Define a lead candidate for clinical development of a novel T cell therapy

Project Information

T2Lead

Grant agreement ID: 101100460

DOI

10.3030/101100460

Project closed

EC signature date 13 March 2023

Start date 1 September 2023

End date 28 February 2025

Funded under

• European Research Council (ERC)

Total cost

No data

EU contribution

€ 150 000,00

Coordinated by

LUDWIG-MAXIMILIANS-UNIVERSITAET MUENCHEN
Germany

Periodic Reporting for period 1 - T2Lead (Define a lead candidate for clinical development of a novel T cell therapy)

Reporting period: 2023-09-01 to 2025-02-28

Summary of the context and overall objectives of the project

Patients suffering from Acute myeloid leukemia (AML) have a dismal outcome when relapsing or progressing after initial therapy. Unlike other hematological malignancies, cellular therapies such as chimeric antigen receptor (CAR) engineered T cells could not demonstrate efficacy in this disease. A major cause of such lack of efficacy is the difficulty for CAR T cells so far to differentiate between healthy and cancer cells in AML patients, thus narrowing the therapeutic window of such therapies. In preliminary work, we could identify and demonstrate preclinical activity of novel AML-directed CAR T cells. The purpose of T2LEAD was now to identify, generate and test a CAR, which could then be further developped towards clinical testing. T2LEAD was successfull in identifying such promissing candidate, which we are currently continuing to develop and are seeking further funding thereto. Ultimately if successfull this concept could bring an innovative treatment to AML patients.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

T2LEAD generated and tested new CAR against a proprietary target for AML. We successfully expressed these in primary human T cells and tested these in a variety of models. We could define a lead candidate for further development and testing, which is free of third party rights and would thus grant us freedom to operate. We have applied for further funding and defined a potential IP and business strategy for further development.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

As outlined above, we could define a CAR lead candidate for further development. This is critical to be able to advance our strategy to further valorisation and clinical testing. Subsequent steps will include funding for regulatory development, safety requirements defined by regulators, pre-GMP-testing, process development, GMP upscale and funding for a clinical study. Depending whether this is managed in a spin out, a licence or directly from hospital, requirements will differ. Ultimately, our study may bring an innovative product to AML-patients in need.