TRIANA Biomedicines, a leading biopharmaceutical innovator, has announced that the first patient has been dosed in a Phase 1/2 clinical trial of TRI-611, a novel ALK-fusion molecular glue degrader, for patients with ALK-positive (ALK+) non-small cell lung cancer (NSCLC).

 

NSCLC is the most common form of lung cancer, accounting for roughly 85% of cases. ALK+ NSCLC, a subset driven by ALK fusion proteins, remains particularly challenging, as patients often develop resistance to existing ALK tyrosine kinase inhibitors (TKIs) and have few combination therapy options. 

 

“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,” TRIANA noted.

 

The global, first-in-human, open-label trial will assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of TRI-611. The Phase 1 portion involves dose escalation in patients previously treated with standard ALK TKIs, while Phase 2 will expand to evaluate efficacy and safety across broader 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 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 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.”