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news.The European Medicines Agency (EMA) has granted orphan drug status for Immunomedics' solid-tumor antibody-drug conjugates (ADCs), isactuzumab govitecan, or IMMU-132, to treat pancreatic cancer.
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The drug has also been designated an orphan drug by the US Food and Drug Administration (FDA) to treat pancreatic cancer and small-cell lung cancer.
The company claims that in an ongoing Phase II clinical trial, the ADC has resulted in partial responses in patients with colorectal cancer, esophageal cancer, triple negative breast cancer, and small-cell and non-small-cell lung cancers.
Immunomedics president and chief executive officer Cynthia Sullivan said the company is happy to receive this orphan designation from EMA, the first for IMMU-132 in the European Union.
"We will have significant updates on the Phase II studies involving IMMU-132, as well as IMMU-130, at the World ADC Summit in San Diego, CA, and the EORTC/NCI/AACR Symposium on Molecular Targets in Cancer Therapeutics in Barcelona, Spain," Sullivan said.
The drug is composed of hRS7, a humanized antibody that binds to the trophoblast cell-surface antigen (TROP-2), also known as the epithelial glycoprotein-1 antigen (EGP-1).