Alkermes to Present Preclinical Data on ALKS 4230 at the American Association for Cancer Research Annual Meeting
March 27 2017 - 7:00AM
Business Wire
— Novel Engineered Fusion Protein
Designed for Selective IL-2 Receptor Activation to Enhance
Tumor-Killing Immune Cells —
Alkermes plc (NASDAQ: ALKS) today announced that preclinical
data on the company’s immuno-oncology drug candidate, ALKS 4230, an
engineered fusion protein designed for selective activation of the
interleukin-2 (IL-2) receptor, will be presented at the upcoming
American Association for Cancer Research (AACR) Annual Meeting to
be held from April 1-5, 2017 in Washington D.C. ALKS 4230 is
designed to preferentially bind and signal through the intermediate
affinity IL-2 receptor complex, thereby selectively activating and
increasing the number of tumor-killing immune cells while avoiding
the expansion of immunosuppressive cells that interfere with
anti-tumor response.
Details of the preclinical data poster presentations are as
follows:
April 2, 2017, 1:00 - 5:00 p.m. ET – Abstract 591
(Poster): Efficacy of ALKS 4230, a novel immunotherapeutic agent,
in murine syngeneic tumor models alone and in combination with
immune checkpoint inhibitors.
- In a murine lung tumor metastasis
model, treatment with ALKS 4230 as a single agent resulted in
greater anti-tumor efficacy relative to recombinant human IL-2
(rhIL-2) and was associated with selective expansion of memory CD8+
T cells and NK cells (tumor-killing cells), without expansion of
regulatory T (Treg) cells. Specifically, ALKS 4230 treatment
resulted in dose-dependent reduction of lung tumor colonization,
with 100% inhibition at the highest dose tested. In contrast, the
maximal level of inhibition achieved by rhIL-2 was 60-70% at
multiple dose levels, demonstrating that increasing doses of rhIL-2
did not result in greater inhibition.
- Combination regimens with ALKS 4230 and
either anti-CTLA4 or anti-PD-1 checkpoint inhibitor therapies in
murine tumor models resulted in durable anti-tumor
immunotherapeutic effects and increased survival rates.
April 3, 2017, 1:00 - 5:00 p.m. ET – Abstract 2663
(Poster): Characterization of the pharmacodynamic immune response
to a novel immunotherapeutic agent, ALKS 4230, in mice and
non-human primates.
- Data demonstrated that ALKS 4230 drove
dose-dependent expansion of memory CD8+ T cells and NK cells in
mice, and total CD8+ T cells and NK cells in non-human primates,
without activation and minimal expansion of CD4+ Tregs in mice and
non-human primates. These pharmacodynamics effects persisted for
several days after ALKS 4230 was cleared from circulation.
In addition to these preclinical data presentations, a poster
outlining the dose selection rationale for the ongoing phase 1
study of ALKS 4230 will be presented. The poster presentation
details are as follows:
April 4, 2017, 1:00 - 5:00 p.m. ET – Abstract 4088
(Poster): First-in-human dose selection for ALKS 4230, an
investigational immunotherapeutic agent.
- The selection of the 0.1 µg/kg
starting dose for the first-in-human study of ALKS 4230 was
determined, based on the Minimal Anticipated Biological Effect
Level (MABEL) approach.
For more information, including a complete list of abstracts,
please visit the AACR website at http://www.aacr.org.
About ALKS 4230ALKS 4230 is
an engineered fusion protein designed to preferentially bind and
signal through the intermediate affinity interleukin-2 (IL-2)
receptor complex, thereby selectively activating and increasing the
number of immunostimulatory tumor-killing immune cells while
avoiding the expansion of immunosuppressive cells that interfere
with anti-tumor response. The selectivity of ALKS 4230 is designed
to leverage the proven anti-tumor effects while overcoming
limitations of existing IL-2 therapy, which activates both
immunosuppressive and tumor-killing immune cells.
About AlkermesAlkermes
plc is a fully integrated, global biopharmaceutical company
developing innovative medicines for the treatment of central
nervous system (CNS) diseases. The company has a diversified
commercial product portfolio and a substantial clinical pipeline of
product candidates for chronic diseases that include schizophrenia,
depression, addiction and multiple sclerosis. 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.
Note Regarding Forward-Looking
StatementsCertain 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
therapeutic value of, and clinical development plans for, ALKS
4230. The company cautions 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 performance and 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 results for ALKS 4230
will be predictive of future clinical study results; whether ALKS
4230 could be shown to be unsafe or ineffective; whether future
clinical trials for ALKS 4230 will be initiated or completed on
time or at all; changes in the cost, scope and duration of ALKS
4230 clinical trials; and those risks described in the Alkermes plc
Annual Report on Form 10-K for the fiscal year ended Dec. 31, 2016,
and in other 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. The information contained in this
press release is provided by the company as of the date hereof,
and, except as required by law, the company disclaims any intention
or responsibility for updating or revising any forward-looking
information contained in this press release.
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Alkermes plcFor Investors:Eva Stroynowski, +1
781-609-6823orSandy Coombs, +1 781-609-6377orFor Media:Jennifer
Snyder, +1 781-609-6166
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