KRAKOW, Poland — 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.
About Ryvu Therapeutics
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’s most advanced program is RVU120, 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. 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. Ryvu Therapeutics is also engaged in oncology collaborations with BioNTech and Exelixis.
The company was founded in 2007 and is headquartered in Kraków, Poland. Ryvu is listed on the Warsaw Stock Exchange and is a component of the sWIG80 index.
Contact
Ryvu Therapeutics
Anna Wilk
+48 532 698 425
anna.wilk@ryvu.com