7/103 sources · 3 publishersUpdated Oct 9, 13:54 UTC
HCW Biologics receives FDA Type B meeting guidance and targets IND filing in 1H 2027 for lead T‑Cell Engager
HCW Biologics said the FDA provided clear regulatory guidance at a recent Type B meeting on preparing an IND for its lead T‑Cell Engager candidate, HCW11‑018b, aimed at solid tumors. The company is manufacturing cGMP clinical‑trial material and remains on track to submit the IND in the first half of 2027. Founder and CEO Dr. Hing C. Wong expressed satisfaction with the guidance and reaffirmed the timeline.
Why it matters
The company expects the IND filing in 1H 2027 to enable a first‑in‑human study, which could unlock future clinical milestones and revenue potential.
Key facts
- 1The FDA gave clear guidance at a recent Type B meeting regarding preparation of an IND for HCW11‑018b. globenewswire.com
- 2HCW11‑018b is the lead candidate in HCW Biologics’ second‑generation T‑Cell Engager program. globenewswire.com
- 3Manufacturing of cGMP material for clinical trials is underway. globenewswire.com
- 4The IND application is planned to be filed in the first half of 2027. globenewswire.com
- 5Dr. Hing C. Wong, founder and CEO, said the company is pleased with the FDA’s regulatory guidance. globenewswire.com
Summary written by AlphAI AI Desk from 3 of 3 sources. Not investment advice. Figures are as stated by the linked sources.