TME Pharma N.V. announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for NOX-A12 (olaptesed pegol), TME Pharma'sCXCL12 inhibitor, in combination with radiotherapy and bevacizumab for use in the treatment of the aggressive adult brain cancer, glioblastoma, in the newly diagnosed setting where the tumor is resistant to chemotherapy and measurable tumor remains after surgery. The FDA's Fast Track designation aims to bring important new drugs to patients more quickly, facilitating the development and expediting the review of therapies intended to treat serious conditions and address unmet medical needs. Companies whose programs are granted Fast Track designation can benefit from more frequent interactions with the FDA during the clinical development process and potentially "accelerated approval" and "priority review" if the relevant criteria are met.

TME Pharma continuously evaluates ways to advance the clinical development of NOX-A12 while remaining focused on identifying and securing financial resources from multiple sources, including those having no or minimalutive effect on its shareholders, such as governmental grants or free supply of combination drugs. The company would prioritize such programs that support financial compensation for therapies leading to revenue generation, thus potentially reducing the financial needs of late-stage clinical development and also helping to generate real-world clinical evidence. Recently announced clearance by the FDA of TME Pharma'sInvestigational New Drug (IND) application for a Phase 2 study with NOX-A12 in glioblastoma, that the company plans to initiate later this year, was a pre requisite to having Fast Track designation granted by the FDA.

Having Fast Track designation in addition to an open IND with an FDA-approved study design that addresses questions of dosing and contribution of components optimizes late phase development and offers an economically efficient model which further de-risks TME Pharma's glioblastoma program. Following IND approval, this Fast Track designation is an external validation of NOX-A12's potential to address the unmet need for glioblastoma patients. The necessary preparatory steps for the NOX-A12 Phase 2 in glioblastoma are ongoing, and TME Pharmais aiming to initiate the new Phase 2 study as soon as the necessary resources from financial and industrial partners have been secured.