Abpro Holdings (NASDAQ:ABP) and South Korean biopharma giant Celltrion announced on January 6, 2026, that the U.S. FDA has cleared the Investigational New Drug (IND) application for ABP-102 (CT-P72).
This clearance transitions Abpro’s lead oncology program into the clinic, targeting a wide array of HER2-positive solid tumors, including breast, gastric, colorectal, and pancreatic cancers.
ABP-102 is a multispecific T-cell engager (TCE) designed with a "tetravalent" IgG1-scFv format.
Unlike traditional antibodies, it acts as a molecular bridge: it binds bivalently to the HER2 receptors on cancer cells while simultaneously engaging the CD3 receptor on T-cells to trigger a direct immune attack.
A key differentiator is its "affinity-tuned" design—Abpro engineered the molecule to have high selectivity for tumor cells with massive HER2 overexpression while minimizing binding to normal tissues with low HER2 levels.
This strategy is specifically intended to reduce the risk of Cytokine Release Syndrome (CRS), a common and dangerous side effect of earlier T-cell engager therapies.