RIANA 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, announced that the first patient has been dosed in a Phase 1/2 clinical trial evaluating TRI-611, a novel ALK-fusion molecular glue degrader, in patients with anaplastic lymphoma kinase–positive (ALK+) non-small cell lung cancer (NSCLC).

NSCLC is the most common type of lung cancer, accounting for about 85 percent of all lung cancer cases. ALK+ NSCLC represents an important subset of lung cancer, characterized by a dependence on ALK fusion proteins for its growth and survival. Despite therapeutic advances with ALK tyrosine kinase inhibitors (TKI), resistance to TKI-based therapies and limited combination therapy options remain major clinical challenges for these younger, non-smoking patients, underscoring the profound and long-lasting impact of this disease. Addressing this persistent unmet need represents a significant opportunity to elevate the standard of care and meaningfully improve outcomes for people living with ALK+ NSCLC.

The Phase 1/2 clinical 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 TKI therapies. The Phase 2 portion will further evaluate and characterize the efficacy and safety of TRI-611 across different patient cohorts.

“We are excited to have TRI-611 in the clinic and to advance this new potential therapy for people living with lung cancer,” said Dr. Caroline Germa, Chief Medical Officer of TRIANA. “Despite progress in treatments, many patients continue to face limited options. This study represents an important step in our mission to develop innovative therapies that may ultimately improve outcomes for ALK+ NSCLC patients and their families.”

“Dosing of the first patient with TRI-611 marks an important milestone for TRIANA and for the ALK+ NSCLC patient community,” said Dr. Patrick Trojer, President and CEO of TRIANA. “This study reflects our commitment to treating diseases in entirely new ways by applying our molecular glue technology to highly relevant cancer targets. We are excited to advance TRI-611 and bring its potential impact one step closer to patients.”