Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 206 |
| INN | Lemzoparlimab |
| Status | Clinical |
| Drug code(s) | ABBV-IMAB-TJC4, TJ011133, TJ133, TJC4 |
| Brand name | None |
| mAb sequence source | mAb human |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG4 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | CD47 |
| Indications of clinical studies | Myelodysplastic syndrome, Acute Myeloid Leukemia, Solid tumors or lymphomas |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | December 28, 2018 |
| Start of Phase 2 | January 15, 2022 |
| Start of Phase 3 | March 30, 2023 |
| 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 | Tianjing Biopharma |
| Licensee/Partner | None |
| Comments about company or candidate | NCT05709093 / CTR20230090 Phase 3 study recruiting as of last update in Apr 2024 April 2024: The agreement to divest assets and business operations in China was completed on April 2, 2024. The Company transferred 100% of the outstanding equity interest in I-Mab Biopharma Co., Ltd ("I-Mab Shanghai") to I-Mab Biopharma (Hangzhou) Co., Ltd (now known as "Tianjing Biopharma" or "TJ Biopharma"), on a cash-free and debt-free basis, for an aggregate consideration of the RMB equivalent of up to $80 million, contingent on TJ Biopharma's achievement of certain future regulatory and sales-based milestone events. Sep 2023: I-Mab received a notice on September 21, 2023, from AbbVie Global Enterprises Ltd (“AbbVie”), terminating the license and collaboration agreement between the parties dated September 3, 2020, and subsequently amended on August 15, 2022, relating to certain CD47 antibody compounds and products. The termination of the Collaboration Agreement in its entirety by AbbVie is based on the previous program discontinuation and AbbVie’s strategic decision. The termination will take effect on November 20, 2023. As a result, the Company will regain the full global rights to develop and commercialize certain CD47 compounds and products under the Collaboration Agreement, including lemzoparlimab. Apr 2023: I-Mab announced that the first patient in a Phase 3 registrational trial (ClinicalTrials.gov Identifier: NCT05709093) in China for patients with higher-risk myelodysplastic syndrome (MDS) has been treated with lemzoparlimab, a novel CD47 antibody, in combination with azacitidine. In September 2022, the Company obtained approval from the Center for Drug Evaluation (CDE) to initiate a Phase 3 registrational trial evaluating lemzoparlimab in combination with azacitidine as a first-line treatment for patients with newly diagnosed HR-MDS. This is the first approved Phase 3 trial for anti-CD47 therapies in China. AbbVie discontinued the global Phase 1b study of lemzoparlimab combination therapy with AZA and venetoclax in patients with MDS and acute myeloid leukemia (AML), and a Phase 1b study of lemzoparlimab in patients with relapsed/refractory multiple myeloma. This discontinuation was not related to any specific or unexpected safety concerns. Sept, 13, 2022-- I-Mab announced that it has successfully completed an End-of-Phase 2 (EoP2) meeting with the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA), and has obtained approval from the CDE to initiate a Phase 3 registrational trial evaluating lemzoparlimab, a novel CD47 antibody, in combination with azacitidine (AZA) for the first-line treatment of patients with newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS) Jan 18, 2022: I-Mab a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, announced that the first patient has been dosed in its China phase 2 trial of lemzoparlimab in combination with the PD-1 antibody toripalimab (TUOYI®) in patients with advanced solid tumors. Sept. 4, 2020: AbbVie and I-Mab announced today that AbbVie and I-Mab have signed a broad, global collaboration agreement for the development and commercialization of lemzoparlimab (also known as TJC4), an innovative anti-CD47 monoclonal antibody internally discovered and developed by I-Mab for the treatment of multiple cancers. In addition, the two partners have the potential to expand the collaboration to additional transformative therapies. NCT04202003 Phase 1/2 in AML recruiting as of March 2020. NCT03934814 Phase 1 study recruiting as of May 19, 2019. Jan. 28, 2019: I-Mab Biopharma ("I-Mab"), a China-based clinical stage biopharmaceutical company exclusively focused on the development of innovative biologics in immuno-oncology and autoimmune diseases, announces on Jan. 25, 2019 that its IND application for TJC4, has been approved by the US Food & Drug Administration (FDA). TJC4 is a fully human anti-CD47 monoclonal antibody that I-Mab discovered and developed internally for cancer immunotherapy. This IND enables I-Mab to initiate phase 1/1b clinical trials to assess safety, tolerability, and efficacy of TJC4 in patients with solid tumors and lymphoma as monotherapy and combination therapies. I-Mab expects to initiate the study in several clinical sites across United States in Q2 2019. |
| Full address of company | 2440 Research Blvd,, Suite 400, Rockville, MD 20850 USA North America United States of America https://www.i-mabbiopharma.com/contact/ |
Immune checkpoint target. TJC4 is a fully human anti-CD47 monoclonal antibody
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |