Fate Therapeutics, Inc. · NASDAQ:FATE
Fate Therapeutics — Technical Presentation (November 2020)
8 slides from Fate Therapeutics's technical presentation, Nov 16, 2020
Slide 1: A Phase I Study of FT538, an iPSC-Derived NK-Cell Therapy in r/r AML and MM
A Phase I Study of FT538, a First-of-Kind, Off-the-Shelf, Multiplexed Engineered, iPSC-Derived NK-Cell Therapy As Monotherapy in Relapsed/Refractory Acute Myelogenous Leukemia and in Combination with Daratumumab or Elotuzumab in Relapsed/Refractory Multiple Myeloma Murali Janakiram, MD1, Ravi Vij, M
Slide 2: Background and iPSC Product Platform
Background and iPSC Product Platform • Allogeneic natural killer (NK) cell therapies have been well tolerated, including absence of GvHD, cytokine release syndrome and neurotoxicity (Liu et al. 2020), with documented anti-tumor activity in patients with relapsed/refractory (r/r) acute myelogenous le
Slide 3: FT538, an iPSC-Derived, Multi-Engineered, NK-Cell Therapy
FT538, an iPSC-Derived, Multi-Engineered, NK-Cell Therapy Expanded Peripheral FT538 • FT538 is an investigational, multi- Blood NK CD38–Targeted mAbs engineered, NK-cell therapy generated SLAMF7–Targeted mAbs hnCD16 “Universal from a clonal master iPSC line that Secondary Engager” 1 serves as a rene
Slide 4: FT538 Demonstrates Enhanced Long-Term Killing in the Presence of Daratumumab
FT538 Demonstrates Enhanced Long-Term Killing in the Presence of Daratumumab in a Serial Stimulation Cytotoxicity Assay Compared to Peripheral Blood NK cells MM.1R Killing MM.1R Killing Round 1 Round 2 Normalized MM.1R Normalized MM.1R Cell Count Cell Count Collect all effector cells and transfer to
Slide 5: FT538-101: Study Design
FT538-101: Study Design Study Treatment Schema: Regimen A: r/r AML 3 + 3 Dose Escalation and Expansion Regimen A: r/r AML Escalation Expansion (18 -1.59 FT538 Monotherapy (n=15) cells) Regimen B: r/r MM Escalation Expansion (18 -1.59 FT538 + Daratumumab (n=15) cells) Regimen C: r/r MM Escalation Exp
Slide 6: FT538-101: Patient Population
FT538-101: Patient Population Key Inclusion Key Exclusion Regimen A Regimen A • Primary refractory AML • r/r AML • Diagnosis of promyelocytic leukemia with t(15;17) • De novo AML: Complete response (CR) not achieved after translocation ≥2 inductions (if >60 years old, ≥1 induction required) • Second
Slide 7: FT538-101: Objectives and Endpoints
FT538-101: Objectives and Endpoints Objectives Endpoints Primary Primary • To determine the recommended Phase II dose (RP2D) for • Incidence and nature of dose limiting toxicities (DLTs) to FT538 monotherapy in r/r AML determine maximum tolerated dose or maximum • To determine the RP2D for FT538 ± d
Slide 8: FT538-101: Initial Site Activation
FT538-101: Initial Site Activation (up to 8 planned) • Projected enrollment: Up to 105 subjects • ClinicalTrials.gov Identifier: NCT04614636 University of Minnesota Minnesota Memorial Sloan Kettering New York Hackensack University New Jersey Washington University Missouri Mayo Clinic Arizona 9
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