UK Biopharma company Evolutec has signed a deal with Wacker Biotech to produce Evolutec's new autoimmune disease drug candidate rEV576 for clinical trials.
Under the terms of the deal, German contract manufacturer Wacker Biotech will develop a scaleable method for the production of current Good Manufacturing Practice (cGMP) grade rEV576, which is required for the Phase I clinical trials expected to start next year.
The agreement then provides for Wacker to scale-up the cGMP process as and when required.
rEV576 is a complement C5 inhibitor, a new class of drugs that target the complement system. The protein proved to be active against autoimmune diseases myasthenia gravis and Guillain-Barré syndrome.
"Promising preclinical data and progress made by Wacker Biotech points to the commercial potential of rEV576," said Mark Carnegie Brown, Evolutec's CEO.
"We look forward to maintaining this momentum in the development programme."
The agreement follows a successful feasibility study in which Wacker Biotech proved that its Escherichia coli secretion technology, a technique for cost-efficient production of proteins, enabled the production of rEV576.
At the basis of the technology is the firm's E. coli K12 strain, which is capable of secreting recombinant proteins in their native form into the fermentation broth during cultivation.
According to Wacker Biotech, extracellular production facilitates straightforward purification of recombinant products, eliminates tedious refolding steps and makes the whole manufacturing process more efficient and cost effective.
"There was already evidence from other projects that our secretion technology is a very cost-efficient means of producing therapeutic proteins," said Thomas Maier, managing director of Wacker Biotech.
"We are very pleased that it proved to add value to the development of rEV576."
In previous preclinical trials, rEV576 also showed activity against acute myocardial infarction (AMI) by reducing damage to heart tissue by 25 per cent with good effect even at low doses.
There are approximately one million cases of AMI every year in the US making this a substantial market opportunity with unmet need.
In AMI, heart muscle is damaged following coronary thrombosis and the objective of therapy is to reduce this damage.
The approved thrombolytics re-establish blood flow following heart attack but do not address the damage to heart tissue.
"rEV576 has already generated considerable scientific interest and this result emphasises its potential in acute cardiovascular indications such as AMI, stroke and cardiopulmonary bypass," said Carnegie Brown.
"The result adds to the promising efficacy seen with rEV576 in an acute preclinical model of the auto-immune disease myasthenia gravis and underlines the potential of Evolutec's pipeline."