ARX-788 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 44% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how ARX-788’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.

ARX-788 overview

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 biopharmaceutical company. The company’s pripeline products include anti-HER2 ADC (ARX788), anti-PSMA ADC (ARX517) and anti-CD70 ADC (ARX305). It carries out the research and development of bio-conjugates for animal health, and drugs to treat nonalcoholic steatohepatitis (NASH), heart failure, oncology and immune-oncology diseases. Ambrx creates long acting therapeutic peptides and proteins, modified antibodies and bi-specific fragments through its ReCODE expression system; and larger and complex proteins using its EuCODE expression system. The company works in collaboration with Bristol Myers Squibb, TSRI and Abbvie, Sino Biopharmaceutical, Sino Biopharmaceutical Co Ltd and BeiGene to discover, develop and commercialize antibody-drug conjugates (ADCs). Ambrx is headquartered in La Jolla, California, the US.

For a complete picture of ARX-788’s drug-specific PTSR and LoA scores, buy the report here.


GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.