DUBLIN and BOULDER, Colo., June
22, 2020 /PRNewswire/ -- Alkermes plc (Nasdaq:
ALKS) and Clovis Oncology, Inc. (Nasdaq: CLVS) today announced
positive preclinical data from a study designed to evaluate the
combination potential of ALKS 4230, Alkermes' investigational
engineered interleukin-2 (IL-2) variant immunotherapy, with
lucitanib, Clovis' investigational angiogenesis inhibitor. The data
will be presented during a poster session at the American
Association for Cancer Research (AACR) Virtual Annual Meeting II,
taking place June 22-24, 2020.
The study evaluated the antitumor efficacy and mechanism of
action of mALKS 4230, a mouse ortholog of ALKS 4230, and
lucitanib as monotherapies and in combination in a preclinical
syngeneic mouse model of colon cancer. The combination of
mALKS 4230 with lucitanib resulted in dose-dependent,
durable complete responses (absence of any detectable tumor) and
enhanced survival compared with monotherapy treatment with mALKS
4230 and lucitanib.
"Combining treatments with complementary mechanisms may offer
synergistic clinical benefit and expand treatment options for a
broader set of patient populations," said Craig Hopkinson, M.D., Chief Medical Officer and
Executive Vice President of Research & Development at Alkermes.
"These compelling preclinical data provide a foundational rationale
to further explore novel combination options, such as an
angiogenesis inhibitor, for ALKS 4230, with the goal of bringing
improved therapeutic outcomes to patients across multiple tumor
types."
Key findings presented in the poster include the following:
- In the group that received the higher dose of mALKS 4230
(out of two doses tested) combined with lucitanib, 100 percent of
the treated mice exhibited complete tumor regression and protection
from new tumor growth upon re-challenge, an indication of the
development of immunological memory.
- The combination of mALKS 4230 with lucitanib resulted in
an increase in intratumoral immune cells, including CD8+
T cells and dendritic cells, compared to monotherapy treatment,
changes that are associated with anti-tumor immune responses.
- The combination of mALKS 4230 with lucitanib elicited a
distinct gene expression profile associated with anti-tumor
activity, including increased immune cytolytic gene expression with
decreased expression of genes with pro-angiogenic functions.
A virtual poster titled, "The Combination of a Mouse Ortholog of
ALKS 4230, a Selective Agonist of the Intermediate-Affinity IL-2
Receptor, and the Angiogenesis Inhibitor Lucitanib Enhances
Antitumor Activity," along with a pre-recorded audio presentation
by Dr. Jared Lopes, Principal
Scientist, Alkermes will be available on the AACR website at
https://www.aacr.org/meeting/aacr-annual-meeting-2020/.
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 Lucitanib
Lucitanib is an oral, potent
inhibitor of the tyrosine kinase activity of vascular endothelial
growth factor receptors 1 through 3 (VEGFR1-3), platelet-derived
growth factor receptors alpha and beta (PDFGRα/β) and fibroblast
growth factor receptors 1 through 3 (FGFR1-3). Emerging clinical
data support the combination of angiogenesis inhibitors and
immunotherapy to increase effectiveness in multiple cancer
indications. Angiogenic factors, such as vascular endothelial
growth factor (VEGF), are frequently up-regulated in tumors and
create an immunosuppressive tumor microenvironment. Use of
antiangiogenic drugs reverses this immunosuppression and can
augment response to immunotherapy.
Lucitanib is an unlicensed medical product.
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.
About Clovis Oncology
Clovis Oncology, Inc. is
a biopharmaceutical company focused on acquiring, developing and
commercializing innovative anti-cancer agents in the U.S.,
Europe and additional
international markets. Clovis Oncology targets development programs
at specific subsets of cancer populations, and simultaneously
develops, with partners, diagnostic tools intended to direct a
compound in development to the population that is most likely to
benefit from its use. Clovis Oncology is headquartered in
Boulder, Colorado; please visit
www.clovisoncology.com for more information, including
additional office locations in the U.S. and Europe.
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 monotherapy or in
combination. 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 preclinical and preliminary, interim or final clinical
results for ALKS 4230—whether as a monotherapy or in
combination—will be predictive of future data from the same
studies, results of future clinical studies or real-world results;
whether ALKS 4230, as a monotherapy or in combination, could be
shown to be unsafe or ineffective; 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
March 31, 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.
Clovis Oncology Note Regarding Forward-Looking
Statements
To the extent that statements contained in this press release
are not descriptions of historical facts regarding Clovis
Oncology, they are forward-looking statements reflecting the
current beliefs and expectations of management. Examples of
forward-looking statements contained in this press release include,
among others, statements regarding the potential benefit of our
drug candidate lucitanib in combination with ALKS 4230 and
expanding treatment options for a broader set of patient
populations. Such forward-looking statements involve
substantial risks and uncertainties that could cause our future
results, performance or achievements to differ significantly from
that expressed or implied by the forward-looking
statements. Such risks and uncertainties include, among
others, whether future pre-clinical or clinical study results will
support continued development or regulatory approval, whether our
clinical development programs for our drug candidates and those of
our partners can be completed on time or at all, whether future
study results will be consistent with study findings to date,
and actions by the FDA, the EMA or other regulatory
authorities regarding data required to support drug applications
and whether to accept or approve drug applications that may be
filed, as well as their decisions regarding drug labeling,
reimbursement and pricing, and other matters that could affect the
development, approval, availability or commercial potential of our
drug candidates. Clovis Oncology does not undertake to
update or revise any forward-looking statements. A further
description of risks and uncertainties can be found in Clovis
Oncology's filings with the Securities and Exchange
Commission, including its Annual Report on Form 10-K and its
reports on Form 10-Q and Form 8-K.
Alkermes
Contacts:
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For
Investors:
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Sandy
Coombs
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+1 781 609
6377
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For Media:
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Sourojit Bhowmick,
Ph.D.
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+1 781 609
6397
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Clovis
Contacts:
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For
Investors:
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Breanna
Burkart
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+1 303 625
5023
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Anna
Sussman
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+1 303 625
5022
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For Media:
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Lisa
Guiterman
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+1 301 217
9353
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SOURCE Alkermes plc