Terns Pharmaceuticals provides program updates

Terns announced that management will participate in the TD Cowen 45th Annual Healthcare Conference taking place from March 3-5, 2025 in Boston and provided program updates across the Company’s development programs. Program Updates: TERN-701: Oral, allosteric BCR-ABL tyrosine kinase inhibitor for chronic myeloid leukemia: Dose escalation in Phase 1 CARDINAL study is complete as of January 2025, with dose expansion portion expected to initiate in the second quarter of 2025; Backfill dosing of new participants continues in existing cohorts of dose escalation; New data on drug-drug interactions from the ongoing healthy volunteer study demonstrate that TERN-701 is not a clinically relevant inhibitor of CYP3A4 or OATB1/3; Over 60% of FDA-approved small molecule drugs are primarily metabolized by the CYP3A4 pathway1; OATB1/3 is a transporter for cholesterol lowering statins; Results support dosing of TERN-701 with common concomitant medications and represent a key safety differentiation of TERN-701 within the allosteric TKI class; Side effects from DDIs may include corrected QT interval prolongation and decreases in TKI concentrations, which may reduce efficacy; Terns expects to publish DDI data at a future scientific conference; Terns previously announced positive early data from the Phase 1 CARDINAL trial of TERN-701, demonstrating: Compelling molecular responses starting at the lowest dose in heavily pre-treated patients with high baseline BCR-ABL transcript levels; Encouraging safety profile with no dose limiting toxicities, adverse event-related treatment discontinuations or dose reductions across all dose escalation cohorts; Additional safety and efficacy data are expected in the fourth quarter of 2025; Data expected to include a larger cohort of patients with longer durations of treatment and read through to approval endpoint of 6-month major molecular response. TERN-601: Oral, small-molecule glucagon-like peptide-1 receptor agonist for obesity: Terns announces design of the FALCON Phase 2 clinical trial, expected to initiate early in the second quarter of 2025 with 12-week data expected in the second half of 2025; U.S.-based, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of TERN-601; Once-daily dosing without regard to food in adults with overweight or obesity, without diabetes; Patients randomized to one of four active cohorts: 250 mg, 500 mg, 500 mg slow titration, 750 mg or placebo; Primary endpoint is percent change from baseline in body weight compared to placebo over 12 weeks: Secondary endpoints include safety, tolerability and proportion of patients achieving 5% weight loss or greater: Doses and titration schema for Phase 2 were selected based on positive results from the Phase 1 trial, announced in September 2024, demonstrating weight loss over 28-days up to 5.5% and favorable safety and tolerability despite rapid dose titration every three days: Phase 2 titration will range between two to four weeks at each intermediate dose before achieving the target dose: Titration design features the fewest steps and lowest fold change to target dose amongst leading oral, small-molecule GLP-1R agonists in a 12-week study: Slower titration aims to achieve competitive 12-week weight loss, best-in-class tolerability and simplest titration amongst the oral, small-molecule class. TERN-501: Oral, thyroid hormone receptor-beta agonist: Terns continues to evaluate opportunities for TERN-501 in metabolic diseases: Based on non-clinical studies, THR-beta is a complementary mechanism to GLP-1, potentially providing broader metabolic and liver benefits in addition to increased weight loss: Posters are available on Terns’ scientific publications website. TERN-800 Series: Oral, small-molecule glucose-dependent insulinotropic polypeptide receptor modulators: Discovery efforts are ongoing for small molecule GIPR modulators for obesity, which have the potential for combination with GLP-1 receptor agonists, such as TERN-601; Terns is prioritizing its discovery efforts on nominating a GIPR antagonist development candidate based on in-house discoveries and growing scientific rationale supporting the potential of GLP-1 agonist/GIPR antagonist combinations for obesity