Krakow, Poland – 12 May, 2021 –  Ryvu Therapeutics [WSE:RVU] today announced that three abstracts demonstrating clinical and pre-clinical activity of its selective CDK8/19 inhibitor RVU120 (SEL120) and its selective PIM/FLT3 inhibitor SEL24(MEN1703) have been accepted for presentation at the Annual European Hematology Association (EHA) 2021 Virtual Congress, being held from June 9 – June 17, 2021.

“RVU120/SEL120 CDK8/19 inhibitor – a drug candidate for the treatment of MDS can induce erythroid differentiation in transformed CD34+ hematopoietic progenitor cells” has been accepted for an oral presentation at the Congress.

• Abstract Number: S164
• Date and Time: on-demand video recording will be available on Friday, June 11, followed by a Live Q&A Session on one of the Thematic Days (June 13-17)

Preclinical studies indicated strong antileukemic potential of RVU120 (SEL120) that was often associated with multilineage commitment of CD34+ AML cells. Moreover, research shows that RVU120 could improve proliferation and induce erythroid differentiation of CD34+ cells derived from Diamond-Blackfan anemia patients. Presented results indicate strong erythroid differentiation potential of RVU120 in (Lin-) CD34+, that acquired genetic abnormalities resulting in arrested erythroid commitment, characteristic of many MDS (myelodysplastic syndromes) and AML (acute myeloid leukemia) subtypes. Observed differentiation phenotype strikingly resembles effects of RVU120 in DBA cells caused by disruption of genes encoding ribosomal proteins. Detailed transcriptomic profiling strongly associated differentiation with enrichment of genes representing regulators of erythroid commitment and hemoglobin metabolism. Further studies are warranted to investigate efficacy of RVU120 in anemias associated with bone marrow failures in AML and MDS patients.

“CLI120-001 Phase1b Study of SEL120/RVU120 in patients with AML or High Risk MDS: Preliminary clinical and PK results from initial dose escalation cohorts” (abstract number: EP480) has been accepted for a poster presentation.

The First in Human Phase Ib clinical trial with RVU120 in patients with relapsed/refractory (R/R) AML or High Risk MDS is currently open for enrollment at 6 sites in the US (NCT04021368). The poster will present the preliminary results of the first four single patient dose escalation cohorts which have shown a favorable safety and PK profile of RVU120. The first signals of single agent clinical activity have been observed at doses 50 to 75 mg.

In addition, a clinical abstract regarding the First in Human study of dual PIM/FLT3 inhibitor SEL24(MEN1703) conducted by Ryvu’s partner Menarini Group, has also been accepted for a poster presentation at the upcoming EHA Congress.

“Results from DIAMOND-01 (CLI24-001) trial: First In Human study of SEL24/MEN1703, a dual PIM/FLT3 kinase inhibitor, in patients with acute myeloid leukemia” presents updated data including patients enrolled in the Phase II, cohort expansion (CE) of the study. SEL24(MEN1703) confirmed a manageable safety profile at RD and preliminary single agent efficacy in R/R AML. These results warrant further investigation of SEL24(MEN1703) in AML.

“We are very pleased that all of the abstracts which we submitted for presentation at the upcoming EHA Congress have been accepted. We are very encouraged by the initial signals of activity of RVU120 in both AML and High Risk MDS patients. Promising early clinical data with the strong translational validation in MDS to be presented at EHA in parallel to non-clinical AML data we recently presented at AACR offer a good scientific foundation for the future of the program” – said Setareh Shamsili, MD, PhD, Chief Medical Officer and EVP at Ryvu Therapeutics. “We are also proud that our second program SEL24 (MEN1703), developed in collaboration with Menarini, continues to build momentum in the clinic.“

All abstracts are now available online and can be obtained from conference site: https://ehaweb.org/.