This is a multicenter rollover study to provide continued treatment to eligible participants previously enrolled in a RVU120 clinical study and to evaluate the safety of the treatment and record the time on treatment when continued under the same regimen as in the parent study.
To be eligible for this rollover study, participants must be continuing to benefit from their treatment, show an acceptable safety profile, and not have access to commercially available comparator anticancer therapy. Once transitioned to this study, participants will continue with their next planned dose per the regimen of their parent study.

开始日期2025-12-15

申办/合作机构

Ryvu Therapeutics SA

NCT06397313

/ Recruiting临床2期

An Open-Label Clinical Trial of RVU120 as Monotherapy and in Combination With Ruxolitinib in Patients With Intermediate or High-Risk, Primary or Secondary Myelofibrosis (POTAMI-61)

The objective of this clinical trial is to evaluate the efficacy (how well the drug works), safety, pharmacokinetics (PK), and pharmacodynamics (PD) of the study drug, RVU120, in treating adult patients with intermediate or high-risk, primary or secondary myelofibrosis. RVU120 will be given as a single agent or in combination with ruxolitinib.

开始日期2024-09-19

申办/合作机构

Ryvu Therapeutics SA

NCT06243458

/ Recruiting临床2期

A Phase II, Open-label, Multicenter Study of Orally Administered RVU120 for the Treatment of Anemia in Patients With Lower-risk Myelodysplastic Neoplasms (MDS)

This study will evaluate orally administered RVU120, a novel small molecule Cyclin-dependent Kinase (CDK) 8/19 inhibitor, in terms of erythroid hematologic improvement (HI-E) and safety in participants with lower-risk myelodysplastic syndrome (MDS). Responding patients are eligible to continue treatment until loss of response/disease progression.

开始日期2024-09-10

申办/合作机构

GCP Service International Ltd & Co KG

[+6]

100 项与 SEL-120 相关的临床结果

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100 项与 SEL-120 相关的转化医学

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100 项与 SEL-120 相关的专利（医药）

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项与 SEL-120 相关的文献（医药）

2025-07-01·BIOCHEMICAL PHARMACOLOGY

Identification of pyrazole scaffold inhibitors targeting cyclin-dependent kinase 8 for potential use in pulmonary fibrosis

Article

作者: Yen, Shih-Chung ; Sung, Tzu-Ying ; Yang, Chia-Ron ; Chang, Yu-Wei ; Hsu, Jui-Yi ; Tsai, En-Yun ; Wu, Yi-Wen ; Hsu, Kai-Cheng ; Huang, Wei-Jan ; Pan, Shiow-Lin ; Hsieh, Jui-Hua ; Chou, Ching-Hsuan ; Lin, Tony Eight

Idiopathic Pulmonary Fibrosis (IPF) is a disease that includes inflammation and scarring of the lung tissues. Cyclin-dependent kinase 8 (CDK8) is a target of interest due to its role in inflammatory pathways. CDK8 can also modulate the TGF-β/Smad signaling associated with IPF. Herein, a structure-based virtual screening (SBVS) campaign led to the identification of three CDK8 inhibitors. Testing of candidate inhibitors in protein and cellular assays confirmed CDK8 inhibition, with the most potent inhibitor producing an IC₅₀ value of 398.8 nM. Computational analysis identified pharmacological interactions that lead to CDK8 inhibition. No significant cytotoxicity was observed when the inhibitor was treated in vitro. Further results showed that the inhibitor can disrupt proteins associated with the epithelial-mesenchymal transition (EMT) and reduce cell migration. Additionally, the inhibitor can disrupt the TGF- β1/Smad signaling axis in the nucleus, potentially impacting the transcription of IPF related protein expression, when treated in cells at 5 µM. Comparisons to structures of known CDK8 inhibitors showed the identified inhibitor to be structurally novel. When tested against a panel of kinases at 1 µM, the most potent inhibitor demonstrated a favorable CDK8 selectivity profile. The identification of the CDK8 inhibitors in this study can be used in future drug design studies and as CDK8 probes to explore alternative therapeutics for IPF.

2024-06-01·PROTEIN SCIENCE

An ensemble machine learning model generates a focused screening library for the identification of CDK8 inhibitors

Article

作者: Hsu, Kai‐Cheng ; Yang, Chia‐Ron ; Huang, Wei‐Jan ; Pan, Shiow‐Lin ; Yen, Shih‐Chung ; Wu, Yi‐Wen ; Sung, Tzu‐Ying ; Yen, Dyan ; Hsu, Jui‐Yi ; Hsieh, Jui‐Hua ; HuangFu, Wei‐Chun ; Lin, Tony Eight

Abstract:

The identification of an effective inhibitor is an important starting step in drug development. Unfortunately, many issues such as the characterization of protein binding sites, the screening library, materials for assays, etc., make drug screening a difficult proposition. As the size of screening libraries increases, more resources will be inefficiently consumed. Thus, new strategies are needed to preprocess and focus a screening library towards a targeted protein. Herein, we report an ensemble machine learning (ML) model to generate a CDK8‐focused screening library. The ensemble model consists of six different algorithms optimized for CDK8 inhibitor classification. The models were trained using a CDK8‐specific fragment library along with molecules containing CDK8 activity. The optimized ensemble model processed a commercial library containing 1.6 million molecules. This resulted in a CDK8‐focused screening library containing 1,672 molecules, a reduction of more than 99.90%. The CDK8‐focused library was then subjected to molecular docking, and 25 candidate compounds were selected. Enzymatic assays confirmed six CDK8 inhibitors, with one compound producing an IC50 value of ≤100 nM. Analysis of the ensemble ML model reveals the role of the CDK8 fragment library during training. Structural analysis of molecules reveals the hit compounds to be structurally novel CDK8 inhibitors. Together, the results highlight a pipeline for curating a focused library for a specific protein target, such as CDK8.

2024-05-23·JOURNAL OF MEDICINAL CHEMISTRY

Discovery of a Novel and Potent Cyclin-Dependent Kinase 8/19 (CDK8/19) Inhibitor for the Treatment of Cancer

Article

作者: Cai, Xin ; Xu, Jianyu ; Steurer, Barbara ; Zhang, Man ; Ren, Feng ; Liu, Jinxin ; Aliper, Alex ; Wang, Zhen ; Ding, Xiao ; Qi, Hongyun ; Wang, Ling ; Zhavoronkov, Alex

The mediator kinases CDK8 and CDK19 control the dynamic transcription of selected genes in response to various signals and have been shown to be hijacked to sustain hyperproliferation by various solid and liquid tumors. CDK8/19 is emerging as a promising anticancer therapeutic target. Here, we report the discovery of compound 12, a novel small molecule CDK8/19 inhibitor. This molecule demonstrated not only decent enzymatic and cellular activities but also remarkable selectivity in CDK and kinome panels. Besides, compound 12 also displayed favorable ADME profiles including low CYP1A2 inhibition, acceptable clearance, and high oral bioavailability in multiple preclinical species. Robust in vivo PD and efficacy studies in mice models further demonstrated its potential use as mono- and combination therapy for the treatment of cancers.

项与 SEL-120 相关的新闻（医药）

2026-03-19

·ryvu.com

Ryvu Therapeutics Reports 2025 Fiscal Year Financial Results and Provides Corporate Update

