We value collaboration with strategic partners as an important part in our mission to develop innovative treatments that can address the unmet needs of rare disease patients and we seek the best partnering opportunities to maximize the potential of our technology platform.
We see opportunities to expand our IgG-cleaving enzyme technology platform into new indications and next generation technologies. Imlifidase could potentially be used in a variety of transplantation and autoimmune indications and may have wide applicability as a pre-treatment ahead of gene therapy. Through our NiceR program, we are also developing the next generation of IgG-cleaving enzymes designed to have lower immunogenicity and thereby enable more frequent dosing.
Our organization has extensive expertise in biology (particularly in the areas of autoimmune diseases and transplantation), pharmacology, non-clinical and clinical development of therapeutics, and mechanistic and structural approaches related to IgG antibodies. In addition, we have extensive expertise in the launch of rare disease therapeutics.
In transplantation and autoimmune disease indications, we aim at commercializing our assets through our own commercial organization for major markets in Europe and in the U.S. For other markets, we aim at leveraging the market potential through commercial partnerships in the form of distribution or license agreements, depending on the partner, the territory and the specific indication.
In other disease areas such as gene therapy or oncology, we welcome partners to develop the use of our antibody-cleaving enzyme as a pre-treatment or combined treatment. We may furthermore rely on our partners to commercialize while aiming to secure certain rights to co-promote or co-market, depending on the partner, the territory and the indication.
Our current strategic partnerships
Our IgG-cleaving enzyme technology has received external validation through multiple collaborations with strategic partners, and it could potentially be used in a variety of transplantation and autoimmune indications, and as a pre-treatment ahead of gene therapy. We welcome partnering opportunities to explore combination therapies that can provide innovative solutions to ongoing challenges in these fields.
In 2020, we established an exclusive agreement with Sarepta Therapeutics to develop and promote imlifidase as a potential pre-treatment prior to the administration of gene therapy for Duchenne muscular dystrophy and Limb-girdle muscular dystrophy in patients with neutralizing antibodies (NAbs) to adeno-associated virus (AAV). We collaborate with Sarepta to explore the role that our technology can play as a pre-treatment prior to their gene therapies and to enable gene therapy in a larger group of patients.
In 2021, we entered into a preclinical research collaboration agreement with argenx to evaluate the therapeutic potential of combining the two companies’ IgG-modulating technologies, both of which are in development for indications known to be driven by disease-causing IgGs. The preclinical research collaboration has been set up to explore the potential of combining the two companies’ technologies, with potential applications in both the acute and chronic disease within auto- and alloimmunology.
In 2022, we entered into an agreement with AskBio to evaluate the use of imlifidase as a pre-treatment prior to the administration of gene therapy in Pompe disease in a preclinical and clinical feasibility program for patients with pre-existing neutralizing antibodies (NAbs) to adeno-associated virus (AAV). The collaboration aims at evaluating the combination of our technology with AskBio’s treatments for Pompe disease to potentially enable gene therapy for those patients with pre-existing neutralizing antibodies.
In 2023 we established a research and development collaboration with Généthon to assess the use of imlifidase as a pre-treatment preceding the administration of Généthon’s gene therapy in Crigler-Najjar syndrome in patients with pre-existing neutralizing antibodies (NAbs) to adeno-associated virus (AAV). The collaboration, set as a preclinical and clinical feasibility program, evaluates the safety and efficacy of imlifidase in this setting.
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