Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1354 |
| INN | Uliledlimab |
| Status | Clinical |
| Drug code(s) | TJ004309, TJ4309, TJD5 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | CD73 |
| Indications of clinical studies | Non-small cell lung cancer, Ovarian cancer, Solid tumors |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Phase 2/3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | December 15, 2018 |
| Start of Phase 2 | November 02, 2021 |
| Start of Phase 3 | March 27, 2024 |
| 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 | TRACON Pharmaceuticals |
| Licensee/Partner | I-Mab Biopharma |
| Comments about company or candidate | Sep 25, 2024: Sanofi licensed rights in China. https://endpts.com/sanofi-inks-deal-with-i-mab-wave-discloses-175m-offering-on-heels-of-dmd-data/ CTR20240650 is a A phase II/III, randomized, multicenter, open-label study comparing ulelimab plus toripalimab, toripalimab alone, and pembrolizumab alone in patients with previously untreated locally advanced, unresectable or metastatic PD-L1 and CD73-selective non-small cell lung cancer started in Mar 2024. As of Aug 2023, I-Mab plans a registrational trial start in 2023 NCT05001347 Phase 2 study started in Nov 2021. May 13, 2020: I-Mab announced that the first patient has been dosed in a Phase 1/2 clinical study in China to evaluate I-Mab's proprietary CD73 antibody TJD5, also known as TJ004309, in patients with advanced solid tumors (CTR20200445; NCT04322006). NCT04322006 Phase 1/2 study not yet recruiting when first posted on March 26, 2020. Jan 2020: I-Mab announced that it has obtained the IND approval from the Chinese NMPA and plans to begin a clinical trial to evaluate the safety, tolerability, PK/PD, and potential efficacy of TJD5 primarily in patients with solid tumors, including lung cancer. NCT03835949 Phase 1 study started recruiting April 12, 2019. Jan. 22, 2019: I-Mab Biopharma announced that the Investigational New Drug (IND) application for the initiation of a Phase 1 clinical study for TJD5 in patients with advanced solid tumour has cleared the required 30 day review by the U.S. Food and Drug Administration (FDA). Dec. 26, 2018: TRACON Pharmaceuticals, a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, today announced that TRACON has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration for the initiation of a Phase 1 clinical study of TJ4309 in patients with advanced solid tumors. TJ4309, also known as TJD5, is a CD73 antibody from I-Mab’s proprietary discovery pipeline that is being co-developed through an agreement between TRACON and I-Mab that was signed on November 28, 2018. The agreement between the two companies is part of a broad strategic partnership to develop multiple immuno-oncology programs with first-in-class and best-in-class potential from I-Mab’s immuno-oncology portfolio, including several proprietary bispecific antibodies under development by I-Mab. |
| Full address of company | California, United States North America United States of America https://traconpharma.com/ |
Immune checkpoint target. TJ4309, also known as TJD5, is a novel, humanized antibody against CD73, highly expressed on various cancer cells that converts extracellular adenosine monophosphate (AMP) to adenosine, leading to the formation of immunosuppressive tumor microenvironment. TJD5 is expected to start a phase I clinical trial in the US in early 2019 to assess the tolerability and preliminary efficacy as a single agent and in combination with a PD-1/PD-L1 checkpoint inhibitor in patients with advanced solid tumors. The antibody is also expected to be studied in clinical trials in China sponsored by I-Mab. Produced in a Chinese hamster ovary (CHO)-K1 cell line, non-glycosylated
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |