Acumen Pharmaceuticals, Inc. and Halozyme Enter Global Collaboration and License Agreement to Develop Subcutaneous Formulation of ACU193 with ENHANZE® Technology
06 November 2023 - 11:30PM
Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS) (“Acumen” or the
“Company”), a clinical-stage biopharmaceutical company developing a
novel therapeutic that targets toxic soluble amyloid beta oligomers
(AβOs) for the treatment of Alzheimer’s disease (AD), today
announced a global non-exclusive collaboration and license
agreement with Halozyme Therapeutics Inc. (“Halozyme”). The
collaboration will provide Acumen access to Halozyme's
ENHANZE® drug delivery technology, based on a recombinant
human hyaluronidase PH20 enzyme (rHuPH20), for the development of a
subcutaneous formulation of ACU193, the first clinical-stage
AβO-targeting antibody. ENHANZE® has been commercially validated in
seven approved therapies, with global collaborations covering more
than 60 therapeutic targets.
Acumen intends to explore using ENHANZE® with ACU193 and
plans to initiate Phase 1 development in human subjects in mid-2024
to compare the pharmacokinetics (PK) of a subcutaneous form of
ACU193 to the intravenous (IV) form. Acumen recently completed the
Phase 1 INTERCEPT-AD trial in patients with early AD, which
demonstrated robust, dose dependent target engagement for ACU193
and additionally produced amyloid plaque reduction following three
administrations of ACU193 at 25 mg/kg or 60 mg/kg. At or near a
three-month timepoint, ACU193 reduced amyloid plaque to a
comparable level as that observed with administration of
LEQEMBI®.
Under the terms of the agreement, in return for an upfront
payment to Halozyme and other considerations, Acumen will receive
non-exclusive rights to ENHANZE®. Acumen is obligated to make
future payments to Halozyme, subject to achievement of specified
development, regulatory and sales-based milestones. Halozyme
will also be entitled to receive royalties on sales of
commercialized medicines using the ENHANZE® technology.
"We are thrilled to partner with Halozyme, the market leader in
rapid subcutaneous drug delivery technology, and look forward to
working closely with their team to advance a subcutaneous
formulation of ACU193," said Daniel O’Connell, President and Chief
Executive Officer. "Acumen is a patient-driven organization, and
with the recent momentum of subcutaneous administration of
Alzheimer’s therapies, we look forward to being able to provide
another treatment option that has the potential to broaden patient
access and decrease treatment burden."
About Acumen Pharmaceuticals, Inc.
Acumen, headquartered in Charlottesville, VA, with additional
offices in Indianapolis, IN and Newton, MA, is a clinical-stage
biopharmaceutical company developing a novel therapeutic that
targets toxic soluble amyloid beta oligomers (AβOs) for the
treatment of Alzheimer’s disease (AD). Acumen’s scientific founders
pioneered research on AβOs, which a growing body of evidence
indicates are early and persistent triggers of Alzheimer’s disease
pathology. Acumen is currently focused on advancing its
investigational product candidate, ACU193, a humanized monoclonal
antibody that selectively targets toxic soluble AβOs, following
positive topline results in INTERCEPT-AD, a Phase 1 clinical trial
involving early Alzheimer’s disease patients. For more information,
visit www.acumenpharm.com.
Acumen Forward-Looking Statement
This press release contains forward-looking statements within
the meaning of The Private Securities Litigation Reform Act of
1995. Any statement describing Acumen’s goals, expectations,
financial or other projections, intentions or beliefs is a
forward-looking statement and should be considered an at-risk
statement. Words such as “believes,” “expects,” “anticipates,”
“could,” “should,” “would,” “seeks,” “aims,” “plans,” “potential,”
“will,” “milestone” and similar expressions are intended to
identify forward-looking statements, although not all
forward-looking statements contain these identifying words.
Forward-looking statements include statements concerning Acumen’s
business, Acumen’s ability to achieve its strategic goals, the
therapeutic potential of Acumen’s product candidate, ACU193, with
and without the ENHANZE® technology, and Acumen’s obligations under
the Agreement. These statements are based upon the current beliefs
and expectations of Acumen management, and are subject to certain
factors, risks and uncertainties, particularly those inherent in
the process of discovering, developing and commercializing safe and
effective human therapeutics. Such risks may be amplified by the
impacts of geopolitical events and macroeconomic conditions, such
as rising inflation and interest rates, supply disruptions and
uncertainty of credit and financial markets. These and other risks
concerning Acumen’s programs are described in additional detail in
Acumen’s filings with the Securities and Exchange Commission
(“SEC”), including in Acumen’s most recent Annual Report on Form
10-K, and in subsequent filings with the SEC. Copies of these and
other documents are available from Acumen. Additional
information will be made available in other filings that Acumen
makes from time to time with the SEC. These forward-looking
statements speak only as of the date hereof, and Acumen expressly
disclaims any obligation to update or revise any forward-looking
statement, except as otherwise required by law, whether, as a
result of new information, future events or
otherwise.LEQEMBI® is a registered trademark of Eisai R&D
Management Co., Ltd.
CONTACTS:
Investors: Alex Braunabraun@acumenpharm.com
Media: AcumenPR@westwicke.com
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