TMS Enters into Exclusive Negotiation Agreement with European Company for Malignant Brain Tumor Program
Plans to Establish a Subsidiary and Explore Joint Clinical Development Funded by External Capital

TOKYO, Japan, October 29, 2026 – TMS Co., Ltd. (the “Company”) today announced that it has entered into a term sheet (the “Term Sheet”) with TME Pharma AG (“TME Pharma”), headquartered in Berlin, Germany, providing for exclusive negotiations regarding worldwide development rights to NOX-A12 (olaptesed pegol), which is being developed for the treatment of brain tumors.

 

In addition to binding provisions governing the exclusive negotiations, the Term Sheet sets out non-binding terms for the proposed collaboration. These include conducting new cohorts of the Phase 1/2 GLORIA clinical trial in newly diagnosed glioblastoma (“GBM”); establishing a Japanese subsidiary dedicated to the project (“NewCo”); entering into a definitive agreement between NewCo and TME Pharma covering global development, manufacturing and commercialization rights once NewCo has secured a specified level of funding; and TME Pharma participating in the project as a minority shareholder of NewCo.

 

NOX-A12 is currently being developed in Germany for glioblastoma (GBM), the most common and most aggressive malignant brain tumors in adults. Treatment and analysis have already been completed for 17 patients across multiple cohorts of the GLORIA trial. Notably, in the six-patient Expansion Cohort, which evaluated NOX-A12 in combination with radiotherapy and the anti-VEGF antibody bevacizumab in a particularly difficult-to-treat population characterized by incomplete surgical resection and unmethylated MGMT status, overall survival (“OS”) was statistically significantly longer than in historical controls (19.9 months versus 9.5 months). These findings were published in Nature Communications in April 2026.¹

 

NOX-A12 specifically inhibits CXCL12, a chemokine that plays an important role in vasculogenesis, thereby seeking to prevent the re-formation of blood vessels around tumors following radiotherapy. Vasculogenesis is one mechanism by which blood vessels are re-established to supply the oxygen and nutrients required for GBM cell growth. It is distinct from VEGF-mediated angiogenesis.

 

Historically, large-scale clinical trials of the anti-VEGF antibody bevacizumab, an angiogenesis inhibitor, in combination with radiotherapy did not demonstrate an extension of OS in patients with GBM. One hypothesis is that oxygen and nutrients continue to reach GBM cells through CXCL12-mediated vasculogenesis rather than angiogenesis. This has provided a rationale for combining an anti-VEGF antibody with a CXCL12 inhibitor.

 

Under the proposed project, the parties plan to conduct new GLORIA trial cohorts comprising five treatment arms with 20 patients each, for a total of 100 patients, to establish proof of concept (“POC”).² GLORIA is an open-label study, and analyses will be conducted on an ongoing basis as the trial progresses. The study is initially expected to begin in Germany, where six clinical sites are already operational. Conducting the trial in the United States, where an Investigational New Drug (“IND”) application has already been authorized, and in Japan will also be considered.

 

For the GBM indication, NOX-A12 has received Orphan Drug Designation and Fast Track Designation in the United States, as well as Orphan Drug Designation in Europe.

 

Management Comment:

Takuro Wakabayashi, President and Chief Executive Officer of the Company, commented:

“We are very pleased to have the opportunity to participate in the development of NOX-A12, which has a compelling mechanism of action and has demonstrated remarkable clinical trial results, albeit in a small number of patients, in glioblastoma, an extremely challenging disease. Our pipeline has focused on diseases for which existing treatments are largely unavailable or clearly inadequate, including ischemic stroke, acute kidney injury and spinal cord injury. GBM similarly offers limited treatment options and is a particularly difficult cancer to treat.

We will continue to leverage our integrated organization, which works as one team from research through clinical trials, together with our experience in global clinical and business development, to advance drug discovery and development connected to the world. As NewCo will be a Japanese company, we will also actively explore the development of NOX-A12 in Japan.”

 

In consideration for the exclusive negotiation rights granted under the Term Sheet, the Company will pay TME Pharma up to EUR 300,000 in accordance with its terms, unless the parties mutually agree to modify the amount in light of factors including the prospects for securing external funding. The Company expects the impact on its financial results for the current fiscal year to be immaterial.

 

 

¹ Frank A. Giordano et al., “RNA aptamer-based CXCL12 inhibition combined with radiotherapy and bevacizumab in newly-diagnosed glioblastoma: expansion of the phase I/II GLORIA trial,” Nature Communications (2026).

² The clinical development plan described above reflects current assumptions set out in the non-binding provisions of the Term Sheet and may change or may not be implemented depending on subsequent discussions, financing and other conditions.