Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 965 |
| INN | None |
| Status | Clinical |
| Drug code(s) | M701 |
| Brand name | None |
| mAb sequence source | mAb chimeric |
| General Molecular Category | Bispecific |
| Format, general category | Fragment-Fc |
| Format details | YBODY |
| Isotype (Fc) | TBD |
| Light chain isotype | TBD |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | YBODY platform |
| Target(s) | EpCAM, CD3 |
| Indications of clinical studies | Malignant Ascites Caused by Advanced Epithelial Solid Tumors, Gastrointestinal or Ovarian Cancer, malignant Pleural Effusions Caused by NSCLC, Malignant Ascites |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | October 15, 2018 |
| Start of Phase 2 | November 15, 2021 |
| Start of Phase 3 | March 20, 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 | Wuhan YZY Biopharma Co. Ltd. |
| Licensee/Partner | Chia Tai Tianqing Pharmaceutical Group Co Ltd |
| Comments about company or candidate | NCT06432296 Phase 3 in malignant ascities started in Mar 2024 NCT06266091 Phase 2 in Gastrointestinal or Ovarian Cancer started in Nov 2021. We completed a Phase I clinical trial of M701 in treating malignant ascites (MA) in January 2022. We are currently conducting a Phase II clinical trial to evaluate the efficacy of M701 in combination with systematic treatment in MA patients. In addition, we commenced a Phase Ib/II clinical trial of M701 in treating malignant pleural effusion (MPE) in China in November 2022. NCT05543330 Phase 1/2 due to start in Sep 2022. NCT04501744 Phase 1, Multicenter, Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability and PK/PD of Recombinant Anti-EpCAM and Anti-CD3 Human-Mouse Chimeric Bispecific Antibody Via Intraperitoneal Infusion in Malignant Ascites started in Oct 2018. IND filed in China in 2016. |
| Full address of company | Biolake, C2-1, No. 666 High-tech Avenue, Wuhan, Hubei, China Asia China https://en.yzybio.com/ |
Based on YBODY® platform, we have developed three T cell-engaging BsAbs, namely M701, M802 and Y150.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |