Business Wire
TME Pharma Announces Strategic Plan to Externalize and Monetize Second Clinical Stage Asset NOX-E36
Business Wire
6 min read

In This Article:

  • NOX-E36 presents promising opportunity for development in eye diseases with a high need for well-tolerated therapies with anti-fibrotic effect

  • Anti-fibrotic mode of action of NOX-E36 was demonstrated in preclinical eye disease model performed by leading Singapore Eye Research Institute

  • Preclinical, clinical data and available drug supply lay optimal framework for rapid path to Phase 2 clinical proof-of-concept

  • TME Pharma plans to enable separate corporate entity focused on NOX-E36 in ophthalmology to monetize the program and mobilize private investor support

BERLIN, July 22, 2024--(BUSINESS WIRE)--Regulatory News:

TME Pharma N.V. (Euronext Growth Paris: ALTME), a clinical-stage biotechnology company focused on developing novel therapies for treatment of cancer by targeting the tumor microenvironment (TME), announces its plan to externalize and monetize the company's second clinical stage asset NOX-E36 – an L-stereoisomer RNA aptamer inhibiting the CCL2 chemokine. This decision leverages the compound’s potential, as shown by clinical and preclinical data, to safely address significant unmet medical needs in ophthalmic diseases impacted by fibrosis.

The presence of the target of NOX-E36, CCL2, has been shown to predict early failure of glaucoma surgical intervention in patients and inhibition of the pathway targeted by NOX-E36 in preclinical models of glaucoma surgery prevents fibrosis thereby prolonging the success of the intervention1. NOX-E36 has already been administered to 175 clinical trial participants with an excellent safety and tolerability profile and showing activity on its target, already derisking a number of steps in early clinical development.

Fibrosis is a significant cause of treatment failure or increased severity in many clinically important eye diseases2 with unmet needs such as diabetic retinopathy (9.6 million cases in the US, of which 1.84 million vision-threatening3), age-related macular degeneration (20 million cases in the US, of which 1.5 million vision-threatening4), and primary open angle glaucoma (>3 million cases in the US5).

"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. 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."

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