Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1373 |
| INN | None |
| Status | Clinical |
| Drug code(s) | TPX-4589, LM-302 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | ADC |
| Format, general category | Full length Ab conjugate |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | TBD |
| Linker | Valine-Alanine (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 | Gastro-Intestinal Cancer, 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) | November 26, 2021 |
| Start of Phase 2 | July 15, 2023 |
| Start of Phase 3 | June 24, 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 | LaNova Medicines Zhejiang Co. Ltd. |
| Licensee/Partner | Bristol Myers Squibb |
| Comments about company or candidate | NCT06351020 Phase 3 study in Claudin (CLDN) 18.2-positive, Gastric or Gastroesophageal Junction Adenocarcinoma start in June2024. NCT05934331 Phase II, Open-Label, Multicenter Study Evaluating the Efficacy, Safety, and Tolerability of LM-302 Combined With Toripalimab in CLDN18.2 Positive Patients advanced gastro-Intestinal Cancer due to start in July 2023 June 2022: Bristol Myers Squibb and Turning Point Therapeutics, Inc. announced a definitive merger agreement under which Bristol Myers Squibb will acquire Turning Point Therapeutics for $76.00 per share. The transaction was unanimously approved by both the Bristol Myers Squibb and Turning Point Therapeutics Boards of Directors and is anticipated to close during the third quarter of 2022. May 05, 2022 I Turning Point Therapeutics, Inc. announced that it has entered into an exclusive license agreement with LaNova Medicines Limited (LaNova) to develop and commercialize LM-302, a novel antibody drug conjugate (ADC) targeting Claudin18.2, in the U.S. and rest of the world, excluding Greater China and South Korea. FDA has granted TPX-4589 two orphan drug designations for the treatment of pancreatic cancer and for the treatment of gastric cancer, including cancer of the gastroesophageal junction. NCT05001516 and NCT05188664 are Phase 1/2 studies in Patients With Claudin(CLDN)18.2-Positive Advanced Solid Tumors Listed as Phase 1 on company website accessed July 2021; company is based in China |
| Full address of company | 999 Cailun Road, Building 1, Floor 5 Pudong District, Shanghai, China 201203 Asia China https://www.lanovamedicines.com/en/contact-us |
TPX-4589, a novel antibody-drug conjugate (ADC) developed to target CLDN18.2, is comprised of a recombinant humanized anti-CLDN18.2 IgG1 monoclonal antibody (mAb) [LM-102] coupled with cytotoxic payload monomethyl auristatin E (MMAE) https://www.lanovamedicines.com/en/our-science/publications-presentations/lm-302 Val-cit linker. Described in Turning Point's May 5, 2022 investor call
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |