Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 2323 |
| INN | Farletuzumab |
| Status | Terminated |
| Drug code(s) | MORAb-003 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| 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 | None |
| Target(s) | FR alpha |
| Indications of clinical studies | Ovarian Cancer; Fallopian Tube Cancer, Peritoneal Neoplasms, Pituitary Adenoma, Lung 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) | February 15, 2005 |
| Start of Phase 2 | May 15, 2006 |
| Start of Phase 3 | September 15, 2008 |
| 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 | Eisai Co. Ltd |
| Licensee/Partner | Eurofarma Laboratórios S.A. |
| Comments about company or candidate | March 2021: Eisai will present abstract on Farletuzumab at the virtual Society of Gynecologic Oncology (SGO) 2021 Annual Meeting on Women's Cancer, March 19-25 (#SGOMtg). Data to be presented in the Focused Plenary V: Ovary – Time to Return to the Drawing Board session include an abstract (Plenary Session ID # 10240) on results from a randomized, double-blind, placebo-controlled, Phase 2 study evaluating the efficacy and safety of farletuzumab in combination with carboplatin plus paclitaxel or carboplatin plus pegylated liposomal doxorubicin in women with low CA125 platinum-sensitive ovarian cancer (NCT02289950), which was completed in Aug 2020. Dec 2020: No onoing studies, not listed in Eisai pipeline dated Nov 5, 2020. Aug 2019: No development reported, but still listed as Phase 2 in Eisai Co., Ltd. pipeline dated July 31, 2019. NCT02289950 Phase 2 study in ovarian cancer started in March 2015 active not recruiting as of Aug 2019; all other studies are complete or terminated. October 3, 2016 -- Morphotek®, Inc., a subsidiary of Eisai Inc., announced today that it signed an exclusive licensing agreement with Eurofarma Laboratórios S.A. (Eurofarma) to develop and commercialize farletuzumab (MORAb-003) in Latin America. November 17, 2015 I Morphotek®, Inc., a subsidiary of Eisai Inc., announced today that it entered into an agreement with the Targeted Alpha Therapy Group (TAT Group) at the University of Gothenburg in Sweden to collaborate on the research and development of farletuzumab as an alpha therapy vector being studied for radioimmunotherapy in ovarian cancer. NCT02289950 Phase 2 study in Combination With Carboplatin Plus Paclitaxel or Carboplatin Plus Pegylated Liposomal Doxorubicin (PLD) in Subjects With Low CA125 Platinum-Sensitive Ovarian Cancer started in March 2015. In Phase 3 as of March 2009; failed to meet endpoint in NCT00849667 Phase 3 study in Combination With Carboplatin and Taxane in Subjects With Platinum-sensitive Ovarian Cancer in First Relapse started in 2009. All subjects received carboplatin plus paclitaxel or docetaxel (for six cycles combined with randomized test product 1:1:1 farletuzumab 1.25 mg/kg, farletuzumab 2.5 mg/kg, or placebo), and single-agent test product was continued weekly until disease progression. Neither farletuzumab dose met the study's primary progression-free survival (PFS) endpoint when compared to placebo, with PFS of 9.0, 9.5 (hazard ratio [HR] = 0.99) and 9.7 months (HR = 0.86) for the placebo, farletuzumab 1.25 mg/kg, and farletuzumab 2.5 mg/kg arms, respectively. |
| Full address of company | 4-6-10 Koishikawa, Bunkyo-ku, Tokyo 112-8088, Japan Asia Japan https://www.eisai.com/news/news200712.html |
A therapeutic humanized monoclonal antibody with high affinity for FRalpha, named MORAb-003, which was derived from the optimization of the LK26 antibody using a whole cell genetic evolution platform. Here we show that MORAb-003 possesses novel, growth-inhibitory functions on cells overexpressing FRalpha. In addition, MORAb-003 elicited robust antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) in vitro, and inhibited growth of human ovarian tumor xenografts in nude mice. Because of its multimodal activity in vitro and its safe toxicology profile in non-human primates, MORAb-003 development has recently been advanced to clinical trials involving ovarian cancer patients. https://pubmed.ncbi.nlm.nih.gov/17346028/
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |