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Opna Bio宣布2024年ASH报告,重点介绍了BET抑制剂OPN-2853与Ruxolitinib在骨髓纤维化中的第一阶段联合研究的中期数据,以及EP300/CBP溴碘甲烷抑制剂OPN-6602在多发性骨髓瘤中的有前景的临床前数据

Opna Bio Announces 2024 ASH Presentations Highlighting Interim Data from Phase 1 Combo Study of BET Inhibitor OPN-2853 with Ruxolitinib in Myelofibrosis, and Promising Preclinical Data with EP300/CBP Bromodomain Inhibitor OPN-6602 in Multiple Myeloma

businesswire 等信源发布 2024-11-13 20:58

可切换为仅中文


SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Opna Bio, a clinical-stage biopharmaceutical company focused on the discovery and development of novel oncology therapeutics, announced today that two abstracts have been accepted for poster presentations at the American Society of Hematology (ASH) annual meeting, taking place Dec 7-10, 2024 in San Diego.

加利福尼亚州南旧金山——(商业新闻短讯)——专注于发现和开发新型肿瘤治疗药物的临床阶段生物制药公司Opna Bio今天宣布,两篇摘要已被接受在2024年12月7日至10日在圣地亚哥举行的美国血液学会(ASH)年会上进行海报展示。

The presentations will highlight data from Opna’s lead clinical programs, OPN-2853 and OPN-6602..

演讲将重点介绍Opna主要临床项目OPN-2853和OPN-6602的数据。。

The data presentations will include an interim analysis of the ongoing Phase 1 study of OPN-2853, a bromodomain and extra-terminal motif (BET) inhibitor being tested in combination with ruxolitinib, a Janus kinase 1/2 (JAK1/2) inhibitor, in patients with myelofibrosis who are no longer responding to ruxolitinib alone.

数据介绍将包括对正在进行的OPN-2853第一阶段研究的中期分析,OPN-2853是一种溴结构域和末端外基序(BET)抑制剂,正在与Janus激酶1/2(JAK1/2)抑制剂ruxolitinib联合测试,用于骨髓纤维化患者不再单独使用ruxolitinib。

The study is testing the hypothesis that a continuous daily dosing regimen of oral agents will reduce disease burden. This investigator-initiated study is led by Professor Adam Mead at the University of Oxford through a collaboration with Cancer Research UK (CRUK) and is run through the Cancer Research UK Clinical Trials Unit at the University of Birmingham.

这项研究正在验证这样的假设,即口服药物的连续每日给药方案将减轻疾病负担。这项由研究者发起的研究由牛津大学亚当·米德教授通过与英国癌症研究所(CRUK)的合作领导,并通过伯明翰大学的英国癌症研究临床试验部门进行。

As of February 2024, 16 patients have been enrolled at different dose levels. Encouraging levels of spleen reduction, with minimal toxicities and adverse events, have been observed thus far..

截至2024年2月,已有16名患者以不同的剂量水平入选。到目前为止,已经观察到令人鼓舞的脾脏减少水平,毒性和不良事件最小。。

A second presentation features preclinical data with OPN-6602, an oral, small molecule inhibitor of the E1A binding protein (EP300) and CREB-binding protein (CBP) currently being tested in a Phase 1 trial in multiple myeloma (MM). In human-derived MM models, OPN-6602 suppresses tumor growth, while downregulating key MM driving genes, with synergistic effects observed in combination with dexamethasone, pomalidomide and mezigdomide..

第二篇介绍介绍了OPN-6602的临床前数据,OPN-6602是一种口服的E1A结合蛋白(EP300)和CREB结合蛋白(CBP)的小分子抑制剂,目前正在多发性骨髓瘤(MM)的1期临床试验中进行测试。在人类来源的MM模型中,OPN-6602抑制肿瘤生长,同时下调关键的MM驱动基因,与地塞米松,pomalidomide和mezigdomide联合观察到协同作用。。

“We are excited about the upcoming data disclosures at ASH. Both OPN-2853 and OPN-6602 were intentionally designed to have a high C-max and short half-life. This distinct pharmacokinetic profile allows for continuous daily dosing that potentially results in a lower incidence of toxicities and improved efficacy,” said Gideon Bollag, PhD, chief scientific officer of Opna Bio..

