TME Pharma N.V. announced that the US Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND)1 application for NOX-A12, TME Pharma'sCXCL12 inhibitor, for use in the treatment of aggressive adult brain cancer, glioblastoma. With the IND now open at the FDA, TME Pharmaplans to proceed with the continued clinical development of NOX-A12 in a Phase 2 randomized controlled study in approximately 100 newly diagnosed, chemotherapy-resistant glioblastoma patients having residual measurable tumor remaining after surgery. The study is expected to be initiated later this year, starting first in Europe, once the necessary resources and preparations are in place.

Sufficient NOX-A12 clinical grade material has already been manufactured to initiate the study. The study will address questions of dosing and contribution of components ? NOX-A12 and bevacizumab ?

to overall efficacy of the combination therapy and will allow TME Pharma to optimize late phase development by testing multiple doses of NOX-A12 with bevacizumab in a patient population that is also randomized to standard of care. Together with the IND submission TME Pharmahas also submitted a Fast-Track Designation2 request to the FDA to secure an expedited regulatory pathway for NOX-A12 in glioblastoma and the company expects to receive the FDA's decision before the end of March 2024. Based on discussions with the FDA last year and further interaction during the IND application process, the FDA-approved study design includes five arms, with 20 patients per arm: Arm 1: NOX-A12 - 200mg/week + radiotherapy and bevacizumab, Arm 2: NOX-A12 - 400mg/week + radiotherapy and bevacizumab, Arm 3: NOX-A12 - 600mg/week + radiotherapy and bevacizumab, Arm 4: NOX-A12 - 600mg/week + radiotherapy and Arm 5: Standard of Care control (temozolomide + radiotherapy).

TME Pharma'sregulatory interactions were supported by recent survival data from the GLORIA Phase 1/2 study in which NOX-A12 demonstrated an unprecedented median Overall Survival (mOS) of 19.9 months in combination with bevacizumab and radiotherapy in glioblastoma patients with measurable chemotherapy-resistant residual tumors after surgery. This survival rate compares very favorably to a matched standard of care reference cohort, which achieved an mOS of approx. 10 months, and exceeds what TME Pharmabelieves to be all relevant competitor therapy trials in newly diagnosed glioblastoma patients resistant to standard chemotherapy.