EN
登录

Jubilant Therapeutics在 2026年 SOHO会议上宣布 JBI-802治疗骨髓增殖性肿瘤患者的 ongoing I/II期研究的首批初步临床数据

Jubilant Therapeutics Announces First Preliminary Clinical Data from Ongoing Phase 1/2 Study of JBI-802 in Patients with Myeloproliferative Neoplasms at SOHO 2026

CISION 等信源发布 2026-09-15 21:32

可切换为仅中文


Presentation highlights data demonstrating that the dual LSD1/HDAC6 inhibitor achieves rapid and sustained dose-responsive reductions in platelet counts in patients with essential thrombocythemia (ET), with consistent activity also observed in polycythemia vera (PV) and other myeloproliferative neoplasms (MPNs).

演示重点展示了相关数据,表明该LSD1/HDAC6双重抑制剂在原发性血小板增多症(ET)患者中可实现快速且持续的剂量依赖性血小板计数降低,并在真性红细胞增多症(PV)及其他骨髓增殖性肿瘤(MPN)中也观察到一致的活性。

YARDLEY, Pa.

宾夕法尼亚州亚德利

,

,

Sept. 15, 2026

2026年9月15日

/PRNewswire/ -- Jubilant Therapeutics Inc., a clinical-stage biopharmaceutical company advancing precision therapies for hematological malignancies, today announced the presentation of the first clinical data from its ongoing Phase 1/2 study of JBI-802, the company's first-in-class oral dual LSD1/HDAC6 inhibitor, at the Society of Hematologic Oncology (SOHO) 2026 Annual Meeting, which took place during September 9-12, 2026, in Houston, Texas.

/美通社/ -- 专注于推进血液系统恶性肿瘤精准疗法的临床阶段生物制药公司Jubilant Therapeutics Inc.今日宣布,其首款同类口服双重LSD1/HDAC6抑制剂JBI-802正在进行的1/2期研究的首批临床数据,已在2026年9月9日至12日于德克萨斯州休斯顿举行的血液肿瘤学会(SOHO)2026年年会上发表。

The data demonstrated the first clinical evidence supporting dual inhibition of LSD1 and HDAC6 as a differentiated therapeutic approach for patients with myeloproliferative neoplasms (MPNs), a group of blood cancers, including essential thrombocythemia (ET) and polycythemia vera (PV)..

该数据提供了首个临床证据,支持将LSD1和HDAC6双重抑制作为骨髓增殖性肿瘤(MPNs)患者的一种差异化治疗方法;MPNs是一组血液癌症,包括原发性血小板增多症(ET)和真性红细胞增多症(PV)。

The presentation titled, 'Breaking the Limits of LSD1 Inhibition: Dual LSD1/HDAC6 Epigenetic Targeting with JBI-802 in MPNs,' was given by Dr. Sandra Aung, Chief Development Officer, and reported clinical activity across patients (n = 12) with ET, PV, myelofibrosis (MF) and myelodysplastic syndrome/ myeloproliferative neoplasm (MDS/MPN), with rapid, sustained and durable, dose-dependent reductions in platelet counts with a manageable safety profile..

题为“突破LSD1抑制的局限:JBI-802在骨髓增殖性肿瘤(MPN)中对LSD1/HDAC6的双重表观遗传靶向作用”的报告由首席开发官Sandra Aung博士发表,报告了在一组患者(n=12,包括原发性血小板增多症[ET]、真性红细胞增多症[PV]、骨髓纤维化[MF]以及骨髓增生异常综合征/骨髓增殖性肿瘤[MDS/MPN])中观察到的临床活性,结果显示血小板计数迅速、持续且持久地呈剂量依赖性下降,且安全性可控。

Clinical Highlights

临床亮点

Rapid and Meaningful Platelet Reductions Across MPN Subtypes

在骨髓增殖性肿瘤各亚型中快速且有意义的血小板减少

As of June 30, 2026, twelve patients across four dose cohorts (5 mg, 7 mg, 15 mg, and 20 mg) were evaluated in the dose-escalation portion of the study.

截至2026年6月30日,在研究的剂量递增阶段,共有12名患者接受了评估,他们分属四个剂量组(5 mg、7 mg、15 mg和20 mg)。

Key findings included:

主要发现包括:

Platelet reductions were observed across ET, PV, MF and MDS/MPN patients, with clinical activity seen across JAK2, CALR, and MPL-mutated disease.

在ET、PV、MF和MDS/MPN患者中观察到血小板减少,并且在JAK2、CALR和MPL突变的疾病中均可见临床活性。

At the 15 mg dose level, all three patients achieved rapid and substantial platelet reductions of 75%, 72%, and 81%, respectively within the first 30 days of treatment.

在15 mg剂量水平下,三名患者均在治疗的前30天内实现了快速且显著的血小板减少,降幅分别为75%、72%和81%。

9 of 9 ET/PV patients, evaluable for platelet reduction, achieved reductions ranging from 36-91%. Four ET/PV patients with extreme thrombocytosis (baseline platelet counts >1,000 × 10⁹/L) achieved rapid platelet reductions of 30% to 75% within the first 30 days of treatment and subsequently achieved maximum platelet reductions ranging from 72% to 91% during treatment..

在9名可评估血小板减少情况的ET/PV患者中,全部实现了36%至91%的血小板减少。4名患有极端血小板增多症(基线血小板计数>1,000 × 10⁹/L)的ET/PV患者,在治疗的前30天内迅速实现了30%至75%的血小板减少,并在后续治疗中达到了72%至91%的最大血小板减少幅度。

Platelet responses were durable and maintained through dose modification, supporting a controllable pharmacokinetic-pharmacodynamic relationship.

血小板反应持久,并通过剂量调整得以维持,支持药代动力学-药效学关系可控。

Manageable Safety Profile

可控的安全性特征

As of June 30, 2026, data cutoff:

截至2026年6月30日,数据截止:

No investigator assessed dose-limiting toxicities were observed at the 5 mg, 7 mg, or 15 mg dose levels.

在5 mg、7 mg或15 mg剂量水平下,未观察到研究者评估的剂量限制性毒性。

One dose-limiting thrombocytopenia event was observed at the 20 mg dose level and was successfully managed through protocol-defined dose modification. Following dose reduction to 10 mg, the patient remains on treatment with platelet counts maintained within the normal range.

在20 mg剂量水平观察到1例剂量限制性血小板减少事件,并通过方案规定的剂量调整成功处理。剂量降至10 mg后,患者继续接受治疗,血小板计数维持在正常范围内。

Of the 12 treatment-emergent adverse events (TEAEs) reported, 10 were Grade 1 or 2 in severity and two were Grade 3 or higher. No patients discontinued treatment due to thrombocytopenia or treatment-related adverse events.

在报告的12例治疗期间出现的不良事件(TEAEs)中,10例为1级或2级严重程度,2例为3级或更高。没有患者因血小板减少症或与治疗相关的不良事件而停止治疗。

'These preliminary findings highlight several characteristics that we believe are important for the long-term management of myeloproliferative neoplasms,'

“这些初步发现突出了我们认为对骨髓增殖性肿瘤的长期管理至关重要的几个特征,”

said Daniel O'Connor, President and Chief Executive Officer of Jubilant Therapeutics

Jubilant Therapeutics 总裁兼首席执行官 Daniel O'Connor 表示

. 'In addition to rapid and sustained reductions in platelet counts across multiple MPN subtypes, JBI-802 has demonstrated a favorable tolerability profile, with patients remaining on treatment for more than six months and continuing to derive clinical benefit. We are particularly encouraged by the combination of meaningful clinical activity, prolonged treatment exposure, and a pharmacokinetic profile that supports flexible dose adjustment.

“除了在多种骨髓增殖性肿瘤(MPN)亚型中实现快速且持续的血小板计数降低外,JBI-802还展现出良好的耐受性,患者治疗持续时间超过六个月并持续获得临床获益。令人尤为鼓舞的是,该药物兼具显著的临床活性、较长的治疗暴露时间以及支持灵活剂量调整的药代动力学特征。”

Together, these data suggest JBI-802 has the potential to offer a differentiated therapeutic option for patients living with these chronic hematologic malignancies.'.

