Adaptimmune News Today

First marketed engineered T-cell therapy for a solid tumor; BLA for afami-cel on track to complete submission in mid-2023Compelling clinical data with late-stage programs targeting MAGE-A4 and mesothelinPreclinical

Approximately 39% of patients had clinical responses after a single dose of afami-cel in Cohort 1 of the pivotal SPEARHEAD-1 trial and the median duration of response was ~12 months (CTOS 2022)Median

Completed submission of the clinical module (Part 2) of the afami-cel BLA; afami-cel is targeted to be the first marketed engineered T-cell therapy for a solid tumorAdaptimmune and GSK agreed terms for

Adaptimmune and TCR2 Therapeutics have complementary technologies and an aligned strategy of developing cell therapies for solid tumors, but this marriage is preceded by divorce. Before consummating the TCR2 deal, Adaptimmune ended an alliance with a larger pharmaceutical company.

BLA submission initiated for afami-cel, with aim to complete in mid-2023; afami-cel has the potential to be the first marketed engineered TCR T-cell therapy for a solid tumor52% (13/25) response rate

- Afami-cel has the potential to be the first approved engineered TCR T-cell therapy for a solid tumor - -Synovial sarcoma has a high unmet medical need and the pivotal trial met its primary endpoint

- Data indicate continued clinical responses with an acceptable safety profile in heavily pre-treated patients with late-stage synovial sarcoma after a single dose of afami-cel -- Overall response rate

Adaptimmune gains full control of late-stage preclinical optimized PRAME TCR; IND-ready in 2023 -GSK to deliver data from the ongoing Phase 2 / potential registrational trial with lete-cel in sarcoma

- 44% Objective Response Rate (ORR) with a single dose of ADP-A2M4CD8 in 25 heavily pre-treated patients with late-stage ovarian, urothelial, and head & neck cancers -- Further clinical development planned

- Patients who responded to afami-cel had longer progression-free survival (median 58 weeks) compared to non-responders (median 12 weeks) -- Responses occurred across subgroups, with greater response