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 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.
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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