- Agreement provides opportunity to expand
Alexion’s clinical-stage anti-FcRn portfolio with ABY-039 -
- Affibody to receive $25 million upfront
payment with potential for additional milestone-dependent and
royalty payments, and option for U.S. co-promote -
- Affibody’s technology offers potential for
extended half-life compared to other anti-FcRn therapies and low
volume subcutaneous administration -
Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) and Affibody AB
today announced a partnership to co-develop ABY-039 for rare
Immunoglobulin G (IgG)-mediated autoimmune diseases. Currently in
Phase 1 development, ABY-039 is a bivalent antibody-mimetic that
targets the neonatal Fc receptor (FcRn). ABY-039 has been
specifically designed to combine Affibody’s protein therapeutics
platform (Affibody® molecules) and Albumod™ technology to achieve a
long half-life, which, along with its small size provides the
potential for less frequent, convenient, at-home subcutaneous
administration.
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“We believe there is significant opportunity to transform
patient care with FcRn-targeted therapies and are thrilled to add a
second clinical-stage anti-FcRn medicine to our pipeline with this
collaboration,” said John Orloff, M.D., Executive Vice President
and Head of Research & Development at Alexion. “While clinical
development is still early, we are excited by ABY-039’s potential
to be an optimal subcutaneous therapy across a number of
IgG-mediated diseases, providing patients with the possibility of a
convenient self-administered treatment option.”
“ABY-039 offers an innovative and novel approach to treating
IgG-mediated diseases. Its rapid onset, sustained response, long
half-life and potential for low volume administration hold great
promise as a self-administered subcutaneous anti-FcRn therapy of
choice,” said David Bejker, Chief Executive Officer of Affibody.
“We look forward to building our partnership with Alexion and
leveraging their significant development and commercial experience
to accelerate the development of ABY-039. This collaboration is
another key step in the evolution of our company that is aligned
with our key strategic objectives.”
ABY-039 is being evaluated in a Phase 1 study in healthy
volunteers. This adaptive, double-blind, placebo-controlled study
is evaluating the safety, tolerability, pharmacokinetics and
pharmacodynamics of ABY-039 and will aid in dose selection for
future studies. The companies are assessing potential indications
for future development.
Under the terms of the agreement, Alexion will provide Affibody
with an upfront payment of $25 million, with the potential for
additional development- and sales-based milestones of up to $625
million and tiered low double-digit royalty payments. Alexion will
lead joint clinical development of ABY-039 and commercialization
activities. Affibody has the option to co-promote ABY-039 in the
U.S. and will lead clinical development for an undisclosed
indication.
The companies expect to close the transaction in the second
quarter of 2019, subject to clearance under the Hart-Scott Rodino
Antitrust Improvements Act.
Alexion will discuss the partnership further during today’s
Investor Day event and webcast.
About FcRn Antibodies play an important role in a healthy
body’s defense by fighting infections from bacteria and other
invaders. In autoimmune diseases, however, the body mistakenly
attacks itself through the production of pathogenic
(disease-causing) antibodies of the Immunoglobulin G (IgG) subtype.
Neonatal Fc receptor (FcRn) rescues IgGs from lysosomal degradation
by binding them to endosomes and returning them to the bloodstream.
This helps prolong the half-life of IgG. In healthy individuals,
this function contributes to a normal immune response. In many
autoimmune conditions, however, FcRn prevents lysosomal degradation
of pathogenic IgGs associated with driving the disease. Therefore,
blocking the FcRn-IgG interaction has the potential to drive
degradation of IgG within cells and rapidly reduce circulating
pathogenic IgG.
About ABY-039 ABY-039 is a novel anti-FcRn
antibody-mimetic, which has been specifically designed to utilize
the advantages of Affibody’s technology platform to differentiate
from competing antibody and Fc-based approaches. ABY-039 is a small
protein ligand (~19 kDa, approximately an eighth of the size of an
antibody) and has an in vivo half-life exceeding that of
antibody-based approaches.
About Affibody’s Technology Platform Affibody® molecules
are a class of small optimized proteins with high affinity based on
a non-immunoglobulin three-helix bundle domain scaffold. Affibody®
molecules have certain potentially advantageous features for
therapeutic applications including (i) small size resulting in
rapid tissue penetration and efficient delivery of higher molar
doses for the same mass vs. larger proteins, and (ii) robustness
resulting in potential for alternative administration routes. The
Albumod™ Platform uses a small optimized protein with an albumin
binding domain (5 kDa) with high affinity to albumin (sub pM) to
provide half-life extension and a wider distribution profile than
antibodies to Affibody® molecules and other therapeutic proteins.
The Affibody® technology, which includes the Affibody® molecules (6
kDa size, no Fc function) and Albumod™ platform, enables modified
and enhanced pharmacokinetics through the albumin binding domain,
offering the same distribution profile as albumin.
About Alexion Alexion is a global biopharmaceutical
company focused on serving patients and families affected by rare
diseases through the discovery, development and commercialization
of life-changing therapies. As the global leader in complement
biology and inhibition for more than 20 years, Alexion has
developed and commercializes two approved complement inhibitors to
treat patients with paroxysmal nocturnal hemoglobinuria (PNH) as
well as the first and only approved complement inhibitor to treat
atypical hemolytic uremic syndrome (aHUS) and anti-acetylcholine
receptor (AchR) antibody-positive generalized myasthenia gravis
(gMG), and is also developing it for patients with neuromyelitis
optica spectrum disorder (NMOSD). Alexion also has two highly
innovative enzyme replacement therapies for patients with
life-threatening and ultra-rare metabolic disorders,
hypophosphatasia (HPP) and lysosomal acid lipase deficiency
(LAL-D). In addition, the company is developing several
mid-to-late-stage therapies, including a second complement
inhibitor, a copper-binding agent for Wilson disease and an
anti-neonatal Fc receptor (FcRn) antibody for rare Immunoglobulin G
(IgG)-mediated diseases as well as several early-stage therapies,
including one for light chain (AL) amyloidosis and a second
anti-FcRn therapy. Alexion focuses its research efforts on novel
molecules and targets in the complement cascade and its development
efforts on the core therapeutic areas of hematology, nephrology,
neurology, and metabolic disorders. Alexion has been named to the
Forbes list of the World’s Most Innovative Companies seven years in
a row and is headquartered in Boston, Massachusetts’ Innovation
District. The company also has offices around the globe and serves
patients in more than 50 countries. This press release and further
information about Alexion can be found at: www.alexion.com.
[ALXN-G]
About Affibody Affibody is a private clinical-stage
Swedish biotech company focused on developing into an integrated
biopharma company utilizing next generation biotherapeutics based
on its unique proprietary technology platforms: Affibody® molecules
and Albumod™. The company operates a focused experimental medicine
model and currently has three clinical-stage programs. The first
two are therapeutic programs that target psoriasis and rare
Immunoglobulin G (IgG)-mediated autoimmune diseases. The third
program is a diagnostic imaging program that is directed primarily
towards metastatic breast cancer. In addition to its portfolio of
innovative drug projects, the company offers the half-life
extension technology, Albumod™, for outlicensing. For more
information on Affibody, please visit the company’s website at
www.affibody.com.
Affibody AB is a holding of Patricia Industries, a subsidiary of
investment holding company Investor AB. Investor AB, a Swedish
investment company founded in 1916 by the Wallenberg family, is the
leading owner of high quality Nordic-based international companies.
The company makes controlled investments in leading companies with
strong market positions, brands and corporate cultures within
industries positioned for secular growth with the ambition to be
the sole owner of their companies, together with strong management
teams and boards.
Forward-Looking Statement This press release includes
forward-looking statements, including statements related to the
therapeutic and commercial potential of ABY-039, the research and
development plans for ABY-039, the potential of ABY-039 and other
anti-FcRn-targeted therapies and the potential benefits of the
collaboration. Such forward-looking statements are subject to risks
and uncertainties that could cause actual results to differ
materially from those expressed or implied in such statements. The
process by which an early stage product such as ABY-039 could
potentially lead to an approved product is long and subject to
highly significant risks, including for example, decisions of
regulatory authorities regarding the adequacy of our research,
marketing approval or material limitations on the marketing of our
products, delays, interruptions or failures in manufacture and
supply, failure to satisfactorily address matters raised by the
U.S. Food and Drug Administration and other regulatory agencies,
the possibility that results of clinical trials are not predictive
of safety and efficacy results in broader patient populations, the
possibility that clinical trials could be delayed, the risk that
anticipated regulatory filings are delayed, and a variety of other
risks set forth from time to time in Alexion's filings with the
SEC, including but not limited to the risks discussed in Alexion's
Annual Report on Form 10-K for the fiscal year ended December 31,
2018 and in Alexion’s other filings with the SEC. Alexion and
Affibody AB disclaim any obligation to update any of these
forward-looking statements to reflect events or circumstances after
the date hereof, except when a duty arises under law.
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version on businesswire.com: https://www.businesswire.com/news/home/20190320005268/en/
Alexion:MediaMegan Goulart, +1-857-338-8634Senior
Director, Corporate Communications
InvestorsSusan Altschuller, Ph.D., +1-857-338-8788Vice
President, Investor Relations
Affibody:MediaDavid Bejker, CEO +46 706
454 948Johan Stuart CFO +46 706 644 096
InvestorsAlan Lada, +1-617-221-8006Solebury Trout
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