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What is CAR-T Cell Therapy? A New Way to Treat Cancer.

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CAR-T cell therapy is as a type of immunotherapy that teaches T cells to recognize and destroy cancer. CAR-T cell therapy has demonstrated promising results in a range of patients across the globe. In some patients, this can lead to the total elimination of the cancer. In others, there is a significant improvement of the disease.

For those who are facing cancer, it is important to answer the question “What is CAR-T?” This guide will answer the most common questions about CAR-T cell therapy for readers who want to understand this novel technology platform for treating cancer.  [Read more…]

Disrupting the Cell Therapy Market: Nucleus Biologics Brings Transparency, Customization & Control

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In recent years, the cell culture company Nucleus Biologics has been at the forefront of market disruption. In this interview with David Sheehan (CEO), we explore how the company has been growing its team, expanding its production capabilities, launching new products, and impressively, rolling out the world’s first online portal for instantaneous custom cGMP cell culture media configuration.

The pace never slows when your mission is to enable lifesaving science! [Read more…]

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…]

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…]

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