ARX-788 is under clinical development by Ambrx Biopharma and currently in the Phase I and Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect ARX-788’s likelihood of approval (LoA) and phase transition for Human Epidermal Growth Factor Receptor 2 Positive Breast Cancer (HER2+ Breast Cancer) took place on 14 Sep 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their ARX-788 Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

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.

Quick View ARX-788 LOA Data

Report Segments
  • Innovator
Drug Name
  • ARX-788
Administration Pathway
  • Intravenous
Therapeutic Areas
  • Oncology
Key Developers
Highest Development Stage
  • Phase III

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.