TME Pharma gets FDA Fast Track for Glioblastoma

TME Pharma N.V. with research sites in France and Germany (listed at Euronext Growth Paris: ALTME) is developing novel therapies for treatment of cancer by targeting the tumor microenvironment (TME) with their sepcial chemical compounds (spiegelmere) which are particularly stable. The company announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for NOX-A12 (olaptesed pegol). This is TME Pharma’s CXCL12 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.

CXCL12 is an intravenously administered, PEGylated L-stereoisomer RNA aptamer that targets CXCL12 (C-X-C Chemokine Ligand 12), a key chemokine (signaling) protein. 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.
 
Recently announced clearance by the FDA of TME Pharma’s Investigational 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 prerequisite 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 this 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.
 
TME Pharma’s latest regulatory milestones were supported by recent survival data from the GLORIA Phase 1/2 study in which NOX-A12 demonstrated an unprecedented median Overall Survival of 19.9 months in chemotherapy resistant patients with residual tumor after surgery, which compared very favorably to a matched standard of care reference cohort and exceeds all relevant competitor therapy trials in newly diagnosed glioblastoma patients resistant to standard chemotherapy.

“At the start of this year, we announced the next phase of our development of NOX-A12 by targeting IND approval and an expedited regulatory pathway in the US and we are very proud to have successfully achieved these milestones within the timeframe we set out,” said Aram Mangasarian, CEO of TME Pharma. “While advancing discussions with potential industrial and financial partners may require some time to materialize, the open IND and Fast Track designation awarded by the FDA are well-received signals by these partners.”