Immunomedics has received orphan drug designation from the US Food and Drug Administration’s (FDA) Office of Orphan Products Development for its IMMU-132 for pancreatic cancer therapy.
IMMU-132 is Immunomedics’ antibody-drug conjugate in clinical development for treatment of patients with solid cancer.
Immunomedics president and CEO Cynthia Sullivan said that this is the second orphan designation from FDA for IMMU-132, which has demonstrated activity in patients with advanced pancreatic cancer, as well as partial responses in five other types of solid cancer.
The FDA previously granted orphan drug designation to IMMU-132 for treatment of small-cell lung cancer patients.
In an ongoing Phase I/II clinical study, IMMU-132 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.
IMMU-132 is composed of a humanised antibody, hRS7, that binds to the trophoblast cell-surface antigen (TROP-2), also known as the epithelial glycoprotein-1 antigen (EGP-1).
The humanised antibody internalises into cancer cells following binding to TROP-2, making it a suitable candidate for the delivery of cytotoxic drugs.
In preclinical studies, IMMU-132 has demonstrated that it delivers 120-times the amount of SN-38, the active metabolite of irinotecan, to a human pancreatic tumor xenograft than when irinotecan is given.
IMMU-132 significantly improves survival and tumour regression in various animal models of human cancers.