“我们对ASH即将公布的数据感到兴奋。OPN-2853和OPN-6602都被有意设计为具有较高的C-max和较短的半衰期。这种独特的药代动力学特征允许连续每日给药,这可能会降低毒性发生率并提高疗效,”Opna Bio首席科学官吉迪恩·博拉格博士说。。

Investigator-sponsored study

Title: “PROMise Trial: Interim analysis of PROMise, a clinical study combining the BET inhibitor OPN-2853 with ruxolitinib in patients with advanced myelofibrosis experiencing an inadequate response to ruxolitinib”

标题:“PROMise试验:PROMise的中期分析,一项将BET抑制剂OPN-2853与ruxolitinib联合用于对ruxolitinib反应不足的晚期骨髓纤维化患者的临床研究”

Publication Number: 3186

出版编号:3186

Session Name: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster II

会话名称:634。骨髓增生综合征:临床和流行病学:海报II

Date and Time: December 8th, 6-8 PM

日期和时间:12月8日下午6-8点

Presenter: Adam Mead, PhD, Professor of Haematology, Radcliffe Department of Medicine, CRUK Senior Cancer Research Fellow

主持人:亚当·米德博士,拉德克利夫医学系血液学教授,克鲁克高级癌症研究员

Opna-sponsored research

Opna赞助的研究

Title: “OPN-6602, an Orally Bioavailable EP300/CBP Bromodomain Inhibitor, Targets Multiple Myeloma Through Suppression of IRF4 and MYC”

标题:“口服生物可利用的EP300/CBP溴结构域抑制剂OPN-6602通过抑制IRF4和MYC靶向多发性骨髓瘤”

Publication Number: 1908

出版编号:1908

Session Name: 651. Multiple Myeloma and Plasma Cell Dyscrasias: Basic and Translational: Poster I

会话名称:651。多发性骨髓瘤和浆细胞恶液质症:基础和翻译:海报I

Date and Time: December 7th, 5:30 – 7:30 PM

日期和时间:12月7日下午5:30至7:30

Presenter: Bernice Matusow, MS, Director, Preclinical Development, Opna Bio

主持人:Bernice Matusow,医学博士,Opna Bio临床前开发总监

About Opna Bio

Opna生物

Opna Bio is a clinical-stage biopharmaceutical company focused on the discovery and development of novel oncology therapeutics. The company’s broad portfolio targets multiple drivers of cancer, including a novel oncology discovery program focused on the fragile-X multifunctional RNA-binding protein (FMRP) and a diversified pipeline of promising oncology assets.

Opna Bio是一家临床阶段的生物制药公司,专注于发现和开发新型肿瘤治疗药物。该公司的广泛投资组合针对多种癌症驱动因素,包括一项专注于脆性X多功能RNA结合蛋白(FMRP)的新型肿瘤学发现计划和一系列有前途的肿瘤学资产。

The Opna team has a proven track record of scientific expertise and commercial value creation, having advanced multiple FDA-approved drugs to market. Opna’s lead clinical compounds include OPN-2853, a potentially best-in-class BET bromodomain inhibitor, being evaluated in patients with myelofibrosis in combination with ruxolitinib, and OPN-6602, a dual EP300/CBP inhibitor, currently being studied in a first-in-human Phase 1 clinical trial in multiple myeloma patients.

Opna团队在科学专业知识和商业价值创造方面有着良好的记录,已经将多种FDA批准的药物推向市场。Opna的主要临床化合物包括OPN-2853,一种潜在的最佳BET溴结构域抑制剂,正在与ruxolitinib联合用于骨髓纤维化患者的评估,以及OPN-6602,一种双重EP300/CBP抑制剂,目前正在多发性骨髓瘤患者的首次人体1期临床试验中进行研究。

For more information, please visit opnabio.com..

有关更多信息,请访问opnabio.com。。