LEXINGTON, Mass. — TRIANA Biomedicines said the U.S. Food and Drug Administration has granted Fast Track designation to its experimental therapy TRI-611 for the treatment of anaplastic lymphoma kinase-positive non-small cell lung cancer.
The designation is intended to speed development and regulatory review for drugs that address serious conditions and unmet medical needs. The company said there remains a significant need for new treatment options for patients whose disease progresses after standard therapies, including ALK tyrosine kinase inhibitors.
“This Fast Track designation underscores the potential of TRI-611 to address the significant unmet need for patients with ALK+ NSCLC who have been previously treated with two or more ALK tyrosine kinase inhibitors,” said Dr. Patrick Trojer, President and CEO of TRIANA. “TRI-611 was designed as an innovative therapeutic approach to target ALK fusion proteins. We look forward to working closely with the FDA to potentially bring TRI-611 forward to the lung cancer patient community.”
TRI-611 is an oral investigational small-molecule therapy designed to degrade ALK fusion proteins. The company said the treatment is engineered to penetrate the brain and uses a molecular glue mechanism that links target proteins to the body’s natural protein-degradation system.
Earlier this month, TRIANA announced that the first patient had been dosed in a Phase 1/2 clinical trial. The global, first-in-human, open-label study is evaluating the therapy’s safety, tolerability, pharmacokinetics, and early anti-tumor activity in patients with ALK-positive non-small cell lung cancer.
The Phase 1 portion of the trial is focused on dose escalation in patients previously treated with standard ALK-targeted therapies, while the Phase 2 portion will further assess safety and effectiveness across multiple patient groups.
The company said TRI-611 is designed to overcome limitations seen with currently available ALK inhibitors by targeting the protein through a mechanism independent of the kinase active site.
