Fate Therapeutics (FATE) TD Cowen 45th Annual Healthcare Conference summary

Living drug platform and manufacturing

• Living drugs are responsive to disease burden, expanding to eliminate disease, unlike traditional drugs.

• iPSC-derived cell therapies enable off-the-shelf, on-demand treatments, with master cell banks allowing large-scale, consistent, and cost-effective production.

• Manufacturing process yields thousands of uniform doses at $3,000 each, with a GMP facility capable of producing 50,000 doses per year.

• Platform avoids donor variability and heterogeneity, ensuring product purity and scalability.

Clinical program updates: FT819 and FT825

• FT819, a CD8 CAR-T targeting CD19, showed strong safety and moderate efficacy in aggressive DLBCL, with 25% CR rate, increasing to 40% in CAR T-naïve patients.

• FT819 transitioned to SLE, showing promising B cell depletion and immune reset, with the first patient achieving six-month clinical remission and improved quality of life.

• Regimen A uses bendamustine or cyclophosphamide as conditioning; Regimen B combines FT819 with maintenance therapy, aiming to discontinue maintenance drugs.

• FT825, a next-generation CAR-T for solid tumors, incorporates seven genetic edits and dual targeting (HER2 and CD16) for multi-antigen tumor targeting.

Next-generation engineering and future outlook

• Sword and shield technology enables CAR-T cells to actively defend against host immune attack, potentially reducing the need for conditioning chemotherapy.

• Additional edits, such as ADR and CD58 knockout, enhance in vivo expansion and protection in allogeneic settings.

• Preclinical models show robust activity and tumor elimination with multi-targeting strategies.

• Upcoming clinical updates for SLE and solid tumor programs are planned at EULAR and ACR conferences.