TERN-701 CARDINAL study progressing well; dose expansion expected to initiate in 2Q25 with additional safety and efficacy data in 4Q25
New TERN-701 data from ongoing U.S. healthy volunteer PK study shows improved drug-drug interaction profile compared to asciminib
Introduces TERN-601 Phase 2 FALCON obesity study design; on track to initiate study in early 2Q25 with 12-week data expected 2H25
Cash and cash equivalents expected to provide runway into 2028
FOSTER CITY, Calif., Feb. 25, 2025 (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 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 as outlined below.
“Since our positive interim data readout from the TERN-701 CARDINAL study, we have maintained strong enrollment momentum and continue to see compelling safety and clinical activity across the dose range. We look forward to sharing additional data from CARDINAL later this year,” said Emil Kuriakose, chief medical officer at Terns. “Additionally, we are excited to share new drug-drug interaction (DDI) data showing TERN-701 has a superior DDI profile compared to asciminib, allowing for safer co-administration of many commonly prescribed drugs, including statins. This is meaningful for patients with chronic myeloid leukemia (CML) who are on life-long therapy with tyrosine kinase inhibitors (TKIs). The compelling early data from CARDINAL, along with the lack of food effect and improved DDI compared to asciminib, reinforce TERN-701's class-leading potential in CML.”
“Oral, small molecule GLP-1R agonists have shown meaningful, consistent weight loss in clinical trials over 12-weeks. However, the major limitation within the class continues to be poor gastrointestinal tolerability, necessitating complicated dose titration schedules that are burdensome for patients,” said Amy Burroughs, chief executive officer at Terns. “The unique pharmaceutical properties of TERN-601 allowed for rapid titration in our 28-day Phase 1 study, resulting in competitive weight loss without dose interruptions, reductions, or discontinuations. Our goal in Phase 2 is to generate 12-week data that achieves competitive weight loss and best-in-class tolerability without the need for complicated dose titrations. Further establishing this differentiated profile will be an important catalyst in determining next steps for the program.”
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 (DDIs) 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 (QTc) 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 (MMR)
TERN-601: Oral, small-molecule glucagon-like peptide-1 (GLP-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 (BMI ranges from ≥30 to <50 kg/m2 or ≥27 to <30 kg/m2 with at least one weight-related comorbidity)
Patients randomized to one of four active cohorts (n=30 per cohort): 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
Terns continues to evaluate opportunities for TERN-501 in metabolic diseases
Based on non-clinical studies, THR-β 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
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
Financial Update
Terns’ third quarter cash balance as of September 30, 2024, was $372.8 million which is expected to provide cash runway into 2028.
Investor Conferences
Members of Terns’ senior leadership team will participate at the following upcoming investor conference in March:
TD Cowen 45th Annual Health Care Conference Date: March 3-5, 2025 Location: Boston, MA Format: Corporate Presentation Date/Time: Tuesday, March 4th at 2:30PM ET
A live webcast will be available on the investor relations page of the Terns Pharmaceuticals website at http://ir.ternspharma.com. A replay of the webcast will be archived on Terns’ website for at least 30 days following the event.
About Terns Pharmaceuticals Terns Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity. Terns’ pipeline contains three clinical stage development programs including an allosteric BCR-ABL inhibitor, a small-molecule GLP-1 receptor agonist, a THR-β agonist, and a preclinical GIPR modulator discovery effort, prioritizing a GIPR antagonist nomination candidate. For more information, please visit: www.ternspharma.com.
Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements about the Company within the meaning of the federal securities laws, including those related to expectations, timing and potential results of the clinical trials and other development activities of the Company and its partners; the potential indications to be targeted by the Company with its small-molecule product candidates; the therapeutic potential of the Company’s small-molecule product candidates; the potential for the mechanisms of action of the Company’s product candidates to be therapeutic targets for their targeted indications; the potential utility and progress of the Company’s product candidates in their targeted indications, including the clinical utility of the data from and the endpoints used in the Company’s clinical trials; the Company’s clinical development plans and activities, including the results of any interactions with regulatory authorities on its programs; the Company’s expectations regarding the profile of its product candidates, including efficacy, tolerability, safety, metabolic stability and pharmacokinetic profile and potential differentiation as compared to other products or product candidates; the Company’s plans for and ability to continue to execute on its current development strategy, including potential combinations involving multiple product candidates; the potential commercialization of the Company’s product candidates; the Company’s plans and expectations around the addition of key personnel; and the Company’s expectations with regard to its cash runway and sufficiency of its cash resources. All statements other than statements of historical facts contained in this press release, including statements regarding the Company’s strategy, future financial condition, future operations, future trial results, projected costs, prospects, plans, objectives of management and expected market growth, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. The Company has based these forward-looking statements largely on its current expectations, estimates, forecasts and projections about future events and financial trends that it believes may affect its financial condition, results of operations, business strategy and financial needs. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. These statements are subject to risks and uncertainties that could cause the actual results and the implementation of the Company’s plans to vary materially, including the risks associated with the initiation, cost, timing, progress, results and utility of the Company’s current and future research and development activities and preclinical studies and clinical trials. These risks are not exhaustive. For a detailed discussion of the risk factors that could affect the Company’s actual results, please refer to the risk factors identified in the Company’s SEC reports, including but not limited to its Annual Report on Form 10-K for the year ended December 31, 2023. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason.
