Fate Therapeutics Inc (NASDAQ:FATE) closed Tuesday’s trading session at $15.00 amid its announcement last week that its FT516 Investigational New Drug (IND) application received FDA clearance.
FT516 is Fate Therapeutics’ natural killer cell product that the company has been developing. The company has a lot invested in the treatment because it is the first clinical testing-approved cell therapy that has been developed from engineered pluripotent stem cells. It is also the second iPSC-derived NK cell off-the-shelf product that has received the FDA’s clinical investigation clearance within two months.
Fate Therapeutics plans to kick off FT516’s clinical testing in patients that suffer from various elapsed hematologic malignancies. Some of those malignancies include multiple myeloma (MM), Hodgkin’s lymphoma (NHL), and acute myelogenous leukemia (AML).
“This allowance by the FDA of our FT516 IND application is a watershed event in the clinical development of engineered cell therapies,” stated Fate Therapeutics CEO, Scott Wolchko.
The CEO also noted that Fate Therapeutics’ industry-leading iPSC product platform facilitates the creation of engineered cell products. Its products feature extensive characterization, cryopreservation, and on-demand delivery so that it can enhance patient reach. Wolchko also added that the company is eager to treat patients using multiple FT516 doses. This includes a combination that features a monoclonal antibody therapy that is FDA approved. This will be done across the first clinical study’s multiple treatment cycles.
Understanding how the mechanism works
Most of the monoclonal antibodies that are approved for treating numerous cancers use the ADCC mechanism which is a marker for the clinical efficacy of those antibodies. NK cells use this mechanism to identify and eliminate cancer cells coated with antibodies. NK cells are also characterized by a natural expression called CD16 which acts as an ADCC mediator. Cancer patients may experience noteworthy down-regulation of CD16 expression on the NK cells. This affects the immune system’s ability to respond to tumors.
FT516’s mechanism introduces an innovative CD16 Fc receptor that is designed to prevent down-regulation. FT516’s initial clinical study will evaluate the safety and tolerability profile of the treatment when administered in three weekly doses to combat various hematologic malignancies.