Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 886 |
| INN | Lenzilumab |
| Status | No development reported |
| Drug code(s) | KB003 |
| 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 | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Humaneered™ technology |
| Target(s) | GM-CSF |
| Indications of clinical studies | Chronic Myelomonocytic Leukaemia, COVID-19, CAR-T-related neurotoxicity, Leukemia, Rheumatoid Arthritis, Asthma |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Phase 2/3 |
| Status | No development reported |
| Start of clinical phase (IND filing or first Phase 1) | December 15, 2007 |
| Start of Phase 2 | October 15, 2009 |
| Start of Phase 3 | April 30, 2020 |
| 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 | Taran Therapeutics |
| Licensee/Partner | None |
| Comments about company or candidate | Sep 2024: Humanigen sold off its biopharma business to Taran Therapeutics, including lenzilumab, ifabotuzumab and HGEN005, for $20 million. Humanigen, Inc. has been acquired by Taran Therapeutics, Inc. Humanigen, a clinical-stage biopharmaceutical company focused on preventing and treating certain inflammatory and oncological conditions filed chapter 11 on January 3, 2024, in the United States Bankruptcy Court for the District of Delaware. https://www.schgroup.com/press-release/scamph-capital-advises-humanigen-in-sale-to-taran-therapeutics/ Company refers to PREACH-M study as Phase 2/3 (https://www.humanigen.com/_files/ugd/daef6a_fa2075b14b0d4cb9a5405cf8705013d0.pdf) ACTRN12621000223831 PREACH-M study is a phase II Trial Studying the Efficacy of Lenzilumab and High Dose Ascorbate with Azacitidine Based on Molecular Profiling of participants with Chronic Myelomonocytic Leukaemia. 2022 H1 update: The company has strategically realigned its pipeline and resources with plans to accelerate the development of lenzilumab in CMML, for which the Phase 2 “PREcision Approach to Chronic Myelomonocytic Leukemia,” or “PREACH-M” study (ACTRN12621000223831), is already underway and to continue the “Risk Adapted Therapy in Acute GvHD,” or “ RATinG” study, in patients undergoing bone marrow transplant, that is expected to enroll its first patient in the third quarter of 2022. These studies are majority funded by the company’s partners. Under the realignment plan, the company will deemphasize the deployment of certain resources for the development of lenzilumab for COVID-19. July 2022: Humanigen reported initial topline results showing that its lenzilumab in combination with remdesivir failed to achieve statistical significance on the primary endpoint of the National Institute of Allergy and Infectious Diseases’ ACTIV-5/BET-B clinical trial in hospitalised Covid-19 patients. EUA for COVID-19 requested in May 2021. Sep 9, 2021: U.S. FDA has declined its request for emergency use authorization of lenzilumab to treat newly hospitalized COVID-19 patients. In its letter, FDA stated that it was unable to conclude that the known and potential benefits of lenzilumab outweigh the known and potential risks of its use as a treatment for COVID-19. NCT04351152 Phase 3 study started in April 2020. April 15, 2020 – Humanigen, Inc., a clinical stage biopharmaceutical company focused on preventing and treating cytokine storm with lenzilumab, the company’s proprietary Humaneered® anti-human GM-CSF monoclonal antibody, announced that FDA has given permission to commence a Phase III study of lenzilumab in patients with COVID-19. March 20, 2020 – Humanigen, Inc., a clinical stage biopharmaceutical company focused on preventing and treating cytokine storm with lenzilumab, the company’s proprietary Humaneered® anti-human- granulocyte-macrophage colony stimulating factor(GM-CSF) monoclonal antibody, announced that the company is seeking to conduct a Phase III, randomized, controlled, clinical trial to rapidly advance the clinical development of lenzilumab for the prevention and treatment of cytokine storm which can lead to acute respiratory distress syndrome (ARDS) associated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in COVID-19. May 2019: Humanigen in collaboration with Kite plans a phase I/II trial for B-cell lymphoma (Second-line therapy or greater, refactory metastatic disease) in the fourth quarter of 2019 in USA. Feb 2018: Humanigen expects to start a phase Ib/II trial with lenzilumab for the prevention of CAR-T-related neurotoxicity in the second quarter of 2018. Lenzilumab is a specific, high-affinity and selective antagonist of circulating granulocyte-macrophage colony-stimulating factor (GM-CSF). August 7, 2017 – Humanigen, Inc. announced that its new name is effective. Phase 1 in CMML patients started end of July 2016. KaloBios in bankrupcy as of Nov 2015; emerged from bankrupcy in early July 2016. July 29, 2015 press release; Moffitt Cancer Center in Florida and the University of California, Davis (UC Davis) have suspended the planned clinical trial of KaloBios Pharmaceuticals Inc.’s KB003 following arrest of CEO on securities fraud charges. The FDA has cleared the company's IND application for KB003, an anti-GM-CSF monoclonal antibody (mAb), in patients with chronic myelomonocytic leukemia (CMML), and that the IND is now active. Did not meet primary endpoint in Phase 2 study of patients with severe asthma |
| Full address of company | New Jersey, United States North America United States of America https://ir.humanigen.com/English/overview/default.aspx |
None
| Anticipated events | Termination |
| Factor(s) contributing to discontinuation | None |