biotech / news / / The Manila Times
The U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for HBM7004, enabling the initiation of a first-in-human (FIH) Phase I clinical trial.
The FDA cleared Harbour BioMed's IND application for HBM7004, a novel B7H4xCD3 bispecific antibody.
KEY POINTS
- HBM7004, developed on the HBICE platform, targets advanced solid tumors with a differentiated immunotherapy approach.
- Preclinical studies showed HBM7004 provides B7H4-dependent T cell activation with reduced systemic toxicity.
- Combining HBM7004 with a B7H4x4-1BB bispecific antibody produced strong synergistic effects in animal models.
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