{"id":394510,"date":"2020-12-07T10:08:11","date_gmt":"2020-12-07T15:08:11","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=394510"},"modified":"2020-12-07T10:08:11","modified_gmt":"2020-12-07T15:08:11","slug":"precigen-presents-new-data-supporting-the-safety-clinical-activity-expansion-and-persistence-of-prgn-3006-ultracar-t-at-the-62nd-ash-annual-meeting-and-exposition","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/precigen-presents-new-data-supporting-the-safety-clinical-activity-expansion-and-persistence-of-prgn-3006-ultracar-t-at-the-62nd-ash-annual-meeting-and-exposition\/","title":{"rendered":"Precigen Presents New Data Supporting the Safety, Clinical Activity, Expansion and Persistence of PRGN-3006 UltraCAR-T\u00ae at the 62nd ASH Annual Meeting and Exposition"},"content":{"rendered":"
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– PRGN-3006 has been safe and well-tolerated to date –<\/h2>\n

– Case study demonstrated persistence of PRGN-3006 administered without prior lymphodepletion in blood at seven months post-infusion and reduction in blood and bone marrow blasts –<\/h2>\n

– Milestone marks a global first report of direct infusion of non-expanded CAR-T cells leading to in vivo expansion and long-term persistence in patients –<\/h2>\n

PR Newswire<\/p>\n<\/p><\/div>\n

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\n GERMANTOWN, Md.<\/span>, Dec. 7, 2020<\/span> \/PRNewswire\/ — Precigen, Inc.<\/a>, a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, today announced at the 62nd ASH Annual Meeting and Exposition (Abstract 2864<\/a>) clinical progress and new data from the ongoing Phase 1\/1b<\/span> clinical study of PRGN-3006\u00a0UltraCAR-T\u00ae\u00a0in patients with relapsed or refractory (r\/r) acute myeloid leukemia (AML) and higher risk myelodysplastic syndrome (MDS) (clinical trial identifier: NCT03927261<\/a>).\u00a0<\/p>\n

AML is a rapidly progressing disease with poor prognosis and high unmet need. Precigen’s UltraCAR-T platform is designed to overcome limitations of currently available chimeric antigen receptor (CAR)-T therapies by utilizing an advanced overnight non-viral gene delivery manufacturing process at a medical center’s cGMP facility without the need for ex vivo<\/i> expansion. Current CAR-T cell therapies are limited due to, inter alia<\/i>, the prolonged interval between apheresis to product infusion and an exhausted phenotype of T cells resulting from lengthy ex vivo<\/i> expansion. As announced in November 2020<\/span>, UltraCAR-T cells for the PRGN-3006 study are now manufactured<\/a>\u00a0overnight using Precigen’s proprietary UltraPorator\u2122<\/span> device. PRGN-3006 UltraCAR-T is a multigenic autologous CAR-T simultaneously expressing a CAR specifically targeting CD33; membrane bound IL-15 (mbIL15) for enhanced in vivo<\/i> expansion and persistence; and a kill switch to conditionally eliminate CAR-T cells for an improved safety profile. CD33 is over-expressed on AML blasts with lesser expression on normal hematopoietic stem cells.<\/p>\n

An investigator-initiated, non-randomized Phase 1\/1b<\/span> dose-escalation study to evaluate the safety and maximal tolerated dose of PRGN-3006 UltraCAR-T is currently ongoing in collaboration with the H. Lee Moffitt Cancer Center & Research Institute (Moffitt). The study population includes adult patients (\u2265 18 years) with r\/r AML and hypomethylating agent (HMA) failure, higher risk MDS or chronic myelomonocytic leukemia (CMML) patients with \u2265 5% blasts. To test the hypothesis that expression of mbIL15 on PRGN-3006 can promote UltraCAR-T cell expansion and persistence without the need for lymphodepletion and improve the overall safety profile, study\u00a0subjects receive the PRGN-3006 infusion either without prior lymphodepletion (Cohort 1) or following lymphodepleting chemotherapy (Cohort 2). A multicenter expansion of the trial is planned.<\/p>\n

Key findings:<\/p>\n