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J&J to Compete in CAR-T: Subsidiary Janssen Biotech Signs $350M Deal with Legend Biotech

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Janssen Enters Worldwide Collaboration and License Agreement with Chinese Company Legend Biotech to Develop Investigational CAR-T Anti-Cancer Therapy

HORSHAM, Pa., Dec. 21, 2017 — Janssen Biotech, Inc. (“Janssen”), a Janssen Pharmaceutical Company of Johnson & Johnson, announced today that it has entered into a worldwide collaboration and license agreement with Legend Biotech USA Inc. and Legend Biotech Ireland Limited (“Legend”), subsidiaries of Genscript Biotech Corporation, to develop, manufacture and commercialize a chimeric antigen receptor (CAR) T-cell drug candidate, LCAR-B38M, which specifically targets the B-cell maturation antigen (BCMA). LCAR-B38M is currently accepted for review by the China Food and Drug Administration (CFDA) and in the planning phase of clinical studies in the United States for multiple myeloma. [Read more…]

FDA Lifts Clinical Hold on Cellectis Phase 1 Clinical Trials with UCART123 in AML and BPDCN

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NEW YORK — Cellectis (Paris:ALCLS) (NASDAQ:CLLS) a clinical-stage biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold, previously announced on September 4, 2017, on Phase 1 trials of Cellectis’ UCART123 product candidate in acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN).

Cellectis agreed with the FDA to the following main revisions to be implemented in Phase 1 UCART123 protocols to lift the hold:

  • Decrease of the cohort dose level to 6.25×104 UCART123 cells/kg;
  • Decrease of the cyclophosphamide dose of the lympho-depleting regimen to 750 mg/m²/day over three days with a maximum daily dose of 1.33 grams of cyclophosphamide;
  • Inclusion of specific criteria at Day 0, the day of UCART123 infusion, such as no new uncontrolled infection after receipt of lymphodepletion, afebrile, off all but replacement dose of corticosteroids, no organ dysfunction since eligibility screening;
  • Provision to ensure that the next three patients to be treated in each protocol will be under the age of 65;
  • Provision to ensure that the enrollment will be staggered across the UCART123 protocols AML123 and ABC123: at least 28 days should elapse between the enrollments of two patients across the two studies.

[Read more…]

Mustang Bio Establishes CAR T Cell Therapy Manufacturing Facility in Massachusetts

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Facility located in the UMass Medicine Science Park will support clinical development and commercialization of CAR T pipeline

Preparations underway for clinical production in 2018

NEW YORK, Oct. 30, 2017 — Mustang Bio, Inc. (“Mustang”) (NASDAQ:MBIO), a Fortress Biotech, Inc. (NASDAQ:FBIO) company focused on the development of novel immunotherapies based on proprietary chimeric antigen receptor engineered T cell (CAR T) technology, announced today that it has entered into a lease agreement with the UMass Medicine Science Park in Worcester, Massachusetts, for a manufacturing facility to support the clinical development and commercialization of the Company’s CAR T product candidates.

Mustang Bio - CAR-T ManufacturingThe facility is expected to be operational for the production of personalized CAR T therapies in 2018. Mustang anticipates initially building cell-processing capabilities to support its lead CAR T product candidates MB-101 in glioblastoma, and MB-102 in acute myeloid leukemia and blastic plasmacytoid dendritic cell neoplasm. [Read more…]

BioLife Solutions Customer Kite Pharma Receives FDA Approval for Yescarta™ CAR T-Cell Therapy

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Each Yescarta Dose is Frozen in Proprietary CryoStor® Freeze Media to Maintain CAR T-Cell Viability and Enable Worldwide Distribution

BOTHELL, Washington — October 19, 2017 —BioLife Solutions, Inc. (NASDAQ: BLFS), the leading developer, manufacturer and marketer of proprietary clinical grade cell and tissue hypothermic storage and cryopreservation freeze media (“BioLife” or the “Company”), today announced that its customer Kite Pharma, Inc., a wholly-owned subsidiary of Gilead Sciences, has received US FDA approval for Yescarta, the first CAR T-cell therapy for treatment of adult patients with relapsed or refractory large B-Cell lymphoma after two or more lines of systemic therapy. [Read more…]

FDA approval brings first gene therapy to the United States

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CAR T-cell therapy approved to treat certain children and young adults with B-cell acute lymphoblastic leukemia

U.S. FDA, August 30, 2017 – The U.S. Food and Drug Administration issued a historic action today making the first gene therapy available in the United States, ushering in a new approach to the treatment of cancer and other serious and life-threatening diseases. [Read more…]

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