Fate Therapeutics Inc (NASDAQ:FATE) Gets FDA Approval On IND Application Of iPSC-based CAR T-Cell Therapy

Fate Therapeutics Inc (NASDAQ:FATE) recently announced that it received the FDA’s green light for an iPSC-based CAR T-Cell therapy that the company calls FT819.

Fate Therapeutics has been developing FT819 as a chimeric antigen receptor (CAR) that is engineered to combat CD19+ malignancies. It is the first CAR T-cell therapy that is made using clonal master induced pluripotent stem cell (iPSC). This technology allows the drug to be fitted with features that allow it to have better safety and efficacy profile.

The approval of FT819’s Investigational New Drug (IND) represents an important milestone for the company and for patients suffering from various types of cancer. The CAR T-cell therapy will be used for various indications, including non-Hodgkin lymphoma (NHL), acute lymphoblastic leukemia (ALL), and chronic lymphocytic leukemia (CLL). In other words, it will be used to target relapsed B-cell malignancies.

“The clearance of our IND application for FT819 is a ground-breaking milestone in the field of cell-based cancer immunotherapy,” stated Fate Therapeutics CEO Scott Wolchko.

The CEO also noted that his company’s ability to make CAR T cells from an iPSC line that has been master engineered prevents more patients from accessing treatment in a timely manner. It also provides patients with therapies that have more curative potential. Wolchko also pointed out that the current level of progress that Fate Therapeutics has achieved with CAR T-cell therapy is courtesy of the partnership that the company struck with Memorial Sloan Kettering four years ago.

Fate Therapeutics made FT819 address some of the shortcomings of the currently available CAR T-cell therapies derived from donors and patients. The company also announced recently that it signed an exclusive license deal with Baylor College of Medicine. The deal is aimed at developing iPSC-derived therapies that are rejection-resistant.

Wolchko pointed out that strategies that allow allogeneic cells to overcome immune rejection while facilitating normal functions of the hematopoietic system have been gaining a lot of traction and interest lately. He also added that preclinical data has already demonstrated that the ability to allogeneic cell therapies can deliver significant efficiencies.