- Option framework agreement with SERI establishes ownership- and revenue-sharing model for all NOX-E36 ophthalmic disease rights
- TME Pharma to lead commercial discussions for potential spin-out or out-licensing
- SERI to lead first proof-of-concept Phase 1b study of NOX-E36 in ophthalmology
- TME Pharma demonstrates continued ability to advance its asset portfolio during the period of strategic transition
Regulatory News:
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TME Pharma N.V. (Euronext Growth Paris: ALTME), a clinical-stage biotechnology company and the Singapore Eye Research Institute (SERI), a leading ophthalmology research institution, today announced the continuation of their collaboration through the signing of an option framework agreement. The agreement aims to advance the development of TME Pharma's NOX-E36 anti-CCL2 RNA aptamer for ophthalmic indications, including glaucoma filtration surgery (GFS) and also conditions involving fibrosis and inflammation in the back of the eye.
The agreement establishes a strategic collaboration framework for NOX-E36, with TME Pharma securing an exclusive two-year option to out-license all rights related to NOX-E36 to either a newly created company or a third-party licensee. The framework reflects TME Pharma's foundational investment and ownership of the underlying asset, while duly recognizing SERI's pivotal contributions in early-stage ophthalmic research. Taking these respective contributions into account, the parties agreed to a fixed revenue-sharing model, with TME Pharma receiving a larger share of future licensing consideration. TME Pharma will lead the commercial discussions, streamlining engagement with potential investors and licensing partners interested in advancing NOX-E36's development in ophthalmology.
Through this collaboration, TME Pharma and SERI aim to progress NOX-E36 from preclinical research into clinical studies, leveraging their combined expertise to accelerate development. The near-term financial commitments include TME Pharma funding preclinical local ocular tolerance studies, while SERI will seek grants to fund and conduct the Phase 1b clinical study. Moreover, SERI will provide its deep expertise in ophthalmology research, pharmacological testing in animal models, and clinical evaluation, while TME Pharma will bring its prior clinical, regulatory and manufacturing experience and documentation as well as drug supply for both preclinical and clinical studies and will manage new intellectual property (IP).
TME Pharma and SERI have already filed patent applications covering use of NOX-E36 in glaucoma filtration surgery and other ophthalmic diseases1 and will continue working together to secure joint IP protection for any patentable innovations arising from this research.
"We are excited to deepen our collaboration with SERI as we work towards advancing NOX-E36 as a potential treatment for significant unmet needs in ophthalmology including diseases affecting both the front and the back of the eye. This agreement provides the framework to bring all relevant intellectual property of both TME Pharma and SERI to an ophthalmology company dedicated to advancing NOX-E36 towards commercialization. We look forward to combining our expertise and resources to accelerate the development of this promising compound," said Aram Mangasarian, CEO of TME Pharma
"Our work with NOX-E36 in preclinical models of ocular fibrosis has shown promising results that challenge the current standard of care treatment. This partnership with TME Pharma allows us to take the crucial next steps in translating these findings into clinical benefits for patients with difficult to treat ocular scarring," 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.
Fibrosis is a major contributor to treatment failure and increased severity in several clinically important eye diseases2 with significant unmet needs, such as proliferative diabetic retinopathy and age-related macular degeneration. Collectively, these conditions affect approximately 30 million people in the US alone, with millions at risk of vision-threatening complications3,4. This underscores the substantial market potential for innovative anti-fibrotic therapies like NOX-E36.
SERI has long been at the forefront of research on the CCL2 target in ophthalmology, with significant contributions to the field.5 Over the past several years, SERI has been evaluating NOX-E36 in preclinical models, generating promising data that suggest NOX-E36 may provide meaningful clinical benefits by enabling sustained success of GFS, also known as trabeculectomy. This procedure to treat glaucoma creates an opening through the white part of the eye, the sclera, to release intraocular pressure. While effective, the surgery often fails over time despite the use of toxic substances such as mitomycin C to prevent scarring (fibrosis), which can obstruct the newly created drainage channel compromising pressure reduction. In mouse experiments, TME Pharma's CCL2 inhibitor has been shown to be as effective as mitomycin C in preventing fibrosis while having a more favorable safety profile, thus improving long-term control of intraocular pressure.
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1 TME Pharma press release on March 13, 2025 |
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 Chong 2010, Ophthalmology 117:2353; Chong 2017, Invest Ophthalmol Vis Sci 58:3432 |
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, TME Pharma'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.
Visit TME Pharma on LinkedIn and X.
About Singapore Eye Research Institute (SERI)
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 253 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 255 adjunct faculties from various eye departments, biomedical institutes and tertiary centres in Singapore. SERI has published an impressive array of 5,942 scientific papers, and has secured external peer-reviewed competitive grants worth more than $473 million. As of December 2024, SERI's faculty has been awarded with more than 1,425 national and international prizes and filed 188 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 the GLORIA Study
GLORIA (NCT04121455) is TME Pharma'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 TME Pharma'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 TME Pharma'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.
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Contacts:
For more information, please contact:
TME Pharma N.V.
Aram Mangasarian, Ph.D., CEO
Tel. +49 (0) 30 16637082 0
investors@tmepharma.com
Investor and Media Relations:
LifeSci Advisors
Guillaume van Renterghem
Tel. +41 (0) 76 735 01 31
gvanrenterghem@lifesciadvisors.com
NewCap
Arthur Rouillé
Tel. +33 (0) 1 44 71 00 15
arouille@newcap.fr
