Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 324 |
| INN | Anvatabart opadotin |
| Status | Clinical |
| Drug code(s) | ARX788, JNJ-0683, NCB-001 |
| 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 | kappa |
| Linker | Oxime (Non-cleavable linker) |
| Ave. DAR | 1.8 (Site-specific) |
| Conjugated/fused moiety | Tubulin inhibitor, Amberstatin 269 (Auroxime) |
| Discovery method/technology | None |
| Target(s) | HER2 |
| Indications of clinical studies | HER2-positive, Metastatic Breast Cancer, Advanced Cancers With HER2 Expression |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | March 15, 2016 |
| Start of Phase 2 | April 15, 2021 |
| Start of Phase 3 | July 01, 2021 |
| 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 | Johnson & Johnson |
| Licensee/Partner | NovoCodex, Zhejiang Medicine Co. Ltd |
| Comments about company or candidate | Jan. 08, 2024 -- Ambrx Biopharma, Inc. announced that it has entered into a definitive agreement pursuant to which Johnson & Johnson will acquire all of the outstanding shares of Ambrx for $28.00 per share in cash, representing an approximately 105% premium to Ambrx’s closing stock price on January 5, 2024, for a total equity value of approximately $2.0 billion. March 1, 2023: Ambrx Biopharma Inc. announced that it has been informed by its partner, NovoCodex Biopharmaceuticals, Inc. (NovoCodex), that an interim analysis for ACE-Breast-02, a randomized Phase 3 breast cancer clinical trial investigating Ambrx’s ARX788, an anti-HER2 antibody drug conjugate (ADC), has met its pre-specified interim primary efficacy endpoint with statistical significance, demonstrating a greater progression free survival (PFS) benefit compared to the active control. October 2022: The company will pause development of Ambrx-sponsored clinical trials involving ARX788. Instead, Ambrx will continue to work collaboratively with NovoCodex and seek a development partner(s) ex-China to progress ARX788. NCT05426486 Phase 2/3 in breast cancer started in May 2022. July 2021: Listed as Phase 3 in NovoCodex-sponsored study in China as 2L+ in breast cancer (ACE-Breast-02). Pivotal studies: ACE-Breast-02 Phase 3 pivotal trial for HER2+ metastatic breast cancer (China – Enrolling) ACE-Breast-03 Phase 2 pivotal trial for HER2+ metastatic breast cancer (Global – Initiated) ACE-Gastric-02 Phase 3 pivotal trial for gastric/GEJ cancer (Global – Initiated) https://s27.q4cdn.com/912984828/files/doc_presentations/2021/07/Ambrx-Corporate-Presentation-(Non-Confidential)-Summer-2021.pdf NCT04829604 Phase 2 in breast cancer started in April 2021. March 2021: The FDA has granted an orphan drug designation to ARX788 for the treatment of patients with HER2-positive gastric cancer. Jan 2021: Ambrx announced that the U.S. Food and Drug Administration (FDA) granted ARX788 Fast Track Designation as monotherapy for the treatment of advanced or metastatic HER2-positive breast cancer patients who have received one or more prior anti-HER2 based regimens in the metastatic setting. NCT03255070 Phase 1 study started recruiting March 12, 2018; still recruiting as of Aug 1, 2019. NCT02512237 Phase 1 study terminated. Anti-HER2 antibody-drug conjugate; Ambrx and Zhejiang Medicine Co. Ltd have commercialization agreement; ZMC will manufacture the product to world-class standards for clinical and commercial supplies on a global basis. WuXi PharmaTech will provide integrated services for ARX788, including the development and manufacturing of the toxin, antibody and ADC, pre-clinical development and clinical trials. Ambrx licensed the China rights of ARX788 to its partner NovoCodex. |
| Full address of company | New Brunswick, New Jersey, United States North America United States of America https://www.jnj.com/contact-us |
Also referred to as Anvatabart pactil (https://searchusan.ama-assn.org/usan/documentDownload?uri=%2Funstructured%2Fbinary%2Fusan%2Fanvatabart-pactil.pdf) Site-specific ADC. ARX788 is a homogeneous and highly stable antibody drug conjugate (ADC) targeting the HER2 receptor. ARX788 is a Precision Biologic ADC that consists of two cytotoxic payloads site-specifically conjugated to a Herceptin® (trastuzumab) based antibody. ARX788 was designed for maximum performance in the preclinical setting by optimizing the number, position and chemical bonds that conjugate the cytotoxic AS269 payload to the antibody. AS269 is a proprietary tubulin inhibitor specifically designed to form a highly stable covalent bond with our synthetic amino acids, a fundamental step in the creation of a Precision ADC. DAR = 2. Anvatabart (ARX788) is an IgG1-kappa antibody genetically modified to incorporate the non-natural amino acid (nnAA) p-acetylphenyalanine (pAF), a site-specific conjugation in Phe121 and Phe121".
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |