Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 341 |
| INN | Ficlatuzumab |
| Status | Clinical |
| Drug code(s) | AV299, SCH900105 |
| 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) | HGF |
| Indications of clinical studies | Pancreatic cancer, Head and neck cancer, Acute Myeloid Leukemia, Non-Small Cell-Lung cancer, Solid Tumor; Lymphomas; 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 01, 2008 |
| Start of Phase 2 | December 15, 2014 |
| Start of Phase 3 | January 15, 2024 |
| 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 | LG Chem Ltd. |
| Licensee/Partner | Biodesix |
| Comments about company or candidate | NCT06064877 Phase 3 in head and neck cancer started in Jan 2024 recruiting as of last update Sep 2024. Oct 2022: LG Chem, Ltd. acquired AVEO Pharmaceuticals, Inc. Sep 2021: AVEO Oncology announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to ficlatuzumab for the treatment of patients with relapsed or recurrent head and neck squamous cell carcinoma. NCT02318368 Phase 2 study in NSCLC terminated (sponsor's decision) September 08, 2020 I AVEO Oncology announced that it has regained full global rights to ficlatuzumab, AVEO’s potent hepatocyte growth factor (HGF) inhibitory antibody which binds to the HGF ligand with high affinity and specificity to inhibit HGF/c-Met biological activities. AVEO also announced today that it plans to fund the clinical manufacture of ficlatuzumab to enable a potential registrational Phase 3 clinical trial in head and neck squamous cell cancer (HNSCC), as well as additional potential development in Phase 2 studies in pancreatic cancer and acute myeloid leukemia (AML). Following the decision, Biodesix, a leading diagnostic company, has exercised its contractual right to reduce its future financial obligations in exchange for reduced partnership economics. Under the terms of the agreement between AVEO and Biodesix, Biodesix will continue to fund 50% of the ongoing HNSCC Phase 2 trial, and will be entitled to a low double digit royalty on any future product sales as well as 25% of future licensing revenue, subject to certain limitations. March 27, 2020: AVEO Oncology and Biodesix announced the discontinuation of the CyFi-2 study, a randomized Phase II clinical study evaluating ficlatuzumab, AVEO’s potent hepatocyte growth factor (HGF) inhibitory antibody product candidate, in combination with high-dose cytarabine vs. high-dose cytarabine alone in patients with relapsed and refractory acute myeloid leukemia (AML). The decision is being taken due to the urgent shift among clinical sites toward efforts to combat the COVID-19 pandemic, which has impacted the feasibility of completing the study within the shelf-life of the current ficlatuzumab clinical trial supply. The study has not yet begun patient enrollment. Nov 7, 2019: start of Phase 2 study in AML announced. NCT04100330 Phase 2 study in Acute Myeloid Leukemia not yet recruiting as of Jan 31, 2020. In April 2019, AVEO announced the presentation of positive data from an investigator-sponsored Phase 1b expansion cohort of ficlatuzumab, AVEO’s potent hepatocyte growth factor (HGF) inhibitory antibody in combination with cytarabine in patients with relapsed and refractory acute myeloid leukemia (AML), at the American Association for Cancer Research (AACR) Annual Meeting, held March 29 - Apr 3, 2019 in Atlanta. Listed in AVEO pipeline accessed online Sep 2 2018; NCT03422536 Phase 2 study in head and neck cancers started in Dec 2017, but sponsored by NCI. NCT03316599 Phase 1 study in pancreatic cancer recruiting. Jun. 5, 2017-- AVEO Oncology and Biodesix, Inc., co-development partners, today announced the presentation of results from two investigator-sponsored Phase 1 studies of ficlatuzumab at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting taking place in Chicago, Illinois. The first is a study of ficlatuzumab in combination with the EGFR inhibitor cetuximab in patients with cetuximab-resistant, metastatic head and neck squamous cell carcinoma (HNSCC), and the second is a study of ficlatuzumab in combination with high-dose cytarabine in patients with high risk relapsed or refractory acute myeloid leukemia (AML). Also announced expected Initiation of an Investigator-Initiated, Randomized, Phase 2, Multicenter Trial of Ficlatuzumab and Cetuximab in HNSCC in 2H 2017. NCT02277197 Phase 1 study in combination with cetuximab recruiting as of April 2016. NCT01039948 Phase 1/2 active not recruiting and asset is still listed in AVEO pipeline as of Feb 2014; AVEO restructured (eliminating 140 positions) in June 2013. Collaboration with Schering-Plough started in April 2007; SP acquired by Merck in 2009. |
| Full address of company | LG Twin Towers,128, Yeoui-daero,, Yeongdeungpo-gu, Seoul, South Korea Asia Republic of Korea https://www.lgchem.com/company/company-information/about |
Hepatocyte growth factor (HGF) identical to scatter factor (SF) is a glycoprotein involved in the development of a number of cellular phenotypes, including proliferation, mitogenesis, formation of branching tubules and, in the case of tumour cells, invasion and metastasis.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |