- Agreement provides opportunity to expand Alexion’s clinical-stage anti-FcRn portfolio with ABY-039 -
- Affibody to receive
- Affibody’s technology offers potential for extended half-life compared to other anti-FcRn therapies and low volume subcutaneous administration -
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190320005268/en/
“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
“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
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
[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.
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
View source version on businesswire.com: https://www.businesswire.com/news/home/20190320005268/en/
Source:
Alexion:
Media
Megan Goulart, +1-857-338-8634
Senior
Director, Corporate Communications
Investors
Susan Altschuller, Ph.D., +1-857-338-8788
Vice
President, Investor Relations
Affibody:
Media
David Bejker, CEO +46 706 454 948
Johan
Stuart CFO +46 706 644 096
Investors
Alan Lada, +1-617-221-8006
Solebury Trout