RVU120

RVU120 is a cutting-edge, clinical-stage, first-in-class selective dual inhibitor of CDK8 and CDK19 kinases—key components of the mediator complex responsible for regulating gene transcription. By precisely targeting these kinases, RVU120 disrupts critical transcriptional programs that support cancer cell survival and maintain their undifferentiated state. This innovative mechanism positions RVU120 as a promising therapy for various cancers, including hematologic malignancies such as acute myeloid leukemia (AML).

Key highlights

RVU120 was discovered by Ryvu Therapeutics. The compound acts on the CDK8/CDK19-mediator complex, a critical player in cancer cell proliferation and survival.

 

In March 2020, the U.S. Food and Drug Administration (FDA) granted orphan drug designation (ODD) to RVU120 for AML, underscoring its potential to address an unmet medical need in blood cancer treatment. Further advancing its development, Ryvu has partnered with the Leukemia & Lymphoma Society’s Therapy Acceleration Program® (TAP), aimed at accelerating innovative therapies for blood cancers.

 

With robust preclinical data and promising clinical results, RVU120 holds significant potential for addressing AML and other hematologic malignancies.

The power of RVU120

High selectivity

RVU120 is a highly selective inhibitor of CDK8 and CDK19, minimizing off-target effects and enhancing therapeutic efficacy. This targeted approach disrupts key transcriptional programs essential for cancer cell survival while sparing healthy cells.

 

Low risk of drug-drug interactions (DDI)

RVU120 has demonstrated a low potential for drug-drug interactions, making it a safer choice for patients undergoing multiple concurrent treatments. This reduces the likelihood of adverse interactions and supports better overall treatment outcomes.

 

Orally bioavailable

Unlike many cancer therapies requiring intravenous administration, RVU120’s oral bioavailability allows it to be administered in pill form. This convenience improves patient compliance and makes it a practical option for long-term therapy.

 

Favorable safety profile

Clinical trials have shown RVU120 to have a favorable safety profile, with no dose-limiting toxicities observed at therapeutic doses. Most adverse events were mild and manageable, such as low-grade nausea and vomiting, making it a tolerable option for patients.

 

Easy formulation

RVU120’s versatile formulation ensures it can be adapted into various dosage forms, meeting diverse patient needs and enhancing its accessibility for clinical use.

RVU 120 Pipeline

Clinical programs

program

indication

discovery

PRECLINICAL

PHASE I

PHASE II

partner

program

RVU120
(CDK8/19)

indication

RIVER-81
R/R AML
(combo with venetoclax)

discovery

PRECLINICAL

PHASE I

PHASE II

partner

indication

POTAMI-61
Myelofibrosis
(mono and combo with ruxolitinib)

discovery

PRECLINICAL

PHASE I

PHASE II

indication

REMARK
LR-MDS (monotherapy)

discovery

PRECLINICAL

PHASE I

PHASE II

partner

indication

RIVER-52 (enrollment suspended)
R/R AML/HR-MDS
(monotherapy)

discovery

PRECLINICAL

PHASE I

PHASE II

partner

For Patients and Caregivers

RVU120 is currently being investigated in Phase II clinical trials to treat patients with acute myeloid leukemia (AML), low-risk MDS, and myelofibrosis. These trials aim to evaluate the safety, efficacy, and potential benefits of RVU120 for patients with these blood cancers.

Contact

FOR MEDICAL PROFFESIONALS & INVESTIGATORS

If you are a medical professional, an investigator for a RYVU trial, or would like information about becoming an investigator, please contact us at [email protected] or use contact form.