TME Pharma Announces Filing of Patents for Use of CCL2 Inhibitor NOX-E36 in Ophthalmology and Presentation at ARVO 2025 of Preclinical Data Showing Benefit in Glaucoma Filtration Surgery
TME Pharma and Singapore Eye Research Institute (SERI) file new patent applications covering NOX-E36 for treatment of glaucoma filtration surgery and other ophthalmic diseases
Preclinical data will be presented by SERI at the Association for Research in Vision and Ophthalmology (ARVO) 2025 Annual Meeting held in Salt Lake City, Utah from May 4 to 8, 2025
mNOX-E361 demonstrates similar efficacy in reducing scarring following glaucoma filtration surgery while showing improved safety over standard of care
BERLIN, March 13, 2025--(BUSINESS WIRE)--Regulatory News:
TME Pharma N.V. (Euronext Growth Paris: ALTME), a clinical stage biotechnology company, and the Singapore Eye Research Institute (SERI) announce that an abstract highlighting data from preclinical studies performed with mNOX-E36 by SERI has been selected for poster presentation at the Association for Research in Vision and Ophthalmology (ARVO) 2025 Annual Meeting, taking place in Salt Lake City, Utah, USA, May 4-8, 2025.
Preclinical data show that mNOX-E36 is as efficacious as standard of care mitomycin C (MMC) at attenuating post-operative inflammation and scarring (fibrosis) following glaucoma filtration surgery (GFS), a common procedure to reduce intraocular pressure while having a much more favorable safety profile. Unlike MMC, mNOX-E36 does not destroy blood vessels in the conjunctiva, potentially overcoming the substantial toxicity seen with MMC which is a key limitation of this current standard treatment.
"Ocular scarring remains the major cause of failure in glaucoma filtration surgery, and while MMC has increased the five-year success rate of GFS to between 60 and 80 percent, this still means 20 to 40 percent of these surgeries still fail," said Professor Tina Wong, Co-Head Ocular Therapeutics and Drug Delivery Research Group, Singapore Eye Research Institute, and Senior Consultant, Glaucoma Service, Singapore National Eye Centre. "Our in vivo research demonstrates that the treatment with mNOX-E36 is comparable to MMC in inhibiting fibrosis which is necessary to maintain the success of the procedure. However, unlike MMC, mNOX-E36 is not toxic for conjunctival vasculature, which is expected to reduce severe complications post-GFS."
Due to these new findings and other unpublished data, TME Pharma and the Singapore Eye Research Institute have filed patent applications covering use of NOX-E36 in glaucoma filtration surgery and other ophthalmic diseases to support its development through a license to an industrial partner or the creation of a new corporate entity.
"These latest data from the SERI preclinical studies demonstrate the potential of NOX-E36 to address significant unmet medical needs in ophthalmic diseases impacted by fibrosis and we are very pleased the results are being presented at the highly regarded ARVO Annual Meeting," said Aram Mangasarian, CEO of TME Pharma. "We also jointly filed with SERI our first patents covering NOX-E36 ophthalmic diseases, which form the foundation of the IP protection around our asset in ophthalmology. These latest developments show that our strategy to generate of proof-of-concept NOX-E36 clinical data at limited cost to the company is progressing well, and our goal remains the creation of a new corporate entity in collaboration with SERI with full rights to develop NOX-E36 further in ophthalmology, supported by private investors."
Details of the poster presentation at the ARVO 2025 Annual Meeting are as follows:
Title: Inhibition of MCP-1 with mNOX-E36 reduces scarring in an experimental murine model of glaucoma filtration surgery Presenter: Professor Tina Wong, Singapore Eye Research Institute Session: Poster Session, Poster number A0418 Time and Date: 8.30-10.15 a.m. MDT, Tuesday, May 06, 2025
Established in 1997, SERI is Singapore’s national research institute for ophthalmic and vision research. SERI’s mission is to conduct high-impact eye research that prevents blindness, low vision and major eye diseases common to Singaporeans and Asians. Over the last decade, SERI has conducted landmark research projects that have led to tangible outcomes, patient benefits, and success stories. It has paved the way for significant improvements in how eye diseases are treated and prevented, not just for Singaporeans or Asians, but on a global scale.
At its inception, SERI saw a national remit in ophthalmic and vision research, and till today, SERI ensures that its facilities and resources are open to researchers across Singapore so that the greatest benefit may be obtained from what is a relatively small clinical ophthalmology catchment area in Singapore.
SERI has grown from a founding team of five in 1997 to a faculty of more than 196 staff, encompassing clinician scientists, scientists, research fellows, PhD students and support staff. This makes SERI one of the largest research institutes in Singapore, as well as the largest eye research institute in the Asia Pacific region. SERI has also over 220 adjunct faculties from various eye departments, biomedical institutes and tertiary centres in Singapore. SERI has published an impressive array of 4,504 scientific papers and has secured external peer-reviewed competitive grants worth more than $360 million. As of August 2021, SERI’s faculty has been awarded with more than 1,755 national and international prizes and filed 145 patents.
