Adaptimmune Starts SPEARHEAD-1 Trial with ADP-A2M4 SPEAR T-cells for patients with Synovial Sarcoma or MRCLS
- Category: DNA RNA and Cells
- Published on Thursday, 25 July 2019 17:05
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PHILADELPHIA, PA, USA and OXFORDSHIRE, UK I July 25, 2019 I Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, has started its SPEARHEAD-1 trial with ADP-A2M4 SPEAR T‑cells for patients with synovial sarcoma or myxoid/round cell liposarcoma (MRCLS). Earlier this year, Adaptimmune presented compelling data with responses observed in synovial sarcoma patients treated in the ADP-A2M4 pilot study.
“This is a pivotal moment for Adaptimmune as we move into the next phase of clinical development with our ADP-A2M4 SPEAR T-cells. We started SPEARHEAD-1 based on the compelling data we recently reported in synovial sarcoma patients. Since our update in May, we have started the three new clinical trials we had committed to: SPEARHEAD-1, SURPASS, and the low-dose radiation sub-study with ADP-A2M4,” said Rafael Amado, Adaptimmune’s President of Research & Development. “We are collaborating with excellent centers in this sarcoma trial. We look forward to reporting data from this trial and our other ongoing trials in due course.”
The SPEARHEAD-1 trial will treat up to 60 patients with inoperable or metastatic synovial sarcoma or MRCLS who have received prior chemotherapy. Patients will receive doses of up to 10 billion ADP-A2M4 SPEAR T-cells and the lymphodepletion regimen of fludarabine (30 mg/m2/day for 4 days) and cyclophosphamide (600 mg/m2/day for 3 days). The primary endpoint is overall response rate by RECIST v1.1 by independent review. Safety endpoints will be reviewed by an Independent Data Safety Monitoring Board.
“As we make continued progress on the development of our proprietary SPEAR T-cells in solid tumors, we have started preparing for the time when we make our first product commercially available to cancer patients,” said Helen Tayton-Martin, Chief Business Officer at Adaptimmune. “We are focused on how to optimally deliver our products through clinical trials and into scaled-up production post-approval. As part of these efforts, we are working with Vineti, the first cloud-based software platform to efficiently take T-cell therapies through clinical trials and into mainstream medicine at commercial scale.”
Adaptimmune is a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapy products for cancer patients. The Company’s unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T‑cell platform enables the engineering of T-cells to target and destroy cancer across multiple solid tumors. For more information, please visit http://www.adaptimmune.com.