- Clinically meaningful benefit of RVU120 monotherapy: a
complete remission (CR) in a DNMT3A/NPM1-mutated AML patient; more
than 18-month duration of therapy in a DNMT3A-mutated high-risk MDS
patient; stable diseases (SD) with blast reductions in three
additional patients
- Partner Menarini Group presents updated data from Phase 1/2
study of SEL24 (MEN1703), in patients with IDH1/2-mutated
AML
KRAKOW, Poland, June 10,
2022 /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, today announced updated data from the ongoing
Phase 1b dose-escalation study of
RVU120 in patients with acute myeloid leukemia (AML) or high-risk
myelodysplastic syndromes (HR-MDS) at the Annual European
Hematology Association (EHA) 2022 Hybrid Congress, June 9-17 in Vienna,
Austria. In addition, Ryvu's partner, Menarini Group,
presented a clinical update on the Phase 1/2 study of SEL24
(MEN1703) in patients with IDH1/2-mutated AML.
"The data presented at this year's EHA Congress demonstrate
Ryvu's commitment to developing effective, first-in-class treatment
options for people with hematologic malignancies," said
Hendrik Nogai, M.D., Chief Medical
Officer at Ryvu Therapeutics.
"We are excited to share these promising results from our
ongoing Phase 1b dose-escalation
study in patients with AML and HR-MDS, in which we have seen
single-agent activity of RVU120, validating its mechanism of action
even at doses that resulted in less than complete target
engagement. These clinical data support our responder hypothesis in
a molecularly defined subset of patients with DNMT3A and NPM1
mutations. Based on the encouraging data, we plan to continue dose
escalation and further advance the clinical development of RVU120
in both biomarker-selected AML patients and the unselected broader
AML population."
"The emerging RVU120 clinical data are very promising with the
potential to achieve durable benefit in patients with very few
treatment options," said Pawel Przewiezlikowski, CEO of Ryvu
Therapeutics. "We are also proud that the SEL24 (MEN1703) program,
developed in collaboration with our partner Menarini, continues to
make progress in the clinic. We look forward to providing future
updates from our clinical programs throughout 2022 as we advance
new and innovative therapeutics for patients suffering from
cancer."
Poster presentations featured at the Congress:
RVU120: orally available CDK8/19 inhibitor
Abstract Title: "CLI120-001 Phase1b Dose
Escalation Study of RVU120 in Patients with AML or High-Risk MDS
Safety and Efficacy Data Update," Abstract Number: #P501
Preliminary results were presented from the first seven cohorts,
demonstrating a favorable safety and a predictable pharmacokinetic
(PK) profile for RVU120.
As of the data cutoff date of May 26,
2022, 16 patients with AML or HR-MDS have been dosed (5
ongoing) with a median of three prior lines of therapy.
Clinically meaningful benefit of RVU120 monotherapy has been
observed at doses that resulted in less than complete target
engagement, with one complete remission (CR) and stable diseases
with blast reductions in several ongoing patients who failed
multiple prior lines of therapy and presented with a very poor
prognosis:
- Complete remission in an AML patient with FLT3/DNMT3A/NPM1
mutations
- Stable disease with a duration of therapy of more than 18
months in a high-risk MDS patient with DNMT3A mutations;
significant reductions in red blood cells (RBC) transfusions at
various timepoints
- Three additional patients ongoing with stable disease and blast
count reductions
Dose escalation is ongoing, with active enrollment in the 100 mg
dose cohort (NCT04021368).
Abstract Title: "Preclinical and Clinical Signs of
RVU120 Efficacy, a Specific CDK8/19 Inhibitor in DNMT3A Mutation
Positive AML and HR-MDS," Abstract Number: #P450
Preclinical data demonstrate that treatment with RVU120
demonstrated a pronounced anti-cancer effect in AML patient-derived
cells with DNMT3A and NPM1 mutations.
Preliminary evidence of clinical response to RVU120 has been
shown in a r/r AML patient with DNMT3A and NPM1 mutations, who
achieved a complete remission. Anti-cancer efficacy of RVU120
was associated with transcriptomic reprogramming involving lineage
commitment and inhibition of homeobox genes. Repression of homeobox
genes in the responder patient confirms the on-target activity of
RVU120.
Further molecular studies in a larger number of patients under
RVU120 treatment are ongoing and are expected to provide additional
evidence for predictive markers of response to RVU120 in AML.
SEL24/MEN1703: orally available dual PIM/FLT3
inhibitor
Abstract Title: "Phase 1/2 Study of SEL24/MEN1703, a
First-In-Class Dual PIM/FLT3 Kinase Inhibitor, in Patients with
IDH1/2-Mutated Acute Myeloid Leukemia: The DIAMOND-01
Trial," Abstract Number: #P520
Ryvu's partner Menarini Group reported the updated safety and
efficacy results from an additional expansion cohort of the
DIAMOND-01 trial, which enrolled patients with relapsed or
refractory (R/R) IDHm AML, treated with the dual PIM/FLT3
inhibitor, SEL24 (MEN1703).
As of a data cutoff of April 21,
2022, 25 patients were enrolled in the IDHm AML expansion
cohort. SEL24 (MEN1703) was well tolerated, with no drug
discontinuations or deaths due to treatment-related adverse events
(TRAEs). Promising efficacy was observed, with overall response
rates (ORR) and complete remission (CR) / CR with incomplete
hematologic recovery (CRi) / CR with partial hematologic recovery
(CRh) of 13% for the IDHm cohort, which is similar to monotherapy
activity of other drugs in R/R AML.
Based on these data, SEL24/MEN1703 may be a feasible therapy in
this difficult-to-treat population of patients with R/R AML
who harbor IDH mutations. Clinical trials are planned in order to
better explore the potential of SEL24/MEN1703 in different AML
populations.
All posters are now available for download from Ryvu corporate
website: https://ryvu.com/investors-media/publications/.
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.
Ryvu's most advanced programs are RVU120 - 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, and SEL24
(MEN1703) - 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 and is headquartered in Krakow,
Poland. Ryvu is listed on the main
market of the Warsaw Stock Exchange and is a component of the
sWIG80 index. For more information, please see www.ryvu.com.
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SOURCE Ryvu Therapeutics