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ABP News
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Abpro and Celltrion Receive FDA Clearance for ABP-102 Clinical Trial
Abpro announced, together with its co-development partner Celltrion, that the U.S. Food and Drug Administration, FDA, has cleared the Investigational New Drug, IND, application for ABP-102 / CT-P72, Abpro's lead multispecific antibody oncology program. The IND clearance enables the initiation of a Phase 1 clinical trial evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of ABP-102 / CT-P72 in patients with HER2-positive solid tumors. The Phase 1 clinical study will be led by Celltrion as part of the ongoing joint strategic collaboration to ensure the robust progression of the ABP-102 / CT-P72 program.
Abpro Holdings Submits IND for ABP-102/CT-P72
Abpro Holdings announced the submission of an investigational new drug application to the U.S. Food and Drug Administration for ABP-102/CT-P72, a HER2 CD3 T cell engager engineered with optimized CD3 and HER2 binding to improve tumor selectivity. Pending regulatory clearance, this IND will support the initiation of a phase 1 clinical trial, anticipated to begin in 1H 2026 in patients with HER2-positive cancers including breast and gastric cancers. This submission represents a significant milestone in the companies' collaborative development of ABP-102/CT-P72 and marks an important advance for Abpro's broader immuno-oncology pipeline. Abpro Holdings and CELLTRION, INC. recently presented preclinical results for ABP-102/CT-P72 at the American Association for Cancer Research 2025 Annual Meeting and at the Society for Immunotherapy of Cancer 40th Anniversary Annual Meeting, highlighting selective activity in HER2-high tumor models and lower activity on cells with normal-tissue-level HER2 expression in preclinical studies. In non-human primates, ABP-102/CT-P72 was well tolerated. Together, these findings support the potential for a favorable therapeutic index in clinical studies. Upon FDA authorization to proceed, the planned phase 1 study will evaluate the safety, pharmacokinetics, and preliminary efficacy of ABP-102/CT-P72 in a dose-escalation and dose-expansion format. Data generated from the trial will inform dose selection and guide subsequent clinical development.
Abpro Holdings and Celltrion to Showcase Preclinical Findings for CT-P72/ABP-102
Abpro Corporation and Celltrion announced that they will present new preclinical data for CT-P72/ABP-102, a tetravalent bispecific antibody targeting HER2 and CD3, at the Society for Immunotherapy of Cancer 2025 Annual Meeting, being held November 6-10, 2025, at the Gaylord National Resort and Convention Center in National Harbor, Maryland. Following a prior oral presentation at the American Association of Cancer Research New Drugs on the Horizon Session earlier this year, these additional preclinical results will be featured at SITC 2025, highlighting the growing body of evidence supporting CT-P72/ABP-102's advancement toward first-in-human studies. Key Findings: Selective tumor binding: CT-P72/ABP-102 binds selectively to HER2 high tumor cells with reduced binding to HER2-expressing normal tissues while binding CD3 on T cells with reduced affinity for added safety. Potent, Selective Anti-Tumor Activity: The molecule demonstrated robust T-cell activation, PBMC-mediated cytotoxicity, and cytokine release in vitro using human PBMCs. Potency was preserved in HER2-high tumor target cells but was reduced in HER2-low cells, which are typical of normal tissues, confirming enhanced tumor selectivity. Strong preclinical activity in vivo including in Enhertu-resistant models: In vivo, CT-P72/ABP-102 inhibited the growth of HER2-high BT-474 tumors in a dual xenograft model and demonstrated efficacy in both an Enhertu-resistant gastric cancer model and the KPL4 xenograft model. Favorable Safety Profile: A GLP repeated-dose toxicity study in cynomolgus monkeys demonstrated good tolerability at all tested doses, including the highest dose, supporting a favorable safety profile in non-human primates.
Abpro Holdings declares a 1-for-30 reverse stock split.
Abpro announced that its previously approved 1-for-30 reverse stock split of its common stock became effective at 5:01 p.m. Eastern Time on October 31, 2025. The Company's common stock will begin trading on a split-adjusted basis at the open of trading on November 3, 2025 under the ticker symbol "ABP" and the new CUSIP number will be 000847202. "This action is a highly necessary step in our efforts to maintain our Nasdaq listing and reflects a broader realignment of Abpro for the future," said Miles Suk, Chief Executive Officer and Chairman of Abpro. "With a leaner cost structure, a major global partner in Celltrion, and a differentiated antibody platform, we are positioned to execute more effectively and create long-term value for our shareholders."
Abpro Holdings, Celltrion unveils preclinical data for ABP-102/CT-P72
Abpro Holdings and Celltrion unveiled preclinical data for ABP-102/CT-P72 in an oral presentation at the American Association for Cancer Research, AACR, Annual Meeting 2025, in the New Drugs on the Horizon session. Key Findings: Highly Selective Tumor Killing: ABP-102/CT-P72 achieves potent cytotoxicity in HER2-overexpressing breast and gastric cancer models while significantly reducing activity against HER2-low cells, addressing a key limitation of prior HER2-targeted T-cell engagers. Enhanced Tumor Growth Inhibition: In vivo studies showed ABP-102/CT-P72 had up to a two-fold increase in tumor suppression compared to a biosimilar of runimotamab, a benchmark HER2 x CD3 bispecific antibody. Reduced Cytokine Release: Engineered for functionally monovalent CD3 binding, ABP-102/CT-P72 minimizes cytokine-related toxicities, as demonstrated by reduced cytokine release in HER2-low cell models while maintaining potent cytotoxicity in HER2-high models. Improved Tolerability: Dose escalation studies in cynomolgus monkeys confirmed that ABP-102/CT-P72 was well tolerated, even at doses exceeding 180 times the maximum tolerated dose observed with the parental antibody, suggesting a broader therapeutic window.
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