Krakow, Poland – April 27, 2022 – Ryvu Therapeutics (WSE: RVU), a clinical-stage drug discovery and development company focusing on novel small molecule therapies that address emerging targets in oncology, today announced project updates from its most advanced oncology program RVU120 and a selective PIM/FLT3 inhibitor SEL24 (MEN1703) will be made available at the 2022 ASCO Annual Meeting, taking place June 3-7 in Chicago, IL, U.S.

Update details:

• Title: Phase 1/2 study of SEL24/MEN1703, a first-in-class dual PIM/FLT3 kinase inhibitor, in patients with IDH1/2-mutated acute myeloid leukemia: The DIAMOND-01 trial
  Abstract Number for Publication: 7024
  Session Title: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
  Session Date and Time: Saturday, June 4, 2022, 8:00 AM-11:00 AM CDT

• Title: Phase I/II trial of RVU120 (SEL120), a CDK8/CDK19 inhibitor in patients with relapsed/refractory metastatic or advanced solid tumors
  Abstract Number for Online Publication: e15091

The full texts of ASCO Abstracts will be released on May 26 at 5:00 PM (EDT)/(23:00 CET).

About RVU120 (SEL120)

RVU120 (SEL120) is a clinical-stage, highly specific, and orally bioavailable dual inhibitor of CDK8/CDK19 kinases, which has demonstrated efficacy in a number of solid tumor in vitro and in vivo models as well as in hematologic malignancies.

At present, Ryvu is conducting two clinical studies with RVU120: (i) Phase Ib in patients with AML/HR-MDS (NCT04021368) and (ii) Phase I/II in relapsed/refractory metastatic or advanced solid tumors (NCT05052255). Additionally, multiple translational research activities are underway.

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 AML.

RVU120 has been internally discovered by Ryvu and has received support from the Leukemia & Lymphoma Society Therapy Acceleration Program® (TAP)

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 (NCT03008187), a First-in-Human, Phase I/II, dose-escalation and cohort expansion trial, as a 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.

On November 4, 2021, the U.S. Food and Drug Administration (FDA) granted orphan drug designation (ODD) to SEL24, for the treatment of AML.