Orchard Therapeutics commits to gene therapies production facility with plans to hire 100 workers

Orchard Therapeutics said it intended to use some of the proceeds of an IPO to build a manufacturing facility for its gene therapies program and now it is. With about $225 million in hand from the IPO, the biotech will spend much of that on a plant in California.

The transatlantic biotech announced on Thursday that it has leased a 150,000-square-foot facility in Fremont, California. Orchard already has R&D facilities in Foster City and Menlo Park, California. Work on building out the facility is set to start in 2019, and the company expects to bring on about 100 workers over the next few years for its operation. A spokesperson said today that Orchard will invest from $80 million to $90 million to design and outfit the facility. 

"We believe that this new facility, as an early investment in our own manufacturing, will not only drive efficiencies and scalability in terms of lentiviral vector and drug product development, it will also complement the capabilities of our existing vector and drug product manufacturing partners to support the potential launch of our gene therapy clinical product candidates," Stewart Craig, chief manufacturing officer for Orchard, said in a statement.

Orchard in November raised $225 million from its IPO and will use proceeds to build the Bay Area plant and to advance its pipeline of gene therapies. It is believed to have one of the broadest clinical-phase gene therapy pipelines after adding to its own pipeline earlier this year with the acquisition of GlaxoSmithKline’s portfolio. That included the EU-approved "bubble boy" drug Strimvelis, a $625,000 rare disease treatment with almost no sales, as well as another ADA-SCID treatment that has been approved in the European Union. It also included late-stage assets for MLD and WAS and the program in beta thalassemia. GSK took a 19% equity stake and a seat on the Orchard board as part of the deal.

Its process involves using hematopoietic stem cells (HSCs) derived from the patient’s mobilized peripheral blood and drug products manufactured using HSCs derived from the patient’s bone marrow. It has said initially that it intends to seek approval of its immune system therapies with products and vectors manufactured at contract manufacturers.

If its plan comes to fruition, Orchard will close out 2021 with four approved gene therapies, including Strimvelis. While the "bubble boy" drug has been sold in Europe since 2016, it has had a slow commercial start and could be supplanted by Orchard’s OTL-101, its ADA-SCID candidate in development.

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