Amphivena Therapeutics Inc., of San Francisco, said the FDA accepted its IND for AMV564, its T-cell redirecting bispecific CD33/CD3 antibody. The company plans to initiate a phase I dose-escalation and expansion trial of AMV564 in acute myeloid leukemia patients this year. The trial will evaluate safety, pharmacokinetics and pharmacodynamics of escalating AMV564 doses and will be followed by a preliminary evaluation of the antitumor activity. It also will allow for the identification of the maximum tolerated dose as well as the recommended dose for phase II studies.