KRAKOW, Poland, November 03, 2025 / Biotech Newswire / --

波兰克拉科夫，2025年11月3日 /生物技术新闻社/ --

Ryvu Therapeutics

Ryvu治疗学

(WSE: RVU), a clinical-stage drug discovery and development company focusing on novel therapies that address emerging targets in oncology, today announced it will present data on romaciclib (RVU120) and dapolsertib (MEN1703) at the 2025 American Society of Hematology (ASH) Annual Meeting, December 6-10, 2025, in Orlando, Florida..

（WSE：RVU），一家专注于肿瘤学新兴靶点的临床阶段药物发现与开发公司，今日宣布将于2025年12月6日至10日在佛罗里达州奥兰多举行的2025年美国血液学会（ASH）年会上展示romaciclib（RVU120）和dapolsertib（MEN1703）的数据。

Hendrik Nogai, M.D., Chief Medical Officer of Ryvu Therapeutics, said:

亨德里克·诺盖医学博士，Ryvu Therapeutics首席医疗官表示：

'We are excited to share the latest data highlighting the breadth and growing maturity of Ryvu’s clinical pipeline. Romaciclib continues to demonstrate meaningful activity across multiple hematologic malignancies, while dapolsertib offers an innovative approach to address treatment resistance in aggressive lymphomas.

“我们很高兴分享最新的数据，展示Ryvu临床管线的广度和日益增长的成熟度。Romaciclib在多种血液恶性肿瘤中持续显示出显著活性，而dapolsertib则提供了一种创新方法来应对侵袭性淋巴瘤的治疗耐药性。

These results strengthen our confidence in the potential of our targeted therapies to improve outcomes for patients with difficult-to-treat blood cancers.'.

这些结果增强了我们对靶向疗法在改善难治性血癌患者预后方面的潜力的信心。

Details on the abstracts, which were submitted on July 31, 2025, are as follows:

2025年7月31日提交的摘要详细信息如下：

Abstract Title:

摘要标题：

Preliminary results from

初步结果来自

RIVER-81

河流-81

, a phase 2 study of romaciclib (RVU120) + venetoclax in patients with acute myeloid leukemia failing first-line venetoclax + hypomethylating agent (HMA)

，一项关于罗米西利布（RVU120）+维奈托克在一线维奈托克+低甲基化剂（HMA）治疗失败的急性髓系白血病患者中的二期研究

Session name:

会话名称：

616. Acute myeloid leukemias: Investigational drug and cellular therapies: Poster 2

616. 急性髓系白血病：研究性药物与细胞疗法：海报2

Session date and time:

会话日期和时间：

December 7, 6:00-8:00 PM EST

12月7日，东部时间下午6:00-8:00

Poster number:

海报编号：

3424

3424

The Phase II RIVER-81 study evaluates the combination of romaciclib (RVU120), a selective CDK8/CDK19 inhibitor, with venetoclax (VEN) in patients with relapsed or refractory AML following frontline VEN+HMA therapy. As of July 11, 2025, 48 patients with relapsed/refractory AML after VEN+HMA failure were treated in the ongoing RIVER-81 study.

RIVER-81二期研究评估了选择性CDK8/CDK19抑制剂罗米西利布（RVU120）与维奈托克（VEN）联合用于一线VEN+HMA治疗后复发或难治性AML患者的效果。截至2025年7月11日，在正在进行的RIVER-81研究中，已有48名VEN+HMA治疗失败后的复发/难治性AML患者接受了治疗。

No dose-limiting toxicities were observed up to romaciclib 200 mg QD combined with venetoclax 400 mg QD, supporting favorable tolerability across dose levels. Pharmacokinetic analyses confirmed dose-proportional exposure, and pharmacodynamic assessments demonstrated robust inhibition of STAT5 phosphorylation, consistent with on-target CDK8/19 activity.

在罗米西利布每日200毫克与维奈托克每日400毫克的联合用药中，未观察到剂量限制性毒性，这表明在各个剂量水平上具有良好的耐受性。药代动力学分析证实了剂量与暴露成比例，而药效学评估显示STAT5磷酸化的显著抑制，这与CDK8/19靶向活性一致。

The most common adverse events were low-grade gastrointestinal symptoms, anemia, febrile neutropenia, and pneumonia. Among 28 evaluable patients, composite complete remission (CR + CRi) rates were 23% in Stage 1 of Part 2 and 43% among treated patients in Cohort 4, with several ongoing durable responses.

最常见的不良事件为低级别的胃肠道症状、贫血、发热性中性粒细胞减少和肺炎。在28名可评估的患者中，复合完全缓解率（CR + CRi）在第2部分第1阶段为23%，在队列4的治疗患者中为43%，其中数例患者持续有效。

In Cohort 6, two patients were evaluable, with one achieving a CRi and the other patient achieving a substantial blast reduction. Five of eight responding patients remain on therapy, with durations ranging from 0.6 to 7 months. Early efficacy signals suggest romaciclib may restore sensitivity to venetoclax in resistant AML.

在队列6中，两名患者可评估，其中一名达到CRi，另一名患者白血病细胞显著减少。八名应答患者中有五名仍在接受治疗，持续时间从0.6到7个月不等。早期疗效信号表明，罗马西利布可能恢复耐药性AML对维奈托克的敏感性。

These findings support continued enrollment and further evaluation of romaciclib + VEN as a potential therapeutic option for patients with poor-prognosis AML..

这些发现支持继续招募患者，并进一步评估罗米西尼布 + VEN 作为预后不良的急性髓系白血病患者的潜在治疗选择。

Ryvu Therapeutics S.A. is implementing a project co-funded by the European Union: 'Conducting a multicenter, open-label Phase II clinical trial (RIVER-81) evaluating the safety and efficacy of RVU120 in combination with venetoclax in patients with relapsed/refractory acute myeloid leukemia who have failed prior therapy with venetoclax and a hypomethylating agent.' The project is being carried out under grant agreement no.

Ryvu Therapeutics S.A. 正在实施一个由欧盟共同资助的项目：“开展一项多中心、开放标签的II期临床试验（RIVER-81），评估RVU120联合维奈托克治疗复发/难治性急性髓系白血病患者的安全性和有效性，这些患者之前接受维奈托克和低甲基化剂治疗失败。” 该项目正在拨款协议编号下进行。

2022/ABM/06/00002 – 00..

2022/ABM/06/00002 – 00..

Abstract Title:

摘要标题：

An open-label, phase I/II clinical trial of wromaciclib (RVU120) as monotherapy and in combination with ruxolitinib in patients with intermediate or high-risk, primary or secondary myelofibrosis (

一项开放标签、I/II 期临床试验，评估wromaciclib（RVU120）单药治疗及与鲁索替尼联合用于中危或高危原发性或继发性骨髓纤维化患者的安全性和有效性 (

POTAMI-61

POTAMI-61

)

)

Session name:

会话名称：

634. Myeloproliferative syndromes: Clinical and epidemiological: Poster 1

634. 骨髓增殖综合征：临床与流行病学：海报1

Session date and time:

会话日期和时间：

December 6, 5:30-7:30 PM EST

12月6日，东部时间下午5:30-7:30

Poster number:

海报编号：

2045

2045

The Phase II POTAMI-61 study evaluates romaciclib (RVU120), a selective CDK8/19 inhibitor, as monotherapy and in combination with ruxolitinib (RUX) in patients with myelofibrosis (MF) who have failed or shown suboptimal response to JAK inhibitor therapy. As of July 25, 2025, 23 patients were enrolled in Part A (12 monotherapy, 11 combination), with enrollment in Part B ongoing.

POTAMI-61二期研究评估了选择性CDK8/19抑制剂罗马西利布（RVU120）作为单药治疗以及与鲁索替尼（RUX）联合使用，用于对JAK抑制剂治疗失败或反应不佳的骨髓纤维化（MF）患者。截至2025年7月25日，A部分已招募23名患者（12名单药治疗，11名联合治疗），B部分的招募正在进行中。

Romaciclib was administered in 21-day cycles, and treatment was generally well tolerated; the most common adverse events were grade 1–2 nausea (52%) and vomiting (43%). Grade 3 events included anemia, thrombocytopenia, nausea, vomiting, urinary tract infection, and fatigue, each reported in ≤3 patients.

Romaciclib 按 21 天周期给药，治疗总体耐受性良好；最常见的不良事件为 1-2 级恶心 (52%) 和呕吐 (43%)。3 级事件包括贫血、血小板减少、恶心、呕吐、尿路感染和疲劳，每项事件报告均 ≤3 例患者。

Among four evaluable patients, one achieved spleen volume reduction (SVR) ≥20% at 24 weeks, three showed some degree of SVR, and two achieved >50% reduction in total symptom score (TSS). One patient demonstrated complete symptom resolution, and another achieved improvement in bone marrow fibrosis after 12 weeks.

在四名可评估的患者中，一名在24周时脾脏体积减少（SVR）≥20%，三名显示出一定程度的SVR，两名总症状评分（TSS）降低超过50%。一名患者表现出完全的症状缓解，另一名患者在12周后骨髓纤维化有所改善。

Pharmacokinetic results confirmed expected exposure and no drug-drug interaction between romaciclib and RUX. These early data indicate that romaciclib is well tolerated and show initial clinical activity, supporting continued evaluation of romaciclib as a potential therapeutic option for patients with MF..

药代动力学结果证实了预期的暴露量，且romaciclib与RUX之间无药物相互作用。这些早期数据表明romaciclib耐受性良好，并显示出初步的临床活性，支持继续评估romaciclib作为MF患者的潜在治疗选择。

Abstract Title: REMARK

摘要标题：REMARK

: A phase II, open-label, multicenter study of orally administered romaciclib (RVU120) for the treatment of anemia in patients with lower-risk myelodysplastic neoplasms (LR-MDS)

：一项二期、开放标签、多中心研究，口服罗马西利布（RVU120）治疗低风险骨髓增生异常肿瘤（LR-MDS）患者的贫血

Session name:

会话名称：

637. Myelodysplastic syndromes: Clinical and Epidemiological: Poster 3

637. 骨髓增生异常综合征：临床与流行病学：海报 3

Session date and time:

会话日期和时间：

December 8, 6:00-8:00 PM EST

12月8日，东部时间下午6:00-8:00

Poster number:

海报编号：

5649

5649

The Phase II REMARK study evaluates romaciclib (RVU120), an oral CDK8/CDK19 inhibitor, in patients with lower-risk myelodysplastic neoplasms (LR-MDS), a disease characterized by anemia and limited treatment options. As of the data cutoff, 42 patients had initiated treatment, of whom 15 remained on therapy.

第二阶段的REMARK研究评估了口服CDK8/CDK19抑制剂罗马西利布（RVU120）在低风险骨髓增生异常肿瘤（LR-MDS）患者中的效果，该疾病以贫血和治疗选择有限为特征。截至数据截止日期，已有42名患者开始治疗，其中15名仍在继续治疗。

Romaciclib was administered at 150 mg every other day for 13 days in 21-day cycles, with an option to escalate to 250 mg in non-responders or relapsing patients. Preliminary results demonstrated early signs of clinical activity, including one patient with high transfusion burden (≥8 RBC units/16 weeks) who achieved a primary erythroid response (HI-E) per IWG 2018 criteria after 24 weeks of treatment.

Romaciclib 每隔一天以 150 毫克的剂量给药，持续 13 天，在 21 天的周期内进行，并可选择对无应答者或复发患者将剂量增加至 250 毫克。初步结果显示了早期临床活性的迹象，包括一名高输血负担（≥8 个红细胞单位/16 周）的患者在治疗 24 周后根据 IWG 2018 标准达到了主要的红系反应 (HI-E)。

This responder carried an SF3B1 mutation and had previously failed three standard therapies (ESA, luspatercept, lenalidomide). No new safety signals were identified; the most frequent treatment-related adverse events were nausea, vomiting, asthenia, and decreased appetite. These AEs were predominantly low grade; however, they led to discontinuation in some patients.

该患者携带SF3B1突变，并且之前已经失败了三种标准疗法（ESA、luspatercept、lenalidomide）。没有发现新的安全性信号；最常见的治疗相关不良事件是恶心、呕吐、乏力和食欲下降。这些不良事件大多为低级别；然而，在某些患者中导致了停药。

Ongoing analyses aim to define further romaciclib’s erythroid activity, optimal dosing, and molecular predictors of response in LR-MDS..

正在进行的分析旨在进一步确定罗米西利布在低危MDS中的红系活性、最佳剂量以及反应的分子预测因子。

Abstract Title:

摘要标题：

An open-label, phase 2 study of

一项开放标签、2期研究

dapolsertib

达泊西尼

(MEN1703, SEL24) as monotherapy and in combination with glofitamab in patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma

(MEN1703，SEL24) 作为单药治疗以及与glofitamab联合使用，用于治疗复发或难治性侵袭性B细胞非霍奇金淋巴瘤患者。

Session name:

会话名称：

627. Aggressive lymphomas: Targeted and pharmacologic therapies: Poster 3

627. 侵袭性淋巴瘤：靶向和药物治疗：海报3

Session date and time:

会话日期和时间：

December 8, 6:00-8:00 PM EST

12月8日，东部时间下午6:00-8:00

Poster number:

海报编号：

5481

5481

The Phase II JASPIS-01 study evaluates dapolsertib (MEN1703), a dual PIM/FLT3 kinase inhibitor, as monotherapy and in combination with the CD20xCD3 bispecific antibody glofitamab in patients with relapsed or refractory (R/R) aggressive B-cell lymphomas who have received at least 2 prior lines of therapy.