综上所述,这些数据表明JBI-802有望为患有这些慢性血液系统恶性肿瘤的患者提供一种差异化的治疗选择。

A Novel Approach to Epigenetic Targeting in MPNs

骨髓增殖性肿瘤表观遗传靶向治疗的新方法

JBI-802 is the only oral dual LSD1/HDAC6 inhibitor currently in clinical development and is administered once daily. JBI-802 was designed to simultaneously inhibit LSD1 and HDAC6, two complementary epigenetic regulators involved in the abnormal blood cell proliferation and production characteristic of MPNs.

JBI-802 是目前临床开发中唯一的口服双重 LSD1/HDAC6 抑制剂,每日给药一次。JBI-802 旨在同时抑制 LSD1 和 HDAC6,这两种互补的表观遗传调控因子参与骨髓增殖性肿瘤(MPN)特征性的异常血细胞增殖和生成。

Preclinical studies have suggested that dual inhibition may provide broader biological activity than selective inhibition of either pathway alone..

临床前研究表明,双重抑制可能比单独选择性抑制任一通路具有更广泛的生物活性。

The molecule has a short half-life of approximately 1.5 to 2 hours and is rapidly cleared from circulation, a profile that may offer several advantages for chronic treatment including predictable systemic exposure, rapid reversibility of pharmacologic effects, flexible dose titration and the ability to promptly manage on-target hematologic effects through dose titration..

该分子的半衰期较短,约为1.5至2小时,并能从循环系统中迅速清除。这一特性可能为慢性治疗带来多项优势,包括可预测的系统性暴露、药理作用的快速可逆性、灵活的剂量滴定能力,以及通过剂量滴定及时管理靶点相关的血液学效应。

The ongoing Phase 1/2 study (

正在进行的1/2期研究(

NCT07612280

NCT07612280

) is evaluating JBI-802 in patients with relapsed, refractory, or treatment-intolerant MPNs. Study objectives include evaluation of safety and tolerability, identification of the recommended Phase 2 dose, and assessment of preliminary efficacy through platelet reduction, durability of hematologic response, and molecular outcomes..

正在评估JBI-802在复发、难治性或治疗不耐受的骨髓增殖性肿瘤(MPN)患者中的疗效。研究目标包括评估安全性和耐受性,确定推荐的二期剂量,并通过血小板减少、血液学反应的持久性以及分子结局来初步评估疗效。

Enrollment is ongoing and Jubilant Therapeutics expects to present additional efficacy, safety, and molecular response data as the program advances.

入组工作正在进行中,Jubilant Therapeutics 预计随着项目的推进,将公布更多的疗效、安全性和分子反应数据。

The poster is available on the Jubilant website at

海报可在Jubilant网站上获取,网址为

SOHO 2026 – JBI-802 Poster

SOHO 2026 – JBI-802 海报

About Myeloproliferative Neoplasms (MPNs)

关于骨髓增殖性肿瘤(MPNs)

Myeloproliferative neoplasms (MPNs) are a group of chronic blood cancers driven by mutations in genes such as JAK2, CALR, and MPL, causing the bone marrow to overproduce blood cells. Essential thrombocythemia (ET) is characterized by excess platelet production, while polycythemia vera (PV) is characterized by excess red blood cell production; both are associated with an increased risk of blood clots and can progress to more advanced disease over time.

骨髓增殖性肿瘤(MPNs)是一组慢性血液癌症,由JAK2、CALR和MPL等基因的突变驱动,导致骨髓过度生产血细胞。原发性血小板增多症(ET)的特征是血小板过度生成,而真性红细胞增多症(PV)的特征是红细胞过度生成;两者均与血栓风险增加相关,并可能随时间进展为更晚期的疾病。

Despite available treatments, many patients with ET and PV continue to experience inadequate disease control, underscoring the need for new therapeutic approaches..

