Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 627 |
| INN | Pamrevlumab |
| Status | Terminated |
| Drug code(s) | FG-3019 |
| 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 | Transgenic mouse (GenPharm/Medarex/BMS transgenic mouse platform) |
| Target(s) | Connective tissue growth factor |
| Indications of clinical studies | Pancreatic cancer, Duchenne muscular dystrophy, Idiopathic Pulmonary Fibrosis, Pancreatic Cancer, Liver Fibrosis Due to Chronic Hepatitis B Infection, Diabetes Mellitus; Diabetic Nephropathy, focal segmental glomerulosclerosis |
| 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) | December 15, 2003 |
| Start of Phase 2 | February 15, 2009 |
| Start of Phase 3 | May 10, 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 | FibroGen |
| Licensee/Partner | Bristol Myers Squibb |
| Comments about company or candidate | July 2024: Pamrevlumab arm of the Precision PromiseSM study in metastatic pancreatic cancer, sponsored and conducted by the Pancreatic Cancer Action Network (PanCAN), did not meet the primary endpoint of overall survival as determined by the protocol pre-specified Bayesian statistical analysis. Company will terminate pamrevlumab research and development (R&D) investment and expeditiously wind down remaining obligations. https://investor.fibrogen.com/news-releases/news-release-details/fibrogen-announces-topline-results-two-late-stage-pamrevlumab May 2024: Results from Phase 2/3 and Phase 3 studies in pancreatic cancer expected in 2024. https://fibrogen.gcs-web.com/news-releases/news-release-details/fibrogen-reports-first-quarter-2024-financial-results Aug 30, 2023: FibroGen, Inc. announced topline data from the Phase 3 LELANTOS-2 trial of pamrevlumab for the treatment of ambulatory patients with Duchenne muscular dystrophy (DMD) on background systemic corticosteroids. The study did not meet the primary or secondary endpoints. June 07, 2023: FibroGen, Inc. announced topline data from the Phase 3 LELANTOS-1 placebo-controlled trial of pamrevlumab for the treatment of non-ambulatory patients with Duchenne Muscular Dystrophy (DMD) on background corticosteroids. The study did not meet the primary endpoint of Performance of the Upper Limb 2.0 (PUL 2.0) score at week 52 compared to baseline. June 6, 2023 FibroGen Announces Positive Topline Results from China Pivotal Phase 3 Clinical Trial of Roxadustat for the Treatment of Chemotherapy Induced Anemia, Met primary endpoint of noninferiority of roxadustat to erythropoietin alfa https://fibrogen.gcs-web.com/news-releases/news-release-details/fibrogen-announces-positive-topline-results-china-pivotal-phase . May 2023: FibroGen is set to receive a non-dilutive term loan facility worth up to $150m from funds managed by Morgan Stanley Tactical Value (MSTV) to advance pamrevlumab towards commercialisation. Aug 2022 company presentation update: Phase 3 topline data expected mid-2023 to H1 2024. April 2021: FibroGen, Inc announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the company’s anti-CTGF antibody, pamrevlumab, for the treatment of patients with Duchenne muscular dystrophy (DMD). August 11, 2020 I FibroGen, Inc. announced the initiation of LELANTOS, a Phase 3, randomized, double-blind, placebo-controlled trial of pamrevlumab or placebo in combination with systemic corticosteroids in patients with non-ambulatory Duchenne muscular dystrophy October 23, 2019 I FibroGen, Inc. announced the dosing of the first patient in the LAPIS Phase 3 clinical study of pamrevlumab in patients with unresectable locally advanced pancreatic cancer (LAPC). July 22, 2019: FibroGen announced dosing of the first patient in the ZEPHYRUS Phase III clinical study of pamrevlumab in patients with idiopathic pulmonary fibrosis NCT03941093 Phase 3 study in pancreatic cancer started recruiting in May 2019; NCT03955146 in IPF not yet recruiting as of June 10 2019. April 2019: FibroGen Receives Orphan Drug Designation from the U.S. FDA For Pamrevlumab for the Treatment of Duchenne Muscular Dystrophy. Sep 2018: FibroGen's pamrevlumab, being developed to treat patients with idiopathic pulmonary fibrosis, was granted fast-track designation by the FDA. NCT02606136 Phase 2 in Duchenne Muscular Dystrophy is the only study recruiting patients as of April 2018. March 2018: FibroGen announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the company’s anti-CTGF antibody, pamrevlumab, for the treatment of patients with locally advanced unresectable pancreatic cancer. June 21, 2017: FibroGen, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation status to pamrevlumab, the company’s first-in-class antibody, for the treatment of pancreatic cancer. Jan 2017: updated results from an ongoing clinical study of pamrevlumab (FG-3019) in combination with standard-of-care chemotherapy in patients with locally advanced pancreatic ductal adenocarcinoma (PDAC) were presented in a poster session during the ASCO 2017 Gastrointestinal Cancers Symposium in San Francisco. Ophan drug designation for idiopathic pulmonary fibrosis July 2012; Partnered with BMS; NCT01890265 Phase 2 study recruiting as of Feb 2014 |
| Full address of company | San Francisco, California, United States North America United States of America https://investor.fibrogen.com/ |
None
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |