Terns Pharmaceuticals Selected for Oral Presentation at European Hematology Association Congress For Preclinical Data on Novel Allosteric BCR-ABL Inhibitor TERN-701
Terns Pharmaceuticals (NASDAQ: TERN) announced that preclinical data for its TERN-701, a next-generation allosteric BCR-ABL inhibitor for chronic myeloid leukemia (CML), will be presented at the 30th European Hematology Association Congress in June 2025. The data demonstrates superior potency compared to asciminib across multiple BCR-ABL variants, including difficult-to-treat resistance mutations.
Early Phase 1 CARDINAL study results showed promising molecular responses in heavily pre-treated CML patients, with improved responses in those who had poor response to asciminib. The company expects to release additional safety and efficacy data, including 6-month major molecular response (MMR) rates, in Q4 2025.
Terns Pharmaceuticals (NASDAQ: TERN) ha annunciato che i dati preclinici del suo TERN-701, un inibitore allosterico di nuova generazione di BCR-ABL per la leucemia mieloide cronica (CML), saranno presentati al 30° Congresso della European Hematology Association a giugno 2025. I dati mostrano una potenza superiore rispetto ad asciminib su diverse varianti di BCR-ABL, comprese le mutazioni resistenti difficili da trattare.
I primi risultati dello studio di Fase 1 CARDINAL hanno evidenziato risposte molecolari promettenti in pazienti con CML fortemente pretrattati, con miglioramenti nelle risposte in coloro che avevano una scarsa risposta ad asciminib. L'azienda prevede di pubblicare ulteriori dati su sicurezza ed efficacia, inclusi i tassi di risposta molecolare maggiore (MMR) a 6 mesi, nel quarto trimestre del 2025.
Terns Pharmaceuticals (NASDAQ: TERN) anunció que los datos preclínicos de su TERN-701, un inhibidor alostérico de BCR-ABL de próxima generación para la leucemia mieloide crónica (LMC), serán presentados en el 30º Congreso de la Asociación Europea de Hematología en junio de 2025. Los datos muestran una potencia superior en comparación con asciminib frente a múltiples variantes de BCR-ABL, incluidas mutaciones resistentes difíciles de tratar.
Los primeros resultados del estudio Fase 1 CARDINAL mostraron respuestas moleculares prometedoras en pacientes con LMC muy tratados previamente, con mejores respuestas en aquellos que tuvieron una mala respuesta a asciminib. La compañía espera publicar datos adicionales de seguridad y eficacia, incluidos los índices de respuesta molecular mayor (MMR) a 6 meses, en el cuarto trimestre de 2025.
Terns Pharmaceuticals(NASDAQ: TERN)는 만성 골수성 백혈병(CML)을 위한 차세대 알로스테릭 BCR-ABL 억제제인 TERN-701의 전임상 데이터를 2025년 6월에 열리는 제30회 유럽혈액학회 학술대회에서 발표할 예정이라고 밝혔습니다. 이 데이터는 치료가 어려운 내성 돌연변이를 포함한 여러 BCR-ABL 변이체에 대해 asciminib보다 우수한 효능을 입증했습니다.
초기 1상 CARDINAL 연구 결과, 다중 치료를 받은 CML 환자에서 유망한 분자 반응이 나타났으며, asciminib에 반응이 좋지 않았던 환자들에서 반응이 개선된 것으로 나타났습니다. 회사는 2025년 4분기에 6개월 주요 분자 반응(MMR) 비율을 포함한 추가 안전성 및 효능 데이터를 발표할 예정입니다.
Terns Pharmaceuticals (NASDAQ: TERN) a annoncé que les données précliniques de son TERN-701, un inhibiteur allostérique de nouvelle génération de BCR-ABL pour la leucémie myéloïde chronique (LMC), seront présentées lors du 30e Congrès de l'European Hematology Association en juin 2025. Ces données démontrent une puissance supérieure à celle de l'asciminib sur plusieurs variantes de BCR-ABL, y compris des mutations résistantes difficiles à traiter.
