Fate Therapeutics Inc. (NASDAQ:FATE) has announced its Q3 financial results and provided business highlights for the three months ended September 30, 2020. Revenue in Q3 was $7.6 million derived from the collaboration with Ono Pharmaceutical and Jannsen. The company ended the quarter with $502 million in cash and investments.
Fate advancing iPSC product platform
Scott Wolchko, the company’s CEO, said that Fate’s clinical data across the iPSC product platform continues to solidify its belief that several iPSC-derived NK cells doses can be given off-the-shelf in an outpatient setting. The doses show good tolerability profile and can drive anti-tumour activity when used in combination with monoclonal antibody therapy. Wolchko said that the company had expanded its scope of clinical studies for FT516 to solid tumours and FT596 to chronic lymphocytic leukaemia. This comes following observation of clinical activity in diffuse B-cell lymphoma after the first dose level.
The CEO confirmed that the company had commenced the first-in-human investigation for the first-ever CRISPR-edited, iPSC-derived cell therapy FT538. The therapy incorporates three engineered elements to improve different innate immunity mechanisms in multiple myeloma and acute myeloid leukaemia.
Evaluating FT596 as a CD20 monoclonal antibody in B-cell Lymphoma
Fate is evaluating FT596 in a multi-centre phase 1 clinical study. FT596 is the company’s universal, off-the-shelf, chimeric antigen receptor (CAR) NK cell product candidate. Fate is studying it as a monotherapy and in combination with CD20 directed monoclonal antibody in treating refractory/relapsed B-cell lymphoma. The company has so far treated first patients at the first dose level of 30 million cells in combination with rituximab which allows dual-antigen targeting for CD19 and CD20 shown in malignant B cells. The company has also initiated participant enrolment at a second dose level of 90 million cells as a monotherapy.
In August, the company expanded the clinical scope of FT596 study to include treatment of refractory/relapsed chronic lymphocytic leukaemia. The company has already initiated enrolment at first dose levels as monotherapy. Fate is planning to commence FT596 enrolment in combination with obinutuzumab after dose-limiting clearance of monotherapy.