TRIANA Biomedicines’ TRI-611 Granted U.S. FDA Fast Track Designation for Treatment of ALK Positive Non-small Cell Lung Cancer

• There is an urgent need for innovative therapeutic options that impact disease progression after failure with standard of care, ALK tyrosine kinase inhibitor therapies
• TRI-611 is an oral investigational small molecule therapy designed as a potent, brain-penetrant molecular glue degrader targeting ALK fusion proteins

LEXINGTON, Mass.--(BUSINESS WIRE)--#ALK--TRIANA Biomedicines, Inc. (TRIANA), a leading biopharmaceutical company focused on advancing a target-first and proximity-first molecular glue discovery platform to address difficult to drug disease targets, today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for TRI-611, an investigational molecular glue degrader therapy for the treatment of anaplastic lymphoma kinase–positive (ALK+) non-small cell lung cancer (NSCLC).

Fast Track designation is a U.S. Food and Drug Administration (FDA) program intended to accelerate the development and review of new drugs that have the potential to treat serious conditions and address urgent unmet medical needs.

“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.”

Earlier in March 2026, TRIANA announced that the first patient had been treated with TRI-611 in a Phase 1/2 clinical study. The Phase 1/2 trial is a global, first-in-human, open-label study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of TRI-611 in patients with ALK+ NSCLC. The Phase 1 portion will consist of a dose escalation design, enrolling ALK+ NSCLC patients, who have been previously treated with standard of care ALK tyrosine kinase therapies. The Phase 2 portion will further evaluate and characterize the efficacy and safety of TRI-611 across different patient cohorts. For more information, visit ClinicalTrials.gov (NCT07491497).

About TRI-611

TRI-611 is a novel oral, small-molecule, investigational therapy designed to target and degrade ALK fusion proteins in patients with ALK+ NSCLC. TRI-611 is a potent, brain-penetrant molecular glue degrader that brings ALK fusion proteins and the E3 ligase enzyme cereblon together through a unique binding mechanism that works independently of the ALK kinase active site and harnesses the body’s innate protein-degradation machinery to selectively eliminate the ALK fusion protein. TRI-611 is designed to overcome the limitations observed with currently available ALK inhibitors.

About TRIANA Biomedicines, Inc.

TRIANA Biomedicines is a private biotechnology company, headquartered in Lexington, Massachusetts, focused on building the leading molecular glue discovery platform to regulate disease targets that are difficult to address with any other modality. TRIANA’s drug discovery engine is powered by bespoke chemical libraries, deep biochemical and biological mechanistic insights in addition to high resolution structural biology. TRIANA’s target-first and proximity-first approach to molecular glue discovery is currently focused on inducing or enhancing the degradation of high-profile disease targets. The therapeutic approach pioneered by TRIANA has the potential to fundamentally change the paradigm of small molecule drug discovery and bring significant therapeutic benefits to patients.

IR@trianabio.com