ForTra supports the legally conformant production of new pharmaceutical drug candidates under GMP conditions for direct use in first-in-human clinical trials. To this end, ForTra announced three million euros to be awarded in its call for proposals in August 2022. Following extensive scientific review and appraisal, five projects were approved and are being funded. Due to the extraordinarily positive response, a renewed call for proposals was carried out at the end of 2024. The applications submitted are presently being assessed.
The following projects were approved in 2022:
Production of Corallopyronin A clinical study material:
Prof. Dr. Achim Hoerauf, University Hospital Bonn; Prof. Dr. Karl Wagner, University of Bonn; Prof. Dr. Marc Stadler, Helmholtz Center, Brunswick
Corallopyronin A (CorA) is an antibiotic that is obtained biotechnologically from marine seabed bacteria. Its range of efficacy includes tropical diseases and multiresistant bacteria. For CorA to be effective as a capsule requires it to be embedded in edible polymers that improve solubility. Carrying out clinical testing and trials necessitates a certified production, which is being made possible by ForTra.
GMP production of a non-viral gene transfer vector for ROR1-specific CAR T cells and immunotherapy for ROR1+ tumors:
Prof. Dr. Michael Hudecek, University Hospital of Würzburg
The goal is the production of special genetic material required to establish a ROR1-CAR T cell therapy. Transfection of the genetic material enables T cells to detect the ROR1 protein on the cell surface of tumor cells and to kill them. Within the scope of the LION-1 study, patients with various cancerous diseases are intended to be treated by administring the modified T cells.
Nasal application of Staphylococcus lugdunensis toward eradication of Staphylococcus aureus – a first microbiome intervention study in humans – LuCa:
Prof. Dr. Andreas Peschel, Dr. Meral Esen, University of Tübingen
To prevent severe infections caused by methicillin-resistant Staphylococcus aureus (MRSA), a probiotic strain of bacteria has been developed that displaces MRSA from the nose, the natural habitat of MRSA. This “Staphylococcus lugdunensis” is intended to be studied on volunteers in terms of its effectiveness in order to avert long-term harmful infections in high-risk patients.
Production of autologous GMP-compliant T cells expressing a CSPG4-specific CAR for CSPG4 for clinical treatment of metastasized uveal melanoma:
Prof. Dr. Niels Schaft, Prof. Dr. Caroline Bosch-Voskens, University Hospital Erlangen
Many patients suffering from cancer are unable to generate T cells that effectively detect tumor cells. The technique of RNA electroporation enables the blueprint (RNA) for suitable, cancer-specific receptors to be introduced into T cells, which are subsequently able to kill cancer cells. The funding makes it possible to produce T cells for clinical application in patients with uveal melanoma.
Peptide warehouse for the development of personalized immunotherapies toward eliminating residual leukemic stem/progenitor cells in the case of acute myeloid leukemia (AML):
Prof. Dr. Juliane Walz, University of Tübingen and University Hospital Tübingen
Acute myeloid leukemia is the most frequent acute hematological malignancy occurring in adults. Following therapy, leukemic stem cells (LSCs) often remain which lead to a relapse of the disease. In this project a vaccine is now going to be produced and clinically tested that is supposed to align the immune system against these LSCs in a targeted manner. The intention is to distinctly improve the cure rate among patients as a result.
Call for Proposals can be found here. The funding application calender provides an overview.