Fate Therapeutics Announces FDA Clearance of Landmark IND for FT500 iPSC-derived, Off-the-Shelf NK Cell Cancer Immunotherapy

Company to Initiate First-ever U.S. Clinical Investigation of iPSC-derived Cell Product

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 allowed its Investigational New Drug (IND) Application for FT500, the Company’s universal, off-the-shelf natural killer (NK) cell product candidate derived from a clonal master induced pluripotent stem cell (iPSC) line. The clinical trial of FT500 is expected to be the first-ever clinical investigation in the U.S. of an iPSC-derived cell product.

“The clearance by the FDA of our FT500 IND is a significant milestone and marks the beginning of an exciting new era for the clinical development of cell products,” said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. “Clonal master iPSC lines are a renewable cell source that can uniquely produce cell products which are uniformly engineered and well characterized, can be mass produced in a cost-effective manner, and can be delivered off-the-shelf to treat many patients. This revolutionary paradigm overcomes significant challenges that limit both patient- and donor-derived cell therapy, where heterogeneous populations of primary cells are repeatedly sourced, engineered, expanded and characterized on a batch-by-batch basis resulting in cell therapies with substantial variability in quality, consistency and potency.”

The Company plans to initiate first-in-human clinical testing of FT500 in combination with checkpoint inhibitor therapy for the treatment of advanced solid tumors. This study is expected to evaluate the safety and tolerability of multiple doses of FT500, in multiple dosing cycles with nivolumab, pembrolizumab or atezolizumab, in subjects that have progressed or failed on checkpoint inhibitor therapy.

Cheers!

IND Press Release here

See Fate's dedicated Blog page here

Also recent news from Fate on their partnership with Japan for CAR-T Cell Cancer Immunotherapies based on Fate's iPSC technology here.

Further, Fate licenses new route to master iPS cell lines:

Fate PR announcement here

First Babies Born Using Genome Editing Technology During IVF

Further to the National Academies report on human genome editing, published in 2017, the self-monitoring governance directive on the sicence to resist human clinical trials for the moment has been challenged by a Chinese scientist who has announced the birth of twins genetically modified to resist HIV infection.

See the following announcements and media coverage on the development:

The National Academies - organizing committee statement
The National Academies - President's & Chinese Academy editorial statement 

NIH
FDA

New York Times

BBC

Associated Press

MIT Tech Review

The Niche
Science - George Church, geneticist, interview

At the conclusion of the 2nd Human Genome Editing Summit, where the above referred to announcement was debated, a statement by the Organizing Committee was made on the science (here).

Related Blog posts on the developing technology can be found on the Genetics page - specifically Germline Science & Embryo Use and The Rise of Germline Science. 

Cheers