TME Pharma to Monetize Second Clinical Stage Asset NOX-E36

TME Pharma N.V., a biotechnology firm at the clinical stage, is dedicated to innovating cancer treatments by targeting the tumor microenvironment (TME). The company has unveiled its strategy to outsource and capitalize on its second clinical-stage asset, NOX-E36. This L-stereoisomer RNA aptamer, which inhibits the CCL2 chemokine, has demonstrated through clinical and preclinical studies its safe and effective potential to meet critical medical needs in ophthalmic diseases influenced by fibrosis.

Studies have identified the presence of CCL2, the target of NOX-E36, as a predictor of early failure in glaucoma surgeries. In preclinical glaucoma surgery models, inhibiting the pathway targeted by NOX-E36 has shown to prevent fibrosis and extend the success of these interventions. NOX-E36 has already been administered to 175 clinical trial participants, demonstrating excellent safety, tolerability, and activity on its target, thus reducing the risks in early clinical development.

Fibrosis is a major factor in the failure or increased severity of various critical eye diseases with unmet needs, such as diabetic retinopathy (9.6 million cases in the US, with 1.84 million vision-threatening), age-related macular degeneration (20 million cases in the US, with 1.5 million vision-threatening), and primary open-angle glaucoma (over 3 million cases in the US).

Aram Mangasarian, CEO of TME Pharma, said in a statement, “Our discussions with glaucoma clinicians revealed there is an unmet need for well-tolerated therapies with an anti-fibrotic effect to safely reduce scarring following eye surgery and provide patients with long-term benefit and that this indication could provide a rapid path to regulatory approval," said Aram Mangasarian, CEO of TME Pharma. We have already established NOX-E36's activity on its biological target and demonstrated its excellent safety and tolerability profile in patients, offering us a promising opportunity for rapid advancement in the ophthalmology space and an upside potential for the company's valuation.

He further added, “Since we have sufficient drug supply for initial clinical trials, we are currently working with ophthalmology experts to lay the framework to generate proof-of-concept clinical data at limited cost for the company that could unlock significant business opportunities. Given the successful track record of two other RNA aptamers being approved for use in ophthalmology and the substantial partnerships formed in this space such as the $5.9 billion Astellas acquisition of Iveric primarily for the RNA aptamer now known as Izervay6, we are confident in NOX-E36's potential to attract interest. While TME Pharma will continue its focus on oncology, our goal is to create a new entity with full rights to develop NOX-E36 in ophthalmology supported by private investors. We expect to provide updates on these activities before the end of this year.”