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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…]

Luminary Therapeutics and Case Western Reserve University Enter Formal Collaboration for Development of BAFF CAR

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Luminary Tx and CWRU enter formal collaboration for clinical development of novel BAFF CAR to treat Mantle Cell Lymphoma and Sjogren’s Syndrome

MINNEAPOLIS, MN, USA, July 7, 2020– Luminary Therapeutics (Luminary Tx) and Case Western Reserve University have entered into a formal collaboration agreement that includes an option for Luminary to exclusively license a novel BAFF target for use in CAR-T (chimeric antigen receptor T cells) constructs. [Read more…]

Why is Healthy Donor Tissue So Important for Cell and Gene Therapies?

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Brad Taylor, PhD and Dominic Clarke, PhD
HemaCare Corporation 8500 Balboa Boulevard Suite 130 Northridge CA 91325

Public discourse on cell and gene therapy is focused on novel approaches to long-established procedures such as bone marrow transplants, as well as on truly innovative treatments such as cancer immunotherapy and stem cell therapy for autoimmune disorders and other serious ailments. Positive clinical trial results and the demonstrated success of advanced therapies such as Kymriah® and Yescarta® are fueling a sense of excitement on what could be accomplished with these medicines—and driving a significant increase in the number of cell therapies in the clinical trial pipeline. As of last year, there were nearly 300 different cell and gene therapies in development, and that number is on target to grow.[1] [Read more…]

Novartis’ Kymriah® Wins Latest FDA RMAT (42 Announced)

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Novartis Kymriah® receives FDA Regenerative Medicine Advanced Therapy designation in follicular lymphoma.

  • If approved, relapsed or refractory (r/r) follicular lymphoma would become the third B-cell malignancy indication for Kymriah, joining approvals in children and young adults with r/r ALL, and adults with r/r DLBCL
  • The Regenerative Medicine Advanced Therapy (RMAT) designation reflects the unmet need for patients with r/r follicular lymphoma
  • US regulatory filing for Kymriah in r/r follicular lymphoma anticipated in 2021

[Read more…]

Genetic Modification of CAR-T Cells

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Chimeric antigen receptor-modified T (CAR-T) cells are living therapies that are genetically engineered to express CAR molecules targeting antigens found on tumor cells or target cells of interest. Unfortunately, an obstacle for the field of CAR-T cell therapy is limited CAR T cell persistence after infusion into cancer patients. Thus, genetic engineering strategies to improve CAR T cell persistence will be central to the success of these gene-modified cellular therapies. [Read more…]

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