Ryvu Therapeutics (WSE: RVU), Poland’s largest biotech firm, said today it has signed two agreements with Zakłady Farmaceutyczne Polpharma relating to its lead candidate RVU120 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.
Ryvu notes that the subject of the RIVER-52 study-related agreement is the execution of the API manufacturing campaign for RVU120 in the registration current Good Manufacturing Practice (cGMP) 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).
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