Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1835 |
| INN | Ganitumab |
| Status | Terminated |
| Drug code(s) | AMG 479 |
| 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 | Phage display library derived |
| Target(s) | IGF-1R |
| Indications of clinical studies | Pancreatic Cancer, Non-Small Cell Lung Cancer, Colorectal Cancer, Askin's Tumors, Desmoplastic Small Round Cell Tumors, Extraosseous Ewing's Tumor, Ewing's Family Tumor, Ewing's Sarcoma; Breast Cancer |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Terminated at Phase 3 |
| Status | Inactive |
| Start of clinical phase (IND filing or first Phase 1) | July 02, 2005 |
| Start of Phase 2 | October 15, 2007 |
| Start of Phase 3 | April 15, 2011 |
| 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 | Amgen |
| Licensee/Partner | NantCell |
| Comments about company or candidate | No evidence of active commercial clinical development found as of Aug 2020, although non-commercial entities are sponsoring a Phase 1/2 and a Phase 2 study. Not listed in Amgen pipeline dated July 29, 2019. Aug 2018: Novartis terminates a phase I/II trial due to competitive landscape for anticancer therapies in ovarian and breast cancer and given the limited clinical activity observed with combination treatment for Solid tumours (Combination therapy, Late-stage disease) in USA, Belgium, Canada and Spain (IV) (NCT01708161); NCT02306161 still recruiting as of Aug 2018. April 2017: NantCell, Inc. announced that the FDA has granted Orphan Drug Designation to the company's Ganitumab, Insulin Growth Factor-1R (IGF-1R) monoclonal antibody therapy for the treatment of patients with Ewing sarcoma. Ganitumab is a fully human monoclonal antibody directed against IGF-1R that is being investigated in a Phase III human clinical trial titled Combination Chemotherapy with or without Ganitumab in Treating Patients with Newly Diagnosed Metastatic Ewing Sarcoma (NCT02306161) by the National Cancer Institute (NCI) in partnership with Children's Oncology Group (COG) and NantCell at clinical sites across the United States and Canada. Phase 3 NCT02306161 sponsored by NCI started in Dec 2014 recruiting patients as of May 2017. Terminated Phase 3 study NCT01231347 of Metastatic Adenocarcinoma of the Pancreas; Due to a pre planned interim analysis by the independent study DMC, it was recommended to stop the study for futility with no safety concerns. In June 2016, Takeda Pharmaceutical announced revisions on an existing collaboration agreement made in 2008, under which Takeda had rights to develop and commercialize multiple molecules / products from Amgen’s pipeline for the Japanese market. By the revisions, such rights for molecules / products including AMG403 and AMG386 will be returned to Amgen, effective immediately. In January 2015, NantCell, a subsidiary of NantWorks announced that it has entered into a licensing agreement with Amgen for AMG 479. NantCell acquired the exclusive rights to develop and commercialize worldwide, excluding Japan. Financial terms were not disclosed. |
| Full address of company | Thousand Oaks, California, United States North America United States of America https://www.amgen.com/ |
None
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |