Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 927 |
| INN | None |
| Status | Clinical |
| Drug code(s) | LBL-024 |
| Brand name | None |
| mAb sequence source | mAb - source TBD |
| General Molecular Category | Bispecific |
| Format, general category | Appended Ig |
| Format details | scFv-IgG |
| Isotype (Fc) | TBD |
| Light chain isotype | TBD |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | PD-L1, 4-1BB |
| Indications of clinical studies | Solid tumors |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Phase 2 pivotal |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | June 30, 2021 |
| Start of Phase 2 | July 15, 2024 |
| Start of Phase 3 | |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | None |
| Date of first US approval | |
| INN, US product name | None |
| US or EU approved indications | None |
| Company | Nanjing Leads Biolabs Co. Ltd |
| Licensee/Partner | None |
| Comments about company or candidate | Nov 22, 2024: Nanjing Leads Biolabs Co., Ltd., announced that LBL-024, an anti-PD-L1/4-1BB bispecific antibody independently developed by the company with global intellectual property rights for the treatment of neuroendocrine cancer, has obtained Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA). Oct 2024: Breakthrough Therapy Designation granted to LBL-024 by the Center for Drug Evaluation of National Medical Products Administration in China. July 2024: LBL-024 has entered into a single-arm pivotal trial for extrapulmonary neuroendocrine carcinomas (NCT06157827) April 30, 2024: Nanjing Leads Biolabs Co., Ltd. announced that LBL-024, an anti-PD-L1/4-1BB bispecific antibody independently developed by Leads Biolabs with global intellectual property rights has received approval to conduct the single-arm pivotal study for registration and market authorization from the Center for Drug Evaluation (CDE) of the National Medical Products Administration. https://www.biospace.com/article/releases/a-potential-first-in-class-drug-cde-approved-single-arm-pivotal-clinical-study-of-lbl-024-an-anti-pd-l1-4-1bb-bispecific-antibody-developed-by-leads-biolabs/ NCT05170958 Phase 1/2 study started in Jan 2022 recruiting as of last update in Feb 2023 LBL-024 received IND approvals from both FDA and NMPA on July 30, 2021 and September 9, 2021 |
| Full address of company | 122 Huakang Rd,Bldg.05,jiangbei New Area,Nanjing,210031,P.R.C Asia China https://en.leadsbiolabs.com/contactus.html |
LBL-024 is a PD-L1/4-1BB double antibody, consisting of a high-affinity anti-PD-L1 monoclonal antibody and an anti-4-1BB single-chain antibody.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |