Immunomedics' IMMU-132 Gets Orphan Drug Status For Small Cell Lung Cancer

(RTTNews) - Immunomedics, Inc. (IMMU), a biopharmaceutical company focusing mainly on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, said its antibody-drug conjugate for solid cancer therapy, IMMU-132, has received orphan drug status from the Office of Orphan Products Development of the U.S. Food and Drug Administration or FDA for small cell lung cancer or SCLC treatment.

Cynthia Sullivan, President and Chief Executive said: "In addition to small cell lung cancer, the agent is currently in Phase II clinical development focusing on a few select types of solid cancers."

In an early Phase I trial, IMMU-132 produced partial responses in patients with small cell lung cancer, colorectal cancer, and triple negative breast cancer. IMMU-132 is an active antibody-drug conjugate containing the humanized anti-TROP-2 antibody, hRS7, conjugated by a pH sensitive linker to SN-38.

SN-38 is the active metabolite of irinotecan, which is a standard therapy for patients with metastatic colorectal cancer, but has major gastrointestinal and hematologic toxicity. By attaching SN-38 to tumor-targeting antibodies, delivery of SN-38 to the tumor may be increased several-fold while mitigating systemic toxicity.