- Updated data from the Phase I trial of RVU120 in patients
with relapsed/refractory acute myeloid leukemia (r/r AML) or
high-risk myelodysplastic syndromes (HR-MDS) demonstrate promising
clinical activity.
- Preclinical data support the synergistic combination of
RVU120 and venetoclax in patients with AML, including RVU120's
potential to overcome resistance to venetoclax treatment.
- Combination data of RVU120 with other drug candidates in
vitro support potentially new therapeutic options for patients with
myeloproliferative neoplasm (MPN). In vivo data further support
CDK8 inhibition as a potential novel therapeutic strategy in MPNs,
particularly myelofibrosis (MF).
- A webinar with Professor Raajit Rampal covering the
myelofibrosis landscape, latest data, and potential of RVU120 in
MF. The webinar will be held on Friday, May
17, at 3:00 PM (CET).
Registration is available at:
https://ryvu.clickmeeting.com/pre-eha2024-webinar-rvu120-progress-and-opportunity-in-mf/register
KRAKOW, Poland, May 14, 2024
/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,
will present clinical and preclinical data from RVU120 at the
2024 European Hematology Association Congress (EHA), June 13-16, Madrid,
Spain.
"At this year's EHA conference, we proudly unveil the latest
advancements in RVU120 research and clinical development,
illuminating its potential in addressing the unmet need in
hematologic malignancies. RVU120 has demonstrated clinical activity
as a single agent in 15 of 29 evaluable patients with AML and
HR-MDS at tolerated doses. Furthermore, our preclinical data
demonstrate the synergistic potential of RVU120 in combination with
venetoclax, representing a promising strategy against resistance in
AML. We are also excited about the emerging data in MPN models,
where combination regimens with RVU120 could represent a new
treatment paradigm." – Dr. Hendrik
Nogai, Chief Medical Officer, Ryvu Therapeutics.
Based on these data and in line with prior guidance, Ryvu's
development plan for RVU120 includes four Phase II studies: the
RIVER-52 study in patients with AML/HR-MDS as monotherapy, the
RIVER-81 study in combination with venetoclax in patients with r/r
AML, the POTAMI-61 study in patients with myelofibrosis,
and the REMARK study, an investigator-initiated trial in
patients with LR-MDS.
Poster highlights:
Abstract Title: RVU120, a first-in-class CDK8
inhibitor for the treatment of relapsed/refractory AML and
high-risk MDS: preliminary results from two ongoing studies.
Number: 6466
Session date and time: Friday, June 14 (18:00-19:00 CEST)
The abstract includes data on 29 evaluable patients out of 38
total dosed patients.
In the Phase I trial CLI120-001, RVU120 shows promising clinical
activity in patients with AML or HR-MDS. 15 out of 38 patients
experienced clinical benefit with RBC transfusion independence
and/or blast reduction. A complete remission (CR) was achieved in a
patient with NPM1 and DNMT3A mutations as well as 3 marrow CRs in
patients with HR-MDS. Relevant target inhibition was achieved at a
dose of 110 mg or higher, supporting a recommended Phase II dose
(RP2D) of 250mg. The follow-on Phase II RIVER-52 study
investigates RVU120 as a monotherapy in patients with genetically
defined AML or HR-MDS and is currently recruiting.
Abstract Title: Synergistic potential of RVU120, a
first-in-class CDK8/CDK19 inhibitor, with venetoclax in AML:
preclinical and initial clinical insights.
Abstract Number: 6720
Session date and time: Friday,
June 14 (18:00-19:00 CEST)
The abstract presents updated preclinical data supporting the
synergistic combination of RVU120 and venetoclax in AML, including
RVU120's potential to overcome resistance to venetoclax treatment.
Ongoing preclinical research and an ongoing Phase II clinical study
seek to refine patient stratification and enhance therapeutic
outcomes, with initial safety profiles appearing favorable. The
Phase II RIVER-81 study investigates RVU120 in combination
with venetoclax in patients with AML and is currently
recruiting.
Abstract Title: CDK8/19 Inhibition: A Promising
Therapeutic Strategy in Myeloproliferative Neoplasms.
Poster Number: P1018
Session date and time: Friday, June 14
(18:00-19:00 CEST)
The presentation, prepared in collaboration with Prof. Raajit
Rampal's group from Memorial Sloan Kettering Cancer Center,
includes the assessment of RVU120 as a monotherapy and in
combination with JAK inhibitors and other drug candidates for the
treatment of myeloproliferative neoplasms (MPN). Analysis of the
effects from combinations of RVU120 with other compounds in
vitro has revealed potentially new therapeutic options for
patients with MPN sensitivity and resistance to ruxolitinib (RUX).
In vivo data further support CDK8 inhibition as a potential
novel therapeutic strategy in MPNs. Additional mechanistic work
will potentially elucidate disease mechanisms and therapeutic
action independent of JAK-STAT attenuation. This work has led to a
Phase II clinical study (POTAMI-61) for RVU120 as a
monotherapy in patients with myelofibrosis patients not eligible
for RUX or in combination with RUX for those patients with
myelofibrosis and suboptimal RUX response.
The final posters that will be presented on June 14th will contain additional
information.
Investor Event:
Ryvu will host a webinar on Friday, May
17, at 3:00 PM CET with
Professor Raajit Rampal, who will present the myelofibrosis
landscape, the latest data and the potential of RVU120 in MF.
To join the webcast, please register here:
https://ryvu.clickmeeting.com/pre-eha2024-webinar-rvu120-progress-and-opportunity-in-mf/register
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 use 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 include RVU120, a selective
CDK8/CDK19 kinase inhibitor with the potential to treat
hematological malignancies and solid tumors, currently in Phase II
development (i) as a monotherapy for the treatment of patients
with relapsed/refractory acute myeloid leukemia (r/r AML) and
high-risk myelodysplastic syndromes (HR-MDS) as well as (ii) in
combination with venetoclax for the treatment of patients with r/r
AML. Another clinical program, SEL24 (MEN1703), is 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 and Exelixis.
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 mWIG40 index. For
more information, please see www.ryvu.com.
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SOURCE Ryvu Therapeutics