Adaptimmune Reports Third Quarter Financial Results and Business Update
Afami-cel: overall survival for people with synovial sarcoma who received afami-cel is superior to historic controls (CTOS 2023); BLA submission on track to complete in Q4 this year
SURPASS Phase 1 trial: 75% response rate in ovarian, urothelial, and head & neck cancers in patients with ≤ 3 prior lines of therapy (ESMO 2023)
SURPASS trial plans: Phase 1 trial focused on head & neck and bladder cancers in earlier line treatment settings; Phase 2 SURPASS-3 trial initiated for platinum resistant ovarian cancer
Lete-cel: 40% (18/45) of people with synovial sarcoma or MRCLS had clinical responses with lete-cel, by independent review1; primary efficacy endpoint requires 16/60 patients have responses (CTOS 2023)
Pipeline update: Gavo-cel and TC-510 programs terminated based on review of data
Financial: Cash runway confirmed into early 2026
Webcast to be held today, November 8, 2023, at 8:00 a.m. EST (1:00 p.m. GMT)
PHILADELPHIA, PA. and OXFORD, UK, November 8, 2023 – Adaptimmune Therapeutics plc (Nasdaq: ADAP), a leader in cell therapy to treat cancer, today reported financial results for the third quarter ended September 30, 2023 and provided a business update.
Adrian Rawcliffe, Adaptimmune’s Chief Executive Officer: “Adaptimmune has been transformed in 2023. Our hat trick of data at ESMO and CTOS sets us up for commercial transition. We will submit the afami-cel BLA and recover lete-cel this quarter and update on our sarcoma plans in the new year.”
Afami-cel – on track to be Adaptimmune’s first commercial product for the treatment of synovial sarcoma
BLA update
Adaptimmune’s rolling BLA submission for afami-cel is on track for completion in Q4 2023. Adaptimmune has completed submission of the preclinical module (Q4 2022) and the clinical module (Q1 2023).
Adaptimmune and FDA discussed and agreed on the planned content of the BLA, including the CMC dossier, last year. All validation activities required for the CMC dossier have been completed and the last section of the BLA rolling submission is currently being finalized.
1 Substudy 2 in patients who received prior anthracycline treatment; responses for primary efficacy endpoint by independent review