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肿瘤药物研发商eFFECTOR Therapeutics将与Dana-Farber癌症研究所合作开展一项2期临床试验,评估Zotatifin作为ER+子宫内膜癌的联合治疗

eFFECTOR Therapeutics to Collaborate with the Dana-Farber Cancer Institute on an Investigator-Sponsored Phase 2 Clinical Trial Evaluating Zotatifin as Combination Treatment in ER+ Endometrial Cancer

BioSpace 等信源发布 2024-05-20 21:08

可切换为仅中文


SOLANA BEACH, Calif. and REDWOOD CITY, Calif., May 20, 2024 (GLOBE NEWSWIRE) -- eFFECTOR Therapeutics, Inc. (NASDAQ: EFTR), a leader in the development of selective translation regulator inhibitors (STRIs) for the treatment of cancer, today announced a collaboration to conduct an investigator-sponsored trial (IST) evaluating zotatifin in combination with abemaciclib and letrozole in patients with estrogen receptor-positive (ER+) endometrial cancer and low grade serous ovarian cancer at the Dana-Farber Cancer Institute (DFCI) under the direction of Panagiotis Konstantinopoulos, M.D., Ph.D., Director of Translational Research and attending oncologist in the Division of Gynecologic Oncology at DFCI, and an Associate Professor of Medicine at Harvard Medical School..

加利福尼亚州索拉纳海滩(SOLANA BEACH)和加利福尼亚州红木城(REDWOOD CITY),2024年5月20日(Global NEWSWIRE)--在开发用于治疗癌症的选择性翻译调节抑制剂(STRIs)方面处于领先地位的效应治疗公司(纳斯达克:EFTR)今天宣布,在达纳-法伯癌症研究所(DFCI)进行一项由研究者赞助的试验(IST),在Panagiotis Konstantinopoulos医学博士、转化研究主任和肿瘤主治医师的指导下,在雌激素受体阳性(ER+)子宫内膜癌和低度浆液性卵巢癌患者中评估佐他汀联合来曲唑治疗。DFCI妇科肿瘤学系,哈佛医学院医学副教授。。

“Endometrial cancer is the most prevalent cancer affecting the female reproductive organs in the United States,” said Dr. Konstantinopoulos. “While early detection offers hope for successful treatment, patients with recurrent or metastatic disease have limited treatment options. Recent studies of the abemaciclib and letrozole combo in ER+ endometrial cancer patients have shown promising activity, however, most patients either fail to respond or eventually develop resistance to CDK4/6 inhibition, a critical aspect of treatment.

Konstantinopoulos博士说:“子宫内膜癌是影响美国女性生殖器官最普遍的癌症。”。“虽然早期发现为成功治疗提供了希望,但复发或转移性疾病患者的治疗选择有限。最近对ER+子宫内膜癌患者的abemaciclib和来曲唑联合治疗的研究显示出有希望的活性,然而,大多数患者要么没有反应,要么最终对CDK4/6抑制产生耐药性,这是治疗的一个关键方面。

Similarly, low grade serous ovarian cancer has shown sensitivity to combined treatment with aromatase inhibitors and CDK4/6 inhibition, but responding patients eventually develop disease progression. By targeting eIF4A, which subsequently downregulates the key factors implicated in CDK4/6 inhibition resistance, we believe that integrating zotatifin with abemaciclib and letrozole treatment regimen represents a compelling strategy for combating recurrent endometrial cancer and low grade serous ovarian cancer.”.

同样,低度浆液性卵巢癌已显示出对芳香化酶抑制剂和CDK4/6抑制联合治疗的敏感性,但有反应的患者最终会发展为疾病进展。通过靶向eIF4A,其随后下调涉及CDK4/6抑制抗性的关键因素,我们认为将唑他汀与abemaciclib和来曲唑治疗方案相结合代表了对抗复发性子宫内膜癌和低度浆液性卵巢癌的引人注目的策略。“。

Doug Warner, M.D., chief medical officer of eFFECTOR Therapeutics added, “We are thrilled to embark on this investigator-sponsored Phase 2 trial in collaboration with Dr. Konstantinopoulos and his team at the DFCI. This trial represents a significant step forward in our collective efforts to address the complexities of endometrial cancer and low grade serous ovarian cancer.

eFFECTOR Therapeutics首席医疗官Doug Warner医学博士补充道:“我们很高兴与DFCI的Konstantinopoulos博士及其团队合作,开始这项由研究者赞助的2期临床试验。这项试验标志着我们在解决子宫内膜癌和低度浆液性卵巢癌复杂性的集体努力中迈出了重要的一步。

By exploring the potential of zotatifin as a combination treatment and its unique mechanism of action, we aim to redefine the treatment landscape and improve outcomes for these patients. With this comprehensive approach which simultaneously targets tumor cell cycle progression while reducing estrogen levels, we hope to overcome resistance mechanisms and enhance treatment efficacy which we believe could be applied in various malignancies beyond breast and endometrial cancers.

通过探索佐他汀作为联合治疗的潜力及其独特的作用机制,我们旨在重新定义治疗前景并改善这些患者的预后。通过这种同时靶向肿瘤细胞周期进展同时降低雌激素水平的综合方法,我们希望克服耐药机制并提高治疗效果,我们认为这可以应用于乳腺癌和子宫内膜癌以外的各种恶性肿瘤。

In parallel, we continue to advance development of zotatifin in ER+ metastatic breast cancer and anticipate determination of the Phase 2 dose (RP2D) of zotatifin in combination with fulvestrant and abemaciclib, in the second half of 2024.”.

与此同时,我们继续推进佐他汀在ER+转移性乳腺癌中的发展,并预计在2024年下半年确定佐他汀联合氟维司群和abemaciclib的2期剂量(RP2D)。”。

About Zotatifin

Zotatifin

Zotatifin is a potent and sequence-selective small molecule inhibitor of the RNA helicase eIF4A that is designed to suppress the overproduction of cell cycle proteins and oncogenes, including Cyclins D and E, CDKs 4 and 6, ERα, KRAS, HER2, and other RTKs. Zotatifin is currently being evaluated in a Phase 2a expansion cohort in combination with fulvestrant and abemaciclib in ER+ breast cancer.

Zotatifin是RNA解旋酶eIF4A的有效且序列选择性的小分子抑制剂,旨在抑制细胞周期蛋白和癌基因(包括细胞周期蛋白D和E,CDKs 4和6,ERα,KRAS,HER2和其他RTK)的过量产生。Zotatifin目前正在与氟维司群和abemaciclib联合用于ER+乳腺癌的2a期扩展队列中进行评估。

Efficacy data presented at 2023 ASCO and SABCS showed a 26% response rate and mPFS of 7.4 months as a triplet in heavily pretreated patients..

2023年ASCO和SABCS的疗效数据显示,经过严重预处理的患者的有效率为26%,mPFS为7.4个月。。

About eFFECTOR Therapeutics

关于效应疗法

eFFECTOR is a clinical-stage biopharmaceutical company pioneering the development of a new class of oncology drugs referred to as STRIs. eFFECTOR’s STRI product candidates target the eIF4F complex and its activating kinase, mitogen-activated protein kinase interacting kinase (MNK). The eIF4F complex is a central node where two of the most frequently mutated signaling pathways in cancer, the PI3K-AKT and RAS-MEK pathways, converge to activate the translation of select mRNA into proteins that are frequent culprits in key disease-driving processes.

eFFECTOR是一家临床阶段的生物制药公司,率先开发了一类称为STRI的新型肿瘤药物。eFFECTOR的STRI候选产品靶向eIF4F复合物及其活化激酶,丝裂原活化蛋白激酶相互作用激酶(MNK)。eIF4F复合物是一个中心节点,其中癌症中两个最常突变的信号通路PI3K-AKT和RAS-MEK通路会聚在一起,以激活选定mRNA转化为蛋白质,这些蛋白质是关键疾病驱动过程中的常见罪魁祸首。

Each of eFFECTOR’s product candidates is designed to act on a single protein that drives the expression of a network of functionally related proteins, including oncoproteins and immunosuppressive proteins in T cells, that together control tumor growth, survival, and immune evasion. Zotatifin, eFFECTOR’s inhibitor of eIF4A, is currently being evaluated in a Phase 2a expansion cohort in combination with fulvestrant and abemaciclib in ER+ breast cancer and in Phase 2 IST in combination with abemaciclib and letrozole in ER+ endometrial cancer.

每个效应子的候选产品都被设计为作用于单个蛋白质,该蛋白质驱动功能相关蛋白质网络的表达,包括T细胞中的癌蛋白和免疫抑制蛋白,它们共同控制肿瘤的生长,存活和免疫逃避。Zotatifin是eIF4A的效应抑制剂,目前正在2a期扩展队列中与ER+乳腺癌中的氟维司群和abemaciclib联合使用,以及在ER+子宫内膜癌中与abemaciclib和来曲唑联合使用的2期IST中进行评估。

Tomivosertib, eFFECTOR’s MNK inhibitor, is currently being evaluated in an investigator-sponsored trial in AML. eFFECTOR has a global collaboration with Pfizer to develop inhibitors of a third target, eIF4E..

效应物的MNK抑制剂托米沃塞(Tomivosertib)目前正在研究者赞助的AML试验中进行评估。eFFECTOR与辉瑞公司进行全球合作,开发第三个靶标eIF4E的抑制剂。