Alexion Pharmaceuticals announced two big collaboration partnerships today. First, Alexion, headquartered in Boston, and Affibody AB, located in Solna, Sweden, signed a partnership deal to co-develop ABY-039 for Immunoglobulin G (IgG)-mediated autoimmune diseases.
Alexion Pharmaceuticals announced two big collaboration partnerships today. First, Alexion, headquartered in Boston, and Affibody AB, located in Solna, Sweden, signed a partnership deal to co-develop ABY-039 for Immunoglobulin G (IgG)-mediated autoimmune diseases.
ABY-039 is currently in Phase I development. It is a bivalent antibody-mimetic targeting the neonatal Fc receptor (FcRn) and has been designed to combine Affibody’s protein therapeutics platform and Albumod technology for a longer half-life. This makes for better options for subcutaneous injection.
The Phase I trial is in healthy volunteers and is designed to evaluate its safety and tolerability, as well as pharmacokinetics and pharmacodynamics.
Under the terms of the deal, Alexion is paying Affibody $25 million up front with various milestones totaling up to $625 million, along with tiered low double-digit royalties based on any commercialization of the product. Alexion will lead the clinical development and commercialization activities. Affibody has an option to co-promote the therapy in the U.S. and will lead clinical development for an undisclosed indication.
“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,” stated John Orloff, 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.”
FcRn binds IgGs to endosomes, returning them to the bloodstream, which essentially “rescues” the immunoglobulins from being degraded by lysosomes. This helps prolong the half-life of IgG. In healthy people, this function is part of a normal immune response. In many autoimmune diseases, FcRn prevents lysosomal degradation of pathogenic IgGs associated with driving the disease. The theory is that by blocking the interaction between FcRN and IgG, it can increase the degradation of IgG within cells, reducing the amount of pathogenic IgG in circulation.
“ABY-039 offers an innovative and novel approach to treating IgG-mediated diseases,” stated David Bejker, Affibody’s chief executive officer. “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.”
He went on to say, “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.”
Alexion also announced today a collaboration deal with Copenhagen, Denmark-based Zealand Pharma A/S to discover and develop novel peptide therapies for complement-mediated diseases. They will collaborate on discovering and developing subcutaneously delivered peptide therapies to up to four complement pathway targets. Zealand will lead the joint R&D efforts through the preclinical stage. Alexion will lead development efforts starting with filing of the IND and Phase I trials.
Alexion is paying Zealand $25 million for the first target up front, and concurrent $15 million equity investment in Zealand at a premium to the market price. For the lead target, development-related milestones could hit $115 million, and up to $495 million in sales-related milestones and possible high single- to low double-digit royalties. Each of the three other targets can be chosen for an option fee of $15 million with more milestones and royalties at a rate lower than the lead target.
“We know that uncontrolled activation of the complement pathway is responsible for many devastating diseases, and through the development of the first two complement inhibitors—Soliris and Ultomiris—we have shown the transformative impact of C5 inhibition on several of these diseases,” Orloff stated. “We are excited by the potential to explore different targets in the complement pathway and look forward to building on Alexion’s more than 20 years of complement expertise with the development of next-generation peptide therapies in collaboration with Zealand Pharma, which may provide the opportunity to treat many additional diseases.”
