Immunomedics Reports Winning of Fast Track Designation for IMMU-132 for Triple-Negative Breast Cancer

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Immunomedics, Inc.,
IMMU
today announced that it has received notice from the U.S. Food and Drug Administration (FDA) designating as a Fast Track development program the investigation of sacituzumab govitecan, the Company's lead antibody-drug conjugate (ADC), for the treatment of patients with triple-negative breast cancer (TNBC) who have failed prior therapies for metastatic disease. Sacituzumab govitecan (IMMU-132) is a novel ADC developed by Immunomedics by conjugating the moderately-toxic drug, SN-38, site-specifically and at a high ratio of drug to antibody. SN-38 is the active metabolite of irinotecan (Camptosar), which is used to treat certain solid cancers, particularly metastatic colorectal cancers, as a part of combination therapies, so its pharmacology and properties are well-known. Based on the Company's current results with patients having advanced TNBC, which is a serious and life-threatening disease for which there are few therapy options, as well as Immunomedics' clinical development plans for this ADC, the Company gained this designation. Patients with TNBC enrolled to-date have had a median of 4 prior therapies (range, 1-15), including combinations of conventional and experimental drugs. To-date, approximately 30% of assessable patients has shown an objective response rate (complete and partial remissions) by computed tomography, where shrinkage of tumors ranging from 30% to 100% has been observed. The major toxicity is neutropenia, which has been manageable by dose reductions or giving myeloid growth factors. Unlike the parent drug of SN-38, irinotecan, sacituzumab govitecan has not caused severe diarrhea. The Company is also evaluating this ADC in other solid tumors showing objective responses, such as in patients with small-cell and non-small cell lung, colorectal, esophageal, and urinary bladder cancers. Previously, FDA also granted Fast Track status to sacituzumab govitecan for the therapy of patients with small-cell lung cancer, which also constitutes an unmet medical need and where sacituzumab govitecan has induced objective responses. Sacituzumab govitecan has also been designated an orphan drug by FDA for the treatment of patients with small-cell lung or pancreatic cancers. "We are pleased to receive this Fast Track designation from FDA," remarked Cynthia L. Sullivan, President and Chief Executive Officer. "We plan to discuss with FDA and our medical advisers the registration pathway for this valuable agent in breast cancer, and talks with potential licensing partners are continuing," she reiterated. "We are close to completing enrollment of about 50 patients with metastatic TNBC, while we continue to study other indications as well," Ms. Sullivan advised. The Fast Track programs, under the FDA Modernization Act of 1997, are designed to facilitate drug development and to expedite the review of new drugs that are intended to treat serious or life threatening conditions. Compounds selected must demonstrate the potential to address unmet medical needs. The Fast Track designation allows for close and frequent interaction with the agency. A designated Fast Track drug may also be considered for priority review with a shortened review time, rolling submission, and accelerated approval if applicable. The designation does not, however, guarantee approval or expedited approval of any application for the product.
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