Preclinical data highlight improved potency vs. asciminib across multiple clinically relevant variants of BCR-ABL including difficult-to-treat resistance mutations

Early dose-escalation data from Phase 1 CARDINAL study of TERN-701 in CML patients showed compelling molecular responses in patients with heavily pre-treated CML, including deepening responses in patients with poor response to asciminib

Additional safety and efficacy data from CARDINAL, including 6-month major molecular response (MMR) rates expected 4Q 2025

FOSTER CITY, Calif., May 14, 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 preclinical data supporting the potential of TERN-701 as a treatment for chronic myeloid leukemia (CML) will be highlighted in an oral presentation at the 30^th European Hematology Association Congress (EHA25) taking place from June 12-15, 2025 in Milan, Italy.

TERN-701 is an investigational next-generation allosteric BCR-ABL inhibitor specifically targeting the ABL myristoyl pocket. The preclinical data to be presented highlight the potency of TERN-701 on more than 20 clinically relevant resistance mutations in the active-site, P-loop, and allosteric regions of the BCR-ABL oncoprotein, and provide additional data characterizing the drug-like properties of TERN-701 and supporting the potential to provide meaningful clinical benefits over existing therapies.

“We are delighted our abstract has been selected for oral presentation at EHA25. These preclinical data provide further mechanistic insights into the clinical responses we have seen in our ongoing phase 1 study including deepening responses after suboptimal responses to asciminib and other TKIs,” stated Emil Kuriakose, M.D., chief medical officer of Terns Pharmaceuticals. “We are especially encouraged by the greater potency of TERN-701 compared to asciminib against several resistance mutations in the active-site and allosteric domains, implying potential for improved clinical responses with TERN-701 in patients with these mutations and supporting the potential for TERN-701 to be a best in class therapy for CML patients in all lines of therapy.”

Details of the Oral Presentation:

About TERN-701 and CARDINAL Phase 1 Clinical Trial

TERN-701 is currently being evaluated in the CARDINAL trial (NCT06163430), a global multi-center dose escalation and dose-expansion Phase 1 clinical trial to assess safety, tolerability, and efficacy in patients with previously treated chronic phase (CP) CML. The dose escalation portion of the Phase 1 CARDINAL study completed in January 2025 with no dose limiting toxicities (DLTs) observed up to the maximum dose of 500 mg QD. Terns initiated the dose expansion portion study in April 2025 in which patients will be randomized to one of two dose cohorts (320 mg or 500 mg QD) with up to 40 patients per arm. Additional safety and efficacy data expected in the fourth quarter of 2025 will include a larger cohort of patients with longer durations of treatment and read through to approval endpoint of 6-month major molecular response (MMR).

Previously announced positive interim data from the dose escalation portion of the trial demonstrated compelling molecular responses starting at the lowest dose in heavily pre-treated CML patients with high baseline BCR-ABL transcript levels. It also showed an encouraging safety profile with no dose limiting toxicities, adverse event-related treatment discontinuations or dose reductions across all dose escalation cohorts.

In addition, 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 and, therefore, reduces the potential liability of concomitant medication use and provides additional differentiation from asciminib.   

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 statements related to the presentation of positive preclinical data for the treatment of chronic myeloid leukemia at the European Hematology Association Congress; expectations, timing and potential results of the TERN-701 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 “demonstrate,” highlight,” “may,” “observed,” “provides,” “showed,” “support,” “targeting,” “will,” 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, 2024, and in Terns’ future filings with the SEC. All forward-looking statements in this press release are based on information available to Terns as of the date of this press release, and Terns undertakes no obligation to update or revise any forward-looking statements contained herein, except as required by law.

Contacts for Terns

Investors
Kaytee Bock Zafereo
investors@ternspharma.com

Media
Jenna Urban
CG Life
media@ternspharma.com