Orchard turns to layoffs in cutting gene therapy research – BioPharma Dive

Dive Brief:

Orchard recently secured an important agreement on reimbursement in the U.K. for Libmeldy, a gene therapy approved in Europe in December 2020 for children with early-onset metachromatic leukodystrophy. The company is working to expand newborn screening for the ultra-rare disease in other European countries, where two patients were recently treated under early access schemes.

The restructuring announced Wednesday puts Orchard's focus on Libmeldy, which the company hopes to submit for approval in the U.S. later this year or early next, as well as on two earlier gene therapies also for inherited neurometabolic diseases.

"In light of our experiences and knowledge gained in this current and rapidly evolving market environment for gene therapy, our plan is to concentrate resources on programs that have the potential to make a remarkable difference to patients while also providing sustainable value to the business to enable the achievement our long-term vision," said Bobby Gaspar, Orchard's CEO, in a statement.

While Orchard will keep active other research programs for future partnerships, the company will discontinue investment in gene therapies it was developing for rare primary immune deficiencies, including two currently in clinical testing. The path to an approval application in the U.S. for one of those gene therapies is now longer, Orchard said, citing feedback the company recently received from the Food and Drug Administration.

Orchard will also discontinue investment in Strimvelis, a gene therapy originally developed by GlaxoSmithKline that was approved in Europe six years ago. Since then, only 16 patients have received the therapy, which treats a rare immune condition known as ADA-SCID.

The cutbacks aren't the first time Orchard has laid off staff and discontinued research. The company announced layoffs soon after the COVID-19 pandemic began and, in June of last year, stopped developinganother treatment for ADA-SCID.

This time, Orchard has company. At least nine other cell and gene therapy developers have announced layoffs, cost cuts or altered their research plans since December. Bluebird bio, long a leading company in the field, warned investors earlier this month that there was "substantial doubt" about its ability to remain solvent over the next year.

With the expected cost savings, Orchard now anticipates being able to fund operations into 2024 and said it will seek "strategic alternatives" for its discontinued programs.

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Orchard turns to layoffs in cutting gene therapy research - BioPharma Dive