Krakow, Poland – July 31, 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, today announced that it has entered into the agreement with Clinical Services International (CSI), in the area of securing venetoclax supply chain for the RIVER-81 study. The agreement is an essential element for the implementation of Ryvu’s Development Plans for 2022-2024.

• The scope of the agreement is to provide supply chain-related services, including management, procurement, storage, delivery, labelling, QP release, status monitoring, returns, as well as utilization of venetoclax in the RIVER-81 clinical study. The total value of the contract will amount up to approx. 3.94 million EUR.
• The aim of the RIVER-81 study, a Phase II, multicenter, open-label clinical trial, is to evaluate the safety and efficacy of RVU120 in combination with venetoclax in patients with relapsed/refractory Acute Myeloid Leukemia (AML), who have failed prior therapy with venetoclax and a hypomethylating agent. The initiation of this study is planned for the second half of 2023.

 

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

– The RIVER-81 study will have a global reach, spanning multiple clinical sites across the world. Given the complex nature of the combination therapy, it presents additional and substantial logistical and operational challenges. To effectively address these challenges, cooperation with service providers such as CSI is a standard and widely recognized practice in the market. By securing a reliable and efficient venetoclax supply chain, we can focus on schedule-compliant execution of the Phase II clinical trial of RVU120 in combination with venetoclax.

– Preclinical models have demonstrated strong synergy of RVU120 with venetoclax, providing solid reasons to believe that this combination therapy can significantly benefit patients suffering from AML.

 

In case of signing an agreement with the Medical Research Agency, the implementation of the RIVER-81 study will be co-financed by 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, as informed in the current report no. 29/2023 on June 13, 2023.

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.

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).