Biogen, Ginkgo Bioworks join forces on new gene therapy manufacturing platform

Biogen has struck a deal with newly public Ginkgo Bioworks to develop a next-generation production platform for recombinant adeno-associated virus (AAV)-based vectors, the companies announced Friday. According to Biogen, Ginkgo's synthetic biology know-how may help "overcome development challenges" associated with viral vectors for gene therapy.

At the moment, manufacturing is a time-consuming and costly process, making it difficult to produce therapies for diseases with high-dose needs and large patient populations, the companies said. However, Ginkgo is looking to solve these issues via its mammalian cell programming platform, with the goal of improving the efficiency of AAV-producing plasmid vectors and cell lines, which in turn could speed up Biogen's ability to turn out gene therapies. "Ginkgo's unique combination of cell programming expertise, proprietary tools and knowledge of biological systems make them an ideal…partner to explore a large number of design ideas with the goal of optimising constructs," said Alphonse Galdes, head of pharmaceutical operations and technology at Biogen.

Modest upfront payment

Ginkgo receives $5 million upfront as part of the deal, but stands to gain up to $115 million more in milestones if the collaboration programmes achieve certain R&D and commercial targets. In return, Biogen gains access to Ginkgo's cell programming platform, while Ginkgo will use its bioengineering facilities and resources to enhance AAV production titres of Biogen's gene therapy manufacturing processes.

The deal comes shortly after Biogen entered into a collaboration with Capsigen to engineer AAV capsids tailored to meet disease-specific transduction profiles, with the aim of speeding up development of gene therapies for central nervous system and neuromuscular disorders.

The latest tie-up deepens Biogen's investment in gene therapy as it awaits an FDA decision on its highly anticipated Alzheimer's drug aducanumab early in June. However, the company recently reported that its investigational gene therapy cotoretigene toliparvovec failed a Phase II/III trial of patients with X-linked retinitis pigmentosa. For related analysis, see ViewPoints: Biogen’s gene therapy head start starts heading south.

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