- 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 -
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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
“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.
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.
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.
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
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.
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
Megan Goulart, +1-857-338-8634
Senior Director, Corporate Communications
Susan Altschuller, Ph.D., +1-857-338-8788
Vice President, Investor Relations
David Bejker, CEO +46 706 454 948
Johan Stuart CFO +46 706 644 096
Alan Lada, +1-617-221-8006