Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1356 |
| INN | Felzartamab |
| Status | Clinical |
| Drug code(s) | TJ202, MOR202, MOR03087 |
| Brand name | None |
| mAb sequence source | mAb human |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | lambda |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Phage display-derived (HuCAL library) |
| Target(s) | CD38 |
| Indications of clinical studies | Lupus nephritis, Immunoglobulin A (IgA) Nephropathy, Systemic lupus erythematosus, Anti-PLA2R Antibody Positive Membranous Nephropathy (newly diagnosed/relapsed/refractory), Multiple myeloma |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | July 15, 2011 |
| Start of Phase 2 | March 15, 2019 |
| Start of Phase 3 | March 27, 2019 |
| 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 | MorphoSys AG |
| Licensee/Partner | Biogen, I-Mab Biopharma |
| Comments about company or candidate | NCT06685757 Phase 3 in Antibody-mediated Rejection started in Dec 2024. Oct. 09, 2024 -- Biogen Inc. announced that felzartamab, an investigational anti-CD38 monoclonal antibody, has received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for the treatment of late antibody-mediated rejection (AMR) without T-cell mediated rejection in kidney transplant patients. Biogen plans Phase 3 study (https://investors.biogen.com/news-releases/news-release-details/biogen-bolsters-late-stage-pipeline-expands-immunology-portfolio) Listed as Phase 2 in Biogen pipeline; not listed at all in June 2024 I-Mab presentation (https://ir.i-mabbiopharma.com/static-files/449488f3-695e-4d50-b683-8b3dd5079494) May 2024: Novartis meets all tender offer conditions to acquire MorphoSys AG for EUR 68 per share in cash May 2024: Biogen acquires HiBio Nov 2023: I-Mab and HI-Bio have received breakthrough therapy designation from the US Food and Drug Administration (FDA) for the investigational CD38 antibody, felzartamab, to treat primary membranous nephropathy (PMN). June 2023: Listed as BLA in preparation (https://ir.i-mabbiopharma.com/system/files-encrypted/nasdaq_kms/assets/2023/07/13/2-20-15/Corporate%20Presentation_June%202023_Final_v2.pdf) May 25, 2023 – Human Immunology Biosciences (HI-Bio™), a clinical-stage biotechnology company developing targeted therapies for patients with severe immune-mediated diseases (IMDs), today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) for felzartamab May 2023: I-MAB has made significant progress on eftansomatropin alfa and felzartamab, leading to Phase 3 data readout expected in 2H 2023 and potential BLA submission in China by the end of 2023 or early 2024 for eftansomatropin alfa, and at a later time for felzartamab. July 2022: Described as 'pre-BLA' in I-Mab Biopharma corporate update. June 2022: MorphoSys AG and Human Immunology Biosciences, Inc. (HIBio) announced today that the companies entered into an equity participation agreement and license agreements to allow HIBio to develop and commercialize MorphoSys’ felzartamab, an anti-CD38 antibody, and MOR210, an anti-C5aR1 antibody. Under the terms of the agreements, HIBio will obtain exclusive rights to develop and commercialize felzartamab and MOR210 across all indications worldwide, with the exception of Greater China for felzartamab and Greater China and South Korea for MOR210. March 2022: The pipeline is expected to yield three near-term BLA filings and/or product launches between 2023 and 2025 in China, including felzartamab, eftansomatropin alfa, and potentially lemzoparlimab. In January, 2022, the Company signed a partnership agreement with the Hangzhou Qiantang Government in China to manufacture felzartamab locally to accelerate its commercialization. The local manufacturing plan is expected to significantly reduce the cost of goods and render felzartamab commercially more competitive. With the new local manufacturing plan integrated, the Company is making all efforts to submit the BLA package in 2022. Further, a commercialization team has been assembled to prepare for the launch readiness of felzartamab in China. June 2021: I-Mab is currently conducting two parallel registrational trials with felzartamab to aim for registration for the treatment of multiple myeloma in Greater China; early phase study in SLE to start. April 2020: Enrollment/screening of patients in the Phase 1/2 M-PLACE study with MOR202 in Glomerulonephritis is temporarily paused due to pandemic. NCT04145440 Phase 1/2 study in Anti-PLA2R Antibody Positive Membranous Nephropathy started in October 2019. NCT03952091 Phase 3 study started March 27, 2019. April 29, 2019 I 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, and MorphoSys AG, announced today that the first patient has been dosed in a phase 3 randomized and multi-center clinical study in Taiwan to evaluate MorphoSys's investigational human CD38 antibody TJ202/MOR202 in combination with lenalidomide in patients with relapsed or refractory multiple myeloma. I-Mab has the exclusive rights for development and commercialization of TJ202/MOR202 in mainland China, Taiwan, Hong Kong and Macao. March 19, 2019: I-Mab Biopharma (I-Mab), a China-based clinical stage biopharmaceutical company. MorphoSys AG today announced that the first patient dosing (FPD) has been achieved in a phase 2 multi-center clinical study in Taiwan to evaluate an investigational human CD38 antibody TJ202/MOR202 in patients with relapsed or refractory multiple myeloma. TJ202/MOR202 is an antibody developed by MorphoSys AG. NCT03860038 Phase 2 study in MM started recruiting in January 2019. Jan 2019: I-Mab plans to start a pivotal Chinese study of MOR202 in multiple myeloma in Q1 2019. MorphoSys plans to develop MOR202 in the US for an autoimmune indication with a Phase II study expected to initiate in Q3 2019. August 8, 2018: I-Mab Biopharma ("I-Mab"), a Shanghai-based biotech company focused on innovative biologics in oncology and autoimmune disease, and German biopharma company MorphoSys AG announced that I-Mab has Submitted an investigational new drug (IND) application to China National Drug Administration (CNDA) for TJ202/MOR202, a human monoclonal antibody directed against CD38 for the treatment of multiple myeloma. Nov 2017: I-Mab Biopharma acquired exclusive development and marketing rights to MorphoSys' MOR202, which is being developed for the treatment of multiple myeloma, in China, Macau, Hong Kong and Taiwan. NCT01421186 Phase 1/2 study started in July 2011 active not recruiting as of Aug 2018. MorphoSys and Celgene Corp. announced, on June 26 2013, an agreement to jointly develop MOR202 globally and to co-promote MOR202 in Europe; agreement ended in March 2015. |
| Full address of company | MorphoSys AG, Semmelweisstr. 7, 82152 Planegg, Germany Europe Germany https://www.morphosys.com/en/contact-us |
None
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |