Orchard halts plant construction in shift away from ultra-rare diseases

Orchard Therapeutics has ceased work on a manufacturing plant in Fremont, California, reduced investment in some therapeutic programmes and cut its workforce by 25%.

The gene therapy firm announced the changes last week as part of a strategic plan to shift focus from ultra-rare diseases to more common conditions.

According to a document filed with the US Securities and Exchange Commission, Orchard plans to rely on contract development and manufacturing organizations (CDMOs) while it assesses potential development of in-house manufacturing capabilities if its product candidates achieve commercial success.

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The firm said, “We intend to sublease the Fremont facility to a third party at a later date.

“We have spent approximately $2.0 million to date on construction of the Fremont facility and will likely incur additional costs to prepare the facility for sublease or to wind down construction activities.”

As recently as last August Orchard said work on the Fremont facility was progressing well and that the site was on track to open in 2021.

Orchard also said it will close its office in Menlo Park, California and consolidate R&D operations at a site close to its CDMO partners.

The firm’s CDMO partners include Oxford BioMedica – which handles vector manufacturing for the gene therapy Strimvelis – and Lonza, which makes the finished product.

For its candidate metachromatic leukodystrophy (MLD) and Wiskott–Aldrich syndrome (WAS), treatments manufacturing services are provided by MolMed S.p.A, under a deal signed in December 2018.

Less rare diseases

Orchard said it will also reduce investment in OTL-101 – a candidate therapy for adenosine deaminase severe combined immunodeficiency (ADA-SCID) – and OTL-300 – which is intended to treat transfusion-dependent β-thalassemia (TDT).

The firm said it would “reallocate financial resources to other programs, although we will continue to advance ongoing clinical trials and any required regulatory updates for these indications.”

Some of the reallocate R&D dollars will be spent on advancing Orchard’s projects in less rare diseases, including two programs in genetic subsets of frontotemporal dementia (FTD) and Crohn’s disease.

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