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.
Under the terms of their 2022 strategic partnership—worth up to $1.75 billion in milestones and equity—Celltrion will lead the upcoming global Phase 1 trial.
The study, expected to begin in the first half of 2026, will evaluate the safety and preliminary efficacy of ABP-102 in patients who have failed prior therapies, including those resistant to current "gold-standard" antibody-drug conjugates (ADCs) like Enhertu.