Results presented at the American Society of Hematology (ASH) Annual Meeting in December 2025 confirmed the clinical activity of romaciclib (RVU120) in patients with relapsed/refractory acute myeloid leukemia (r/r AML), who have historically poor outcomes following venetoclax-based therapy. In the Phase II RIVER-81 study, complete and incomplete remission rates reached 43% in the 150 mg once-daily cohort, with a favorable safety profile. Romaciclib Phase II POTAMI-61 study in myelofibrosis (MF), which included patients previously exposed or refractory to JAK inhibitors, brought early signals of spleen volume reduction (SVR) and symptom improvement (total symptom score; TSS) without significant myelosuppression. SVR rate of at least 25% (SVR25) was met by 4 out of 14 evaluable patients (29%). At the same time SVR10 was achieved by 7 patients (50%). The Company is progressing research and clinical collaborations with BioNTech, Exelixis, and Menarini Group, as well as strengthening its long-term value drivers with progress in fully owned early pipeline projects. Total operating revenues for the full year 2025 were €20.7 million, compared to €23.7 million for the same period in 2024. EBITDA loss was reduced to €23.2 million, compared to €25.9 million in the previous year. For Q4 alone, those figures were €3.5 million and €8.8 million, respectively. As of March 9, 2026, Ryvu’s cash position was €20.7 million. In addition, Ryvu has secured approximately €20.9 million in non-dilutive grant funding. Krakow, Poland – March 19, 2026 – Ryvu Therapeutics (WSE: RVU), a clinical-stage drug discovery and development company focusing on novel therapies that address emerging targets in oncology, reports its financials for the 2025 fiscal year and provides a corporate update. Pawel Przewiezlikowski, co-founder and Chief Executive Officer of Ryvu Therapeutics, said: – In 2025, we continued to focus on disciplined execution across our clinical programs while maintaining strict cost control. Our priority remains the efficient advancement of romaciclib (RVU120), for which we presented positive Phase II clinical data demonstrating efficacy in difficult-to-treat hematologic malignancies, including acute myeloid leukemia and myelofibrosis. At the same time, we continued to prepare RVU305 for clinical development and to advance multiple early pipeline programs. Thanks to ongoing partnerships and strategic reorganization implemented in Q1 2025, we are generating stable revenue streams and have significantly reduced operating costs. Importantly, we entered 2026 with new grant funding to support our preclinical discovery and research. Krzysztof Brzozka, Ph.D., Executive Vice President and Chief Scientific Officer, said: – Our discovery and research strategy continues to generate promising opportunities in precision oncology. The ONCO Prime platform remains a key engine of innovation, enabling the identification of novel precision oncology targets, including synthetic lethal approaches, in genetically defined cancers. In parallel, we continue to explore next-generation ADC payloads leveraging both synthetically lethal and immunocytotoxic mechanisms. Together with new projects – such as our PERO project (Predictive Engineering for Rational Oncology), which secured significant grant funding in March 2026 – these initiatives are designed to drive the development of future oncology therapies that address high unmet medical needs. 2025 SUMMARY AND RECENT CORPORATE EVENTS Romaciclib (RVU120) clinical development plan progress Ryvu continued to advance the clinical development of romaciclib (RVU120), a first-in-class selective CDK8/CDK19 inhibitor, across multiple hematologic malignancies. Current data support continued development of romaciclib in AML and MF, including further exploration of combination strategies. Throughout 2025, three Phase II studies continued as planned: RIVER-81 (combination with venetoclax in r/r AML), POTAMI-61 (monotherapy and combination with ruxolitinib in MF), and REMARK (monotherapy in LR-MDS; investigator-initiated trial). Ryvu generated further clinical insights and presented updated clinical data from the RIVER-81 and POTAMI-61 studies at the American Society of Hematology (ASH) Annual Meeting. RIVER-81 The Phase II RIVER-81 study evaluates the combination of romaciclib (RVU120), a selective CDK8/CDK19 inhibitor, with venetoclax (VEN) in unfit patients with r/r AML following frontline VEN plus hypomethylating agent (HMA) therapy, a patient population of high unmet need with no approved therapies. In the cohort testing romaciclib dose of 150 mg QD (once daily) and VEN 400 mg , 3 of 7 treated patients (43%) achieved CR/CRi (CRx) and 2 of 7 patients (28%) achieved CR. Overall, the mean duration of response at 150 mg QD was 141 days.   These data support expansion of the RIVER-81 study and present opportunities for investigation in additional AML settings, including the frontline setting. In January 2026, the U.S. Food and Drug Administration (FDA) held the Type C meeting requested by Ryvu. The FDA raised no objections to opening the expansion cohort in the United States with romaciclib at 150 mg QD in combination with VEN. POTAMI-61 The Phase II POTAMI-61 study evaluates romaciclib as monotherapy and in combination with ruxolitinib (RUX) in patients with MF who have failed or shown suboptimal response to JAK inhibitor therapy. Of the 14 patients evaluable for spleen volume evaluation at 12 weeks or more, 9 achieved spleen volume reduction, with 7 (50%) achieving at least SVR10 and 4 (29%) achieving SVR25 or better. One patient achieved a 59% reduction in spleen volume at week 36. Patients with a high-risk mutation in ASXL1 derived clinical benefit from romaciclib.  Significant and durable TSS improvement was achieved in patients in both cohorts.  