II 期 JASPIS-01 研究评估了dapolsertib（MEN1703），一种双重PIM/FLT3激酶抑制剂，作为单药治疗以及与CD20xCD3双特异性抗体glofitamab联合使用，在接受过至少两种前期治疗的复发或难治性（R/R）侵袭性B细胞淋巴瘤患者中的效果。

Dapolsertib targets key oncogenic and survival pathways, including MYC- and BCL6-associated signaling, and has demonstrated preclinical synergy with anti-CD20 antibodies. The study aims to assess the safety, tolerability, and preliminary efficacy of dapolsertib while exploring its potential to overcome resistance associated with CD20 downregulation.

达泊西尼靶向关键的致癌和生存通路，包括MYC和BCL6相关信号传导，并在临床前研究中显示出与抗CD20抗体的协同作用。本研究旨在评估达泊西尼的安全性、耐受性和初步疗效，同时探索其克服与CD20下调相关耐药性的潜力。

In Part 1, patients are enrolled into two groups: bispecific-naïve patients receiving dapolsertib + glofitamab in dose-optimization cohorts, and heavily pretreated patients receiving dapolsertib monotherapy. Two dosing schedules are being explored – 125 mg (2 weeks on/1 week off) and 150 mg (1 week on/2 weeks off) – to identify the optimal therapeutic window.

在第一部分中，患者被分为两组：双特异性抗体初治患者接受达泊塞替布 + 格洛菲单抗的剂量优化队列，以及重度预处理患者接受达泊塞替布单药治疗。目前正在探索两种给药方案——125 mg（服药2周/停药1周）和150 mg（服药1周/停药2周）——以确定最佳治疗窗口。

Dose selection for Part 2 will be guided by the Data and Safety Monitoring Board, following safety review after ≥2 treatment cycles. As of July 11, 2025, enrollment in Part 1 is ongoing in France, Poland, Spain, and the UK, with additional site activations planned. This study represents the first clinical evaluation of dapolsertib in B-cell lymphoma and seeks to establish a foundation for novel combination strategies addressing resistance to CD20-targeted immunotherapies..

第二部分的剂量选择将由数据和安全监测委员会指导，在完成至少2个治疗周期后的安全性审查后确定。截至2025年7月11日，第一部分在法国、波兰、西班牙和英国的入组工作正在进行中，并计划增加更多试验地点。这项研究代表了达泊塞替布在B细胞淋巴瘤中的首次临床评估，并旨在为解决对CD20靶向免疫疗法耐药性的新型联合策略奠定基础。

All abstracts are now available online and can be obtained from the conference site:

所有摘要现在都可以在线获取，并且可以从会议网站获得：

https://www.hematology.org/meetings/annual-meeting/abstracts

https://www.hematology.org/meetings/annual-meeting/abstracts

About

关于

Ryvu Therapeutics

Ryvu治疗学

Ryvu Therapeutics is a clinical-stage drug discovery and development company focused on novel oncology therapies that address emerging targets in oncology. Internally discovered pipeline candidates at Ryvu use diverse therapeutic mechanisms driven by emerging knowledge of cancer biology, including small molecules and antibody-drug conjugates directed at kinases, synthetic lethality, and immuno-oncology targets..

Ryvu Therapeutics是一家临床阶段的药物发现与开发公司，专注于针对肿瘤学新兴靶点的创新肿瘤疗法。Ryvu内部发现的管线候选药物利用了癌症生物学新兴知识驱动的多样化治疗机制，包括小分子和抗体药物偶联物，针对激酶、合成致死性和免疫肿瘤学靶点。

Ryvu’s most advanced program is romaciclib (RVU120, SEL120), a selective CDK8/CDK19 kinase inhibitor with the potential to treat hematological malignancies. RVU120 is currently in Phase II development (i) in combination with venetoclax for the treatment of patients with r/r AML – the RIVER-81 study, (ii) as a monotherapy for the treatment of patients with lower-risk myelodysplastic syndromes (LR-MDS) – the REMARK study, (iii) as a monotherapy and in combination with ruxolitinib for the treatment of patients with myelofibrosis (MF) – the POTAMI-61 study.

