Ryvu Therapeutics (WSE: RVU), a clinical-stage drug discovery and development company focusing on novel small molecule therapies that address emerging targets in oncology and Zaklady Farmaceutyczne Polpharma S.A. have signed two agreements in the area of RVU120 active substance (Active Pharmaceutical Ingredient, API) production for Phase II clinical studies in hematology: RIVER-52 and RIVER-81. The agreements are essential elements of the implementation of Ryvu’s Development Plans for 2022-2024, and contribute to realization of Polpharma growth strategy in the area of APIs where the development of contract development and manufacturing services (CDMO) is one of the key pillars.
- The subject of the RIVER-52 study-related agreement is the execution of the API manufacturing campaign for RVU120 in the registration cGMP (current Good Manufacturing Practice) standard – a key element in preparing for the potential fast-to-market strategy implementation for the Phase II study of RVU120 as monotherapy in the treatment of patients with Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (HR-MDS).
- The RIVER-81 study-related agreement is focused on the development and optimization of the production process, as well as RVU120 API manufacturing in accordance with cGMP requirements for the Phase II study of RVU120 in combination therapy with venetoclax in the treatment of AML/HR-MDS.
- The total value of the two agreements will be approximately EUR 1.7 million.
- Both clinical studies (RIVER-52 and RIVER-81) are scheduled to commence in the second half of 2023.
Pawel Przewiezlikowski, CEO of Ryvu Therapeutics, comments:
– We are delighted to begin our collaboration with Polpharma CDMO, a globally recognized partner in the field of development and contract manufacturing of active substances. This Polish biotech-pharmaceutical project brings us closer to the realization of Phase II clinical trials for RVU120, aimed at helping a larger group of patients with AML or HR-MDS. The initiation of both monotherapy and combination therapy studies is planned for later this year.
– The agreement for the RIVER-52 study is a key element in preparing for the implementation of a potential fast-to-market strategy for RVU120 as a monotherapy in the treatment of AML/HR-MDS patients. According to our timeline, we plan to initiate the drug registration process in 2025.
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.
Sebastian Szymanek, CEO of Zaklady Farmaceutyczne Polpharma S.A., comments:
– Polpharma provides active substance development and production services to customers around the world. However, what makes us particularly happy is when we can cooperate to support development of innovative projects in Poland. We are greatly satisfied that, as the largest Polish pharmaceutical company, we can support such a dynamic Polish entity like Ryvu Therapeutics in the execution of works bringing us closer to the development and introduction to the market of breakthrough therapies for 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.
Zaklady Farmaceutyczne Polpharma S.A. is the leading Polish and one of the largest pharmaceutical manufacturers in the Central and Eastern Europe region. Polpharma is part of an international pharmaceutical group that offers modern drugs, active substances, and innovative solutions for patients and business partners. Polpharma CDMO provides development and contract manufacturing services for active substances to partners worldwide.