As the research institute of the SNEC, and directly affiliated to the Yong Loo Lin School of Medicine, National University of Singapore, as well the Duke-NUS Medical School, SERI undertakes vision research in collaboration with local clinical ophthalmic centres and biomedical research institutions, as well as major eye centres and research institutes throughout the world. SERI ranks first globally in terms of eye publications per capita, far ahead of the US, UK and Japan. With its impressive publication track record, SERI is comparable to renowned eye institutes, both regionally and internationally. Please see www.seri.com.sg.
About TME Pharma
TME Pharma is a clinical-stage company focused on developing novel therapies for treatment of the most aggressive cancers. The company’s oncology-focused pipeline is designed to act on the tumor microenvironment (TME) and the cancer immunity cycle by breaking tumor protection barriers against the immune system and blocking tumor repair. By neutralizing chemokines in the TME, TMEPharma’s approach works in combination with other forms of treatment to weaken tumor defenses and enable greater therapeutic impact. In the GLORIA Phase 1/2 clinical trial, TME Pharma is studying its lead drug candidate NOX-A12 (olaptesed pegol, an anti-CXCL12 L-RNA aptamer) in newly diagnosed brain cancer patients who will not benefit clinically from standard chemotherapy. TME Pharma has delivered top-line data from the NOX-A12 three dose-escalation cohorts combined with radiotherapy of the GLORIA clinical trial, observing consistent tumor reductions and objective tumor responses. Additionally, GLORIA expansion arms evaluate safety and efficacy of NOX-A12 in other combinations where the interim results from the triple combination of NOX-A12, radiotherapy and bevacizumab suggest even deeper and more durable responses, and improved survival. US FDA has approved the design of a randomized Phase 2 trial in glioblastoma and TME Pharma was awarded fast track designation by the FDA for NOX-A12 in combination with radiotherapy and bevacizumab for use in the treatment of the aggressive adult brain cancer, glioblastoma. NOX-A12 in combination with radiotherapy had also previously received orphan drug designation (ODD) for glioblastoma in the United States and glioma in Europe. TME Pharma has delivered final top-line data with encouraging overall survival and safety profile from its NOX-A12 combination trial with Keytruda® in metastatic colorectal and pancreatic cancer patients, which was published in the Journal for ImmunoTherapy of Cancer in October 2021. The company has entered in its second collaboration with MSD/Merck for its Phase 2 study, OPTIMUS, to further evaluate safety and efficacy of NOX-A12 in combination with Merck’s Keytruda® and two different chemotherapy regimens as second-line therapy in patients with metastatic pancreatic cancer. The design of the trial has been approved in the United States. The company’s second clinical-stage drug candidate, NOX-E36 (emapticap pegol, L-RNA aptamer inhibiting CCL2 and related chemokines), showing potential to address fibrosis and inflammation is evaluated in ophthalmic diseases with a high need for well-tolerated therapies with anti-fibrotic effect. Further information can be found at: www.tmepharma.com.
TME Pharma® and the TME Pharma logo are registered trademarks.
Keytruda® is a registered trademark of Merck Sharp & Dohme Corp.
GLORIA (NCT04121455) is TMEPharma’s dose-escalation, Phase 1/2 study of NOX-A12 in combination with radiotherapy in first-line partially resected or unresected glioblastoma (brain cancer) patients with unmethylated MGMT promoter (resistant to standard chemotherapy). GLORIA further evaluates safety and efficacy of NOX-A12 in the expansion arm in which NOX-A12 is combined with radiotherapy and bevacizumab.
About the OPTIMUS Study
OPTIMUS (NCT04901741) is TMEPharma’s planned open-label two-arm Phase 2 study of NOX-A12 combined with pembrolizumab and nanoliposomal irinotecan/5-FU/leucovorin or gemcitabine/nab-paclitaxel in microsatellite-stable metastatic pancreatic cancer patients.
Disclaimer
Translations of any press release into languages other than English are intended solely as a convenience to the non-English-reading audience. The company has attempted to provide an accurate translation of the original text in English, but due to the nuances in translating into another language, slight differences may exist. This press release includes certain disclosures that contain "forward-looking statements." Forward-looking statements are based on TME Pharma’s current expectations and 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, the risks inherent in oncology drug development, including clinical trials and the timing of and TMEPharma’s ability to obtain regulatory approvals for NOX-A12 as well as any other drug candidates. Forward-looking statements contained in this announcement are made as of this date, and TME Pharma undertakes no duty to update such information except as required under applicable law.
1 Note that mNOX-E36 (a rodent version of NOX-E36) is used in preclinical models because NOX-E36 binds to human CCL2, but not to mouse CCL2.
