FDA Allows Continued Treatment for Phase 1 Patient in HanchorBio's…

Event summary

FDA cleared HanchorBio's HCB101 Single-Patient Expanded Access Protocol (HCB101-EA-001) as 'safe to proceed' on September 9, 2026.
The protocol allows a Phase 1 patient experiencing clinical benefit to continue treatment with HCB101 beyond the parent clinical trial.
HCB101 is an engineered SIRPα-Fc fusion protein designed to block the CD47-SIRPα 'don't eat me' signal.
This is believed to be the first reported U.S. Expanded Access case for a SIRPα-Fc fusion protein.
HCB101 holds U.S. FDA Orphan Drug Designation for gastric cancer.

The big picture

HanchorBio's achievement highlights the strategic importance of navigating regulatory pathways to extend treatment for patients with limited options. This milestone underscores the potential of SIRPα-Fc fusion proteins in oncology, positioning HanchorBio as a key player in the next generation of immunotherapies. The FDA's decision could influence how similar compounds are evaluated in the future, potentially accelerating the development of targeted cancer therapies.

What we're watching

Regulatory Precedent: Whether this Expanded Access approval sets a precedent for other SIRPα-Fc fusion proteins in development.
Clinical Validation: How the continued treatment of this patient may influence the design and outcomes of future HCB101 trials.
Commercial Strategy: The pace at which HanchorBio can leverage this milestone to advance HCB101 across multiple tumor types and combination strategies.