- RVU120 as a single agent showed clinical benefit in heavily
pretreated patients with AML and HR-MDS in the Phase 1
RIVER-51 study (CLI120-001). The strongest evidence of benefit was
observed in patients with NPM1 and/or DNMT3A mutations and in
patients with HR-MDS. 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.
- Preclinical results strongly support RVU120 as a candidate
for venetoclax relapsed/refractory and frontline AML
therapy.
- New data in myelofibrosis models show that RVU120 acts
synergistically with JAK inhibitors and BET inhibitor – pelabresib.
These data support new potential therapeutic options for patients
with myelofibrosis. Based on compelling preclinical results, Ryvu
plans to launch the clinical study POTAMI-61
(NCT06397313).
- A webinar covering the latest data in AML, MDS, and MF
will be held on Friday, June 14, at
9:30 (CET). Registration is available at:
https://ryvu.clickmeeting.com/ryvu-eha-2024-results
KRAKOW, Poland, June 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, presents clinical and preclinical data from
RVU120 at the 2024 European Hematology Association Congress (EHA),
June 13-16, Madrid, Spain.
"We are thrilled to share the advancements in RVU120 research
and its clinical development, emphasizing its significant potential
in addressing unmet needs in hematologic malignancies.", states
Dr. Hendrik Nogai, Chief Medical
Officer, Ryvu Therapeutics. "We are proud of the successful
initiation of our Phase II studies. It is reassuring that the
initial clinical safety data of RVU120 in combination with
venetoclax, allow us to continue testing the compelling preclinical
evidence of synergism in patients. Beyond AML and HR-MDS, we
continue to work hard on new therapeutic strategies for patients
with myeloproliferative neoplasms. Over the upcoming months, we are
expecting a ramp up of patient enrollment and data readouts, and we
remain committed to developing innovative treatments that can
provide improved outcomes for patients in need." – underlines
Dr. Hendrik Nogai, Chief Medical
Officer, Ryvu Therapeutics.
Poster highlights:
Poster 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.
Poster Number: P600
Session date and time: Friday, June 14 (9:00 CET on the online platform, 18:00 CET for the poster presentation)
The poster includes data on 30 evaluable patients out of 38
total dosed patients in the Phase I trial (RIVER-51) and initial
data from the Phase II trial (RIVER-52).
- RVU120 as single agent showed clinical benefit in heavily
pretreated patients with AML and HR-MDS in the Phase I trial
CLI120-001 (RIVER-51). The strongest evidence of benefit was
observed in patients with NPM1 and/or DNMT3A mutations, and in
patients with HR-MDS.
- At the poster presentation's cut-off date, the data from the
Phase II RIVER-52 trial of RVU120 as a monotherapy for
patients with relapsed/refractory AML and HR-MDS were not yet
mature enough for efficacy assessment in the target population, but
preliminary signs of clinical benefit have been observed in ongoing
patients.
- The safety and tolerability of RVU120 at the RP2D of 250 mg
administered every other day was confirmed in patients treated in
both trials, with mild or moderate gastrointestinal events being
the most frequently reported.
Poster Title: Synergistic potential of RVU120, a
first-in-class CDK8/CDK19 inhibitor, with venetoclax in AML:
preclinical and initial clinical insights.
Poster Number: P525
Session date and time: Friday, June 14
(9:00 CET on the online platform,
18:00 CET for the poster
presentation)
- Ryvu presents a mechanism of synergy between RVU120 and
venetoclax in preclinical models of acute myeloid leukemia
(AML).
- The combination of RVU120 and venetoclax leads to
caspase-dependent degradation of MCL-1 protein and represses
inflammatory and AML oncogenic pathways at the transcriptomic level
in AML cells.
- RVU120, when combined with venetoclax, exerts cytotoxic
and differentiating effects on leukemic stem cells (LSCs) from a
hierarchical AML model, exceeding the efficacy of venetoclax
alone.
- By countering therapeutic failure caused by
persistent LSCs and MCL-1-mediated venetoclax resistance, this
combination offers hope to patients with AML in both the refractory
and the frontline setting.
- Initial data from the ongoing Phase II study RIVER-81
demonstrate the safety of RVU120 in combination
with venetoclax at the initial dose level in patients with
relapsed/refractory AML. Enrollment is currently ongoing in Cohort
2.
Poster Title: CDK8/19 Inhibition: A Promising
Therapeutic Strategy in Myeloproliferative Neoplasms.
Poster Number: P1018
Session date and time: Friday, June 14
(9:00 CET on the online platform,
18:00 CET for the poster
presentation)
- In murine models of disease, RVU120 effectively attenuates
myeloproliferative neoplasms (MPN) phenotypes (single-agent or
combined with ruxolitinib (RUX)) partly through downregulation of
pro-inflammatory cytokines.
- RVU120 exhibits synergy with JAK inhibitors as a class and
BET inhibitor – pelabresib. These findings open new potential
therapeutic options for MPN patients, including myelofibrosis.
- The combination of RVU120 and RUX acts synergistically by
downregulating JAK/STAT signaling and inflammatory pathways at the
transcriptomic level.
- Based on compelling preclinical results, Ryvu is launching
the clinical study POTAMI-61 (NCT06397313), evaluating RVU120 as a
single agent or in combination with ruxolitinib in patients
with myelofibrosis.
Investor Event:
Ryvu will host a webinar on Friday, June
14, at 9:30 CET, covering the
latest data and potential of RVU120. To join the webcast, please
register here:
https://ryvu.clickmeeting.com/ryvu-eha-2024-results
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