These early data indicate that romaciclib is well tolerated and shows initial clinical activity, supporting continued evaluation of romaciclib as a potential therapeutic option for patients with MF. In September 2025, Ryvu announced the initiation of a collaboration with the Children’s Memorial Health Institute as part of the MEDWAY project, an investigator-initiated Phase I clinical study evaluating romaciclib in combination with everolimus in children with recurrent or progressive Group 3 or 4 medulloblastoma. FPFV (First Patient, First Visit) is expected in Q2 2026. Dapolsertib (MEN1703, SEL24): The JASPIS-01 Phase II study evaluates dapolsertib in patients with relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL) as a monotherapy and in combination with glofitamab. The first patient was dosed in March 2025. JASPIS-01 is fully funded by the Menarini Group and operationally executed by Ryvu. RVU305: Ryvu continues development of RVU305, its potentially best-in-class brain-permeable, MTA-cooperative PRMT5 inhibitor, which is completing IND/CTA-enabling studies in preparation for clinical development. In October 2025, the Company presented preclinical data on RVU305 at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, highlighting its brain-permeable profile and potential in MTAP-deleted cancers. Ryvu continues to advance its dual-pronged preclinical discovery and research strategy, focused on the ONCO Prime platform (novel small-molecule precision medicine, including synthetic lethality targets) and ADCs (antibody-drug conjugates) with novel payloads. Grant funding for the ADCraft project: on April 23, 2025, Ryvu announced signing a grant agreement with the Medical Research Agency (in Polish: Agencja Badań Medycznych, “MRA”) for the “ADCraft – next-generation small-molecule payloads for antibody-drug conjugates in oncology” project. The aim of the Project is to develop methods for discovering and testing a new generation of ADC payloads along with a portfolio of R&D activities focused on new therapeutic modalities used in oncology. The Company expects to receive PLN 9.9 million to support the project of a total net value of PLN 13.2 million. Grant funding for the PERO project: on March 11, 2026, the Company signed the grant agreement with the National Centre for Research and Development (in Polish: Narodowe Centrum Badan I Rozwoju; NCBR) for the PERO (“Predictive Engineering for Rational Oncology”) project. The objective of PERO is to establish an innovative technological platform for the functional validation of structural protein pockets of potential therapeutic targets in oncology. The project addresses a significant technological gap by enabling an in-depth, currently unavailable level of functional target validation based on integrated genomic, structural, and pharmacological data. The funding, PLN 20.0 million of a PLN 32.4 million project, will significantly fund the development of an innovative platform for functional target validation in oncology. Ryvu continues to advance partnerships with Menarini Group, BioNTech, and Exelixis, under which the Company is fully reimbursed for its expenses and has the potential to receive multiple financial milestones. Clinical collaboration with BioNTech: on September 2, 2025, Ryvu announced an expansion of its collaboration with BioNTech. Based on the new agreement, Ryvu supports BioNTech in accelerating site activation and patient enrollment for several of BioNTech’s priority oncology clinical programs in Poland, including indications such as lung, breast, and colorectal cancers. Extension of the research collaboration with BioNTech: on March 16, 2026, Ryvu informed about amending its research collaboration option exclusive license agreement with BioNTech, originally disclosed in November 2022. Under the amendment, the parties agreed to extend its research collaboration by an additional period of one year – until November 2028. KEY UPCOMING INDUSTRY AND INVESTOR EVENTS Ryvu will host partnering and investor meetings at all of the below conferences, with scientific presentations where noted: BIO-Europe Spring (Lisbon, Portugal), March 23-25 LSX World Congress (Lisbon, Portugal), March 24-25 AACR Annual Congress (San Diego, CA), April 17-22: Data to be presented on the ONCO Prime platform BIO Equity Europe (Prague, Czech Republic), May 4-6 ASCO Annual Meeting (Chicago, IL), May 29 to June 2 EHA Annual Congress (Stockholm, Sweden), June 12-15 BIO International Convention (San Diego, CA), June 22-25 2025 FISCAL YEAR FINANCIAL UPDATE Cash Position – On December 31, 2025, Ryvu Therapeutics held €25.5 million in cash, cash equivalents, and investment funds, compared to €52.7 million at the end of 2024. On March 9, 2026, the Company held €20.7 million in cash, cash equivalents and investment funds. In addition, Ryvu has secured approximately €20.9 million in non-dilutive grant funding. Operating Revenues – In 2025, Ryvu recognized total operating revenues (including grants) of €20.7 million, compared to €23.7 million in 2024. Operating costs, related primarily to research and development expenditures, excluding the valuation of NodThera shares and the non-cash cost of valuation of the Incentive Program for 2025, amounted to €43.0 million, compared to €51.1 million in 2024. EBITDA result – EBITDA loss for full-year 2025 was reduced to €23.2 million, compared to €25.9 million in the previous year. EBITDA loss in Q4 2025 was €3.5 million, compared to €8.8 million in the previous year. Net Loss Attributable to Common Shareholders – In 2025, the net loss attributable to common shareholders, excluding the non-cash cost of the Incentive Program, amounted to €23.2 million, compared to €24.9 million in the previous year. RYVU Therapeutics Leona Henryka Sternbacha 2 30-394 Kraków, Poland

