KRAKOW, Poland, Oct. 23, 2023 (GLOBE NEWSWIRE) -- Ryvu Therapeutics (WSE: RVU), a clinical-stage drug discovery and development company focusing on novel small molecule therapies that address emerging targets in oncology, announced today updated clinical Phase I data from RVU120 Phase I/II study in patients with relapsed/refractory metastatic or advanced solid tumors, presented at the European Society for Medical Oncology (ESMO) Congress 2023, taking place October 20-24 in Madrid, Spain.

波兰克拉科夫，2023年10月23日（GLOBE NEWSWIRE）-Ryvu Therapeutics（WSE:RVU），一家专注于解决肿瘤学新兴靶点的新型小分子疗法的临床阶段药物发现和开发公司，今天宣布更新临床来自RVU120 I/II期研究的I期数据，用于复发/难治性转移性或晚期实体瘤患者，在10月20日至24日在西班牙马德里举行的欧洲医学肿瘤学会（ESMO）2023大会上发表。

The Company has also provided an update on the progress of the ongoing Phase Ib study in patients with acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (HR-MDS), and presented the updated RVU120 program development plan. Based on the recently updated Phase I study results in patients with solid tumors presented at ESMO, along with data from patients with AML/HR-MDS, the company has updated the development plan for RVU120: Both Phase I studies of RVU120 in patients with solid tumors (AMNYS-51) and AML/HR-MDS (RIVER-51) have provided convincing RVU120 safety data, effectively reducing the risk associated with both the target and the molecule as a first-in-class CDK8/19 inhibitor.Both studies have demonstrated relevant levels of target inhibition at safe doses.Meaningful signs of clinical activity have been reported in patients with AML and HR-MDS, including a complete remission in a patient with NPM1 and DNMT3 mutations, in line with the preclinical data first published by Ryvu in 2019.

该公司还提供了急性髓性白血病（AML）和高危骨髓增生异常综合征（HR-MDS）患者正在进行的Ib期研究进展的最新情况，并提出了更新的RVU120计划开发计划。根据ESMO最近更新的实体瘤患者I期研究结果以及AML/HR-MDS患者的数据，该公司更新了RVU120的发展计划：RVU120在实体瘤患者中的I期研究（AMNYS-51）和AML/HR-MDS（RIVER-51）提供了令人信服的RVU120安全性数据，有效降低与靶标和分子相关的风险，作为一流的CDK8/19抑制剂。这两项研究都证明了安全剂量下相关的靶向抑制水平。据报道，AML和HR-MDS患者具有有意义的临床活动迹象，包括NPM1和DNMT3突变患者完全缓解，这与Ryvu于2019年首次发表的临床前数据一致。

The Phase II development in AML/HR-MDS is planned to be initiated in Q4 2023 with two cohorts of genetically defined patients with AML or HR-MDS as a single agent (RIVER-52) and in combination with venetoclax (RIVER-81).Induction of erythropoiesis in multiple patients in RIVER-51, con.

AML/HR-MDS的II期开发计划于2023年第四季度开始，其中两组基因定义的AML或HR-MDS患者作为单一药物（RIVER-52）并与venetoclax（RIVER-81）。在RIVER-51，con的多个患者中诱导红细胞生成。