Ryvu公司最先进的项目是romaciclib（RVU120，SEL120），这是一种选择性CDK8/CDK19激酶抑制剂，有潜力治疗血液系统恶性肿瘤。RVU120目前处于II期开发阶段：(i) 联合维奈托克用于治疗r/r AML患者——RIVER-81研究，(ii) 作为单药治疗低风险骨髓增生异常综合征（LR-MDS）患者——REMARK研究，(iii) 作为单药以及联合鲁索替尼用于治疗骨髓纤维化（MF）患者——POTAMI-61研究。

Dapolsertib (MEN1703, SEL24) is a dual PIM/FLT3 kinase inhibitor licensed to the Menarini Group that is currently being investigated in a Phase II study in diffuse large B-cell lymphoma (DLBCL) – the JASPIS-01 study. RVU305, a potentially best-in-class, brain-permeable PRMT5 inhibitor aiming to treat multiple solid tumors, is currently in IND/CTA-enabling studies.

达波尔塞替布（Dapolsertib，MEN1703，SEL24）是一种双重PIM/FLT3激酶抑制剂，已授权给美纳里尼集团，目前正在弥漫性大B细胞淋巴瘤（DLBCL）的二期研究中进行试验——即JASPIS-01研究。RVU305是一种潜在的同类最佳、可穿透血脑屏障的PRMT5抑制剂，旨在治疗多种实体瘤，目前正处于IND/CTA支持性研究阶段。

Ryvu Therapeutics is also engaged in oncology collaborations with BioNTech and Exelixis..

Ryvu Therapeutics还与BioNTech和Exelixis在肿瘤学领域展开合作。

Ryvu was founded in 2007 and is headquartered in Kraków, Poland. It is listed on the Warsaw Stock Exchange and is a component of the sWIG80 index.

Ryvu 成立于2007年，总部位于波兰克拉科夫。该公司在华沙证券交易所上市，是sWIG80指数的成分股。

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ontact

联系

Ryvu Therapeutics

瑞武治疗学

Anna Wilk

安娜·威尔克

+48 532 698 425

+48 532 698 425

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Keywords: Congresses as Topic; Clinical Trials, Phase II as Topic; Clinical Trials, Phase I as Topic; venetoclax; ruxolitinib; Primary Myelofibrosis; glofitamab; Hematologic Neoplasms; Leukemia, Myeloid, Acute; Lymphoma; Lymphoma, Non-Hodgkin; Anemia; Hematology; United States; Poland; Krakow; Ryvu Therapeutics; Romaciclib; RVU120; Dapolsertib; MEN1703; American Society of Hematology; ASH Annual Meeting; Acute Myeloid Leukemia; AML; RIVER-81; CDK8; CDK19; STAT5 phosphorylation; Composite Complete Remission; Myelofibrosis; POTAMI-61; Bone Marrow Fibrosis; Myelodysplastic Neoplasms; LR-MDS; REMARK; Luspatercept; Lenalidomide; Aggressive B-cell Lymphoma; JASPIS-01; PIM kinase; FLT3 kinase; Bispecific antibody; Oncology; Hematologic malignancies; Combination therapy; EU grant.

关键词：会议；二期临床试验；一期临床试验；维奈托克；鲁索替尼；原发性骨髓纤维化；格洛菲他单抗；血液肿瘤；急性髓系白血病；淋巴瘤；非霍奇金淋巴瘤；贫血；血液学；美国；波兰；克拉科夫；Ryvu Therapeutics；罗玛西利；RVU120；达泊塞替；MEN1703；美国血液学会；ASH年会；急性髓系白血病；AML；RIVER-81；CDK8；CDK19；STAT5磷酸化；复合完全缓解；骨髓纤维化；POTAMI-61；骨髓纤维化；骨髓增生异常肿瘤；LR-MDS；REMARK；卢帕特赛普；来那度胺；侵袭性B细胞淋巴瘤；JASPIS-01；PIM激酶；FLT3激酶；双特异性抗体；肿瘤学；血液系统恶性肿瘤；联合疗法；欧盟资助。

Source: Biotech Newswire

来源：生物技术新闻社