Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 629 |
| INN | None |
| Status | Clinical |
| Drug code(s) | FG-M108, M108 |
| Brand name | None |
| mAb sequence source | mAb - source TBD |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | TBD |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | Claudin-18.2 |
| Indications of clinical studies | Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma, Solid tumors |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | June 11, 2021 |
| Start of Phase 2 | |
| Start of Phase 3 | December 25, 2023 |
| 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 | FutureGen Biopharmaceutical (Beijing) Co. Ltd |
| Licensee/Partner | None |
| Comments about company or candidate | NCT06177041 Phase 3 in Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma started in Dec 2023. NCT04894825 is A Phase I, Multi-center, Open-label, Single-dose Escalation and Expansion, Dose Escalation and Expansion Combination With Chemotherapy Study Evaluating the Safety, Tolerability and Pharmacokinetic Profile of M108 Monoclonal Antibody in Patients With Advanced Unresectable Solid Tumors in China started in June 2021 recruiting as of last update in July 2022. March 3 2021: Ji Ming biopharmaceutical (Beijing) Co., Ltd. received the M108 notice of a clinical trial approved by the injection of the monoclonal antibody, display the notice " according to" Drug Administration Law "and the relevant provisions of the State Food and Drug Administration approved Mingji Biopharmaceuticals will use M108 monoclonal antibody injection in clinical trials for the treatment of advanced solid tumors " , marking that a new treatment plan will benefit the people. |
| Full address of company | Room 201, Floor 2, Building 1, No. 16, Baocan South Street, Daxing Biomedical Industry Base, Zhongguancun Science and Technology Park, Daxing District, Beijing Asia China https://www.futuregenbiopharm.com/#/contact |
FG-M108 is an ADCC- enhanced afucosylated IgG1 monoclonal antibody targeting CLDN18.2 (DOI: 10.1016/j.annonc.2024.08.1499) independently developed by Mingji Biopharmaceutical for high expression of gastric cancer and other digestive system cancer tumor antigens . It mainly uses high-throughput phage display library screening technology to screen specific binding monoclonal antibodies at the cellular level. Source antibodies, while making full use of the antibody’s immunological anti-tumor mechanism, fully mobilize the patient’s immune cells to kill tumor cells through the enhanced ADCC effect. Non-clinical studies of drugs have shown that antibodies have shown good efficacy in a variety of gastric cancer animal models, and can completely inhibit tumor growth in specific models.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |