KRAKOW, Poland, May 14,
2020 /PRNewswire/ -- Ryvu Therapeutics (WSE: RVU)
today announced that abstracts regarding Phase 1/2 study of its
selective CDK8 inhibitor SEL120 and dual PIM/FLT3 inhibitor
SEL24/MEN1703, accepted for poster presentations at the Virtual
25th Annual European Hematology Association (EHA) Congress, are now
available online.
The poster concerning SEL24/MEN1703, is the first report on the
successful completion of Phase I clinical study of SEL24/MEN1703 in
Acute Myeloid Leukemia: "Results of the dose escalation part of
DIAMOND trial (CLI24-001): First-in-human study of SEL24/MEN1703, a
dual PIM/FLT3 kinase inhibitor, in patients with acute myeloid
leukemia".
The study was initiated in March
2017 and is the first clinical trial testing a dual
PIM/FLT3- inhibitor. The dual PIM/FLT3 inhibition of SEL24/MEN1703
suggested its potential to be active in acute myeloid leukemia
(AML) regardless of FLT3 status and to overcome FLT3 inhibitor
resistance.
The primary objectives of the dose escalation part of the study
were the identification of dose limiting toxicities, the
determination of the maximum tolerated dose and recommended dose
for the phase 2 part of the study, as well as characterization of
the pharmacokinetics of SEL24/MEN1703 in AML – relapsed or
refractory as well previously untreated - patients unsuitable for
chemotherapy.
Throughout the dose escalation part, SEL24/MEN1703 showed an
acceptable safety profile up to the recommended dose established at
125 mg/day (14 days ON – 7 days OFF in 21-day cycles). Initial
evidence of single agent efficacy was observed with 1 CR and 1 CRi
in elderly patients who had exhausted standard therapeutic options.
Cohort Expansion study planned in relapsed/refractory AML patients
in the United States and
Europe including Poland will further investigate the single
agent activity and the safety profile of SEL24/MEN1703.
"The promising results from the dose-escalation phase of the
DIAMOND trial provide a strong rationale to progress to the cohort
expansion phase of the study," said Dirk Laurent, Global Therapeutic Area Head -
Oncology of Menarini Ricerche. "We look forward to further
revealing the potential of the SEL24/MEN1703 program to the benefit
of AML patients who need innovative and effective therapeutic
options."
"We are thrilled with the initial Phase 1 results for
SEL24/MEN1703 reported by Menarini, which demonstrate early signs
of single agent efficacy of SEL24/MEN1703 in treatment of patients
with AML. We couldn't be more happy to see that the first drug
discovered internally by Ryvu, is showing therapeutic potential in
treatment of AML, a disease where patients still face poor
prognosis," – comments Krzysztof
Brzozka, PhD, Chief Scientific Officer and Executive VP at
Ryvu Therapeutics.
Additional information on the Phase 1/2 study, which is being
conducted by Ryvu's partner Menarini Group, is available
at https://clinicaltrials.gov/ct2/show/NCT03008187.
The second poster concerning SEL120, entitled "A
First-in-human study of SEL120, a novel oral selective CDK8/19
inhibitor, in patients with acute myeloid leukemia and high-risk
myelodysplastic syndrome" (abstract EP636) reports on the
current development of the project.
SEL120 is an oral, selective inhibitor of CDK8 kinase which is
implicated in the development of hematological malignancies and
solid tumors. A clinical phase 1b
study of SEL120 is currently enrolling in 6 investigational sites
in USA, investigating safety and preliminary efficacy of SEL120 in
treatment of patients with relapsed or refractory AML or high-risk
myelodysplastic syndrome (HR-MDS).
Current translational data suggest that SEL120 is particularly
effective in undifferentiated AML STAT5-positive cancers.
Administration of SEL120 in orthotopic AML patient derived
xenograft models reduced tumor burden to the level undetectable in
the peripheral blood, decreased splenomegaly and resulted in
partial bone marrow recovery at well tolerated doses, providing
therefore a strong rationale for the clinical development of SEL120
as an effective treatment for AML and potentially other
hematological malignancies. The SEL120 FIH study is currently
recruiting adult patients with relapsed/refractory AML or HR-MDS in
the United States and aims to
assess safety and tolerability of SEL120.
On March 25, 2020 the U.S. Food
and Drug Administration (FDA) granted an orphan drug designation
(ODD) to SEL120, for the treatment of patients with acute myeloid
leukemia (AML).
Both poster abstracts can be obtained from conference site:
https://ehaweb.org/. Both posters will be presented as an
e-Poster presentation and made available on the virtual Congress
platform.
About the 25th EHA Congress
The Annual
Congress of EHA is a flagship meeting held in a major European city
every June—a significant meeting place for hematologists from every
area of specialization. Annual congresses encompass the entire
spectrum of hematological studies, where over 11,000 participants
who share passion for this field, can learn about the latest
findings and innovations. Due to the massive worldwide impact
of the COVID-19 crisis, the 25th Congress of the European
Hematology Association (EHA) will be replaced by a Virtual Edition:
"Unfolding the future!"
About Ryvu Therapeutics
Ryvu Therapeutics is a clinical stage biopharmaceutical company
developing novel small molecule therapies that address emerging
targets in oncology. Pipeline candidates make use of diverse
therapeutic mechanisms driven by emerging knowledge of cancer
biology, including small molecules directed at kinase, synthetic
lethality, immuno-oncology and cancer metabolism targets. SEL120 is
a selective CDK8 kinase inhibitor with potential for the treatment
of hematological malignancies and solid tumors currently in Phase 1
clinical studies for the treatment of acute myeloid leukemia and
myelodysplastic syndrome. SEL24/MEN1703 is a dual PIM/FLT3 kinase
inhibitor licensed to the Menarini Group in Phase 2 clinical
studies for the treatment of acute myeloid leukemia. Ryvu is listed
on the Warsaw Stock Exchange in Poland (WSE:RVU). For more information, please
see www.ryvu.com.
Contacts Ryvu:
Media:
Natalia Baranowska
+48 784-069-418
natalia.baranowska@ryvu.com
Investors:
Julia Balanova
+1 646-378-2936
jbalanova@troutgroup.com
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SOURCE Ryvu Therapeutics
