T-MAXIMUM PHARMACEUTICAL has been cleared by the U.S. Food and Drug Administration to begin a Phase 2 clinical study of MT027 in patients with brain metastases from lung cancer and breast cancer, the company said. MT027 is an investigational B7-H3-targeted universal, or allogeneic, CAR-T therapy that the company developed in-house and delivers locally into the brain. The FDA had previously cleared a Phase 2 study of MT027 in recurrent glioblastoma, making this the second such clearance for the therapy, which also holds Orphan Drug Designation and Fast Track Designation.
Brain metastases most often arise in patients with lung cancer, breast cancer, melanoma, renal cell carcinoma and colorectal cancer, and the company cited international studies estimating that roughly 20% of cancer patients may develop them over the course of their disease, a share that can reach 20% to 40% among patients with advanced solid tumours. In 2022 there were nearly 20 million new cancer cases worldwide, including nearly 2.5 million cases of lung cancer and about 2.3 million cases of female breast cancer, the two leading primary tumour types giving rise to the condition. Asia accounts for roughly half of new cancer cases globally, and an estimated 200,000 to 300,000 patients are newly diagnosed with brain metastases each year in the United States. The company noted that the condition can come with headaches, seizures and cognitive and motor impairment.
The company pointed to data from the same platform. Results from an investigator-initiated trial of MT026, published in Nature Communications in 2026, covered five patients with recurrent high-grade glioma: one complete response and three partial responses, an objective response rate of 80%, with no treatment-related adverse events of Grade 3 or higher. Early MT027 data in refractory brain metastases from lung cancer were presented at the IASLC 2026 World Conference on Lung Cancer; the company said five heavily pretreated patients with no guideline-recommended subsequent treatment options completed treatment, and that among the three evaluable patients two partial responses were observed, with no Grade 3 or higher adverse events and no graft-versus-host disease.
MT027 is made using a fully non-viral gene-editing process rather than the lentiviral vector approach the company described as mainstream in the industry, and the manufacturing process was established and locked before the therapy entered Phase 2 development. The company said MT027 is investigational and that its safety and efficacy have not been established, adding that early results from small numbers of patients may not predict results in larger studies.
