Disitamab vedotin by RemeGen for Esophageal Cancer: Likelihood of Approval

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.

Disitamab vedotin overview

Disitamab vedotin (Aidexi) is an antibody-conjugated drug that contains the human epidermal growth factor receptor-2 (HER2) antibody portion, linker and the cytotoxic drug monomethyl auristatin E (MMAE). It is developed based on antibody-drug conjugates technology. It is formulated as solution for injection for intravenous route of administration. Aidexi is indicated for the treatment of locally advanced or metastatic gastric cancer (including gastroesophageal junction adenocarcinoma) with HER2 over-expression in patients who have received at least two types of systemic chemotherapy.

Disitamab vedotin (RC-48) is under development for the treatment of solid tumors including breast cancer, HER2 expressing non-small cell lung cancer, non-muscle invasive bladder cancer (NMIBC), metastatic liver cancer, advanced or metastatic urothelial carcinoma of unresectable origin including urothelial carcinoma of bladder, ureter cancer, renal pelvis cancer, and urethral cancer, advanced melanoma, advanced or metastatic HER2 expressing biliary tract cancer, bile duct cancer, gallbladder cancer, muscle invasive bladder cancer (MIBC), HER2 expressing urothelial carcinoma and HER2 low to non expressing urothelial cancer, metastatic cholangiocarcinoma, HER2 expressing gastric cancer, gastro-esophageal junction cancer or gastroesophageal junction adenocarcinoma and refractory HER2 low expressing metastatic breast cancer, HER2 positive and negative breast cancers, cervical cancer, epithelial ovarian cancer, fallopian tube cancer, peritoneal cancer, endometrial cancer, vulvar cancer, vaginal cancer, metastatic colorectal cancer, salivary gland tumor, head and neck squamous cell carcinoma, esophageal carcinoma, metastatic castration resistant prostate cancer (mCRPC), oral cavity cancer, oropharyngeal cancer, hypopharyngeal cancer, laryngeal cancer and primary sarcoma of the gynecological reproductive system. It is a recombinant humanized anti-HER2 monoclonal antibody-monomethyl auristatin E (MMAE) antibody-drug conjugate administered through intravenous and intravenous drip routes in the form of powder for solution. The drug candidate acts by targeting the human epidermal growth factor receptor 2 (Her2). The drug candidate is developed based on antibody-drug conjugates technology. It was also under development for the treatment of ovarian cancer and bladder cancer

RemeGen overview

RemeGen, a subsidiary of Yantai Rongchang Pharmaceutical Co Ltd, is a biopharmaceutical company that focuses on the discovery, development and commercialization of therapeutic antibody drugs such as antibody-drug conjugates (ADCs), antibody fusion proteins, monoclonal antibodies and bispecific antibodies for the treatment of cancer, autoimmune and eye diseases. RemeGen investigating its lead product candidate RC18, a novel BLyS/APRIL-induced fusion protein against rheumatoid arthritis, multiple sclerosis, neuromyelitis optica spectrum disorder (NMOSD) and other autoimmune diseases. It also evaluates RC48, a HER2-directed antibody-drug conjugate targeting gastric, urothelial, breast, lung and bile duct cancer; and RC28 molecule to treat WAMD (wet age-related macular degeneration) and multiple solid cancers. It operates research facilities and offices in China and the US. RemeGen is headquartered in Yantai, Shangdong, China.

For a complete picture of Disitamab vedotin’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 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.