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 effects and result

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.

Planned 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.