Krakow, Poland – August 4, 2023 – 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 entered into two agreements with Fortrea [formerly known as LabCorp’s Clinical Development and Commercialization Services], a global Contract Research Organization (CRO), to operationally execute two Phase II clinical trials of RVU120 as a monotherapy (RIVER-52 study) and in combination therapy with venetoclax (RIVER-81 study) for the treatment of patients with Acute Myeloid Leukemia/High-Risk Myelodysplastic Syndrome (AML/HR-MDS). The agreements are essential elements of the implementation of Ryvu’s Development Plans for 2022-2024.

• In both studies, Fortrea will provide services related to the operational execution of clinical trials, including but not limited to clinical project management, medical and safety monitoring, as well as clinical site management and monitoring.
• The total value of both agreements is estimated to be up to approx. EUR 22.3 million and will cover all services, as well as investigators and clinical sites-related fees for the studies. The costs will be incurred as the clinical trials progress.
• Depending on the observed clinical activity, the total enrollment in both studies under these agreements could be up to approx. 230 patients, with enrollment taking place in up to approx. 90 clinical sites, in up to eight countries worldwide. Fortrea will provide continuous support at all study locations.
• The initiation of the RIVER-52 and RIVER-81 studies is planned for the second half of 2023.

 

– We are very pleased to collaborate with Fortrea on these global Phase II trials of RVU120 in patients with AML or HR-MDS, said Hendrik Nogai, M.D., Chief Medical Officer of Ryvu Therapeutics.

– To date, RVU120 has shown promising evidence of anti-leukemic activity, and we believe it holds the potential to offer improved outcomes for patients with AML and HR-MDS both as a single agent and in combination with venetoclax or other BCL-2 inhibitors. By leveraging Fortrea’s extensive expertise in clinical research and clinical trial execution, we can accelerate the development process of RVU120 and potentially bring this innovative therapy to patients in need.

 

Under the terms of the agreements, Fortrea will operationally execute two studies:

• RIVER-52: a global, multicenter, Phase II study that will evaluate RVU120 as a monotherapy for the treatment of patients with acute myeloid leukemia and high-risk myelodysplastic syndrome (AML/HR-MDS). The Company assumes a possible fast-to-market strategy for this study, with a potential initiation of the drug registration process in 2025.
• RIVER-81: a global, multicenter, Phase II study that will evaluate the safety and efficacy of RVU120 in combination with venetoclax in patients with relapsed/refractory AML, who have failed prior therapy with venetoclax and a hypomethylating agent. The implementation of the RIVER-81 study will be co-financed by the Medical Research Agency (ABM), in the framework of a competition for the development of targeted or personalized medicine based on nucleic acid therapy or small-molecule compounds, in which the Company has been selected as one of the beneficiaries and proceeded to enter into financing agreement with ABM, as informed in the current report no. 38/2023 on July 31, 2023

 

– We are satisfied with the terms of collaboration established with Fortrea, said Kamil Sitarz, Ph.D., Chief Operating Officer of Ryvu Therapeutics. On the business side, our primary objective is to optimize the efficiency of invested capital, and to that end, we have carefully developed comprehensive plans and secured a range of risk management tools. Our financial commitments will be spread over time, according to the progress of the studies.

 –  Agreements with Fortrea conclude a series of key contracts from the perspective of conducting Phase II clinical trials of RVU120 in hematology: RIVER-52 and RIVER-81. The commencement of both studies is scheduled for later this year.

 

About RVU120

RVU120 is a selective, first-in-class dual CDK8/CDK19 kinase inhibitor that has shown signs of clinical activity in treated patients, as well as efficacy in numerous in vitro and in vivo models of hematologic malignancies and solid tumors. Currently, two dose escalation clinical studies of RVU120 are ongoing in patients with AML/HR-MDS and solid tumors. Results from the ongoing RVU120 study in AML/HR-MDS have shown a favorable safety profile and clinical benefit in 11 out of 24 evaluable patients (dose up to 135 mg, data cut-off on May 25).

 About Venetoclax

Venetoclax is a BCL-2 inhibitor that is approved in combination with a hypomethylating agent for the treatment of newly diagnosed AML in patients that are unfit to receive intensive induction chemotherapy. Its use has been widely adopted in the treatment paradigm. In the non-clinical studies, RVU120 was synergistic with venetoclax in both venetoclax-sensitive and venetoclax-resistant models.