• The primary goal of the JASPIS-01 study is to assess the safety and anti-tumor activity of dapolsertib, both as a monotherapy and in combination with glofitamab for the treatment of patients with DLBCL. 

• Dapolsertib hydrochloride is the newly approved INN for MEN1703 (SEL24), as recognized by the World Health Organization (WHO). 

• The JASPIS-01 study was initiated at clinical sites in Poland, and expansion to other EU and non-EU locations is already underway. The study is fully funded by Menarini and executed by Ryvu. 

Krakow, Poland – March 26, 2025 – Ryvu Therapeutics (WSE: RVU), a clinical-stage drug discovery and development company focusing on novel therapies that address emerging targets in oncology, announced today that the first patient has been dosed in the JASPIS-01 study, a Phase II clinical trial investigating dapolsertib (MEN1703, SEL24) for the treatment of patients with relapsed/refractory (r/r) diffuse large B-cell lymphoma (DLBCL).  

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

“We are pleased that the first patient has been dosed in the JASPIS-01 study. DLBCL remains a challenging disease with limited treatment options, particularly in the relapsed/refractory setting. We believe that dapolsertib, with its novel dual inhibition of PIM and FLT3 kinases, holds the potential to offer meaningful therapeutic benefits to these patients. This study is a major step forward in our partnership with the Menarini Group, and we look forward to advancing this program.” 

The JASPIS-01 study is an open-label, Phase II clinical trial investigating dapolsertib as a monotherapy and in combination with glofitamab for the treatment of patients with r/r DLBCL. It comprises three parts: Part 1 focuses on evaluating safety and preliminary anti-tumor activity in approximately 18 patients; Part 2 will assess anti-tumor activity as a primary objective in a larger group of patients, as well as safety and tolerability; and Part 3 will offer an optional randomized comparison to show the contribution of dapolsertib and glofitamab over glofitamab alone. The study is registered on ClinicalTrials.gov under NCT06534437. 

Nassir Habboubi, MD, Chief Medical Officer of Stemline Therapeutics, a wholly-owned subsidiary of the Menarini Group, said:  

“We are excited to progress dapolsertib into a Phase II clinical trial in relapsed/refractory DLBCL. Our partnership with Ryvu continues to be instrumental in advancing this promising therapy. By evaluating dapolsertib as a monotherapy and in combination with glofitamab, we hope to demonstrate its potential to address this difficult-to-treat cancer. We remain committed to driving the development of dapolsertib and other innovative therapies for patients with hematologic malignancies.” 

Dapolsertib is a selective, small-molecule dual inhibitor of PIM and FLT3 kinases, two enzymes, that play a significant role in the malignant transformation of hematopoietic cells and lymphomagenesis. The compound has been discovered by Ryvu and is currently in clinical development in collaboration with the Menarini Group as a therapeutic option for various cancers.  

A licensing agreement with Menarini was signed in March 2017, and Menarini holds global development and commercial rights to dapolsertib. Initially, dapolsertib was developed as a potential treatment for patients with relapsed/refractory acute myeloid leukemia (r/r AML). More details on the completed Phase I/II clinical study in AML can be found at ClinicalTrials.gov under NCT03008187. Data from this study has been presented at various scientific conferences and symposia.  

Encouraged by promising results from translational research, Menarini decided to continue the development of dapolsertib by initiating a new Phase II study in patients with r/r DLBCL – the JASPIS-01 study. Menarini fully funds all study activities, while Ryvu is the operational partner for executing the JASPIS-01 study on behalf of Menarini. Translational work in other hematologic indications also continues.