Dyax says the entry of its human antibody drug candidate DX-2930 into clinical trials is thanks to successful development and up-scale manufacturing by Laureate Biopharma.
Working with the cell line producing DX-2930, scientists from Laureate - a CDMO (contract development and manufacturing organization) - were able to successfully scale-up and manufacture a high-titer antibody process of Dyax’ hereditary angioedema (HAE) drug candidate.
“Entry into human subjects is an important milestone for the DX-2930 development program,” said Dyax CEO Gustav Christensen.
“This valuable partnership has enabled us to advance this fully human monoclonal antibody into the clinic and closer toward our goal of a new therapeutic for the prevention of HAE attacks.”
DX-2930 is a fully human monoclonal antibody which inhibits plasma kallikrein and is being developed by Laureate as a potential candidate to treat hereditary angioedemas, a genetic mutation that causes rapid swelling of the dermis.
The drug is GMP produced in both Laureate’s stainless-steel and single-use bioreactors and according to Dr. Michiel Ultee - Laureate’s Chief Scientific Officer – “this project showcased Laureate’s scientific expertise in rapid development of efficient, high-yielding processes for clinical production of therapeutic antibodies.”
Dyax filed an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) in June, according to a conference call discussing the firm’s second quarter results last month (transcript here ), and is hoping to initiate the phase I clinical trial in the third quarter, with Phase II scheduled for 2014.
In May Dyax raised approximately $30m (€22.5m) with the net proceeds intended to be used to fund the continuous R&D of DX-2930, CFO George Miguasky told stakeholders on the call.