Terns Pharmaceuticals Announces Data from Ongoing Phase 1 Pharmacokinetic Study of Allosteric BCR-ABL Inhibitor TERN-701 in Adult Healthy Volunteers and Highlights Potential for Competitive Differentiation

Ability to dose TERN-701 without regard to food represents a key potential differentiator within the allosteric BCR-ABL inhibitor class

Pharmacokinetic data show no clinically significant difference in exposure between fed and fasted dosing

Phase 1 CARDINAL trial evaluating TERN-701 in 2L+ CML patients remains ongoing, with interim data from initial cohorts anticipated in second half of 2024

FOSTER CITY, Calif., April 29, 2024 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. (“Terns” or the “Company”) (Nasdaq: TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity, today announced findings from a Phase 1 study of TERN-701 in Western healthy volunteers. The study is an ongoing Phase 1 open-label, single ascending dose trial to evaluate the pharmacokinetics (PK), food effect, safety and tolerability of TERN-701 in healthy adults. TERN-701 is Terns’ proprietary, oral, potent, allosteric BCR-ABL inhibitor, a novel class of therapy for CML that has demonstrated superior efficacy and safety compared to traditional active-site tyrosine kinase inhibitors (TKIs).

“We are pleased with the interim findings from this healthy volunteer study, which indicate TERN-701 can be administered once-daily (QD) with or without food at doses that achieve clinically efficacious exposures. TERN-701 has the potential to be a differentiated BCR-ABL inhibitor with advantages over asciminib, including more convenient dosing to improve treatment options and quality of life for people living with CML,” said Emil Kuriakose, MD, chief medical officer at Terns Pharmaceuticals.  

“We are excited to see clinical PK data continuing to support once-daily dosing and new data showing lack of food effect with TERN-701. The ability to dose with or without food is a key potential differentiator from asciminib, the only currently approved allosteric BCR-ABL inhibitor, which requires three hours of fasting with each dose, and twice-daily dosing in multiple clinical settings. We look forward to reporting interim dose escalation data from the ongoing Phase 1 CARDINAL trial in the second half of 2024,” concluded Dr. Kuriakose.