Updated: Oct 10
Ryvu Therapeutics Announces Entering into Agreement with Clinical Services International (CSI) in the Area of Securing Venetoclax Supply Chain for RVU120 Phase II Clinical Trial in Combination Therapy in Hematology
Krakow, Poland and London, UK – Ryvu Therapeutics, a clinical-stage drug discovery and development company focusing on novel small molecule therapies that address emerging targets in oncology, has entered into an agreement with Clinical Services International (CSI), a leader in sourcing, managing, and distributing certified commercially available medicines, comparators, concomitant medications, and rescue medications for clinical trials, 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 supply chain strategy, project management, procurement, storage, delivery, labelling, QP release, status monitoring and returns venetoclax in the RIVER-81 clinical study.
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 therapy with venetoclax for the treatment of 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, said:
“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.”
Vanessa Dekou, PhD, MBA, Founder and Managing Director of Clinical Services International (CSI), said:
"We are excited to partner with Ryvu on their RIVER-81 study. CSI and Ryvu will build an enduring and strategic relationship through this collaboration, and through our fully integrated service reduce costs and shorten timelines on their groundbreaking study. We are proud to have been chosen through Ryvu’s competitive selection process for our proven ability to procure medicines and manage the logistics of international studies. CSI’s partnership with Ryvu Therapeutics confirms our long-standing commitment to clinical research and best-in-class ability to support sponsors with complex global clinical trials."
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).