TME Pharma Announces Strategic Plan to Externalize and Monetize Second Clinical Stage Asset NOX-E36

• 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--(BUSINESS WIRE)--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).

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¹ Chong (2017) Invest Ophthalmol Vis Sci 58:3432 & Chong (2010) Ophthalmology 117:2353

² Sorenson (2024) Frontiers in Ophthalmology 2024 Vol. 4

³ Lundeen (2023) JAMA Ophthalmol. 2023;141(8):747-754

⁴ Rein (2022) JAMA Ophthalmol. 2022;140(12):1202-1208

⁵ US National Eye Institute Glaucoma Tables, Link