临床2期临床结果引进/卖出ASH会议临床1期

2025-11-20

·ryvu.com

Ryvu Therapeutics Reports Third Quarter 2025 Financial Results

Three romaciclib (RVU120) abstracts and one dapolsertib (MEN1703) abstract were accepted for poster presentation at the 2025 American Society of Hematology (ASH) Annual Meeting in December. Romaciclib continues to demonstrate meaningful activity in the Phase II study across multiple hematologic malignancies, including AML and myelofibrosis, while dapolsertib offers an innovative approach to address treatment resistance in aggressive lymphomas. Ryvu presented new preclinical data on RVU305 (brain-penetrant, MTA-cooperative PRMT5 inhibitor) and the ONCO Prime novel target discovery platform at the 2025 AACR-NCI-EORTC Conference in October. As of November 11, 2025, Ryvu’s cash position was €28.2 million. In addition, Ryvu has secured approximately €18.5 million in non-dilutive grant funding. Krakow, Poland – November 20, 2025 – Ryvu Therapeutics (WSE: RVU), a clinical-stage drug discovery and development company focusing on novel therapies that address emerging targets in oncology, today reported financial results for the third quarter ended September 30, 2025, and provided a corporate update. Pawel Przewięźlikowski, co-founder and Chief Executive Officer of Ryvu Therapeutics, said: – We are excited to present Phase II clinical data at the ASH conference in December, with three abstracts on romaciclib and one on dapolsertib. Romaciclib continues to show meaningful activity across multiple hematologic malignancies, and dapolsertib is being tested as an innovative option for aggressive lymphomas. Q3 2025 SUMMARY AND RECENT CORPORATE EVENTS Romaciclib (RVU120): In the third quarter of 2025, Ryvu advanced romaciclib, its selective CDK8/CDK19 inhibitor, across three Phase II clinical studies in hematologic malignancies. Three abstracts were accepted for presentation at the 2025 American Society of Hematology (ASH) Annual Meeting (December 6-9), highlighting continued progress and clinical activity across AML, myelofibrosis, and lower-risk MDS. Acute myeloid leukemia (AML): Data from the Phase II RIVER-81 trial suggest that romaciclib restores sensitivity to venetoclax in resistant AML, inducing complete remissions with a favorable safety profile. Myelofibrosis (MF): Interim results from the Phase II POTAMI-61 study indicate clinically meaningful spleen volume and symptom reductions, supporting romaciclib’s potential role in the post-JAK inhibitor setting. Lower-risk myelodysplastic syndrome (LR-MDS): In the Phase II REMARK study, one heavily pretreated patient achieved a major erythroid response. New IIT Phase I study: on September 9, Ryvu announced the initiation of a collaboration with the Children’s Memorial Health Institute as part of the MEDWAY project – a new, investigator-initiated Phase I clinical study aimed to evaluate romaciclib in combination with everolimus in children with recurrent or progressive Group 3 or 4 medulloblastoma. Dapolsertib: a dapolsertib abstract was accepted for presentation at the 2025 ASH Annual Meeting, reflecting growing clinical experience with the program. The ongoing Phase II JASPIS-01 study is evaluating dapolsertib in aggressive B-cell lymphomas, both as a single agent and in combination with glofitamab.  