On July 18, 2019 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, reported that it has initiated SURPASS, its first clinical trial with a next-generation SPEAR T-cell targeting MAGE-A4 (Press release, Adaptimmune, JUL 18, 2019, View Source [SID1234537589]). This next-generation SPEAR T-cell, known as ADP-A2M4CD8, expresses the CD8α co-receptor alongside the engineered TCR that targets MAGE-A4. Preclinical data presented earlier this year at AACR (Free AACR Whitepaper) indicate that co-expression of CD8α may broaden the immune response against solid tumors and increase antitumor activity by leveraging CD4+ cells into CD8+ killer or cytotoxic T-cells while retaining their CD4+ helper function.

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"We are delighted to have started screening for the SURPASS study, not only because it is our first next-generation SPEAR T-cell to be evaluated as an improvement to affinity matured TCRs in a clinical trial, but also because it is the first of three studies we plan to start in the second half of this year to assess the safety and efficacy of our SPEAR T-cell platform," said Rafael Amado, Adaptimmune’s President of Research & Development. "The preclinical data we presented at AACR (Free AACR Whitepaper) indicate that adding CD8α may enhance the ability of CD4+ SPEAR T-cells to kill tumor cells and broaden antigen presentation."

The SURPASS trial will enroll up to 30 patients across multiple solid tumor indications. Like Adaptimmune’s ongoing trials, the SURPASS trial will be a three-cohort dose escalation study. Unlike the other trials, the stagger between patients will be shorter and the starting dose in the first cohort will be 0.8 to 1.2 billion SPEAR T-cells, instead of 100 million SPEAR T-cells. Each dose cohort will enroll 3 patients and can be expanded to 6 patients if a dose limiting toxicity occurs. The dose ranges for the other two cohorts are: 1.2 to 3 billion and 3 to 6 billion SPEAR T-cells. After dose escalation is complete, there is an expansion phase with doses up to 10 billion cells.