Investigational New Drug application cleared by U.S. Food and Drug Administration Design leverages insights from partner’s ongoing Phase 1 trial in China that support starting dose that appears safe and clinically active based on emerging early clinical data Patient screening anticipated in December 2023, with initial data expected in second half of 2024 FOSTER CITY, Calif., Oct.

美国食品和药物管理局设计批准的研究性新药申请利用合作伙伴在中国正在进行的第一阶段试验的见解，支持基于新出现的早期临床数据的安全和临床活性的起始剂量患者筛查预计于2023年12月，初步数据预计将在下半年加利福尼亚州福斯特城2024年10月。

16, 2023 (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, non-alcoholic steatohepatitis (NASH) and obesity, today announced the U.S.

162023（GLOBE NEWSWIRE）-Terns Pharmaceuticals，Inc.（“Terns”或“Company”）（纳斯达克股票代码：TERN），一家临床阶段生物制药公司，开发一系列小分子候选产品以解决严重疾病，包括肿瘤学，非酒精性脂肪性肝炎（NASH）和肥胖症，今天美国宣布。

Food and Drug Administration’s (FDA’s) clearance of the Company’s Investigational New Drug application and the design of the CARDINAL Trial, Terns’ global Phase 1 clinical trial to evaluate the safety, tolerability, pharmacokinetics (PK) and efficacy of TERN-701 in participants with chronic myeloid leukemia (CML).

美国食品和药物管理局（FDA）批准该公司的研究性新药申请和设计CARDINAL试验，Terns的全球1期临床试验，以评估TERN-701在参与者中的安全性，耐受性，药代动力学（PK）和疗效。慢性粒细胞白血病（CML）。

TERN-701 is the Company’s proprietary, allosteric BCR-ABL tyrosine kinase inhibitor (TKI), designed to target the BCR-ABL myristoyl pocket. “Allosteric BCR-ABL inhibitors comprise a novel class of therapy for CML that has been shown to have superior efficacy and improved safety compared to active-site inhibitors in prior studies.

TERN-701是该公司专有的变构BCR-ABL酪氨酸激酶抑制剂（TKI），旨在靶向BCR-ABL肉豆蔻酰口袋。“变构BCR-ABL抑制剂包括一类新型的CML治疗方法，与先前研究中的活性部位抑制剂相比，该方法已显示出优越的功效和更高的安全性。

We are particularly pleased with our Phase 1 trial design for TERN-701 as it will recruit chronic CML patients who experienced treatment failure on at least one prior second-generation TKI. This will allow us to offer a novel investigational allosteric inhibitor to CML patients in as early as their second line of therapy, where there are currently no approved allosteric inhibitors,” said Emil Kuriakose, MD, chief medical officer-oncolo.

我们对TERN-701的1期试验设计特别满意，因为它将招募至少在一个先前的第二代TKI上经历过治疗失败的慢性CML患者。这将使我们能够在CML患者的第二线治疗中提供一种新型的研究性变构抑制剂，目前尚无批准的变构抑制剂，“首席医疗官oncolo的医学博士Emil Kuriakose说。