Alkermes Announces Initiation of Phase 1 Clinical Study of Immuno-Oncology Drug Candidate ALKS 4230
May 25 2016 - 7:00AM
Business Wire
— Novel Selective Effector Cell
Activator (SECA™) Protein Designed for Targeted IL-2 Receptor
Activation to Enhance Tumor-Killing Immune Cells —
Alkermes plc (NASDAQ: ALKS) today announced the initiation of a
phase 1 clinical study of the company’s immuno-oncology drug
candidate, ALKS 4230 (formerly referred to as RDB 1450), a novel
Selective Effector Cell Activator (SECA™) protein designed for
targeted interleukin-2 (IL-2) receptor activation. The multi-center
phase 1 study is designed to evaluate the safety, tolerability and
immunological-pharmacodynamic effects of ALKS 4230 in the treatment
of patients with solid tumors.
The phase 1 study will be conducted in two stages: a
dose-escalation stage followed by a dose-expansion stage. In the
first stage of the study, ALKS 4230 will be administered as an
intermittent intravenous infusion with ascending doses in patients
with solid tumors who are refractory or intolerant to established
therapies. This first stage of the study is designed to determine a
maximum tolerated dose, and to identify the optimal dose range of
ALKS 4230 based on measures of immunological-pharmacodynamic
effects. Following the identification of the optimal dose range of
ALKS 4230 in the first stage of the study, the dose-expansion stage
of the study will evaluate ALKS 4230 in patients with selected
solid tumor types. Initial results from the first stage of the
phase 1 study are expected in 2017.
“ALKS 4230 is a unique immuno-oncology candidate that is
designed to harness the IL-2 mechanism in a selective way that
enhances tumor-killing immune cells, so that a patient’s own immune
system can be activated in order to fight cancer more effectively,”
said Elliot Ehrich, M.D., Chief Medical Officer of Alkermes. “We
have designed this initial clinical study of ALKS 4230 to be highly
informative and to position us for phase 2 studies, including those
that may include ALKS 4230 in combination with other
immuno-oncology therapies. We are excited about the start of the
clinical program and the potential for ALKS 4230 to make an impact
for patients with cancer.”
About ALKS 4230 and the SECA™
Immuno-Oncology ProgramALKS 4230 is a novel selective
effector cell activator (SECA™) 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
immunostimulatory and immunosuppressive receptors.
SECA proteins are engineered using Alkermes’ proprietary
PICASSOTM circular permutation technology leveraging human protein
biology to achieve their unique mechanism of action.
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, clinical development plans and commercial
potential for ALKS 4230. 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
are subject to a variety of risks and uncertainties, many of which
are beyond the company’s control, which could cause actual results
to differ materially from those expressed or implied in the
forward-looking statements. These risks and uncertainties include,
among others, whether preclinical and early clinical 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, 2015 and in any 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.
PICASSO™ and SECA™ are trademarks of Alkermes, Inc.
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AlkermesFor Investors:Sandra Coombs, +1 781-609-6377orFor
Media:Jennifer Snyder, +1 781-609-6166
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