regulatory
confidence high
sentiment positive
materiality 0.75
Abpro and Celltrion announce FDA IND clearance for lead multispecific antibody ABP-102 / CT-P72
Abpro Holdings, Inc.
- FDA cleared IND for ABP-102 / CT-P72, a multispecific HER2 × CD3 T-cell engager targeting HER2-positive solid tumors.
- Phase 1 clinical trial anticipated to commence in H1 2026, led by Celltrion under co-development collaboration.
- Preclinical data showed selective antitumor activity in HER2-high models and was well tolerated in NHP studies up to 80 mg/kg.
- Candidate designed to enhance tumor selectivity and limit activity in HER2-low tissues, aiming to reduce cytokine release syndrome risk.