph nodes (RLN). During the pTTL production process, neoantigen-driven T-cell expansion of RLN cells is obtained in the context of EpiTCer, generating a T cell product harbouring highly tumour-reactive T-cell clones. pTTL is re-infused to the patient where they infiltrate tumours and kill cancer cells, leaving healthy cells untouched. The therapy is broadly applicable to many cancer types, including solid tumours where current cancer immunotherapy is less effective due to lack of immune cellinfiltration to the tumour. Thus pTTL can potentially be applied in cancers with a high unmet medical need. A phase I/IIa First in Human (FIH) clinical trial of pTTL in advanced, Stage IV, colorectal cancer (CRC) patients is ongoing. The primary objective of the trial is to show safety and tolerability of pTTL. Secondary, efficacy parameters like objective response, overall survival, and progression-free survival will be assessed and biomarkers will be explored for signs of afficacy.
In this EIC accelerator project, NEOpTTL, we plan to complete the phase I/IIa clinical trial of the therapy, to optimise the pTTL manufacturing process for the next clinical trials and to establish a development strategy to marketing approval of pTTL.