Fate Therapeutics (FATE) Cleared By FDA of IND Application for FT538


Since April 2020, FATE stock rocketed from a low of $19.92 to $35.23, as it moves progresses with cellular immunotherapies for cancer and immune disorders.

Just days ago, FATE announced the U.S. FDA cleared its investigational new drug (IND) application for FT538, the first CRISPR-edited iPSC-derived cell therapy. FT538 is an off the shelf natural killer (NK) cell immunotherapy.

“We are very pleased to expand the clinical application of our proprietary iPSC product platform to multiple myeloma, where rates of relapse remain high,” said Scott Wolchko, President and Chief Executive Officer of FATE.

FATE stock is up 16% on the announcement.

“Clinical data suggest that deficiencies in NK cell-mediated immunity, which are evident even at the earliest stages of myeloma, continue to accumulate through disease progression. We believe administration of FT538 to patients can restore innate immunity, and that the anti-cancer effect of certain standard of care treatments, such as monoclonal antibodies, can be more effective when combined with the engineered functionality of FT538,” he added.

FATE Reports Sizable Progress in Trials

“We have continued to enroll patients across our three Phase 1 clinical programs, expanded the clinical footprint of our FT596 program into relapse prevention following autologous HSCT, and submitted our IND application to the FDA for FT538, the first-ever CRISPR-edited, iPSC-derived cell therapy, in multiple myeloma,” added Wolchko.

“Additionally, we entered into a transformative collaboration with Janssen that leverages our iPSC product platform and Janssen’s proprietary tumor-targeting antigen binders to develop novel CAR NK and CAR T-Cell product candidates for hematologic malignancies and solid tumors, supporting our fundamental goal of bringing off-the-shelf, iPSC-derived cell-based cancer immunotherapies to patients.”

FATE Lands Major Partner

Just the other week, it secured a $3 billion deal with Janssen Biotech, Inc, one of the Janssen Pharmaceutical Companies of Johnson & Johnson to develop four cancer treatments. (Full story here.)

These treatments belong to a class known as immuno-oncology drugs, which help teach the immune system how to identify hidden cancer cells. Not only does this deal now validate Fate Therapeutics technology, notes Investor’s Business Daily, it removes cash flow concerns, and now adds another four potential cancer treatments for the company.

Ian Cooper’s Personal Position in FATE: None