EpiVax says combining its immune 'off switch’ drugs with Novozymes’ half-life boosting Albufuse platform could deliver a $3bn (€2.2bn) section of the autoimmune disease market.
EpiVax develops drugs based on IgG peptides known as Tregitopes, which stop the body from reacting against its own antibodies and could – according to the firm – prevent the damaging autoimmune responses characteristic of diseases like Type-1 diabetes and multiple sclerosis.
CEO Annie De Goot told in-Pharmatechnologist.com Tregitopes are “off switches for the immune system” and explained that EpiVax had partnered with Novozymes Biopharma after searching for a means of delivering them in a way that is safe and well tolerated.
“Novozymes’ [Albufuse] delivery vehicle provides a safe and effective way of delivering these drugs,” she said, adding that the platform is used by several marketed drugs and familiar to both the European Medicines Authority (EMA) and US Food and Drug Administration (FDA).
Novozymes’ technology is based on albumin that can extend the half-life of protein drugs to which it is linked by as many as 20 days, thereby giving them more time to mediate their therapeutic effects and potentially reduce the number of doses of each required.
The first stage of the collaboration will link a gene encoding EpiVax’s Type 1 diabetes modulating Tregitope to the albumin sequence which, when expressed in Novozymes’ yeast-based system, will produce a combined protein.
Dave Mead, Novozyme’s business development director, explained that: “Initially we will be looking to demonstrate compatibility through experiments followed by small-scale production to ensure manufacturing processes are reproducible and scale-able.”
He added that – if the candidate drug completes preclinical testing, clinical trials and goes on to gain market approval – Novozymes is well positioned to provide long term manufacturing support through its production plant in China and those owned by its partner, Kaketsuken, in Japan.
The potential market for the Tregitope products is huge according to De Goot who believes such drugs could eventually replace intravenous immune globulin (IVIg) based treatments, which generate revenues of around $3bn (€2.2bn) a year.