KRAKOW, Poland, Sept. 6,
2019 /PRNewswire/ -- Selvita (WSE: SLV) today announced
that the first patient enrolled in the Phase 1b study of company's selective CDK8 inhibitor,
SEL120, has received the first dose. SEL120 is being initially
investigated in the treatment of patients with acute myeloid
leukemia (AML) or high-risk myelodysplastic syndrome (HR-MDS). This
open-label, dose-escalation study is being conducted at multiple
sites in the U.S. and evaluates the safety, tolerability and the
preliminary activity of SEL120, as well as establishing a
recommended dose for further clinical development.
"CDK8 represents an important potential therapeutic target in
cancer. SEL120, an orally available small molecule, is potentially
the best in class CDK8 inhibitor and is the first in class to enter
the clinical trials," commented Dr. Setareh Shamsili, Chief Medical
Officer of Selvita.
"SEL120 has been identified through our in-house discovery
platform with having differentiating characteristics, such as high
selectivity, and has potential for development in a broad range of
both hematological and solid malignancies. In preclinical studies,
SEL120 has shown strong proof of concept for the treatment of AML,
a disease where patients still face poor prognosis. We're very
grateful for the strategic support and advisory role that The
Leukemia & Lymphoma Society (LLS) has played in bringing SEL120
into clinical development through its Therapy Acceleration Program®
(TAP). We expect to share the preliminary results of SEL120 study
with the oncology community in 2020."
This Phase 1b study is a
multicenter, sequential, modified 3+3 dose escalation study in
adult patients with AML or HR-MDS who are refractory to treatment
or have relapsed after previous therapies. Patients will be
enrolled in the study independent of specific tumor mutational
burden. The study will also assess pharmacokinetic and
pharmacodynamic parameters of SEL120. Selvita is the sole sponsor
of the Study.
About SEL120
SEL120 is an oral, selective inhibitor of CDK8, a kinase which
is a part of the mediator complex and is essential for the activity
of super-enhancers important to the regulation of RNA
transcription. CDK8 kinase is implicated in the development of
hematological malignancies and solid tumors. SEL120 was discovered
with the Selvita discovery engine platform and is currently in
clinical development for the treatment of acute myeloid leukemia
and high risk myelodysplastic syndrome. SEL120 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 Selvita
Selvita is developing novel small molecule therapies that
address emerging targets in oncology and provides industry-leading
research services. 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 development in
hematological malignancies and in solid tumors, currently in
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 in Phase 1/2
clinical development for the treatment of acute myeloid leukemia.
Selvita is headquartered in Krakow
with offices in the U.S. and U.K. Ardigen, a provider of precision
medicine and artificial intelligence services, and NodThera, a
company developing a new class of medicines to treat chronic
inflammation, were conceived, incubated and launched by Selvita. In
March 2019, Selvita announced the
intent to split its oncology development and research services
divisions into separate companies.
Forward-Looking Statements
This release may contain forward-looking statements, including,
among other things, statements regarding the guidance from
management, timing and/or results of clinical studies. Selvita
cautions the reader that forward-looking statements are not
guarantees of future performance. Forward-looking statements
involve known and unknown risks, uncertainties and other factors
which might cause the actual results, financial conditions,
performance or achievements of Selvita, or industry results, to be
materially different from any historic or future results,
conditions, performance or achievements expressed or implied by
such forward-looking statements. In addition, even if Selvita's
results, performance, and the development of the industry in which
it operates are consistent with such forward-looking statements,
they may not be predictive of results or developments in future
periods. Among the factors that may result in differences are that
Selvita's expectations regarding development programs may be
incorrect, the inherent uncertainties associated with competitive
developments, clinical study and projects development activities
and regulatory approval requirements, Selvita's reliance on
collaborations with third parties, and estimating the commercial
potential of its development programs. Given these uncertainties,
the reader is advised not to place any undue reliance on such
forward-looking statements. These forward-looking statements speak
only as of the date of publication of this document. Selvita
expressly disclaims any obligation to update any such
forward-looking statements in this document to reflect any change
in its expectations with regard thereto or any change in events,
conditions or circumstances on which any such statement is based or
that may affect the likelihood that actual results will differ from
those set forth in the forward-looking statements, unless
specifically required by law or regulation.
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