Humanized CLDN18.2 antibodies
Inventors
Bammert, Lukas • Sadilkova, Lenka Kyrych • Waldmeier, Lorenz • Beerli, Roger • Moebius, Ulrich
Assignees
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Publication Number
US-12624100-B2
Publication Date
2026-05-12
Expiration Date
Abstract
The invention provides humanized antibodies binding to CLDN18.2 with a high affinity. Further, the antibodies do not exhibit cross-reactivity to CLDN18.1. The invention also provides nucleic acids, vectors, host cells and medical uses.
Core Innovation
The patent describes humanized antibodies or fragments thereof that bind claudin 18.2 (CLDN18.2). The antibodies are defined by specified HCDR1, HCDR2, HCDR3, LCDR1, LCDR2, and LCDR3 sequences using enumerated SEQ ID NO combinations, and the disclosure includes multiple specified HCDR/LCDR sequence sets that provide CLDN18.2 binding.
The patent positions the disclosed antibodies as CLDN18.2-selective, including embodiments that show no cross-reactivity to claudin 18.1 (CLDN18.1). Functional binding validation is supported by binding-performance measurements using EC50 and maxMFI values from flow cytometry titration assays on CLDN18.2-expressing cells, with titration results compared to chimeric IMAB362 (Zolbetuximab).
Beyond the HCDR/LCDR definitions, the disclosure includes additional antibody sequence embodiments, including further VH/VL and full heavy/light chain sequence embodiments, and multiple antibody formats. The patent also provides nucleic acids encoding the antibodies, vectors and host cells for expression, and therapeutic and medical uses related to CLDN18.2-overexpressing neoplastic diseases.
Claims Coverage
The partial claim set provided includes one independent claim directed to a CLDN18.2-binding antibody defined by enumerated HCDR/LCDR sequence sets, plus dependent refinements that specify additional sequence and performance constraints and therapeutic method uses. The independent claim’s inventive features are defined around specific HCDR/LCDR sequence combinations (SEQ ID NO sets).
Claudin 18.2 binding antibody defined by enumerated HCDR/LCDR sequence sets
An antibody or fragment thereof binding to claudin 18.2 (CLDN18.2), which comprises specified HCDR1, HCDR2 and HCDR3 sequences together with LCDR1, LCDR2 and LCDR3 sequences as enumerated in the claim (SEQ ID NO combinations a through i).
Across the provided dependent material, the coverage extends from the enumerated HCDR/LCDR-defined CLDN18.2-binding antibody into additional constraints describing reference-based binding-performance metrics (EC50 and/or maxMFI by flow cytometry titration), and into therapeutic method use by administering the recited antibody or fragment to subjects with CLDN18.2-overexpressing neoplastic diseases.
Stated Advantages
Shows higher binding performance than IMAB362 (Zolbetuximab), supported by EC50 and maxMFI results from flow cytometry titration.
Is CLDN18.2-selective, including embodiments described as having no cross-reactivity to CLDN18.1.
Documented Applications
Therapeutic method for treating a subject with a neoplastic disease that overexpresses claudin 18.2 (CLDN18.2) by administering the antibody or its fragment.
The therapeutic indication further includes pancreatic, gastric, esophageal, ovarian, and lung cancer as CLDN18.2-overexpressing neoplastic diseases.
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