ABP-102 / Celltrion, Abpro - LARVOL DELTA

[JPM 2026] Celltrion pitches...four phase 1 readouts at JPM (Korea Biomedical Review) - "Four of them are already in phase 1 testing after receiving investigational new drug approvals last year: three antibody-drug conjugates, CT-P70, CT-P71 and CT-P73, and a multispecific antibody, CT-P72...The company said it expects key results from those four studies to emerge sequentially beginning in the second half of 2026...The company said it plans to seek Fast Track status for CT-P71, CT-P72 and CT-P73 as well."

Fast track • P1 data • Bladder Cancer • Breast Cancer • Colorectal Cancer • Gastric Cancer • Gastroesophageal Cancer • HER2 Positive Breast Cancer • Non Small Cell Lung Cancer

Celltrion said on the 29th that it obtained U.S. Food and Drug Administration (FDA) approval of an investigational new drug (IND) application to conduct a phase 1 clinical trial of its multi-antibody-based anticancer drug candidate 'CT-P72/ABP-102' (Chosun Biz) - "Celltrion plans to evaluate the candidate's safety, tolerability, and initial efficacy in this trial....'We plan to begin dosing patients next year'..."

IND • New P1 trial • Solid Tumor

Abpro Holdings…together with its co-development partner Celltrion…announced the submission of an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for ABP-102/CT-P72, a HER2 × CD3 T cell engager engineered with optimized CD3 and HER2 binding to improve tumor selectivity (GlobeNewswire) - "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....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."

IND • New P1 trial • Gastric Cancer • HER2 Positive Breast Cancer

In the field of bispecific antibody immuno-oncology drugs, the company is partnering with U.S.-based ABPro to develop bispecific antibody new drug candidate substance CT-P72. (Business Korea) - "Preclinical results for CT-P72 were disclosed at the Society for Immunotherapy of Cancer (SITC 2025) held in National Harbor, Maryland on the 7th of this month, with plans to submit Phase 1 IND applications to major domestic and international institutions within the year."

IND • New P1 trial • Solid Tumor

CT-P72/ABP-102: A dual affinity engineered HER2/CD3 tetravalent bispecific antibody with potential to overcome therapeutic barriers in HER2 high tumors with distinct potency, safety, and selectivity (SITC 2025) - "CT-P72/ABP-102 is a tetravalent bispecific HER2 and CD3 T-cell engager engineered with dual affinity-tuned binding to HER2 and CD3 to increase tumor selectivity and reduce off-target effects, thereby lowering the risk of safety concerns, and has potent anti-tumor activity in multiple in-vivo models, including an Enhertu-resistant model.Methods To assess target binding specificity, we evaluated cellular binding affinities of CT-P72/ABP-102 with ELISA, SPR analysis, and flow cytometry. One-way ANOVA with Dunnett's post-hoc analysis was performed to compare results to the control group up to Day 28. *p<0.05; **p<0.01; ***p<0.001; ****p<0.0001"

Clinical • Breast Cancer • Gastric Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Abpro and Celltrion to Present Preclinical Data for CT-P72/ABP-102 at SITC 2025, Highlighting a Next-Generation HER2×CD3 T-Cell Engager (GlobeNewswire) - "CT-P72/ABP-102 demonstrates potent and selective anti-tumor activity in HER2-high models, including Enhertu-resistant tumors. Dual-affinity engineering reduces on-target, off-tumor activity and supports a favorable preclinical safety profile. Data supports advancement toward clinical development in HER2-positive cancers."

Preclinical • Solid Tumor

ABP-102/CT-P72: a novel HER2 x CD3 T cell engager with selective activity for HER2-overexpressing tumors and reduced activity on cells with normal HER2 expression levels (AACR 2025) - "Bispecific antibody T cell engagers (TCEs) have unrealized potential as novel treatments for solid tumors, with notable past successes in hematological malignancies and the encouraging recent FDA approval of tarlatamab for a solid tumor indication...In the HER2-overexpressing models, ABP-102/CT-P72 displayed up to a two-fold increased tumor growth inhibition compared to a biosimilar of runimotamab, a HER2 x CD3 TCE...are co-developing ABP-102, which CELLTRION, INC. has designated under the project code name CT-P72."

Biomarker • Gastric Cancer • Hematological Malignancies • Oncology • Solid Tumor • HER-2

ABIPRO Presents First Preclinical Data on Dual Immunotherapy at AACR [Google translation] (BioTimes) - "ABPRO Holdings, the US affiliate of ABPRO Bio, announced on the 25th that it will participate in the American Association for Cancer Research (AACR, Annual Meeting 2025) to be held in Chicago, Illinois, USA from the 25th and disclose the preclinical data of 'AB-102/CT-P72' for the first time....'AB-102/CT-P72' is indicated for refractory HER2-positive breast cancer and gastric cancer. The company expects that 'AB-102/CT-P72' can be an alternative to existing treatments because it has superior safety compared to existing HER2-targeting dual antibodies in terms of tumor selectivity, tumor growth inhibition, cytokine secretion reduction, and drug tolerability."

Preclinical • Gastric Cancer • HER2 Positive Breast Cancer

Abpro and Celltrion Unveil Preclinical Data for ABP-102/CT-P72 at AACR 2025, Showcasing Potential Best-in-Class HER2 x CD3 T-Cell Engager (GlobeNewswire) - "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....planned to start in the first half of 2026."

New trial • Preclinical • Breast Cancer • Colorectal Cancer • Gastric Cancer • Pancreatic Cancer • HER-2

Abpro Announces Oral Presentation of First Preclinical Data for ABP-102/CT-P72, a Tetravalent Bispecific HER2 x CD3 T-Cell Engager, at AACR Annual Meeting 2025 (GlobeNewswire) - "Abpro Holdings...announced an oral presentation of preclinical data for ABP-102/CT-P72 at the American Association for Cancer Research Annual Meeting 2025 ('AACR 2025') in the New Drugs on the Horizon session."

Preclinical • Oncology

Abpro Finalizes Strategic Partnership with Celltrion for Worldwide Development and Commercialization of a Cancer Treatment Bispecific Antibody (Businesswire) - "Abpro...announced a strategic partnership with Celltrion, a biopharmaceutical company headquartered in Incheon, South Korea, today, for its cancer molecule ABP 102, an antibody therapy for patients suffering from HER2+ cancer, including breast, gastric, and pancreatic cancer. Through this global partnership, Abpro will receive payments from Celltrion of up to $1.75 Billion, including an equity investment, development and commercial milestone payments and worldwide profit sharing. Celltrion will be in charge of the development of ABP 102 following the completion of in vitro studies by Abpro and will have world-wide commercialization rights."

Licensing / partnership • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor