Krakow, Poland – July 14, 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 has signed two agreements with Clinscience Sp. z o.o. in the area of data management and biostatistics-related services for RVU120 Phase II clinical trials in hematology: RIVER-52 and RIVER-81. The agreements are essential elements of the implementation of Ryvu’s Development Plans for 2022-2024.

• Both contracts concern the provision of services in the area of clinical data management and biostatistics, including building and hosting of an Electronic Data Capture (EDC) system. The total value of the contracts will amount to approximately 2.6 million EUR.
• The objective of the RIVER-52 study is to develop RVU120 in Phase II clinical trials as a monotherapy for the treatment of patients with Acute Myeloid Leukemia/High-Risk Myelodysplastic Syndrome (AML/HR-MDS). The Company assumes the possible fast-to-market strategy for this study, with a potential initiation of the drug registration process in 2025.
• The aim of the RIVER-81 study is the development of RVU120 in Phase II clinical trials in combination therapy with venetoclax for the treatment of AML/HR-MDS.
• The initiation of the RIVER-52 and RIVER-81 studies is planned for the second half of 2023.

 

Kamil Sitarz, PhD, Management Board Member and Chief Operating Officer of Ryvu Therapeutics, comments:

– We are working intensively on the initiation of Phase II clinical trials for RVU120 in several therapeutic areas. We carefully select service providers to ensure cost-effectiveness for Ryvu while maintaining the necessary service quality, flexibility, and risk management capabilities.

– Collaboration with Clinscience in the area of clinical data management and biostatistics will provide us with high-quality, comprehensive solutions tailored specifically to our needs. This collaboration represents another step towards the dynamic development of RVU120 in Phase II clinical trials in the hematological field.

In the case of signing an agreement with the Medical Research Agency (“ABM”), the implementation of the RIVER-81 study will be co-financed by AMB, in the framework of a competition for the development of targeted or personalized medicine based on nucleic acid-based medicinal products and small molecule compounds, in which the Company has been selected as one of the beneficiaries, as informed in the current report no. 29/2023 on June 13, 2023.

Krystyna Kowalczyk, Chief Executive Officer of Clinscience, comments:

– Clinscience is thrilled to partner with Ryvu Therapeutics to support the further clinical development of Ryvu’s most advanced fully-owned program – RVU120. Our scientific and technical expertise, specifically in oncology, is perfectly aligned to assist in optimizing the needs of this program. Primarily, we embrace the opportunity to join forces with Ryvu Therapeutics to improve the lives of cancer patients.

 

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).

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.