Development of an in-body cell therapy treatment using nanoparticles

ImmTune Therapies is developing a revolutionary new method of immune cell therapy, whereby patients' cells can be genetically modified inside their bodies to endow them with cancer-fighting properties. Our first focus is in CD19 Chimeric Antigen Receptor (CAR) T-cell therapy, a game-changing cancer treatment where patient's immune cells are modified to express a CAR, which directs them towards a molecule named CD19, which is expressed on cancer cells in many types of B-cell lymphoma. Our product is a targeted nanoparticle gene-delivery technology, called NanoCART-19, designed to deliver CARs to T-cells in the body.

Our groundbreaking method will offer major advantages over current and developing CAR-T technologies, which rely on manufacturing the CAR-T cells outside the body. The currently approved process causes the treatments to cost \>£250,000pp and take 6-8 weeks to reach patients, which renders over 75% of NHS patients in need ineligible to receive therapy. With our method, treatment can become as quick as a **one-step off-the-shelf injection**, and **5-10 fold cheaper**, allowing treatment of **many more patients** and **lowering the burden** on healthcare systems such as the NHS.

Our **rigorous customer discovery** (over a 12-month period) has highlighted the significant market desire for such a technology, from **pharmaceutical to medical professionals**. However, a robust demonstration of the capability of our technology is needed to secure investment and accelerate development.

This project will demonstrate the potential of NanoCART-19 in treating B-cell lymphomas, by experimental validation in preclinical models and will compare CAR-T cells generated by NanoCART-19, to those currently used in the clinic. We will also build a supporting case to take this innovative method of cell therapy into humans for the first time, by engaging with regulatory bodies, investigating manufacturing scale-up and GMP compliance and working to position NanoCART-19 in the rapidly developing CAR-T market.

ImmTune has gathered an **expert team** to deliver this ambitious project, including the **Cell and Gene Therapy Catapult** and **Dr Robert Koechl from King's College London**. The successful completion of this collaboration will drive ImmTune's product **towards the clinic and stimulate growth and investment,** allowing CAR-T therapy to benefit more patients in urgent need.

Today, we are closer than ever to creating cancer treatments that don't just treat patients but can actually cure them, in a single treatment. ImmTune's technology is designed to make these cures available to many more patients who need them, **democratising cell therapy and opening new markets**.