Ryvu Announces First Patient Dosed in Phase I/II Study of RVU120 (SEL120) in Patients with Relapsed/Refractory Metastatic or Advanced Solid Tumors and CMO Transition

KRAKOW, Poland, Aug. 25, 2021 /PRNewswire/ -- Ryvu Therapeutics (WSE: RVU) announced today that the first patient enrolled in the Phase I/II clinical trial investigating RVU120 (SEL120) in relapsed/refractory metastatic or advanced solid tumors, has received the first dose of the study drug.

RVU120 is a highly selective first-in-class CDK8/CDK19 inhibitor, which has demonstrated efficacy in a number of solid tumors in in vitro and in vivo models as well as in hematologic malignancies.

The single-agent, open-label Phase I/II trial, investigating the safety and efficacy of RVU120 in patients with relapsed/refractory metastatic or advanced solid tumors has been approved by the Competent Authority in Poland and obtained a positive Ethics Committee opinion, enabling enrollment of patients in Poland. The CTA submission process has already been initiated in Spain as well, aiming to start enrollment in Q4 2021.

The study is designed in two parts. The Phase I part will assess safety and tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of RVU120 in dose escalation cohorts, as well as determine the recommended Phase II dose (RP2D). The subsequent Phase II part will include specific tumor indications, enrolled in distinct study cohorts. The solid tumor study is the second trial Ryvu is conducting with RVU120, in parallel to the ongoing Phase I in patients with acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS) in which the drug has demonstrated initial signs of single agent efficacy.

"CDK8 represents an important potential therapeutic target in various types of cancer, and RVU120, an orally available small molecule, is potentially both the first and best in class CDK8 inhibitor. We are delighted to have a new Phase I/II RVU120 study in patients with solid tumors conducted in Poland, and we are planning on further expansion of clinical sites in other European countries," comments Pawel Przewiezlikowski, Chief Executive Officer at Ryvu Therapeutics.

Ryvu also announces that Dr. Setareh Shamsili, M.D., PhD resigned from her position as Executive Vice President of the Management Board and Chief Medical Officer of Ryvu for family reasons effective August 31. During the CMO transition period, Prof. Axel Glasmacher, M.D., Ryvu Supervisory Board Member since 2019, will provide additional support for the company on a consulting basis.

"We would also like to thank Setareh for advancing Ryvu's clinical programs, expanding the clinical department, and her involvement in Ryvu corporate development and wish her the best in her career. Axel has been a key member of our Supervisory Board, bringing more than 25 years of corporate and academic oncology drug development experience, and we are excited to have him more involved in our activities," says Przewiezlikowski.

Prof. Glasmacher is an oncologist with more than 25 years of experience in the field. Currently he serves as the non-executive chairperson at the board of 4D Pharma, as well as a board member of the international non-profit organization The Cancer Drug Development Forum. Until recently, Prof. Glasmacher held the position of Senior Vice President and Head of the Global Clinical Research and Development Hematology Oncology at Celgene, where he worked in various global roles for more than ten years and contributed to the development of products including Revlimid (lenalidomide), Vidaza (azacitidine), Idhifa (enasidenib) and Reblozyl (luspatercept). Prof. Glasmacher conducted clinical research with a focus on hematological malignancies at the University of Bonn, where he continues to teach. Prof. Glasmacher received his medical degree from the University of Bonn.

About RVU120 (SEL120)

RVU120 (SEL120) is a selective first-in-class CDK8/CDK19 inhibitor, which has demonstrated efficacy in a number of solid tumor in vitro and in vivo models as well as in hematologic malignancies. The first-in-human Phase I study with RVU120 (SEL120), in relapsed or refractory AML or high-risk MDS, is enrolling patients at 5 investigational sites in the US. (https://clinicaltrials.gov/ct2/show/NCT04021368). Additional sites are planned to be activated in Poland in September 2021.

The initial safety and efficacy data from the first four cohorts in the trial was presented at the Virtual EHA Congress on June 11, 202. RVU120 demonstrated acceptable safety profile and two clinically relevant responses were observed in the first five AML and high-risk MDS patients treated: one complete response (CR) and one erythroid response.

On March 25, 2020, the U.S. Food and Drug Administration (FDA) granted an orphan drug designation (ODD) to RVU120, for the treatment of patients with AML.

RVU120 has been internally discovered by Ryvu and has received support from the Leukemia & Lymphoma Society Therapy Acceleration Program® (TAP), a strategic initiative to partner directly with innovative biotechnology companies and leading research institutions to accelerate the development of promising new therapies for blood cancers.

About Ryvu Therapeutics

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 make use of diverse therapeutic mechanisms driven by emerging knowledge of cancer biology, including small molecules directed at kinase, synthetic lethality, and immuno-oncology targets. RVU120 is 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. SEL24 (MEN1703) is a dual PIM/FLT3 kinase inhibitor licensed to the Menarini Group, currently in Phase II clinical studies in acute myeloid leukemia.

The Company was founded in 2007 (until 2019 operating under the name Selvita S.A.) and currently employs over 160 associates, including more than 80 PhDs. Ryvu is headquartered in Krakow, Poland, listed on the main market of the Warsaw Stock Exchange, and is a component of sWIG80 index. For more information, please see www.ryvu.com.

 Forward-Looking Statements

This press release includes forward-looking statements that are subject to risks, uncertainties and other factors that could cause actual results to differ materially from those referred to in the forward-looking statements and, therefore, the reader should not place undue reliance on them. These risks, uncertainties and other factors include, without limitation, the risk that ongoing and future clinical studies with RVU120 (SEL120) may not be completed in the currently envisaged timelines or at all, the inherent uncertainties associated with competitive developments, clinical trial and product development activities and regulatory approval requirements, Ryvu reliance on collaborations with third parties and that Ryvu estimations regarding RVU120 development program and regarding the commercial potential of RVU120 may be incorrect. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The forward-looking statements contained herein are based on management's current expectations and beliefs and speak only as of the date hereof, and Ryvu makes no commitment to update or publicly release any revisions to forward-looking statements in order to reflect new information or subsequent events, circumstances or changes in expectations.

SOURCE Ryvu Therapeutics