TME Pharma Receives US FDA Fast Track Designation for Lead Asset NOX-A12 in Brain Cancer

On April 2, 2024 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), reported that the US Food and Drug Administration (FDA) has granted Fast Track designation for NOX-A12 (olaptesed pegol), 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 (Press release, TME Pharma, APR 2, 2024, View Source [SID1234641726]).

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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 minimal dilutive effect on its shareholders, such as governmental grants or free supply of combination drugs. In addition to engaging with industry partners and specialized healthcare investors, TME Pharma will also explore the eligibility of NOX-A12-based therapy for compassionate use programs once sufficient Phase 2 data have been generated. 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’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 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 Pharma is aiming to initiate the new Phase 2 study as soon as the necessary resources from financial and industrial partners have been secured. TME Pharma is prioritizing discussions with partners willing to support the company over the long term and having their financial interests aligned with current stakeholders. While discussions are ongoing, and until longer-term agreements with partners are reached, TME Pharma is determined to keep operational costs low to extend the financial visibility as far as possible and increase the chance of success.

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 what TME Pharma believes to be 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. We now have a clear clinical development roadmap with which to take NOX-A12 forward in the treatment of glioblastoma and to support engagement with potential partners. We expect our new Phase 2 study will build on the unprecedented results of our GLORIA trial, which strengthens the potential of NOX-A12 to become the treatment option of choice for newly diagnosed chemotherapy-resistant glioblastoma. We look forward to working closely with the FDA as we advance NOX-A12 to market as quickly as possible for the benefit of patients suffering from this devastating and aggressive cancer for which there is extremely poor prognosis."