KRAKOW, Poland, May 28,
2021 /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, announced today that its Clinical Trial Application (CTA)
to commence a single-agent, open-label Phase I/II trial,
investigating the safety and efficacy of RVU120 (SEL120) in
patients with relapsed/refractory metastatic or advanced solid
tumors in Poland, has been fully
approved by the Polish Office for Registration of Medicinal
Products, Medical Devices and Biocidal Products, and the respective
Central Ethics Committee.
Following the above-mentioned approvals, Ryvu Therapeutics will
be able to initiate a clinical study and start enrolling patients
in Poland.
The study is designed in two phases. Phase I part has the key
objectives of assessing safety and tolerability, pharmacokinetics
(PK), pharmacodynamics (PD), and preliminary anti-tumor activity of
RVU120 (SEL120) during dose escalating cohorts, and determination
of the recommended phase II dose (RP2D), and the phase II part,
subsequently will include specific tumor indications, enrolled at
distinct study groups, such as Triple Negative Breast Cancer
(TNBC).
"With approvals from Polish Office for Registration of Medicinal
Products, Medical Devices, and Biocidal Products and Central Ethics
Committee, we are making another important step in the clinical
development of our flagship RVU120 (SEL120) program. We are very
excited to develop RVU120 (SEL120) as a potential treatment in both
hematological and solid malignancies," comments Setareh
Shamsili, MD, PhD, Chief Medical Officer, and EVP at Ryvu
Therapeutics.
"We are delighted that the new Phase I/II RVU120 (SEL120) study
in patients with solid tumors will be conducted in Poland. Clinical Trial Applications in other
European countries will be submitted over the coming months," adds
Setareh Shamsili.
About RVU120 (SEL120)
RVU120 (SEL120) is a highly selective first-in-class CDK8/CDK19
inhibitor, which has demonstrated efficacy in a number of solid
tumor types in in vitro and in vivo models as well as
in onco-hematological malignancies. The first-in-human (FIH) phase
I study with RVU120(SEL120), in relapsed or refractory AML or
high-risk myelodysplastic syndromes (HRMDS), is currently enrolling
patients in 5 investigational sites in USA
(https://clinicaltrials.gov/ct2/show/NCT04021368).
Current translational data suggest that RVU120 (SEL120) is
particularly effective in undifferentiated AML STAT5-positive
cancers. Administration of RVU120 (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 RVU120 (SEL120) as an effective treatment for AML and
potentially other hematological malignancies.
On March 25, 2020, the U.S. Food
and Drug Administration (FDA) granted an orphan drug designation
(ODD) to RVU120 (SEL120), for the treatment of patients with acute
myeloid leukemia (AML).
On April, 2021 U.S. Food and Drug Administration, FDA, placed a
partial clinical hold on the first in human Phase Ib, dose
escalation clinical trial of RVU120 in patients with
relapsed/refractory (R/R) AML and high-risk MDS. Patients who
are currently taking RVU120 may continue treatment. Ryvu continues
to work closely with the FDA to resolve the partial clinical hold
with the objective of resuming enrollment in the study. RVU120
(SEL120) was discovered with the Ryvu Therapeutics discovery engine
platform and has received support from The Leukemia & Lymphoma
Society Therapy Acceleration Program® (TAP), a strategic initiative
to partner directly with innovative biotechnology companies and
leading research institutions to accelerate the development of
promising new therapies for blood cancers. More information about
TAP program is available at:
https://www.lls.org/therapy-acceleration-program.
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, immuno-oncology
and cancer metabolism targets. RVU120 (SEL120) is a selective
CDK8/CDK19 kinase inhibitor with potential for the treatment of
hematological malignancies and solid tumors currently in Phase
1b clinical development for the
treatment of acute myeloid leukemia and myelodysplastic syndrome.
SEL24 (MEN1703) is a 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 (until 2019 operating under the
name Selvita S.A.) and currently employs over 160 associates,
including more than 80 PhDs. Ryvu is headquartered in Krakow, Poland. Ryvu Therapeutics is listed on the
main market of the Warsaw Stock Exchange, and is a component of
sWIG80 index. For more information, please
see www.ryvu.com.
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