Les premiers résultats de l'étude de phase 1 CARDINAL ont montré des réponses moléculaires prometteuses chez des patients atteints de LMC lourdement traités, avec une amélioration des réponses chez ceux ayant eu une mauvaise réponse à l'asciminib. La société prévoit de publier des données supplémentaires sur la sécurité et l'efficacité, y compris les taux de réponse moléculaire majeure (MMR) à 6 mois, au quatrième trimestre 2025.
Terns Pharmaceuticals (NASDAQ: TERN) gab bekannt, dass präklinische Daten zu seinem TERN-701, einem neuartigen allosterischen BCR-ABL-Inhibitor für chronische myeloische Leukämie (CML), auf dem 30. Kongress der European Hematology Association im Juni 2025 vorgestellt werden. Die Daten zeigen eine überlegene Wirksamkeit im Vergleich zu Asciminib bei verschiedenen BCR-ABL-Varianten, einschließlich schwer behandelbarer Resistenzmutationen.
Frühe Ergebnisse der Phase-1-Studie CARDINAL zeigten vielversprechende molekulare Ansprechraten bei stark vorbehandelten CML-Patienten, mit verbesserten Reaktionen bei Patienten, die schlecht auf Asciminib angesprochen hatten. Das Unternehmen plant, im vierten Quartal 2025 weitere Sicherheits- und Wirksamkeitsdaten, einschließlich der 6-Monats-Major-Molekularantwort (MMR)-Raten, zu veröffentlichen.
- TERN-701 showed greater potency than asciminib against several resistance mutations
- Early Phase 1 study demonstrated compelling molecular responses in heavily pre-treated patients
- Drug shows potential to be best in class therapy for CML patients across all treatment lines
- None.
Insights
TERN-701 shows superior potency against resistance mutations compared to existing CML treatments, with early clinical data supporting its potential efficacy.
Terns Pharmaceuticals' upcoming presentation at the European Hematology Association Congress contains significant preclinical data for their TERN-701 compound, a next-generation allosteric BCR-ABL inhibitor targeting chronic myeloid leukemia (CML). The data reveals superior potency against over 20 clinically relevant resistance mutations compared to asciminib, the current leading allosteric inhibitor on the market.
What makes this particularly noteworthy is that TERN-701 demonstrates effectiveness against mutations in multiple domains of the BCR-ABL oncoprotein - including the active-site, P-loop, and allosteric regions. This broad mutation coverage addresses a critical challenge in CML treatment, as patients frequently develop resistance to existing therapies through these specific mutations.
The company also shared limited but promising early data from their Phase 1 CARDINAL trial, reporting "compelling molecular responses" in heavily pre-treated patients. Most intriguingly, they noted "deepening responses" in patients who previously showed poor response to asciminib, suggesting TERN-701 could potentially overcome resistance to existing treatments.
For context, CML treatment typically follows a sequential approach when resistance develops. The ability to address mutations across multiple domains could position TERN-701 as a valuable option across treatment lines. The company's announcement of upcoming 6-month major molecular response (MMR) data in Q4 2025 will be crucial, as MMR is a standard efficacy measure in CML that correlates with long-term outcomes. If these results confirm the early signals, TERN-701 could potentially become an important addition to the CML treatment armamentarium.
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 30th 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:
| Title: | Characterization & Efficacy of TERN-701 in Pre-Clinical Models of Chronic Myeloid Leukemia |
| Number: | S169 |
| Session: | Novel Approaches of CML Treatment |
| Date/Time: | June 13, 2025; 17:00 - 18:15 CEST |
| Presenter: | Ben Parson, Discovery Scientist, Terns Pharmaceuticals |
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
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investors@ternspharma.com
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FAQ
What is TERN-701 and how does it differ from existing CML treatments?
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