Immunomedics, Inc. IMMU announced that it has reached an agreement with the FDA regarding a special protocol assessment (SPA) of the design of the first phase III trial of its lead antibody-drug conjugate (ADC) candidate, sacituzumab govitecan.
Sacituzumab govitecan is being developed for the treatment of patients suffering from metastatic triple-negative breast cancer.
Simultaneously, the company has announced voting results from its annual meeting.
We remind investors that sacituzumab govitecan was granted fast track designation from the FDA for the treatment of patients suffering from triple-negative breast cancer who have failed prior therapies for metastatic disease and for patients with small-cell lung cancer. The candidate also enjoys orphan drug status for small-cell lung cancer in the U.S. and pancreatic cancer in the U.S. and the EU.
Immunomedics developed sacituzumab govitecan by conjugating SN-38, the active metabolite of Pfizer’s PFE Camptosar (irinotecan).
Meanwhile, Immunomedics has built a pipeline of nine clinical-stage candidates and is working hard to develop them. Another candidate in Immunomedics’ ADC pipeline, labetuzumab govitecan, is presently in phase II development for the treatment of metastatic colorectal cancer.
Immunomedics’ most advanced candidate is 90Y-clivatuzumab tetraxetan. The candidate is currently in a phase III registration study for advanced pancreatic cancer and patient enrolment is expected to be complete in 2016.
Meanwhile, the company also has a worldwide collaboration with Bayer BAYRY for its candidate epratuzumab. The companies have collaborated to study epratuzumab as a thorium-227 labeled antibody.
Immunomedics currently carries a Zacks Rank #4 (Sell). A better-ranked stock in the health care sector is Biodel Inc. BIOD with a Zacks Rank #2 (Buy).
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