DUBLIN, Aug. 19, 2020 /PRNewswire/ -- Alkermes
plc (Nasdaq: ALKS) today announced the initiation of
ARTISTRY-3, a new phase 2 study to evaluate the clinical and
immunologic effects of ALKS 4230 monotherapy on the tumor
microenvironment of a variety of advanced, malignant solid tumors.
ALKS 4230, a novel cytokine, is an investigational, engineered
fusion protein designed to selectively expand tumor-killing immune
cells while avoiding the interleukin-2 (IL-2)-induced activation of
immunosuppressive cells by preferentially binding to the
intermediate-affinity IL-2 receptor complex.
"Early clinical data from our ARTISTRY program showed that ALKS
4230 selectively expanded cancer-fighting immune cells in the
periphery, with negligible effects on regulatory T cells (Tregs),"
said Craig Hopkinson, M.D., Chief
Medical Officer and Executive Vice President of Research &
Development at Alkermes. "Data from the ARTISTRY-3 clinical trial
will provide a deeper understanding of the effects of ALKS 4230 on
immunologic activity in the tumor microenvironment across a variety
of tumor types. Findings from this trial may help us answer
important mechanistic questions and identify the tumor types for
which ALKS 4230 could offer the most clinical benefit, thereby
helping to inform a potential registration strategy."
This single-center, open-label study will evaluate
treatment-emergent changes in the tumor microenvironment and
peripheral blood immunophenotypes, as well as the safety,
tolerability, and pharmacokinetic profile of ALKS 4230 (6µg/kg)
dosed intravenously, as lead-in monotherapy followed by combination
with the anti-PD-1 therapy KEYTRUDA® (pembrolizumab), in
patients with select advanced malignant solid tumors. Paired tumor
biopsies will be collected pre–treatment and following the
monotherapy and combination phases to evaluate the effects of ALKS
4230 on the immune cell repertoire, including changes in density
and ratio of immune cells, within the tumor microenvironment. The
study will also assess clinical antitumor activity (overall
response rate and duration of response) of ALKS 4230 as one of its
secondary objectives.
ARTISTRY-3 is the fourth clinical trial evaluating ALKS 4230 as
a novel immuno-oncology candidate. ARTISTRY-1 and ARTISTRY-2
are ongoing, phase 1/2 studies evaluating ALKS 4230 as a
monotherapy and in combination with pembrolizumab. ARTISTRY-1 and
ARTISTRY-2, are evaluating intravenous and subcutaneous
administration of ALKS 4230, respectively. ION-01 is an ongoing,
phase 2 multi-site trial, designed to estimate the response rate to
ALKS 4230 in combination with pembrolizumab in patients with
advanced or recurrent head and neck squamous cell cancer who did
not achieve complete remission with an anti-PD-(L)1 antibody
treatment.
About ALKS 4230
ALKS 4230 is an investigational,
novel, engineered fusion protein comprised of modified
interleukin-2 (IL-2) and the high affinity IL-2 alpha receptor
chain, designed to selectively expand tumor-killing immune cells
while avoiding the activation of immunosuppressive cells by
preferentially binding to the intermediate-affinity IL-2 receptor
complex. The selectivity of ALKS 4230 is designed to leverage the
proven anti-tumor effects of existing IL-2 therapy while mitigating
certain limitations.
About the ARTISTRY Clinical Development Program
ARTISTRY is an Alkermes-sponsored clinical development program
evaluating ALKS 4230 in patients with advanced solid tumors.
ARTISTRY-1 and ARTISTRY-2 are phase 1/2 studies
evaluating the safety, tolerability, efficacy and pharmacokinetic
and pharmacodynamic effects of ALKS 4230 in patients with
refractory advanced solid tumors, in both monotherapy and
combination settings with the PD-1 inhibitor KEYTRUDA®
(pembrolizumab). In ARTISTRY-1, ALKS 4230 is administered as an
intravenous infusion daily for five consecutive days. In
ARTISTRY-2, ALKS 4230 is administered subcutaneously and is being
evaluated with once-weekly and once-every-three-week dosing
schedules.
ARTISTRY-3 will evaluate the clinical and immunologic activity
of intravenous ALKS 4230 monotherapy on tumor microenvironment in
advanced solid tumor patients.
About Alkermes
Alkermes plc is a fully integrated,
global biopharmaceutical company developing innovative medicines in
the fields of neuroscience and oncology. The company has a
portfolio of proprietary commercial products focused on addiction
and schizophrenia, and a pipeline of product candidates in
development for schizophrenia, bipolar I disorder,
neurodegenerative disorders, and cancer. Headquartered in
Dublin, Ireland, Alkermes plc has
an R&D center in Waltham,
Massachusetts; a research and manufacturing facility in
Athlone, Ireland; and a
manufacturing facility in Wilmington,
Ohio. For more information, please visit Alkermes' website
at www.alkermes.com.
Alkermes Note Regarding Forward-Looking Statements
Certain statements set forth in this press release constitute
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995, as amended, including,
but not limited to, statements concerning: the potential
therapeutic value of ALKS 4230 as a cancer immunotherapy when used
as monotherapy or in combination; and the clinical trial design
for, and potential findings from, the ARTISTRY-3 study. You are
cautioned that forward-looking statements are inherently uncertain.
Although the company believes that such statements are based on
reasonable assumptions within the bounds of its knowledge of its
business and operations, the forward-looking statements are neither
promises nor guarantees and they are necessarily subject to a high
degree of uncertainty and risk. Actual results may differ
materially from those expressed or implied in the forward-looking
statements due to various risks and uncertainties. These risks and
uncertainties include, among others, whether ALKS 4230, as a
monotherapy or in combination, could be shown to be unsafe or
ineffective; whether preclinical and preliminary, interim or final
clinical results for ALKS 4230—whether as a monotherapy or in
combination with pembrolizumab—will be predictive of future data
from the same studies, results of future clinical studies or
real-world results; whether future clinical trials or future stages
of ongoing clinical trials for ALKS 4230, as a monotherapy or in
combination, will be initiated or completed on time or at all;
changes in the cost, scope and duration of, and clinical trial
operations for, development activities for ALKS 4230, including
changes relating to the novel coronavirus (COVID-19); and those
risks and uncertainties described under the heading "Risk Factors"
in the company's Annual Report on Form 10-K for the year ended
Dec. 31, 2019, the company's
Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 and in subsequent filings made by
the company with the U.S. Securities and Exchange Commission (SEC),
which are available on the SEC's website at www.sec.gov. Existing
and prospective investors are cautioned not to place undue reliance
on these forward-looking statements, which speak only as of the
date hereof. Except as required by law, the company disclaims any
intention or responsibility for updating or revising any
forward-looking statements contained in this press release.
KEYTRUDA® is a registered trademark
of Merck Sharp & Dohme Corp.
Alkermes Contacts:
For Investors: Sandy Coombs, +1 781
609 6377
For Media: Sourojit Bhowmick, Ph.D. +1 781 609 6397
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