Unleashing the curative potential of cancer immunotherapy

Project Information

UNLEASHAD

Grant agreement ID: 811693

DOI

10.3030/811693

Project closed

EC signature date 1 June 2018

Start date 1 July 2018

End date 31 December 2021

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 2 528 750,00

EU contribution

€ 1 770 125,00

Coordinated by

TILT BIOTHERAPEUTICS OY
Finland

Periodic Reporting for period 3 - UNLEASHAD (Unleashing the curative potential of cancer immunotherapy)

Reporting period: 2020-07-01 to 2021-12-31

Summary of the context and overall objectives of the project

TILT Biotherapeutics is developing a breakthrough oncolytic immunotherapy treatment for cancer. Advanced solid tumors are currently incurable and limited treatment options are available – preclinical data on TILT technology suggests curative potential. There are 10 million people dying from cancer each year and the incidence is growing rapidly. New immunotherapies for cancer are more widely available in America than in Europe partly because clinical research concentration in the U.S. Cancer patients also in Europe are in the increasing need of new treatment options.

The objective of this project was to generate clinical data for the company’s lead product, TILT-123 alone or given with immune checkpoint inhibitors (ICI) in advanced solid tumors. From the business perspective, this project allowed the company to mature into a stage from where further development can be privately funded and supported by pharmaceutical industry. TILT Biotherapeutics is investing into further development of its pipeline projects, creating more employment and business locally in Finland and Europe, and to bringing an innovative treatment option with curative potential to the reach of European cancer 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

At the end of the Unleashad-project carried out by TILT Biotherapeutics, the company had translated its lead clinical agent TILT-123 to Phase I studies. In total, approximately 20 cancer patients were treated. The dose escalation progressed to the fourth dose level in the first-in-man study, and interim safety and mechanism of action data were generated. Manufacturing of TILT-123 continued throughout the project and an inventory of drug product was made available for clinical use in Europe, the U.S. and China. TILT Biotherapeutics established partnerships with Merck-Pfizer Alliance, Merck MSD, and Biotheus. TILT-123 product development, clinical trials, and collaborations continue beyond Unleashad-project. The estimated primary study completion dates for two trials conducted in the scope of the action are in 2022 and 2023.

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)

This project represented an important funding for TILT Biotherapeutics for Phase I clinical development and preparation for Phase II. The new therapy is expected to result in improved treatment responses in currently incurable treatment refractory patients with melanoma and other solid tumor types as well as to bring a new treatment with curative potential to the reach of European cancer patients. The project allowed the creation of more employment and business locally in Finland and Europe. The company entered into collaborations with three pharmaceutical companies and secured private funding required for later stage development and commercialization.

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