尽管已有可用的治疗方法,许多原发性血小板增多症(ET)和真性红细胞增多症(PV)患者仍未能实现充分的疾病控制,这凸显了对新治疗方法的迫切需求。

About JBI-802

关于 JBI-802

JBI-802 is an orally administered dual inhibitor of lysine-specific demethylase 1, or LSD1, and histone deacetylase 6, or HDAC6. JBI-802 is the only dual LSD1/HDAC6 inhibitor currently in clinical development. JBI-802 simultaneously targets multiple disease-relevant processes, including abnormal megakaryocyte differentiation, platelet production, leukocyte proliferation and inflammatory signaling.

JBI-802 是一种口服给药的赖氨酸特异性去甲基化酶1(LSD1)和组蛋白去乙酰化酶6(HDAC6)双重抑制剂。JBI-802 是目前临床开发中唯一的双重 LSD1/HDAC6 抑制剂。JBI-802 同时靶向多种与疾病相关的过程,包括异常的巨核细胞分化、血小板生成、白细胞增殖以及炎症信号传导。

JBI-802 is being evaluated in an ongoing Phase 1/2 clinical study in patients with essential thrombocythemia, or ET, and other thrombocytosis-predominant myeloid malignancies. Emerging clinical data has demonstrated rapid reductions in platelet counts and activity across multiple molecular subtypes of disease. .

JBI-802 正在一项针对原发性血小板增多症(ET)及其他以血小板增多为主的髓系恶性肿瘤患者的正在进行中的1/2期临床研究中进行评估。新兴的临床数据显示,在多种分子亚型的疾病中,血小板计数和活性均迅速降低。

About Jubilant Therapeutics, Inc.

关于Jubilant Therapeutics, Inc.

Jubilant Therapeutics is a clinical-stage biopharmaceutical company advancing precision therapeutics for oncology and autoimmune diseases. Jubilant Therapeutics leverages deep expertise in medicinal chemistry, structure-based drug design, translational science, and clinical development to discover and develop differentiated small-molecule medicines that address significant unmet medical needs.

Jubilant Therapeutics 是一家处于临床阶段的生物制药公司,致力于推进肿瘤学和自身免疫性疾病领域的精准疗法。Jubilant Therapeutics 凭借在药物化学、基于结构的药物设计、转化科学和临床开发方面的深厚专业知识,发现并开发具有差异化的小分子药物,以满足重大的未满足医疗需求。

The company's lead clinical asset, JBI-802, is a first-in-class dual LSD1/HDAC6 (CoREST) inhibitor currently being evaluated in Essential Thrombocythemia (ET)/ Myeloproliferative Neoplasms (MPN) and other oncology indications. Jubilant's pipeline also includes JBI-3041, a selective first-in-class PAD4 inhibitor with potential applications across cancer and autoimmune diseases.

公司的领先临床资产JBI-802是一种首创的双重LSD1/HDAC6(CoREST)抑制剂,目前正在原发性血小板增多症(ET)/骨髓增殖性肿瘤(MPN)以及其他肿瘤适应症中进行评估。Jubilant的管线还包括JBI-3041,这是一种选择性的首创PAD4抑制剂,在癌症和自身免疫性疾病领域具有潜在应用价值。

Headquartered in Yardley, Pennsylvania, Jubilant Therapeutics is committed to delivering innovative therapies that improve outcomes for patients worldwide.  For more information, please visit .

Jubilant Therapeutics 总部位于宾夕法尼亚州亚德利,致力于提供创新疗法,以改善全球患者的治疗结果。欲了解更多信息,请访问。

www.jubilanttx.com

www.jubilanttx.com

or follow us on Twitter

或者在 Twitter 上关注我们

@JubilantTx

@JubilantTx

and

和

LinkedIn

领英

.

。

SOURCE Jubilant Therapeutics

来源:Jubilant Therapeutics

21

二十一

%

百分比

more press release views with

更多新闻稿浏览量,通过

Request a Demo

申请演示