Date: 2017-05-30
Type of information: Production agreement
Compound: manufacturing services for OTL-101
Company: Orchard Therapeutics (UK) PCT Cell Therapy Services (USA - NJ)
Therapeutic area: Rare diseases - Genetic diseases - Technology - Services
Type agreement: production
Action mechanism: gene therapy
Disease:
Details:
- • On May 30, 2017, Orchard Therapeutics announced that it has entered a new clinical manufacturing services agreement with PCT Cell Therapy Services, a Hitachi Group Company. PCT has previously provided a Strategic Manufacturing Assessment (SMA) and manufacturing process development services to Orchard. Under the terms of this new agreement, PCT will provide GMP-compliant manufacturing services for Orchard’s lead product, OTL-101, an autologous ex-vivo gene therapy for the treatment of adenosine deaminase deficiency severe combined immunodeficiency (ADA-SCID).
- To date, over 40 ADA-SCID patients have been treated with Orchard’s autologous ex-vivo lentiviral gene therapy at University of California Los Angeles (UCLA), US and at the Great Ormond Street Hospital (GOSH) in London, UK. All patients have survived (100% overall survival) and the treatment has been shown to restore patients’ immune function, with a favourable safety profile.
Financial terms:
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Is general: Yes
