On October 31, 2024 TME Pharma N.V. (Euronext Growth Paris: ALTME), a clinical-stage biotechnology company focused on developing novel therapies for treatment of cancer by targeting the tumor microenvironment (TME), reported that it is awarded a non-refundable grant of €2.4 million from the KMU-innovativ funding program run by the German Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung, BMBF) (Press release, TME Pharma, OCT 31, 2024, View Source [SID1234647623]).
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The non-dilutive non-refundable funding will support TME Pharma’s planned Phase 2 randomized controlled study evaluating its lead asset, the CXCL12 inhibitor NOX-A12, for use in the treatment of aggressive adult brain cancer, glioblastoma. Funds will be disbursed after the relevant costs in the trial have been incurred. This grant complements other non-dilutive support worth approximately €5 million for study aspects that are out of the scope of the BMBF grant.
KMU-innovativ ("Innovative SMEs") is the leading funding program of the BMBF specifically designed to support small and medium-sized enterprises (SMEs) in Germany in the realization of innovative projects. The NOX-A12 Phase 2 study met the objectives of the KMU-innovativ Biomedicine program to strengthen the innovative power of SMEs in medical biotechnology and to promote the development of drugs in Germany that lead to the cure, alleviation or prevention of diseases.
"We are pleased that the scientific review by experts at the BMBF recognized the potential of our lead asset in the difficult-to-treat indication of aggressive adult brain cancer and are very grateful to the BMBF for this significant grant of financial support to TME Pharma’s trial," said Aram Mangasarian, CEO of TME Pharma. "The award of this grant is based on the robust study design of our upcoming Phase 2 trial, underpinned by the substantial clinical results NOX-A12 has already achieved showing extraordinary potential as a therapy for glioblastoma. The fact that this funding is non-dilutive is positive news for our existing shareholders. This complements other non-dilutive support TME has secured for different aspects of the trial that will also be provided once the trial has started."
In the Phase 2 study design, approved by the US Food and Drug Administration (FDA) and the German regulator, glioblastoma patients will be treated in five different arms that will address questions of dosing and assess the contribution of the NOX-A12 and bevacizumab components to the overall efficacy of the combination therapy. TME Pharma will be able to optimize late phase development by selecting the best performing treatment arm against standard of care. The Phase 2 results will serve as a basis for discussions with regulatory authorities on the design of the further development strategy, up to market approval, and for discussions with potential partners, such as pharmaceutical companies.