Ryvu Therapeutics (WSE: RVU), Poland’s largest biotech firm, says it licensee, the Italian family-owned Menarini Group, will expand development of MEN1703 (SEL24) by initiating a new Phase II study in relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in addition to continued translational work in other hematologic indications.
“We are excited to begin this Phase II study with our partner Menarini to address the critical unmet need in DLBCL,” said Pawel Przewiezlikowski, co-founder, largest shareholder, and CEO of Ryvu Therapeutics, adding: “The extensive preclinical evidence of MEN1703 activity in multiple types of lymphomas sets a promising foundation for evaluating the molecule’s potential in DLBCL, and we look forward to seeing this program continue to advance in the clinic.”
The Phase II study, which will explore the activity of MEN1703 in combination with standard-of-care therapy in DLBCL and as a single agent, is being initiated based on strong pre-clinical activity of MEN1703 in lymphoma. MEN1703 has completed Phase II studies in relapsed/refractory acute amyloid leukemia (AML), including an expansion cohort in IDH-mutated AML. The studies demonstrated an acceptable safety profile and early signs of single agent activity.
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