Ryvu Therapeutics & Collaborators to Present Clinical and Translational Data from RVU120 and SEL24/MEN1703 at the 63rd ASH Annual Meeting & Exposition and the 44th Annual SABCS

- 6 Poster Presentations Highlight Clinical and Preclinical Activity of RVU120 and SEL24/MEN1703

- Initial Data from Ongoing Phase Ib of RVU120 demonstrates an Acceptable Safety Profile and Early Signs of Efficacy, Including a Complete Response within the First Five Dose Cohorts

- Dose Escalation in AML and HR-MDS is Ongoing

- Translational Research for RVU120 Demonstrated a Strong Trend of Efficacy in DNMT3A-mutated AML Patient-Derived Cells (PDCs)

- Preclinical Models Show Potential for Clinical Efficacy of RVU120 in Breast Cancer

News provided by

Ryvu Therapeutics

Nov 04, 2021, 13:14 ET

KRAKOW, Poland, Nov. 4, 2021 /PRNewswire/ -- Ryvu Therapeutics (WSE: RVU), a clinical-stage drug discovery and development company focusing on novel small molecule therapies that address emerging targets in oncology, announced today that it will present new data demonstrating clinical and preclinical activity of its selective CDK8/19 inhibitor RVU120 (SEL120) and its selective PIM/FLT3 inhibitor SEL24 (MEN1703) during the 63rd American Society of Hematology Annual Meeting & Exposition, being held on December 11 – December 14, 2021, in Atlanta and at the 44^th Annual San Antonio Breast Cancer Symposium (SABCS) being held on December 7 – December 10, 2021.

An acceptable safety profile and early signs of efficacy will be presented for RVU120, a selective CDK8/19 inhibitor being developed in hematologic and solid tumors, in the first-in-human (FIH) Phase Ib dose-escalation trial (CLI120-001) currently ongoing in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (HR-MDS). The preliminary signs of efficacy for RVU120 include a Complete Response (CR) in an AML patient and an erythroid response (ER) in a HR-MDS patient who had relapsed after several lines of previous treatment.

Translational research will be presented that potentially links the clinical response in an AML patient to DNMT3A-mutations via evidence in DNMT3A-mutated AML patient-derived cells (PDCs). Further translational research shows evidence that the clinical erythroid response in an MDS patient is potentially a result of strong erythroid differentiation potential of RVU120 in preclinical models. Enrollment is ongoing in cohort 4 at seven clinical sites in the US and Europe to gather additional safety data in the study.

An additional poster on the potential efficacy of RVU120 in hormone-negative breast cancer models will be presented at the 2021 San Antonio Breast Cancer Symposium®.

Ryvu licensee Menarini Group will be presenting SEL24/MEN1703 data from the First-in-Human, Dose Escalation (DE) and Cohort Expansion (CE) CLI24-001 trial (DIAMOND-01, ClinicalTrials.gov identifier: NCT03008187).

"We are excited to present data from our ongoing Phase Ib dose escalation study of RVU120 in AML and HR-MDS, where we have seen clinical responses, and in solid tumors with strong translational data in breast cancer," said Pawel Przewiezlikowski, Chief Executive Officer at Ryvu Therapeutics. "It is a true milestone for Ryvu and our collaborators from MD Anderson Cancer Center and Menarini to have six posters accepted for presentation on RVU120 and SEL24."

The abstracts accepted for poster presentation at the 63rd ASH Annual Meeting & Exposition include:

CLI120-001 Phase Ib Study of RVU120 (SEL120) in Patients with AML and High-Risk MDS: Updated Safety/Efficacy Results from Initial Dose Escalation (Publication Number: 3418), Camille Abboud Sr., MD (Washington University in Saint Louis/ Washington University School of Medicine) et al.

Session Name: 616. Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies: Poster III
Date: Monday, December 13, 2021
Presentation Time: 6:00 PM - 8:00 PM

RVU120 (SEL120) CDK8/19 Inhibitor - a Drug Candidate for the Treatment of MDS Can Induce Erythroid Differentiation (Publication Number: 1518), Tomasz Rzymski, Ph.D. (Ryvu Therapeutics) et al.

Session Name: 636. Myelodysplastic Syndromes—Basic and Translational: Poster I
Date: Saturday, December 11, 2021
Presentation Time: 5:30 PM - 7:30 PM

Inhibition of Cyclin Dependent Kinase 8 (CDK8): A Novel Approach to Target the Leukemia Initiating Cells (LICs) in T-Cell Acute Lymphoblastic Leukemia (T-ALL) (Publication Number: 2250), Sujan Piya, Ph.D. (MD Anderson Cancer Center) et al.

Session Name: 605. Molecular Pharmacology and Drug Resistance: Lymphoid Neoplasms: Poster II
Date: Sunday, December 12, 2021
Presentation Time: 6:00 PM - 8:00 PM

Preclinical and Clinical Signs of Efficacy of RVU120 (SEL120), a Specific CDK8/19 Inhibitor in DNMT3A-Mutated AML (Publication Number: 2371), Tomasz Rzymski, Ph.D. (Ryvu Therapeutics) et al.

Session Name: 617. Acute Myeloid Leukemias: Biomarkers, Molecular Markers and Minimal Residual Disease in Diagnosis and Prognosis: Poster II
Date: Sunday, December 12, 2021
Presentation Time: 6:00 PM - 8:00 PM

SEL24(MEN1703) Inhibits PIM/FLT3 Downstream Target in Acute Myeloid Leukemia (AML) Patients: Results of the Pharmacodynamics (PD) Assay and Genomic Profiling in the First-in-Human Diamond-01 Trial (Publication Number: 3436), Alessandro Paoli (Menarini Group) et al.

Session Name: 617. Acute Myeloid Leukemias: Biomarkers, Molecular Markers and Minimal Residual Disease in Diagnosis and Prognosis: Poster III
Date: Monday, December 13, 2021
Presentation Time: 6:00 PM - 8:00 PM

All of the abovementioned abstracts are available on-line at: https://www.hematology.org/meetings/annual-meeting/abstracts

The abstract accepted for the poster presentation at the 2021 San Antonio Breast Cancer Symposium®, taking place on December 7-10, 2021, at Henry B. Gonzalez Convention Centre in San Antonio, Texas:

Selective CDK8/CDK19 inhibitor RVU120 demonstrates efficacy against hormone-independent breast cancer cells in vitro and in vivo (#1766), Tomasz Rzymski, Ph.D. (Ryvu Therapeutics) et al.

Program Number: P5-17-13
Poster Session 5: December 10, 2021: 7:00 AM – 8:30 AM

About Ryvu Therapeutics

Ryvu Therapeutics is a clinical stage drug discovery and development company focused on novel small molecule therapies that address emerging targets in oncology. Internally discovered pipeline candidates make use of diverse therapeutic mechanisms driven by emerging knowledge of cancer biology, including small molecules directed at kinase, synthetic lethality, and immuno-oncology targets. RVU120 is a selective CDK8/CDK19 kinase inhibitor with potential for the treatment of hematological malignancies and solid tumors currently in Phase I clinical development for the treatment of acute myeloid leukemia and myelodysplastic syndrome, and Phase I/II for the treatment of r/r metastatic or advanced solid tumors. SEL24 (MEN1703) is a dual PIM/FLT3 kinase inhibitor licensed to the Menarini Group, currently in Phase II clinical studies in acute myeloid leukemia.

The Company was founded in 2007 (until 2019 operating under the name Selvita S.A.) and currently employs over 170 associates, including more than 80 PhDs. Ryvu is headquartered in Krakow, Poland, listed on the main market of the Warsaw Stock Exchange, and is a component of sWIG80 index. For more information, please see www.ryvu.com.

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