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, announced that it has entered into an agreement with the Medical Research Agency (ABM) for the financing of a project involving execution of the RIVER-81 study. 

• The aim of the project co-financed by ABM is to develop a new treatment strategy for Acute Myeloid Leukemia (AML) through execution of the RIVER-81 study – a Phase II, multicenter, open-label clinical trial evaluating 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 total value of funding will amount up to approx. PLN 62.3 million, with a total net project value of up to approx. PLN 132.5 million.
• The RIVER-81 study is an important component of the Development Plans for 2022-2024. The initiation of the study is planned for the second half of 2023.

 

Hendrik Nogai, M.D., Management Board Member and Chief Medical Officer of Ryvu Therapeutics, comments:

– The confirmation of the efficacy of RVU120 and venetoclax therapeutic combination can create completely new treatment possibilities as well as gives a real chance to overcome innate and acquired resistance in patients with relapsed/refractory AML who have already exhausted other treatment options in standard medical care.

– We expect that the effectiveness of our therapy will bring significant benefits to patients with relapsed/refractory AML, directly extending survival time and reducing the disease burden.

Kamil Sitarz, Ph.D., Management Board Member and Chief Operating Officer of Ryvu Therapeutics, comments:

– We remain focused on increasing Ryvu’s access to non-dilutive funding sources. Currently, thanks in part to the agreement signed with the Medical Research Agency, we have successfully secured a budget that covers our capital needs until 2026, clearly exceeding our initial expectations presented in our Development Plans for 2022-2024 last year.

– The RIVER-81 study is an important element of our adopted “pipeline-in-a-pill” strategy for RVU120 development, aimed at maximizing the potential value of the RVU120 program and mitigating typical clinical development risks.

 

Signing of the agreement with the Medical Research Agency (ABM) means that 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.

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.