Krakow, Poland – June 9, 2021 – Ryvu Therapeutics (WSE: RVU), a clinical-stage drug discovery and development company focusing on novel small molecule therapies that address emerging targets in oncology, is pleased to invite everyone interested to participate in a conference call – Discussion On Ryvu Data Presented at EHA 2021.
During the call, we will discuss the therapeutic landscape of AML and MDS, including the patient response evaluation criteria, along with initial clinical data results of RVU120 Phase Ib study, as well as provide a scientific update on RVU120 translational studies and further development plans. In addition, we will briefly present current results and developments of the SEL24 (MEN1703) study.
Date: Friday, June 11, 2021
Time: 1:00 pm CEST/ 7:00 am ET
I. Introductory Educational Session – Przemyslaw Juszczynski, MD, PhD, Profesor at the Institute of Hematology and Transfusion Medicine, Warsaw, Poland
- Introduction to AML and MDS,
- Response Evaluation Criteria,
II. RVU120 Overview – Noemi Angelosanto, MD, Medical Director Hematology, Ryvu Therapeutics and Tomasz Rzymski, PhD, Head of Biology Department, Ryvu Therapeutics
- RVU120 Study Design,
- RVU120 Patient Outcomes,
- RVU120 Scientific Update,
- RVU120 Planned Next Steps in Development,
III. SEL24 Results and Next Steps – Pawel Przewiezlikowski, Chief Executive Officer, Ryvu Therapeutics
To sign up, please visit: live.ryvu.com
About RVU120 (SEL120)
RVU120 (SEL120) is a selective first-in-class CDK8/CDK19 inhibitor, which has demonstrated efficacy in a number of solid tumor types in in vitro and in vivo models as well as in onco-hematological malignancies. The first-in-human (FIH) phase I study with RVU120, in relapsed or refractory AML or high-risk myelodysplastic syndromes (HRMDS), is currently enrolling patients at 5 investigational sites in USA (https://clinicaltrials.gov/ct2/show/NCT04021368).
Translational data suggest that RVU120 is particularly effective in undifferentiated AML STAT5-positive cancers. Administration of RVU120 in orthotopic AML patient derived xenograft models reduced tumor burden to the level undetectable in the peripheral blood, decreased splenomegaly and resulted in partial bone marrow recovery at well tolerated doses.
In addition, RVU120 has demonstrated single agent efficacy in multiple solid tumor models.
On May 28, 2021, Ryvu’s Clinical Trial Application (CTA) to commence a single-agent, open-label Phase I/II trial, investigating the safety and efficacy of RVU120 (SEL120) in patients with relapsed/refractory metastatic or advanced solid tumors, was approved by the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, and the respective Central Ethics Committee.
On March 25, 2020, the U.S. Food and Drug Administration (FDA) granted an orphan drug designation (ODD) to RVU120, for the treatment of patients with acute myeloid leukemia (AML).
On April 7, 2021, U.S. Food and Drug Administration, FDA, placed a partial clinical hold on the first in human Phase Ib, dose escalation clinical trial of RVU120 in patients with relapsed/refractory (R/R) AML and high-risk MDS. Patients who are currently taking RVU120 may continue treatment. Ryvu continues to work closely with the FDA to resolve the partial clinical hold with the objective of resuming enrollment in the study. RVU120 (SEL120) has been internally discovered by Ryvu and has received support from The Leukemia & Lymphoma Society Therapy Acceleration Program® (TAP), a strategic initiative to partner directly with innovative biotechnology companies and leading research institutions to accelerate the development of promising new therapies for blood cancers.
About SEL24 (MEN1703)
SEL24 (MEN1703), a first-in-class, orally available, dual PIM/FLT3 kinase inhibitor discovered and initially developed by Ryvu Therapeutics and licensed to the Menarini Group. SEL24 (MEN1703) is currently evaluated in DIAMOND-01 trial (CLI24-001; clinicaltrials.gov identifier NCT03008187), a First-in-Human, Phase I/II, dose escalation and cohort expansion trial, as single agent for the treatment of patients with Acute Myeloid Leukemia (AML).
In the dose escalation part of DIAMOND-01 trial, SEL24 (MEN1703) demonstrated a manageable safety profile up to the recommended dose (RD) of 125 mg/day, along with initial evidence of anti-leukemic activity in a single agent setting, particularly in patients with IDH mutant disease either naïve or previously exposed to IDH inhibitors, warranting further investigation of the compound in molecularly defined subset of patients.