RVU305: In October 2025, Ryvu presented preclinical data on RVU305, a brain-permeable MTA-cooperative PRMT5 inhibitor, at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, showcasing a potentially best-in-class profile in MTAP-deleted cancers. IND/CTA-enabling studies are planned to be completed in H2 2025. ONCO Prime platform: At the same event (AACR-NCI-EORTC), Ryvu also presented data from ONCO Prime, its proprietary, integrated synthetic lethality discovery platform leveraging patient-driven models, engineered systems, and high-throughput CRISPR/omics analytics – uncovers the identification of novel targets across various cancer types, including colorectal cancer (CRC) in genetically defined patient populations. Ryvu continues to advance its dual-pronged preclinical discovery strategy built around the ONCO Prime platform, focused on novel small-molecule precision medicine, including synthetic lethality targets and ADCs (antibody-drug conjugates) with novel payloads. New strategic agreement with BioNTech: on September 2, Ryvu announced an expansion of its collaboration with BioNTech. Based on the new agreement, Ryvu will support BioNTech in accelerating site activation and patient enrollment for several of BioNTech’s priority oncology clinical programs in Poland, including indications such as lung, breast, and colorectal cancers. Ryvu is progressing R&D partnerships with BioNTech, Exelixis, and Menarini. Ryvu is fully reimbursed for its expenses in these collaborations and has the potential to achieve multiple financial milestones. UPCOMING INDUSTRY AND INVESTOR EVENTS Life Science Open Space (Krakow, Poland), November 27-28: Paweł Przewięźlikowski, CEO of Ryvu, will deliver a presentation entitled: “From Ryvu labs in Krakow to AML patients worldwide – the story of romaciclib”. 2025 American Society of Hematology Annual Meeting (Orlando, US), December 6-9: Ryvu will present four abstracts on romaciclib and dapolsertib and host scientific and partnering meetings. DM BOŚ Investor Conference – Business Outlook for 2026 (online), January 8, 10:00 AM CET: Ryvu will host investor presentation. 11th Oncology Innovation Forum (San Francisco, US), January 10: Ryvu will host partnering and investor meetings. Biotech Showcase (San Francisco, US), January 12-14: Ryvu will host partnering and investor meetings. BIO Partnering at JPM (San Francisco, US), January 12-15: Ryvu will host partnering and investor meetings. Q3 2025 FINANCIAL UPDATE Cash Position – On September 30, 2025, Ryvu Therapeutics held €32 million in cash, cash equivalents, and investment funds, compared to €52.7 million on December 31, 2024. On November 11, 2025, the Company held €28.2 million in cash, cash equivalents, and investment funds. In addition, Ryvu has secured approximately €18.5 million in non-dilutive grant funding. Operating Revenues – In the first three quarters of 2025, Ryvu recognized total operating revenues (including grants) of €14.6 million, compared to €17.1 million in the corresponding period of 2024. Operating costs, primarily related to research and development expenditures, excluding the valuation of NodThera shares and non-cash cost of valuation of the Incentive Program for the first three quarters of 2025, amounted to €33 million, compared to €35.1 million for the same period last year. Thanks to the cost discipline and strategic reorganization announced in February 2025 Ryvu reduced its operating loss in Q3 2025 by €0.2 million (3%) yoy. Net Loss Attributable to Common Shareholders – In the first three quarters of 2025, the net loss attributable to common shareholders, excluding the non-cash cost of the Incentive Program, amounted to €19.1 million, compared to €17.1 million in the same period of the previous year.

