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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…]

Vor Biopharma Raises $110M to Develop Engineered Hematopoietic Stem Cells

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  • Vor Biopharma Closes $110 Million Series B Financing

  • Proceeds will advance the company’s lead program into clinical trials and expand the portfolio

July 07, 2020, CAMBRIDGE, Mass. — Vor Biopharma, an oncology company pioneering engineered hematopoietic stem cells (eHSCs) for the treatment of cancer, today announced it has raised $110 million in a Series B financing. Proceeds will advance the company’s lead candidate VOR33 into clinical trials, deepen its portfolio, and accelerate the validation of additional targets for its scientific platform, which is designed to remove redundant proteins so that transplanted stem cells become invisible to targeted therapies while leaving diseased cells vulnerable. [Read more…]

BioStem Life Sciences Receives Accreditation by The American Association of Tissue Banks® (AATB®)

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BioStem Technologies, Inc. (OTC PINK: BSEM) a leading life sciences company specializing in the development and sale of perinatal tissue-based allografts for use in regenerative therapies, today announced that its subsidiary, BioStem Life Sciences has been awarded the prestigious accolade of accreditation by the American Association of Tissue Banks® (AATB®). BioStem Life Sciences is now accredited for Donor Eligibility Assessment, Processing, Storage, and Distribution of Birth Tissue and Cellular Tissue for Transplantation. [Read more…]

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