iPSC Product Platform - Fate Therapeutics' iPSC product platform is supported by an IP portfolio with over 500 issued patents and over 500 pending patent applications[17] - One iPSC MCB vial has the potential to yield trillions of uniformly-engineered cells[18] - The company has a 40,000 ft2 cGMP manufacturing facility co-located with corporate headquarters[21] FT819 Program (CD19-targeted CAR T-cell) - In a Phase 1 study (n=25), FT819 showed no dose-limiting toxicities (DLTs), immune effector-cell associated neurotoxicity syndrome (ICANS), or graft-versus-host disease (GvHD)[35] - In relapsed/refractory aggressive BCL patients (n=17), FT819 achieved a 47% Overall Response Rate (ORR) and a 24% Complete Response (CR), with 60% ORR and 40% CR in patients naïve to auto CD19-targeted CAR T[35] - In FT819-102, three Lupus Nephritis patients were dosed at DL1 (single dose, 360 million cells) with no dose limiting toxicities (DLTs) observed[45] FT825 Program (HER2-targeted CAR T-cell) - FT825/ONO-8250 is engineered for enhanced solid tumor efficacy, overcoming tumor heterogeneity and improving cell trafficking[62] - Preclinical data shows potent CAR-mediated activity of FT825 that can be further enhanced in combination with mAb[70] FT522 Program (CD19-targeted CAR NK Cell) - Preclinical data shows dose-dependent trafficking, infiltration, & residency in primary, secondary & tertiary tissues without cytokine support at human dose equivalency levels of 250 million & 1 billion cells per dose[112] - FT522 has the unique ability to eliminate both B cells and Plasma Cells Without the Need for Conditioning Chemotherapy[119]
Fate Therapeutics (FATE) Earnings Call Presentation