Completion of Afami-cel’s BLA Submission Delayed; FDA Agrees to Cohort 2 of the SPEARHEAD-1 Trial Acting as Confirmatory Evidence for Full Approval; ADP-A2M4CD8’s SURPASS-3 Trial Initiated; Adaptimmune’s Q2 2023 Earnings Call Summary
On Wednesday, August 9, Adaptimmune held its Q2 2023 earnings call (press release) disclosing that the completion of afami-cel’s (MAGE-A4 SPEAR-T) BLA submission to the FDA has been postponed to Q4 2023 while reporting the initiation of ADP-A2M4CD8’s (next-generation MAGE-A4 SPEAR-T) Ph2 SURPASS-3 trial. Additionally, management highlighted anticipated milestones for assets included in the combined pipeline resulting from the merger with TCR2 Tx. Below, Celltelligence provides insights on the consequences of the delay in afami-cel’s BLA submission while discussing Adaptimmune’s potential pipeline prioritization strategy in ovarian cancer.
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