Shares of cell therapy developer Fate Therapeutics shot up more than 8% Friday morning to $15.31 after the company announced that the FDA accepted its IND application for a cell therapy it’s developing called FT500 to treat advanced solid tumors. The company said it's now planning to start human trials of FT500 combined with checkpoint inhibitors. The timing couldn’t have been better, as the news came on the eve of the closely watched American Society of Hematology (ASH) annual meeting in San Diego.
At ASH, Fate will be presenting new preclinical data on FT500, which had already generated some excitement in the oncology community because unlike other cell therapies—notably Novartis’ and Gilead’s FDA-approved CAR-T treatments—Fate’s won’t have to be tailored to individual patients. FT500, in fact, is one of three off-the-shelf investigational cell therapies from Fate that will be featured at the meeting.
FT500 is a natural killer (NK) cell derived from induced pluripotent stem cells (iPSCs). During an oral presentation at ASH, the company will present data showing the cells killed cancer cells from ovarian, lung and pancreatic tumors. When they combined FT500 with immune-boosting T cells and a drug that blocks the immune checkpoint PD-1, they observed 99% tumor shrinkage, according to an abstract of the presentation.
Fate’s scientists wanted to see whether the stem-cell derived NK cells could enhance the body’s natural immune response to cancer by luring T cells to tumors. So they injected the NK cells into a mouse model of myeloid leukemia, and indeed, they observed far more T cells at the cancerous sites than what was seen in control animals.
Fate is also developing an off-the-shelf CAR-T product derived from stem cells called FT819, and at ASH, it will present data from a mouse study of the therapy in acute lymphoblastic leukemia. The company’s scientists will report that the treatment controlled tumor progression in mice. And when they cultured the CAR-T with multiple tumor cells and Roche’s lymphoma treatment Rituxan, they found it could identify and eliminate cancer cells bearing the target antigens CD19 and CD20.
“Collectively, these preclinical studies suggest that FT819 is a consistent and uniform off-the-shelf product than can be effectively and safely used in the treatment of B cell malignancies,” the authors wrote.
During ASH, Fate will also describe FT519, an off-the-shelf NK-CAR combination it is developing to treat B cell cancers.
Scott Wolchko, CEO of Fate Therapeutics, believes the company’s use of iPSCs to generate cancer cell therapies will help overcome the hurdles associated with personalized CAR-T treatments—not the least of which is cost. Removing T cells from patients and then engineering them to be able to recognize and attack their cancers is a time-consuming and resource-intensive process that Novartis and Gilead have pointed to in justifying the $300,000-$500,000 price tags on their products.
“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,” Wolchko said in a statement announcing the FDA’s acceptance of the IND for FT500.
Fate is not the only company that spots promise in off-the-shelf cell therapy, however. Allogene, the biotech founded by CAR-T veterans Arie Belldegrun and David Chang, raised more than $400 million in private financing for their off-the-shelf technology before pulling off a $288 million initial public offering last month. In June, Precision Biosciences raised $110 million in private financing to take its off-the-shelf CAR-T into human trials.