Ryvu Therapeutics Reports Significant Progress in RVU120 Phase II Studies for Hematologic Malignancies

Ryvu Therapeutics Reports Significant Progress in RVU120 Phase II Studies

Ryvu Therapeutics, a Poland-based clinical-stage biopharmaceutical firm, has recently highlighted encouraging advancements in its Phase II program for RVU120, a pioneering dual CDK8/19 inhibitor aimed at treating hematologic malignancies. The company has initiated four robust clinical studies: RIVER-52, RIVER-81, POTAMI-61, and REMARK, showcasing a committed effort to address critical unmet medical needs in oncology.

Expansion of Clinical Sites and Enrollment Progress

As of December 11, 2024, Ryvu successfully activated 106 clinical sites in pivotal regions including Poland, Italy, Spain, France, Germany, and Canada. By the end of this year, the company anticipates reaching a total of 113 sites. Enrollment has been exponentially accelerating, with 78 patients enrolled so far and expectations to treat approximately 100 patients by year-end 2024. This remarkable recruitment pace illustrates the effectiveness of the clinical operations initiated earlier this year.

This year represents a transformative period for the RVU120 development program, according to Dr. Paweł Przewięźlikowski, the co-founder and CEO of Ryvu Therapeutics. The company aims to maintain its enrollment momentum heading into 2025, fostering ambitious goals for generating critical efficacy data in the forthcoming months.

Efficacy Signals and Safety Profile

The early signals of efficacy emerging from the RIVER-81 and RIVER-52 studies are particularly promising. In the RIVER-81 study, designed to assess RVU120 in combination with venetoclax for relapsed/refractory AML, significant outcomes were reported where one patient achieved complete remission and another showed a notable reduction in disease blasts after receiving RVU120 at the recommended Phase II dose of 250 mg.

Similarly, in the RIVER-52 study evaluating RVU120 as a monotherapy, one patient demonstrated a 50% blast reduction, indicating potential effectiveness among specific cohorts. Overall, the safety profile of RVU120 continues to appear favorable, especially when compared to existing treatment options like those for acute myeloid leukemia (AML).

Looking Ahead: Key Milestones and Expectations

The upcoming months are pivotal as Ryvu anticipates the first key efficacy results from both the RIVER-81 and RIVER-52 studies, in addition to the data collection from the POTAMI-61 and REMARK trials. All studies are aligned with the budget Ryvu had previously set, and the company has confirmed its financial guidance extends into Q1 2026.

Dr. Hendrik Nogai, Chief Medical Officer at Ryvu, emphasized the considerable progress made and the importance of the data expected in H1 2025. As enrollment increases, Ryvu is optimistic about acquiring a substantial number of responses that will inform future treatment strategies for hematologic malignancies.

Understanding RVU120: A Promising New Player

RVU120 is a first-in-class CDK8/CDK19 inhibitor that has shown encouraging clinical activity. Prior studies indicated that about 50% of evaluable patients in earlier trials benefitting from RVU120 achieved significant clinical enhancement, including complete remissions and other favorable outcomes. These results underscore the drug's promising profile against hematologic cancers, particularly for patients with genetic mutations such as NPM1 and DNMT3A.

As Ryvu Therapeutics progresses through the various arms of its Phase II studies, the oncology community eagerly awaits the data that could validate RVU120 as a game-changing therapy in the treatment landscape of blood cancers. Continued updates from the ongoing clinical studies are slated for Q2 2025, where the full scope of RVU120's efficacy and safety may be disclosed, potentially altering treatment paradigms in hematologic malignancies.

Conclusion

Ryvu Therapeutics stands at the forefront of innovation with RVU120, balancing a focus on cutting-edge research with a commitment to patient safety and efficacy. The progress made thus far not only highlights the company’s resolve but also fosters optimism within the cancer therapeutic landscape as they seek to deliver novel solutions to some of the most challenging hematologic disorders.

For more information, visit Ryvu Therapeutics' official website and stay tuned for upcoming clinical updates.