TME Pharma Announces FDA Clearance of Investigational New Drug (IND) Application for NOX-A12 Phase 2 Trial in Brain Cancer

Regulatory News:

TME Pharma N.V. (Euronext Growth Paris: ALTME), a biotechnology company focused on developing novel therapies for treatment of cancer by targeting the tumor microenvironment (TME), announces that the US Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND)¹ application for NOX-A12, TME Pharma's CXCL12 inhibitor, for use in the treatment of aggressive adult brain cancer, glioblastoma.

With the IND now open at the FDA, TME Pharma plans 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.

"Receiving approval of the FDA for the design of our Phase 2 clinical trial in glioblastoma provides a clear roadmap to potential industrial partners and investors on the next steps in clinical development. The discussions with the FDA have been constructive and have allowed us to design a robust Phase 2 that should provide us with solid evidence of the highly differentiated profile of NOX-A12 in combination with bevacizumab in newly diagnosed, chemotherapy-resistant glioblastoma patients. The open IND will also allow us to expand our clinical development into the US, where we expect to generate significant interest in the medical community," said Aram Mangasarian, CEO of TME Pharma. "We also expect to receive the FDA’s decision regarding Fast-Track Designation for NOX-A12 in glioblastoma in the next few weeks, which can further strengthen our regulatory position in the US and should help us in the search for industrial and financial partners who can assist TME Pharma in bringing NOX-A12 to patients in the quickest way possible."

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 Pharma has 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.