BCG car constructs and methods of their manufacture and use
Inventors
Assignees
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Publication Number
US-12522651-B2
Publication Date
2026-01-13
Expiration Date
Abstract
Provided herein are antibodies and antigen binding fragments thereof specific to BCG antigen Ag85B as well as chimeric antigen receptors and lymphocytes comprising Ag85B antibodies as described and methods of treating cancer and tuberculosis infections using the CAR lymphocytes described. In a first aspect, provided herein is an isolated antibody or antigen binding fragment thereof capable of binding Bacillus Calmette-Guerin (BCG) antigen Ag85B.
Core Innovation
The invention relates to an isolated antibody or antigen binding fragment capable of binding Bacillus Calmette-Guerin (BCG) antigen Ag85B. The antibody or antigen binding fragment is defined by specific light chain variable domains and heavy chain variable domains, each comprising CDR regions identified by SEQ ID NOs.
The invention further provides chimeric antigen receptors incorporating the Ag85B-binding antibody or antigen binding fragment. The CAR comprises a transmembrane domain and an intracellular signaling domain selected from defined signaling domains, including CD3zeta and costimulatory options such as CD28, 4-1BB (4-IBB), CD134, CD278, OX40, ICOS, DAP-10, and inhibitory domains such as PD-1 and LAG-3, as well as 2B4, BTLA, and CTLA-4, and combinations thereof.
The invention also addresses therapeutic use involving administering CAR lymphocytes and BCG/Ag85B. The disclosed therapeutic context includes treatment of cancer and tuberculosis by administering lymphocytes that comprise the CAR and a BCG antigen Ag85B composition, with a timing constraint in which the BCG antigen Ag85B composition is administered no more than 48 hours after administering the lymphocyte composition.
Claims Coverage
The partial content explicitly provides one independent claim defining an isolated Ag85B-binding antibody/antigen-binding fragment and identifies dependent claims that refine the antibody format and expand coverage to CAR constructs and use timing. Overall, the inventive claim coverage spans three inventive features.
Ag85b-binding isolated antibody or antigen-binding fragment defined by light and heavy chain CDR regions
An isolated antibody or antigen binding fragment capable of binding Bacillus Calmette-Guerin (BCG) antigen Ag85B comprising a light chain variable domain selected from specific CDRL1, CDRL2, and CDRL3 specifications and a heavy chain variable domain selected from specific CDRH1, CDRH2, and CDRH3 specifications.
Chimeric antigen receptor with transmembrane and intracellular signaling domains
A chimeric antigen receptor comprising the antibody or antigen binding fragment and a transmembrane domain and an intracellular signaling domain.
Temporal dosing constraint between lymphocyte composition and BCG antigen Ag85B composition
The BCG antigen Ag85B composition is administered to the subject no more than 48 hours after administering the lymphocyte composition.
Across the provided claim set, coverage begins with Ag85B-specific isolated antibodies/antigen-binding fragments defined by light and heavy chain CDR regions, extends to CAR constructs that include these binding domains with a transmembrane domain and defined intracellular signaling domains, and includes a therapeutic use concept incorporating an explicit timing constraint.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Treating cancer by administering CAR lymphocytes and BCG/Ag85B, with example mention of bladder cancer, lung cancer, and melanoma.
Treating tuberculosis by administering CAR lymphocytes and BCG/Ag85B.
A ReACT therapy context describing improved remission/survival and reporting detection and effector phenotypes of BCG-CAR T cells in a mouse bladder cancer model.
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