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

NOX-E36 presents a promising development opportunity in ocular diseases with a high need for well-tolerated therapies with an antifibrotic effect
The antifibrotic mode of action of NOX-E36 was demonstrated in a preclinical ocular disease model conducted by the leading Eye Research Institute in Singapore
Preclinical and clinical data and available drug supply provide the optimal framework for a rapid transition to Phase 2 clinical proof of concept
TME Pharma plans to allow a separate commercial entity focused on NOX-E36 in ophthalmology to monetize the program and mobilize support from private investors

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

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

The presence of the NOX-E36 target, CCL2, has been shown to predict early failure of glaucoma surgery in patients and inhibition of the NOX-E36-targeted pathway in preclinical models of glaucoma surgery prevents fibrosis, thereby prolonging operative success.¹NOX-E36 has already been administered to 175 participants in clinical trials with an excellent safety and tolerability profile and showing activity on its target, already reducing a number of steps in early clinical development.

Fibrosis is an important cause of treatment failure or increased severity in many clinically important ocular diseases² with unmet needs such as diabetic retinopathy (9.6 million cases in the United States, including 1.84 million vision-threatening)³), age-related macular degeneration (20 million cases in the United States, 1.5 million of which are vision-threatening)⁴) and primary open-angle glaucoma (> 3 million cases in the United States⁵).

“Our discussions with glaucoma clinicians revealed that there is an unmet need for well-tolerated therapies with an antifibrotic effect to safely reduce scarring after ocular surgery and provide patients with long-term benefit and that this indication could provide a fast track to regulatory approval,” said Aram Mangasarian, CEO of TME Pharma. “We have already established the activity of NOX-E36 on its biological target and demonstrated its excellent safety and tolerability profile in patients, which provides us with a promising opportunity for rapid progress in the ophthalmology field and the potential for upside valuation of the company. As we have sufficient supply of drug for initial clinical trials, we are currently working with ophthalmology experts to establish the framework to generate proof-of-concept clinical data at a limited cost to the company, which could open up significant commercial opportunities. Given the success of two other RNA aptamers approved for use in ophthalmology and the substantial partnerships formed in this area, such as Astellas’ acquisition of Iveric for $5.9 billion, primarily for the RNA aptamer now known as Izervay,⁶We are confident in the potential of NOX-E36 to generate interest. TME Pharma “We will continue our efforts in 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 updated information on these activities before the end of this year.”

About TME Pharma

TME Pharma is a clinical-stage company focused on developing novel therapies for the treatment of the most aggressive cancers. The Company’s oncology-focused pipeline is designed to address the tumor microenvironment (TME) and the cancer immune cycle by disrupting tumor protection barriers against the immune system and blocking tumor repair. By neutralizing chemokines in the TME, TME Pharmaceutical This approach works in combination with other forms of treatment to weaken tumor defenses and enable greater therapeutic impact. In the phase 1/2 GLORIA clinical trial, TME Pharma is studying its lead drug candidate, NOX-A12, in patients recently diagnosed with brain cancer who will not clinically benefit from standard chemotherapy. TME Pharma provided top-line data from the three dose-escalation cohorts of NOX-A12 plus radiation therapy in the GLORIA clinical trial, observing consistent tumor reductions and objective tumor responses. In addition, the GLORIA expansion groups are evaluating the safety and efficacy of NOX-A12 in other combinations where interim results from the triple combination of NOX-A12, radiation therapy, and bevacizumab suggest even deeper and more durable responses and improved survival. The U.S. FDA has approved the design of a randomized Phase 2 trial in glioblastoma and TME Pharma The FDA has granted NOX-A12 orphan drug designation (ODD) in combination with radiation therapy and bevacizumab for the treatment of glioblastoma, an aggressive brain cancer in adults. NOX-A12 in combination with radiation therapy was also previously granted orphan drug designation (ODD) for glioblastoma in the United States and glioma in Europe. TME Pharma delivered top-line data with an encouraging overall survival and safety profile from its NOX-A12 combination trial with Keytruda® in patients with metastatic colorectal and pancreatic cancer, which were published in the Journal for ImmunoTherapy of Cancer in October 2021. The Company entered into its second collaboration with MSD/Merck for its Phase 2 study, OPTIMUS, to further evaluate the safety and efficacy of NOX-A12 in combination with Merck’s Keytruda® and two different chemotherapy regimens as second-line treatment in patients with metastatic pancreatic cancer. The trial design has been approved in France, Spain and the United States. The Company’s second clinical-stage drug candidate, NOX-E36, is designed to target the innate immune system. TME Pharma is investigating several solid tumors for further clinical development. For more information, visit: www.tmepharma.com.

TME Pharma® and the TME Pharma logo are registered trademarks.

Keytruda® is a registered trademark of Merck Sharp & Dohme Corp.

Visit TME Pharma on LinkedIn and X.

About the GLORIA study

GLORIA (NCT04121455) is TME Pharmaceutical Phase 1/2 dose-escalation study of NOX-A12 in combination with radiation therapy in patients with first-line partially resected or unresected glioblastoma (brain cancer) with unmethylated MGMT promoter (resistant to standard chemotherapy). GLORIA is also evaluating the safety and efficacy of NOX-A12 in three additional arms combining NOX-A12 with: A. radiation therapy in patients with complete tumor resection; B. radiation therapy and bevacizumab; and C. radiation therapy and pembrolizumab.

About the OPTIMUS study

OPTIMUS (NCT04901741) is TME Pharmaceutical A planned, open-label, two-arm phase 2 study of NOX-A12 in combination with pembrolizumab and nanoliposomal irinotecan/5-FU/leucovorin or gemcitabine/nab-paclitaxel in patients with microsatellite-stable metastatic pancreatic cancer.

Disclaimer

Translations of any press release into languages other than English are intended solely for the convenience of non-English speaking audiences. The Company has attempted to provide an accurate translation of the original English text, but due to the nuances of translation into another language, slight differences may exist. This press release includes certain information that contains “forward-looking statements.” Forward-looking statements are based on TME Pharma Current expectations are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, risks inherent in the development of oncology drugs, including clinical trials and the timing and implementation thereof. TME Pharmaceutical ability to obtain regulatory approvals for NOX-A12 and any other drug candidates. The forward-looking statements contained in this announcement are made as of this date and TME Pharma does not undertake to update this information, except as required by applicable law.

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¹ Chong (2017) Invest Ophthalmol Vis Sci 58:3432 and 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 Kidney (2022) JAMA Ophthalmol. 2022;140(12):1202-1208
⁵ Glaucoma tables from the US National Eye Institute, link
⁶ Astellas Press Release July 11, 2023, Link

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Contacts

For further information please contact:

TME Pharma NV
Aram Mangasarian, Ph.D., CEO
Tel. +49 (0) 30 16637082 0
[email protected]

Investor and Media Relations:

LifeSci Advisors
Guillaume van Renterghem
Tel. +41 (0) 76 735 01 31
[email protected]

New cap
Arthur Rusty
Tel. +33 (0) 1 44 71 00 15
[email protected]