# 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.

*biotech · news · 2026-05-08 · The Manila Times*

## Key points

- The FDA cleared Harbour BioMed's IND application for HBM7004, a novel B7H4xCD3 bispecific antibody.
- 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.

**Companies:** Harbour BioMed
**Countries:** United States, Netherlands, China

[Read the full story on The Manila Times](https://www.manilatimes.net/2026/05/08/tmt-newswire/pr-newswire/harbour-biomed-announces-us-fda-ind-clearance-for-hbm7004-for-the-treatment-of-advanced-solid-tumors/2339316)

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