临床1期临床2期ASH会议临床结果AACR会议

2025-11-03

·ryvu.com

Ryvu Therapeutics Announces Three Abstracts on Romaciclib (RVU120) and One Abstract on Dapolsertib (MEN1703) at the 2025 ASH Annual Meeting

Romaciclib continues to show efficacy in AML: Data from the Phase II RIVER-81 trial suggest that romaciclib restores sensitivity to venetoclax in resistant AML, inducing complete remissions with a favorable safety profile. Clinical activity in myelofibrosis (MF): Interim results from the Phase II POTAMI-61 study indicate clinically meaningful spleen volume and symptom reductions, supporting romaciclib’s potential role in the post-JAK inhibitor setting. Erythroid response in LR-MDS: In the romaciclib’s Phase II REMARK study, one heavily pretreated patient achieved a major erythroid response. Dapolsertib continues evaluation in aggressive lymphomas: The ongoing Phase II JASPIS-01 study represents the first clinical evaluation of dapolsertib in aggressive B-cell lymphomas, exploring dapolsertib both as a single agent and in combination with glofitamab. Krakow, Poland – November 3, 2025 – Ryvu Therapeutics (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. Hendrik Nogai, M.D., Chief Medical Officer of Ryvu Therapeutics, said: – 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. These results strengthen our confidence in the potential of our targeted therapies to improve outcomes for patients with difficult-to-treat blood cancers. Details on the abstracts, which were submitted on July 31, 2025, are as follows: Abstract Title: Preliminary results from RIVER-81, a phase 2 study of romaciclib (RVU120) + venetoclax in patients with acute myeloid leukemia failing first-line venetoclax + hypomethylating agent (HMA) Session name: 616. Acute myeloid leukemias: Investigational drug and cellular therapies: Poster 2 Session date and time: December 7, 6:00-8:00 PM EST Poster number: 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. 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. 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. 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. These findings support continued enrollment and further evaluation of romaciclib + VEN as a potential therapeutic option for patients with poor-prognosis AML. 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. 2022/ABM/06/00002 – 00. Abstract Title: 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 (POTAMI-61) Session name: 634. Myeloproliferative syndromes: Clinical and epidemiological: Poster 1 Session date and time: December 6, 5:30-7:30 PM EST Poster number: 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. 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. 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. 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. Abstract Title: 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) Session name: 637. Myelodysplastic syndromes: Clinical and Epidemiological: Poster 3 Session date and time: December 8, 6:00-8:00 PM EST Poster number: 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. 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. 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. Ongoing analyses aim to define further romaciclib’s erythroid activity, optimal dosing, and molecular predictors of response in LR-MDS. Abstract Title: An open-label, phase 2 study of dapolsertib (MEN1703, SEL24) as monotherapy and in combination with glofitamab in patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma Session name: 627. Aggressive lymphomas: Targeted and pharmacologic therapies: Poster 3 Session date and time: December 8, 6:00-8:00 PM EST Poster number: 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. 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. 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. 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. All abstracts are now available online and can be obtained from the conference site:  https://www.hematology.org/meetings/annual-meeting/abstracts

临床结果临床2期免疫疗法ASH会议ASCO会议

100 项与 SEL-120 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
晚期恶性实体瘤	临床2期	波兰	Ryvu Therapeutics SA	2025-12-15
晚期恶性实体瘤	临床2期	西班牙	Ryvu Therapeutics SA	2025-12-15
骨髓纤维化	临床2期	意大利	Ryvu Therapeutics SA	2024-09-19
骨髓纤维化	临床2期	波兰	Ryvu Therapeutics SA	2024-09-19
染色体5q缺失综合征	临床2期	法国	Ryvu Therapeutics SA	2024-09-10
染色体5q缺失综合征	临床2期	德国	Ryvu Therapeutics SA	2024-09-10
染色体5q缺失综合征	临床2期	意大利	Ryvu Therapeutics SA	2024-09-10
染色体5q缺失综合征	临床2期	波兰	Ryvu Therapeutics SA	2024-09-10
染色体5q缺失综合征	临床2期	西班牙	Ryvu Therapeutics SA	2024-09-10
骨髓单体7	临床2期	法国	Ryvu Therapeutics SA	2024-09-10

