ABN501 / Abion - LARVOL DELTA

Proteomic Profiling Identifies CLDN3 as a Tumor-Selective Therapeutic Target in Small Cell Lung Cancer. (PubMed, bioRxiv) - "Functional validation using a novel CLDN3-specific monoclonal antibody (ABN501) demonstrated NK cell-mediated cytotoxicity in vitro and tumor regression in vivo , as well as a favorable safety profile. These findings support clinical development of CLDN3-directed therapies and demonstrate the utility of integrated proteogenomic approaches for antigen discovery in solid tumors."

Journal • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • CLDN3 • DLL3

Evaluation of BsABN501: A novel T cell engager targeting CLDN3-positive solid tumors (AACR 2025) - "Previously, ABN501 was developed as a fully human monoclonal antibody targeting CLDN3, demonstrating strong anti-tumor activity and a favorable safety profile...In summary, BsABN501 represents a novel and promising therapeutic strategy for the treatment of CLDN3-positivie solid tumors by effectively recruiting and activating T cells to enhance TDCC. Moving forward, we aim to optimize the CD3 sequence and format of BsABN501 to further improve its anti-cancer efficacy and safety, paving the way for its development as a targeted immunotherapeutic for CLDN3-expressing malignancies."

Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • CLDN3

ABN501: A CLDN3-targeted monoclonal antibody with proven safety, pharmacokinetics, and synergistic anti-tumor efficacy (AACR 2025) - "Its excellent safety profile and synergistic effects in combination with chemotherapy present a promising strategy for improving treatment outcomes, particularly in cancers with limited targeted treatment options. These findings pave the way for further clinical investigation, particularly in lung cancer and other CLDN3-expressing malignancies."

Clinical • PK/PD data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • CLDN3

α-ABN501, a novel antibody targeting claudin-3, demonstrates the potential to be a new therapeutic option for small cell lung cancer (AACR 2024) - "Present study data sets suggest that the α-ABN501 can be a potential new therapeutic option for SCLC. In addition, the α-ABN501 antibody is currently under way of development into new drug platforms for further applications."

Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • CD276 • CLDN3 • DLL3 • FCGR3A

ABION Bio Licenses Solid Tumor Drug Candidate to U.S. Company in $1.315 Bil. Deal (Business Korea) - "ABION Bio announced on June 24 that it had signed a global co-development and license agreement for ABN501 on June 22. The contract is valued at approximately 1.8 trillion won ($1.315 billion). The upfront payment is $5 million (about 68 billion won) per target antibody, with a potential to receive up to $25 million (about 342 billion won)...Under this agreement, ABION Bio will conduct preclinical research on antibodies targeting CLDN3 and four other protein targets, while the contract partner will perform other research, development, and commercialization activities."

Commercial • Small Cell Lung Cancer • Solid Tumor

ABION signs term sheet for potential $800 mil. antibody licensing deal (Korea Biomedical Review) - "Korean biotech ABION said on Monday it has signed a term sheet with an undisclosed antibody-drug conjugate (ADC) developer based in Boston to license out a set of monoclonal and bispecific antibody candidates, including its experimental cancer therapy ABN501....ABION said that if a definitive licensing agreement is reached, the total value of the deal is expected to exceed $800 million....No further details were disclosed, including potential upfront payments, milestones, royalties, or the partner’s identity."

Commercial • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer

Abion unveils phase 2 cut-off results for vabametkib and combination strategy with lazertinib at ASCO 2024 (Korea Biomedical Review) - "In addition to vabametkib, Abion presented the clinical design for a combination therapy involving vabametkib and Johnson & Johnson’s lazertinib, a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI). The first patient enrollment is anticipated in the fourth quarter of this year....Abion also introduced ABN501, the only existing Claudin-3 protein antibody, currently in the preclinical stage and under a joint research partnership with the National Cancer Institute (NCI)...An investigational new drug (IND) application for ABN501 is planned for submission in the second half of next year. In addition, Abion showcased its novel antibody-cytokine fusion protein (ACFP) platform technology, ABN 202."

IND • New trial • Preclinical • Oncology • Solid Tumor

Abion, antibody treatment drug 'ABN501' selected for KDDF project [Google translation] (Health in News) - "Abion (CEO Shin Young-ki) announced on the 11th that its anti-cancer pipeline 'ABN501' was selected as a candidate material derivation task for 'New Drug R&D Ecosystem Construction Research' by the National New Drug Development Agency...Abion will receive a total of 900 million won (based on government subsidies) in R&D expenses for the next two years for the research project."

Financing • Breast Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

ABN501, a novel anti-claudin-3 antibody, shows potent anti-cancer activity in vitro and in vivo (AACR 2023) - "In summary, we suggest that ABN501 can be used as promising tissue-agnostic drug candidates as therapeutics for various types of claudin-3-positive cancers. ABN501 is currently developed with various antibody engineering platforms."

Preclinical • Oncology • Solid Tumor • CLDN3 • CLDN4 • FCGR3A

K-Bio, a large number of AACR launches… active search for new drug candidates [Google translation] (Medical Observer) - "In addition, at this AACR, Abion will also announce the non-clinical results of ABN501....AbClon will present some of the non-clinical and phase 1 clinical results for 'AT101', a candidate for chimeric antigen receptor (CAR)-T treatment under development....The presentation will include clinical research results of AT101 and differences from existing CAR-T treatments. AbClon plans to diversify the target indications for phase 1 clinical trials of AT101 from large B-cell lymphoma (DLBCL) to follicular lymphoma (FL), mantle cell lymphoma (MCL), and marginal paranoid cell lymphoma (MZL)."

P1 data • Preclinical • Trial status • Breast Cancer • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Gynecologic Cancers • Hematological Malignancies • Lung Cancer • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Ovarian Cancer • Solid Tumor

Abion presents 5 research results at AACR in the US [Google translation] (Hankyung) - "ABN501 is a new antibody drug that targets claudin 3, which is expressed in various solid cancers such as breast cancer, lung cancer and ovarian cancer. Confirm the efficacy in a mouse model transplanted with patient-derived cancer cells, and disclose the research results....In addition, Abion plans to disclose the results of research on applying EGFR and TROP2 antibodies to platform technology that enhances anticancer effects by combining antibodies with next-generation interferon beta."

Preclinical • Breast Cancer • Gynecologic Cancers • Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor