Non-clinical risk assessment and strategy for ImmTune Therapies’ NanoCART-19 in vivo CAR-T cell therapy

The Challenge: To perform a non-clinical risk assessment of ImmTune Therapies’ novel in vivo CAR-T cell therapy and to develop a strategy to ensure effective translation of the novel therapy from the preclinical stage to clinical trials.


Enabled with IUK EDGE funding, we provided ImmTune Therapies with a non-clinical strategy, scientific and regulatory advice, and recommendations on pivotal non-clinical studies.


This support provided ImmTune Therapies with a clear understanding of the potential non-clinical risks in addition to a strategy to overcome these risks.

An improved understanding of the regulatory landscape along with the non-clinical risk assessment developed, helped ImmTune Therapies plan their strategy going forward to continue developing this novel in vivo gene therapy.