Ryvu Therapeutics' Global Licensee Menarini to Expand Development of MEN1703 (SEL24) with a New Study in Advanced Diffuse Large B-Cell Lymphoma (DLBCL)

-  Phase II Study to be Initiated in H1 2024

KRAKÓW, Poland , Sept. 14, 2023 /PRNewswire/ -- Ryvu Therapeutics (WSE: RVU), a clinical-stage drug discovery and development company focusing on novel small molecule therapies that address emerging targets in oncology, today announced that Ryvu's licensee, the 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. "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 preclinical activity of MEN1703 in lymphoma. MEN1703 has completed Phase II studies in relapsed/refractory AML, including an expansion cohort in IDH-mutated AML. The studies demonstrated an acceptable safety profile and early signs of single agent activity. Based on these data, development of MEN1703 will continue with focus on DLBCL and potentially other indications. AML will be deprioritized given the existing data and competitive landscape.

Under the terms of the license agreement executed in 2017, Menarini is the global development and commercial licensee. Ryvu remains a strategic partner through the existing Joint Steering Committee and will become an operational partner as part of an amended agreement to enable Ryvu to execute clinical studies on behalf of Menarini. Menarini will continue to be responsible for all research and development costs, including full reimbursement to Ryvu for study execution; the license and financial terms of the original agreement remain unchanged.

"DLBCL is an aggressive and difficult-to-treat type of non-Hodgkin lymphoma, and these patients have limited therapeutic options and face challenges in achieving sustained remissions," said Elcin Barker Ergun, CEO of the Menarini Group. "We are pleased to advance MEN1703 into clinical development and look forward to exploring its therapeutic potential in DLBCL as well as evaluating it in other promising indications."

About MEN1703 (SEL24)

MEN1703 (SEL24) is a clinical-stage program discovered and developed by Ryvu Therapeutics and licensed to the Menarini Group. MEN1703 is a first-in-class, dual PIM/FLT3 kinase inhibitor with a unique activity profile. By design, this profile may provide responses to treatment that are more durable than current options and address a disease that has progressed following FLT3 inhibition. Preclinical data suggests therapeutic potential in both hematological malignancies and in solid tumors. Ryvu has granted the Menarini Group an exclusive worldwide license to further research, develop, manufacture and commercialize MEN1703 (SEL24).

More information on the study at: https://clinicaltrials.gov/ct2/show/NCT03008187.

About Ryvu

Ryvu Therapeutics is a clinical-stage drug discovery and development company focused on novel small-molecule therapies that address emerging targets in oncology. Internally discovered pipeline candidates use of diverse therapeutic mechanisms driven by emerging knowledge of cancer biology, including small molecules directed at kinase, synthetic lethality and immuno-oncology targets.

Ryvu's most advanced programs are RVU120 — a selective CDK8/CDK19 kinase inhibitor with potential for the treatment of hematological malignancies and solid tumors currently in phase I clinical development for the treatment of acute myeloid leukemia and myelodysplastic syndrome, and phase I/II for the treatment of r/r metastatic or advanced solid tumors — and MEN1703 (SEL24), a dual PIM/FLT3 kinase inhibitor licensed to the Menarini Group. Ryvu Therapeutics has signed multiple partnering and licensing deals with global companies, including BioNTech, Exelixis, and Merck KGaA.

The Company was founded in 2007 and is headquartered in Kraków, Poland. Ryvu is listed on the Warsaw Stock Exchange and is a component of the sWIG80 index. From September 18, 2023, Ryvu will be included in the mWIG40 index. For more information, please see www.ryvu.com.

About Menarini Group

The Menarini Group is a leading international pharmaceutical and diagnostics company, with a turnover of over $4.4 billion and over 17,000 employees. Menarini is focused on therapeutic areas with high unmet needs with products for cardiology, oncology, pneumology, gastroenterology, infectious diseases, diabetology, inflammation, and analgesia. With 18 production sites and 9 Research and Development centers, Menarini's products are available in 140 countries worldwide. For further information, please visit www.menarini.com.

SOURCE Ryvu Therapeutics