Collaboration for Paradigm-Shifting Treatment for Autoimmune Disorders

A new albumin-based half-life extension platform should help optimize treatment for autoimmune diseases.

Novozymes Biopharma (Nottingham, UK), part of Novozymes A/S, reported on a collaborative research agreement with EpiVax, Inc. (Providence, RI, USA), a biotech company, to help further the development of a potential “paradigm-shifting” treatment for autoimmune diseases. The research agreement will involve combining EpiVax’s proprietary Tregitope (T regulatory epitopes) immune-modulating therapy for the treatment of type 1 diabetes, to Novozymes’ Albufuse half-life extension platform, helping to enhance its pharmacokinetic and pharmacodynamic effects. Now, it will be possible to modulate half-life of the therapy as a result to offer improved control, enhancing the overall effectiveness of treatment.

“Novozymes is delighted to announce a research agreement with EpiVax in the key area of autoimmune diseases treatment,” said Dave Mead, business development director at Novozymes Biopharma. “The two technologies jointly have a role to play in a wide-range of treatments for autoimmune diseases. By taking EpiVax’s pioneering therapy and combining it with Novozymes’ versatile and clinically demonstrated Albufuse technology, along with the unparalleled expertise of our R&D scientists, we will work together to move the treatment to the next stage in its development.”

EpiVax has identified a set of natural Tregitopes derived from immunoglobulin G (IgG) that induce tolerance to immunogenic proteins. Early research in type 1 diabetes has indicated that Tregitopes specifically induce natural Tregs, and when coadministered with an antigen, lead to the expansion of antigen-specific regulatory T cells. Modulation of autoimmune responses to autologous epitopes by induction of antigen-specific tolerance may prevent ongoing beta-cell destruction and restore the generation of insulin. Combining EpiVax’s therapy with Novozymes’ Albufuse technology will create a safe and effective platform for application of tregitopes to multiple autoimmunity, transplantation, and allergy conditions.

Dr. Annie De Groot, CEO/CSO at EpiVax, commented, “Novozymes’ proven solutions, technical expertise, and reputation as a reliable partner makes it the ideal company for us to work with as we move our Tregitope immune-modulating technology closer to clinical trials. By bringing together our unique knowledge and experience in our respective fields, we look to develop an industry-changing technology that will make significant advancements in treating patients with autoimmune diseases.”

Novozymes’ albumin-based technology offers significant benefits for delivery of a wide-range of molecules as it has the potential to customize half-life according to specific medical requirements. Albumin’s safety, regulatory profile, and long history of therapeutic use makes it a suitable selection for drug delivery. The widely applicable platform has an established regulatory pathway enabling products to reach the market more efficiently and cost effectively. Furthermore, the technology can be used to decrease dose rates and side effects, while improving patient quality of life. These developments open the way for flexibility and efficiency for manufacturers developing new therapies.

EpiVax is a biotechnology company focused on the development of vaccines and immunotherapeutics. EpiVax is a world-leading company involved in the field of immunogenicity screening. The company uses immunoinformatics tools to screen protein therapeutics and to de-immunize these agents so as to reduce adverse effects in the clinic. The Tregitope technology adds to the EpiVax Immunogenicity Toolbox, as it can improve tolerance of protein drugs such as blood factors, replacement enzymes, and monoclonal antibodies. Through the application and utilization of these computational applications, EpiVax is helping to engineer safe, more effective therapeutic proteins and to design protective and efficacious new vaccines.

Novozymes provides over 700 products used in 130 countries.

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