Fate Therapeutics (FATE) 2024 Cantor Fitzgerald Global Healthcare Conference summary

Platform overview and strategy

• Focus on developing off-the-shelf T-cell and NK cell therapies to improve accessibility and scalability compared to autologous approaches.

• Initial emphasis on NK cells, now expanded to T-cells for oncology and autoimmunity indications.

• Three clinical programs in development: FT825 (solid tumors), FT819 (autoimmunity), and an NK cell program advancing into autoimmunity.

• Aim to deliver therapies without conditioning chemotherapy, enabling outpatient and community-based treatment.

• Platform aspires to offer biologics-like convenience and safety, differentiating from traditional autologous cell therapies.

Clinical development and trial design

• FT819 is an iPSC-derived CAR T-cell therapy with a novel 1XX construct, designed for safety and potency.

• Oncology trials showed a clean safety profile, low CRS, no ICANS, and activity in heavily pretreated patients.

• Autoimmunity trials start at a mid-range dose (360 million cells), leveraging oncology safety data.

• Multiple conditioning regimens under evaluation: Cy/Flu, bendamustine, and Cy alone, with a focus on patient-friendly options.

• Regimen B aims to combine FT819 with less intensive, standard immunosuppressive therapies.

Safety, efficacy, and patient access

• Safety is prioritized for autoimmunity patients, with regimens designed to minimize toxicity and avoid hospitalization.

• Off-the-shelf therapies enable broader access, reaching patients outside academic centers.

• Duration of response goals vary by regimen; redosing is considered feasible for maintaining remission.

• Significant therapeutic improvement, even short of cure, is seen as valuable for patients reliant on chronic immunosuppression.