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ORTX

Orchard Therapeutics

$12.09 /

+0.1 (+0.83%)

07:21
10/22/19
10/22
07:21
10/22/19
07:21

Orchard Therapeutics presents data from OTL-200 in patients with MLD

Orchard Therapeutics announced initial results from a clinical trial with a cryopreserved formulation of OTL-200, a gene therapy in development for the treatment of metachromatic leukodystrophy at the San Raffaele-Telethon Institute for Gene Therapy in Milan, Italy. The initial data show that cellular engraftment with OTL-200 using a cryopreserved formulation is similar to that observed using a fresh formulation with the longest patient having 12 months of follow-up since treatment. The data are being featured this week in a poster session at the European Society of Gene & Cell Therapy Annual Congress in Barcelona, Spain. These data compare the initial results of OTL-200 in the first four MLD patients treated using a cryopreserved formulation to a previously presented integrated analysis of 29 patients treated with a fresh formulation that demonstrated meaningful clinical outcomes. Hematopoietic stem cells are collected, purified and transduced in the same way for both formulations. For the cryopreserved formulation, following transduction, the gene-corrected cells are placed in a specific medium that allows them to be stably frozen. After successful testing and release, the cryopreserved cells are shipped to the site of care where they are thawed and administered to patients who have received conditioning. At the time of the analysis, four early-onset MLD patients have been treated with the cryopreserved formulation of OTL-200. All patients are alive and were followed for a minimum of one month, with the longest follow-up out to 12 months in the first patient treated. The age at the time of treatment ranged from seven months to 42 months. The initial results in patients receiving the cryopreserved formulation demonstrated the following: Stable levels of engraftment of gene-corrected cells, as evidenced by the percent of transduced CD34+ cells in the bone marrow, the vector copy number levels in the bone marrow and the VCN levels in peripheral blood mononuclear cells, were within the range observed in patients treated with the fresh formulation. Engraftment of gene-corrected cells in all patients receiving the cryopreserved formulation was seen one month after treatment and remained stable throughout the length of follow-up for each patient. Reconstitution of arylsulfatase-A enzyme activity in the peripheral blood and cerebrospinal fluid to normal or supra-normal levels is consistent with results seen in patients treated with the fresh formulation at the same timepoints. The emerging safety profile of the cryopreserved formulation is consistent with the safety profile observed in the fresh formulation. No treatment related adverse events or signs of oncogenic transformation have been reported in the patients receiving the cryopreserved formulation as of the date of the analysis. Preliminary evidence also suggests that the first patient treated with the cryopreserved formulation has acquired motor capabilities consistent with the physiologically progressive acquisition of new motor skills observed in healthy children. At the time of the 12-month assessment, the patient had surpassed the expected age of disease onset based on an older untreated sibling, while attaining age-appropriate motor development.

  • 07

    Dec

ORTX Orchard Therapeutics
$12.09 /

+0.1 (+0.83%)

09/17/19
Fly Intel: Top five analyst initiations
09/17/19
Guggenheim bullish on Orchard Therapeutics, initiates with a Buy
09/17/19 Guggenheim
Orchard Therapeutics initiated with a Buy at Guggenheim
09/05/19 Barclays
Orchard Therapeutics initiated with an Overweight at Barclays

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