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Fate Therapeutics Gets FDA Clearance of IND Application for World’s First iPSC-derived CAR T-Cell Therapy

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FT819 CAR T-cell Product Candidate Derived from Clonal Master iPSC Line with Novel CD19-specific 1XX CAR Integrated into TRAC Locus

Phase 1 Clinical Study will Evaluate FT819 for Patients with Advanced B-cell Leukemias and Lymphomas

SAN DIEGO, July 09, 2020 — Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, announced today that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for FT819, an off-the-shelf allogeneic chimeric antigen receptor (CAR) T-cell therapy targeting CD19+ malignancies.

FT819 is the first-ever CAR T-cell therapy derived from a clonal master induced pluripotent stem cell (iPSC) line, and is engineered with several first-of-kind features designed to improve the safety and efficacy of CAR T-cell therapy. [Read more…]

What Is An RMAT? List of RMAT Designations (44)

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To date, 44 RMAT (Regenerative Medicine Advanced Therapy) designations have been publicly announced. However, the FDA states it has received 139 requests and issued 48.

Sponsors of cell and gene therapies are eligible to obtain an RMAT designation from the U.S. FDA if their product is intended to treat serious or life-threatening diseases and there is preliminary clinical evidence that it can address unmet medical needs.

The most recent addition to this list was the RMAT jointly awarded to CRISPR Therapeutics and Vertex Pharmaceuticals for CTX001™ in the treatment of severe hemoglobinopathies.

Prior to that, it was Immunicum’s ilixadencel on May 6, 2020. Ilixadencel consists of activated allogeneic dendritic cells used as an immune primer for the treatment of metastatic Renal Cell Carcinoma (mRCC).

[Read more…]

Cellenkos’ Cord Blood T-Regulatory Cells Show Promise in COVID-19 Induced ARDS

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HOUSTON, July 6, 2020 — Physician-investigators at Johns Hopkins University Hospital report on the promising data of treatment of COVID-19 induced acute respiratory distress syndrome with allogeneic, cord blood derived T-regulatory (Treg) cell therapy (manufactured by Cellenkos®), published in peer reviewed journal of Annals of Internal Medicine. Both patients were critically ill and intubated (one on ECMO). Both had failed Tociluzimab (Actemra, Roche) and had multiorgan failure. Patients received cell therapy under FDA Emergency Use IND for up to 3 doses. [Read more…]

B-MoGen Biotechnologies, a Bio-Techne Company, Announces Opening of 2 Class 7 Clean Suites for Cellular Therapy Manufacturing

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Contract Development & Manufacturing (CDMO): 
B-MoGen’s ISO 7 cleanrooms now open for business

B-MoGen Biotechnologies, a unit of Bio-Techne, is proud to announce new cGMP cellular therapy manufacturing capacity for Phase I and Phase II clinical trials.

[Read more…]

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