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Fate Therapeutics and ONO Pharmaceutical to Develop Off-the-Shelf, iPSC-derived CAR-T Cell Cancer Immunotherapies

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Option-based Collaboration to Develop Two CAR T-Cell Product Candidates Using Fate’s Proprietary iPSC Product Platform

SAN DIEGO, Sept. 17, 2018 — 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 it has entered into a collaboration with ONO Pharmaceutical Co., Ltd. for the joint development and commercialization of two off-the-shelf CAR-T cell product candidates. Using Fate Therapeutics’ proprietary induced pluripotent stem cell (iPSC) product platform, the two CAR T-cell collaboration candidates will each be derived from a clonal master iPSC line engineered to completely eliminate endogenous TCR expression, insert a chimeric antigen receptor (CAR) into the TRAC locus and incorporate other anti-tumor functionality. [Read more…]

Your Ultimate Guide to Cell and Gene Therapy Conferences

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Cell and gene therapy conferences have been rapidly multiplying over the past decade. This article is your ultimate guide to cell and gene therapy conferences worldwide. These conferences include presentations on stem cells, CAR-T, exosomes, and other types of cell and gene therapy applications.

Our goal is for this to be a comprehensive guide to cell and gene therapy events worldwide, so we welcome new additions in the comments below.  [Read more…]

Allogene Therapeutics Raises Another $120M as CAR-T Funding Frenzy Continues

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Allogene Therapeutics, a clinical-stage biotechnology company pioneering the development of allogeneic CAR T therapies for cancer, announced that it completed a $120 million private financing of Convertible Notes.

According to the company, “Allogene is advancing its allogeneic CAR T cell portfolio, which includes rights to 16 preclinical CAR T cell therapy targets and U.S. rights to UCART19, an allogeneic CAR T cell therapy candidate that is being developed for the treatment of CD19-expressing hematological malignancies. In partnership with Servier, UCART19 is in Phase 1 development for the treatment of relapsed/refractory acute lymphoblastic leukemia (ALL).” [Read more…]

Novartis Receives Health Canada Approval of its CAR-T cell therapy, Kymriah™

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  • Kymriah, the first chimeric antigen receptor T cell (CAR-T) therapy approved in Canada, is manufactured individually for each patient
  • Novartis is working with qualified treatment centres to prepare for the delivery of this treatment for relapsed/refractory (r/r) pediatric and young adult B-cell ALL and adult r/r DLBCL indications

DORVAL, QC, Sept. 6, 2018 – Novartis is pleased to announce that following a Priority Review, Health Canada has approved Kymriah™ (tisagenlecleucel/ CTL019) the first chimeric antigen receptor T cell (CAR-T) therapy to receive regulatory approval in Canada.

Kymriah, a CD19-directed genetically modified autologous T-cell immunocellular therapy, is approved to treat two life-threatening cancers that have limited treatment options and historically poor outcomes, demonstrating the critical need for new therapies for these patients. [Read more…]

CAR-T Manufacturing | Novartis Selects French CDMO CELLforCURE

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CELLforCURE is a French pharmaceutical group that is authorized to do CAR-T manufacturing at its bioproduction site in Les Ulis (Essonne). CELLforCURE holds two Good Manufacturing Practice (GMP) certificates that allows it to manufacture experimental and commercial cell and gene therapies.

On July 10, 2018, CELLforCURE signed an agreement to manufacture CAR-T products for Novartis. Under the terms of the agreement, CELLforCURE will produce cancer CAR-T therapies (“chimeric antigen receptor T-cells”).

Production is scheduled to begin in 2019 following transfer of Novartis’ CAR-T manufacturing technology to CELLforCURE. [Read more…]

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