Adaptimmune Reports Q2 2024 Financial and Business Updates
Adaptimmune received U.S. FDA accelerated approval of Tecelra® (afami-cel), the first approved engineered cell therapy for a solid tumor
Patients can begin treatment journey; biomarker testing available; Adaptimmune systems ready to receive orders
At the end of Q2, Adaptimmune had Total Liquidity1 of $214.8 million
PHILADELPHIA, PA. and OXFORD, UK, August 12, 2024 – Adaptimmune Therapeutics plc (Nasdaq: ADAP), a company redefining the treatment of solid tumor cancers with cell therapy, today reports financial results and business updates for the second quarter ended June 30, 2024. The Company will host a live webcast at 8:00 a.m. EDT (1:00 p.m. BST) today.
Adrian Rawcliffe, Adaptimmune’s Chief Executive Officer: “On 1 August, we received US FDA approval for Tecelra, the first ever engineered cell therapy for a solid tumor and the first new treatment option for people with synovial sarcoma in more than a decade. We have hit the ground running to make Tecelra available to eligible patients. Patients can start their treatment journey now with healthcare providers able to begin testing and our ordering platform is up and running. Tecelra will be available in 6-10 US authorized treatment centers in the coming weeks. Tecelra is the first product in our sarcoma franchise, and we are planning to commence our rolling BLA submission for lete-cel in 2025 and commercial launch in 2026. We expect our sarcoma franchise to redefine the treatment landscape in advanced soft tissue sarcoma with projected peak US sales of $400 million.”
Sarcoma Franchise with Tecelra® and lete-cel
| ● | U.S. Food and Drug Administration (FDA) approves Tecelra® for the treatment of advanced MAGE-A4+ synovial sarcoma in adults with certain HLA types who have received prior chemotherapy. |
| ● | Tecelra® is the first engineered cell therapy for solid tumors. |
| ● | Tecelra® is the first new treatment option for synovial sarcoma in more than a decade. |
| ● | Tecelra® is a single infusion treatment. |
| ● | No Risk Evaluation and Mitigation Strategies (REMS) program was required for BLA approval. |
| ● | Patients can start their treatment journey now, with testing approved and available in the United States. |
| ● | Sarcoma centers of excellence across the Unites States are being onboarded as Authorized Treatment Centers (ATCs) for Tecelra®. |
| ● | The approval of Tecelra® was based on results of the SPEARHEAD-1 (Cohort 1) trial. The major efficacy outcome was overall response rate (ORR) by independent review and supported by duration of response. Tecelra® treatment resulted in an ORR of 43% with a complete response rate of 4.5%. The median duration of response was 6 months (95% CI: 4.6, not reached). Among patients who were responsive to the treatment, 39.0% had a duration of response of 12 months or longer. Data from the pivotal SPEARHEAD-1 trial were previously published in The Lancet earlier this year. |
1 Total liquidity is a non-GAAP financial measure, which is explained and reconciled to the most directly comparable financial measures prepared in accordance with GAAP below