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Investing.com --ABPRO Holdings Inc (NASDAQ:ABP)stock rose 5.2% in Tuesday premarket trading after the company announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for ABP-102 / CT-P72, the company’s lead multispecific antibody oncology program.
The FDA clearance enables Abpro and its co-development partnerCelltrion Incto begin a Phase 1 clinical trial evaluating the safety and preliminary efficacy of ABP-102 / CT-P72 in patients with HER2-positive solid tumors. This marks Abpro’s first clinical-stage T-cell engager program in oncology.
"This IND clearance marks an important step for Abpro as we advance our lead solid tumor program into clinical evaluation," said Miles Suk, CEO of Abpro. "ABP-102 / CT-P72 represents our first clinical-stage T-cell engager program in oncology, and we believe its differentiated design has the potential to translate into a meaningful therapeutic profile for patients with HER2-positive cancers."
The companies plan to initiate a global Phase 1 clinical trial in the first half of 2026. The study will be led byCelltrionas part of their ongoing strategic collaboration.
ABP-102 / CT-P72 is designed to selectively target HER2-overexpressing tumor cells while engaging cytotoxic T cells, with optimized binding intended to enhance tumor selectivity and limit activity in normal HER2-low tissues.
In preclinical studies, the drug candidate demonstrated antitumor activity in HER2-high tumor models and was well tolerated in non-human primate toxicology studies at doses up to 80 mg/kg, with no significant adverse effects observed.
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