The start of the trial marks an expansion of the firm's oncology pipeline, and the firm hopes mRNA-2808 will be the first of many T-cell engagers in its portfolio.
Based on strong preclinical data on HMPL-A251 in HER2-positive tumor cell lines, the firm wants to take the therapy into clinical trials by year end.
The firm, which had planned to submit a BLA in 2026 for AMT-130, described the FDA's latest feedback as a "drastic change" and "unexpected." ...
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