Anvatabart opadotin is under clinical development by Ambrx Biopharma and currently in Phase II for Human Epidermal Growth Factor Receptor 2 Positive Breast Cancer (HER2+ Breast Cancer). According to GlobalData, Phase II drugs for Human Epidermal Growth Factor Receptor 2 Positive Breast Cancer (HER2+ Breast Cancer) have a 45% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Anvatabart opadotin’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Anvatabart opadotin overview

Anvatabart opadotin (ARX-788) is under development for the treatment of Her2-positive advanced and HER2 low expressing metastatic breast cancer, gastroesophageal junction adenocarcinoma, esophageal cancer, salivary gland cancer, endometrial cancer, metastatic biliary tract cancer, GE junction carcinoma, epithelial ovarian cancer, fallopian tube cancer, peritoneal cancer, metastatic pancreatic cancer and gastric cancer. It is administered through intravenous route. The drug candidate is an HER2 specific monoclonal antibody conjugated with Amberstatin 269. The drug candidate is developed based on site-specific conjugation technology.

It was also under development for the treatment of colon cancer, pancreatic cancer, ovarian cancer.

Ambrx Biopharma overview

Ambrx Biopharma (Ambrx) is a clinical stage biopharmaceutical company that develops anti-body drug conjugates (ADC) and therapies to modulate immune system. The company is developing ARX 788, an anti-HER2 ADC for treatment in areas of breast cancer, gastric cancer, and other solid tumors. Its pipeline product also includes ARX 517 program that targets prostate-specific membrane antigen to treat prostate cancer; and ARX305 for treatment of renal cell carcinoma (RCC), nasopharyngeal cancers, multiple myeloma, non-Hodgkin’s lymphoma, and acute myeloid leukemia (AML). Ambrx works in collaboration with Zhejiang Medicine, Sino Biopharmaceutical, and BeiGene. The company is conducting its ADCs clinical trials in China, and the US. Ambrx is headquartered in La Jolla, California, the US.

For a complete picture of Anvatabart opadotin’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 22 January 2024

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.