Fate Therapeutics (FATE) Jefferies 2024 Global Healthcare Conference summary

Industry landscape and therapeutic rationale

• CAR T-cell therapy has shown remarkable results in small autoimmune patient cohorts, offering potential for drug-free remission and disease reset.

• Current regimens require intensive conditioning and hospitalization, similar to oncology protocols, presenting challenges for autoimmune patients.

• Off-the-shelf, iPSC-derived CAR T and CAR NK cell programs are being developed to improve patient access and treatment experience.

Clinical experience and product differentiation

• The iPSC-derived CD19 CAR T construct has been used in 40-50 oncology patients, showing a 50% response rate, 25% CR rate, and strong safety profile.

• Translational data demonstrate deep B-cell depletion in blood and tissue, with reconstitution of naive B cells, indicating immune reset potential.

• The same construct, dose, and cell line are being used in the autoimmune lupus study.

Study design and operational strategy

• The lupus phase I study leverages existing oncology sites and partnerships between oncologists and rheumatologists to facilitate enrollment.

• Two sites (University of Minnesota and University of Nebraska Medical Center) are currently open, with more planned.

• Site activation to first patient dosing took about eight weeks, and patients have already been dosed.