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临床结果

适应症

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT06191263 (REMARK, ASH2025)	临床2期	贫血 \| 骨髓增生异常/骨髓增生性疾病 SF3B1 mutation	42	Romaciclib 150 mg q.o.d.	壓憲遞獵憲艱鹽簾膚顧(鹹鹽糧衊膚憲選衊蓋觸) = 鬱簾膚範願願鏇糧膚艱積願衊範淵顧醖遞製鬱 (艱鹽選餘憲窪齋窪獵獵 ) 更多	积极	2025-12-06
NCT06397313 (POTAMI-61, ASH2025)	临床1/2期	骨髓纤维化	23	Romaciclib	鏇繭襯簾膚餘齋醖鹽製(窪膚餘廠餘夢築觸願廠) = 繭糧鏇衊選鏇壓選襯選積構鬱鬱遞淵顧鏇願艱 (鏇顧齋蓋窪選選醖蓋夢 ) 更多	积极	2025-12-06
NCT06397313 (POTAMI-61, ASH2025)	临床1/2期	骨髓纤维化	23	Romaciclib + Ruxolitinib	鏇繭襯簾膚餘齋醖鹽製(窪膚餘廠餘夢築觸願廠) = 顧積憲壓構鹽築範憲構積構鬱鬱遞淵顧鏇願艱 (鏇顧齋蓋窪選選醖蓋夢 ) 更多	积极	2025-12-06
NCT06191263 (RIVER-81, EHA2025)	临床2期	急性髓性白血病一线 ASXL1 \| TP53 \| NRAS	36	RVU120+VEN	糧積獵構築鬱廠顧衊廠(範襯獵繭築蓋鹹憲衊襯) = 41% of the treated patients 窪選鏇壓顧醖顧鏇構憲 (壓簾壓鬱鹽艱襯襯艱蓋 ) 更多	积极	2025-05-14
NCT06191263 (RIVER-81, EHA2025)	临床2期	急性髓性白血病一线 ASXL1 \| TP53 \| NRAS	36	Placebo		积极	2025-05-14
NCT04021368 (RIVER-52, EHA2025)	临床1期	急性髓性白血病 \| 难治性高危骨髓增生异常综合征 NPM1 mutation	39	RVU120 250 mg	鑰觸衊選憲醖網衊鬱艱(夢醖顧鹽膚簾鹽選選艱) = Infectious complications were among the most frequent events 夢艱觸鑰餘窪遞顧膚鹽 (齋製艱構觸壓範壓襯獵 ) 更多	不佳	2025-05-14
NCT04021368 \| NCT06268574 (CLI120-001, EHA 12024 \| EHA 22024) 人工标引	临床1/2期	高危骨髓增生异常综合征 \| 难治性急性髓细胞白血病	39	RVU120	憲繭艱鹽鹽夢鬱顧選餘(衊憲築蓋簾艱衊簾鏇餘) = In CLI120-001, Nausea and vomiting (mostly G1-2) were the most frequent treatment-emergent adverse events. In RIVER-52 did not experience any drug-related adverse events in the first cycle 衊衊醖廠積夢鹹積艱憲 (築繭艱餘艱餘齋襯醖齋 ) 更多	积极	2024-05-14
NCT06191263 (RIVER-81, EHA 12024 \| EHA 22024) 人工标引	临床2期	急性髓性白血病二线	3	RVU120+venetoclax	鹽窪衊鏇齋壓願簾觸憲(範觸夢窪願齋選艱壓簾) = None 壓衊鏇繭鹽簾醖鬱製淵 (範鬱鹽鏇淵獵範壓鏇範 ) 更多	积极	2024-05-14
NCT04021368 \| NCT06268574 (EHA2024)	N/A	骨髓增生异常/骨髓增生性疾病二线	39	RVU120	簾觸艱範選窪壓構艱淵(築鏇醖廠願淵鹹顧衊衊) = 廠繭鹹淵獵顧糧遞構鏇遞製製網衊蓋鏇顧構醖 (願繭鹹衊構餘顧鏇網築 )	积极	2024-05-14
NCT04021368 (CLI120-001, Biospace) 人工标引	临床1期	急性髓性白血病 \| 高危骨髓增生异常综合征	38	RVU120 250 mg	夢艱遞蓋鏇觸鹽顧顧鹽(艱醖襯餘積繭選醖壓餘) = 觸壓繭廠鏇衊壓積網齋餘構醖壓夢醖餘鏇遞願 (鬱膚顧選顧獵窪壓餘獵 ) 更多	积极	2023-12-11
NCT05052255 (ESMO 12023 \| ESMO 22023) 人工标引	临床1/2期	实体瘤	30	RVU120	構蓋襯積願獵窪膚選衊(鹽網遞艱選餘構鏇蓋範) = 廠鑰築艱顧齋鏇夢鏇艱鹹糧糧鬱範獵淵衊襯淵 (範選襯壓製壓觸鹽願製 ) 更多	积极	2023-10-23
NCT04021368 (CLI120-001, EHA2023)	临床1期	高危骨髓增生异常综合征 \| 难治性急性髓细胞白血病	22	RVU120	鏇繭積淵顧膚簾鹽遞製(齋廠遞壓簾顧鬱蓋網淵) = in a patient treated at 100 mg 鏇窪淵觸鹽積壓蓋願鹹 (鑰顧簾夢繭製積顧齋鑰 ) 更多	-	2023-06-08