FATE Stock Price Expected to Jump On Clearance of FDA IND Application

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Fate Therapeutics (FATE) has seen an incredible amount of momentum.

Since March, the stock rocketed from a low of $19.92 to $38, as it moves progresses with cellular immunotherapies for cancer and immune disorders. FATE could see even further momentum on news the U.S. FDA 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,” says a spokesperson for FATE.

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From here, the company plans to a clinical investigation of FT819 for the treatment of patients with relapsed / refractory B-cell malignancies, including chronic lymphocytic leukemia (CLL), acute lymphoblastic leukemia (ALL), and non-Hodgkin lymphoma (NHL).

“The clearance of our IND application for FT819 is a ground-breaking milestone in the field of cell-based cancer immunotherapy. Our unique ability to produce CAR T cells from a clonal master engineered iPSC line creates a pathway for more patients to gain timely access to therapies with curative potential,” said Scott Wolchko, President and CEO.

“Four years ago, we first set out under our partnership with Memorial Sloan Kettering led by Dr. Michel Sadelain to improve on the revolutionary success of patient-derived CAR T-cell therapy and bring an off-the-shelf paradigm to patients, and we are very excited to advance FT819 into clinical development,” he added.

Fate Lands Major Partner

Not long ago, Fate Therapeutics secured a $3 billion deal with Janssen Biotech, Inc, one of the Janssen Pharmaceutical Companies of Johnson & Johnson to develop four cancer treatments.

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

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