Terns Pharmaceuticals Advances CML Drug TERN-701 and Obesity Treatment TERN-601 in Clinical Trials
Key Insights
TERN-701, an oral BCR-ABL (search) inhibitor for chronic myeloid leukemia (search), completes dose escalation phase with promising safety profile and molecular responses in heavily pre-treated patients.
TERN-601, an oral GLP-1 receptor (search) agonist for obesity (search), advances to Phase 2 FALCON trial with innovative titration strategy, targeting competitive weight loss outcomes.
Drug interaction studies reveal TERN-701's favorable safety profile with common medications, marking a key differentiation in the allosteric TKI class.
Terns Pharmaceuticals has achieved significant milestones in its clinical development programs, marking progress in both oncology and metabolic disease treatments.
TERN-701: Advancing Treatment for Chronic Myeloid Leukemia
The company has successfully completed dose escalation in its Phase 1 CARDINAL study of TERN-701, an oral allosteric BCR-ABL (search) tyrosine kinase inhibitor, as of January 2025. The program is poised to enter dose expansion in the second quarter of 2025, while continuing backfill dosing in existing cohorts.
Recent drug-drug interaction studies have revealed a crucial advantage for TERN-701. The compound shows no clinically relevant inhibition of CYP3A4 or OATB1/3, key pathways involved in drug metabolism and transport. This characteristic enables safe co-administration with common medications, including statins, representing a significant differentiation within the allosteric TKI class.
Early clinical data from the CARDINAL trial has demonstrated encouraging results:
- Molecular responses observed starting at the lowest dose in heavily pre-treated patients
- Strong safety profile with no dose-limiting toxicities
- No treatment discontinuations or dose reductions due to adverse events
Additional efficacy and safety data, including 6-month major molecular response rates, are expected in the fourth quarter of 2025.
TERN-601: Novel Approach to Obesity Treatment
The company has unveiled plans for the FALCON Phase 2 trial of TERN-601, an oral GLP-1 receptor (search) agonist for obesity (search) treatment. This U.S.-based, multicenter study will commence in early Q2 2025, with 12-week data expected in the second half of the year.
The trial design includes:
- Once-daily dosing without food restrictions
- Four active treatment arms (250mg, 500mg, 500mg slow titration, 750mg) plus placebo
- Primary endpoint measuring percent change in body weight over 12 weeks
- Modified titration approach based on Phase 1 results
Phase 1 results from September 2024 showed promising outcomes:
- Weight loss up to 5.5% over 28 days
- Favorable safety and tolerability despite rapid dose titration
- Simplified titration schedule compared to competing oral GLP-1 agonists
Pipeline Expansion and Future Directions
Terns continues to advance its broader pipeline, including the TERN-501 thyroid hormone receptor-beta agonist program for metabolic diseases. The company is also pursuing the TERN-800 series, focusing on GIPR (search) antagonist development for potential combination therapy with GLP-1 receptor (search) agonists like TERN-601.
Management will present these updates at the TD Cowen 45th Annual Healthcare Conference in Boston, scheduled for March 3-5, 2025.