E!4854, REVOS-TCEA, NEOGAP Therapeutics AB

Purpose and goal:

The aim is to develop a novel high-throughput T-cell potency assay for the assessment of biological tumor killing activity of the cell-based advanced therapy medicinal product, personal Tumor Trained Leucocyte (pTTL) developed for treatment of solid cancer. Expected results and effects:

According to the regulatory guidance for cell products, the pTTL will require a suitable potency assay demonstrating its T cell potency, before entering pivotal clinical trials. We will with our partner Okomera develop a game-changing ex vivo rapid and effective tumor killing assay.The expected result of the project will be a simpel, smooth and robust system that accurately can predict the T cells killing effect on the tumor and thus allows Neogap to advance on it´s quest to market approval.

Approach and implementation:

A start-up meeting with Neogap and Okomera is planned to be held in Paris in March. We will then go through the goals of the various WPs in detail together. A review of various points that must and should be achieved will be documented and archived.

Financial reporting is given special weight. A point for discussion is to have a common view on reporting deviations, who does what, dates for meetings and reports, and how follow-up is done and by whom. This first meeting will be held in Paris and meetings between the companies will be held at regular intervals.