Ryvu Therapeutics has signed an agreement with the global provider of drug development services – the American company Labcorp Drug Development, to conduct phase II clinical trials of RVU120 as a monotherapy in the treatment of relapsed/refractory metastatic or advanced solid tumors, the company announced. The launch of Phase II of the trial is planned as previously announced, i.e. in Q2 2023, under the already approved Phase I/II trial protocol.
“Everything indicates that we are close to completing the Phase I clinical trial of RVU120 in the treatment of solid tumors. Data from the dose escalation step showed a potential therapeutic benefit in disease stabilization. We are also pleased with the safety and efficacy profile of RVU120. We look forward to the start of Phase II of the study with great enthusiasm. In accordance with the schedule presented in the Company’s Development Plans for 2022-2024, we maintain the set goal to start phase II of the study in the second quarter of this year.” – said the medical director, member of the board of Ryvu Hendrik Nogai, quoted in the release.
RVU120 is a selective, first-in-class CDK8/CDK19 inhibitor that has been shown to be effective in haematological malignancies as well as in in vitro and in vivo models in a wide range of solid tumors. Two clinical trials are currently ongoing with RVU120 as monotherapy: (i) a Phase Ib study in AML/HR-MDS patients and (ii) a dose escalation phase of a Phase I/II study in relapsed/refractory metastatic or advanced solid tumours, recalled .
In addition, preclinical data demonstrate the potential of RVU120 in combination therapy with multiple therapeutic antibodies.
Developed by Ryvu Therapeutics researchers, RVU120 has received support from the Leukemia & Lymphoma Society Therapy Acceleration Program (TAP). On March 25, 2020, the American regulator – Food and Drug Administration (FDA) granted RVU120 the possibility of obtaining the status of an orphan drug (Orphan Drug Designation, ODD) in the treatment of patients with AML.
LabCorp is a leading global drug development services company. The company has 25 years of experience in conducting clinical trials, including in the field of oncology, specializing mainly in solid tumors. Over the past five years, the company has conducted over 1,000 clinical trials in oncology, most of which were phase I/II trials.
Ryvu Therapeutics was founded in 2007 (as Selvita). It is a Polish biotechnology company developing innovative small molecule compounds with therapeutic potential in oncology. Ryvu Therapeutics is listed on the main market of the Warsaw Stock Exchange.