Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 348 |
| INN | None |
| Status | Clinical |
| Drug code(s) | AZD0901, CMG901, MRG005 |
| Brand name | None |
| mAb sequence source | mAb - source TBD |
| General Molecular Category | ADC |
| Format, general category | Full length Ab conjugate |
| Format details | None |
| Isotype (Fc) | TBD |
| Light chain isotype | TBD |
| Linker | Cleavable linker |
| Ave. DAR | ___ |
| Conjugated/fused moiety | Tubulin inhibitor, Monomethyl auristatin E (MMAE) |
| Discovery method/technology | None |
| Target(s) | Claudin-18.2 |
| Indications of clinical studies | Gastric or GEJ adenocarcinoma expressing CLDN18.2., 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) | September 02, 2020 |
| Start of Phase 2 | December 13, 2023 |
| Start of Phase 3 | March 04, 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 | LEPU Biopharma, Shanghai Miracogen Inc. |
| Licensee/Partner | AstraZeneca, Keymed Biosciences Inc. |
| Comments about company or candidate | Phase 3 in gastric or GEJ adenocarcinoma expressing CLDN18.2 started in March 2024. NCT06219941 Phase 2 in solid tumors started in Dec 2023. Feb 2023: AstraZeneca and KYM Biosciences Inc.i have entered into a global exclusive licence agreement for CMG901, a potential first-in-class antibody drug conjugate (ADC) targeting Claudin 18.2, a promising therapeutic target in gastric cancer. Under the licence agreement, AstraZeneca will be responsible for the research, development, manufacture and commercialisation of CMG901 globally. KYM Biosciences Inc. is a joint venture established by affiliates of Keymed Biosciences (70% of KYM ownership) and Lepu Biopharma (30% of KYM ownership). Sep 2022: NMPA has granted CMG901 (Claudin 18.2 antibody drug conjugates), a new drug candidate of the Group, breakthrough therapy designation for the treatment of Claudin 18.2-positive advanced gastric cancer that was resistant/refractory or intolerant to prior systemic therapy. April 2022: Keymed Biosciences announced that the U.S. Food and Drug Administration (FDA) granted CMG901 Fast Track Designation as monotherapy for the treatment of unresectable or metastatic gastric and gastroesophageal junction cancer which have relapsed and/or are refractory to approved therapies. This is another milestone after CMG901 received Orphan-drug Designation from the FDA for the treatment of relapsed/refractory gastric cancer and gastroesophageal junction adenocarcinoma. NCT04805307 Phase 1 started in Sep 2020. Keymed Bio started to co-develop CMG901 with Shanghai Miracogen since October 2017 and we established a joint venture with Innocube to develop and commercialize CMG901, in which we and Innocube own 70% and 30% shares, respectively. Shanghai Miracogen and Innocube are under the common control of Lepu Biopharma. The antibody component of CMG901 (i.e. CM311) is not separately evaluated in clinical trials |
| Full address of company | No.651, Lianheng Road, Minhang District, Shanghai, CHINA Asia China https://en.lepubiopharma.com/contact/shanghai |
CMG901 is a Claudin 18.2-targeting ADC comprising of a Claudin 18.2-specific antibody, a cleavable linker and a toxic payload, monomethyl auristatin E (MMAE). Antibody is CM311. https://www1.hkexnews.hk/listedco/listconews/sehk/2021/0625/2021062500031.pdf https://www.astrazeneca.com/content/dam/az/Investor_Relations/events/ESMO-IR-deck-Oct-2023.pdf
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |