MORRIS PLAINS, N.J., May 15, 2015 (GLOBE NEWSWIRE) -- Immunomedics, Inc., (Nasdaq:IMMU) today announced that it has received notice from the U.S. Food and Drug Administration (FDA) designating as a Fast Track development program sacituzumab govitecan, the Company’s lead antibody-drug conjugate (ADC), for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) who have failed two prior lines of therapy (including targeted therapies such as an ALK inhibitor, EGFR inhibitor, and PD-1 inhibitor, if applicable) to demonstrate a clinically important and statistically robust improvement in overall survival over available therapies.
In a mid-stage clinical study in patients with advanced metastatic solid cancers who had failed multiple prior therapies for their disease, sacituzumab govitecan produced promising therapeutic results in patients with several different cancer types, including breast, lung, esophageal, colorectal, and urinary bladder cancers, with limited and tolerable side effects.
“We are pleased to receive this Fast Track designation from FDA,” remarked Cynthia L. Sullivan, President and Chief Executive Officer. “Updated results with sacituzumab govitecan in patients with lung cancer will be reported in an oral presentation at the 2015 Annual Meeting of the American Society of Clinical Oncology, as well as results in triple-negative breast and gastrointestinal cancers,” Ms. Sullivan added. “We are committed to efficiently advance this agent with a corporate partner for the benefit of cancer patients, since it is showing activity in a number of different cancers that have been difficult to treat, especially when they spread,” she reiterated.
Previously, FDA also granted Fast Track status to sacituzumab govitecan for the therapy of patients with triple-negative breast or small-cell lung cancers. Sacituzumab govitecan has also been designated an orphan drug by FDA for the treatment of patients with small-cell lung or pancreatic cancers.
Sacituzumab govitecan is a next generation ADC developed by the Company 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.
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.
About Immunomedics
Immunomedics is a clinical-stage biopharmaceutical company developing monoclonal antibody-based products for the targeted treatment of cancer, autoimmune disorders and other serious diseases. Immunomedics’ advanced proprietary technologies allow the Company to create humanized antibodies that can be used either alone in unlabeled or “naked” form, or conjugated with radioactive isotopes, chemotherapeutics, cytokines or toxins. Using these technologies, Immunomedics has built a pipeline of nine clinical-stage product candidates. Immunomedics has an ongoing collaboration with UCB, S.A. (UCB), to whom the Company licensed epratuzumab for the treatment of all non-cancer indications worldwide. UCB expects Phase 3 data in systemic lupus erythematosus in the first half of 2015. Immunomedics is exploring epratuzumab in oncology in collaboration with independent cancer study groups. Immunomedics’ most advanced candidate to which it retains worldwide rights for all indications is 90Y-clivatuzumab tetraxetan. The Company initiated a Phase 3 registration trial in January 2014 in patients with advanced pancreatic cancer and expects patient enrollment to be completed in calendar year 2016. Immunomedics’ portfolio of wholly owned product candidates also includes antibody-drug conjugates (ADCs) that are designed to deliver a specific payload of a chemotherapeutic directly to the tumor while reducing overall toxic effects that are usually found with conventional administration of these chemotherapeutic agents. Immunomedics’ most advanced ADCs are sacituzumab govitecan (IMMU-132) and labetuzumab govitecan (IMMU-130), which are in Phase 2 trials for a number of solid tumors and metastatic colorectal cancer, respectively. Immunomedics also has a number of other product candidates that target solid tumors and hematologic malignancies, as well as other diseases, in various stages of clinical and pre-clinical development. These include bispecific antibodies targeting cancers and infectious diseases as T-cell redirecting immunotherapies, as well as bispecific antibodies for next-generation cancer and autoimmune disease therapies, created using its patented DOCK-AND-LOCK® protein conjugation technology. The Company believes that its portfolio of intellectual property, which includes approximately 267 active patents in the United States and more than 400 foreign patents, protects its product candidates and technologies. Immunomedics’ strength in intellectual property has resulted in a top-8 ranking in the Biotechnology industry by the Patent Board for the 2014 fiscal year. For additional information on the Company, please visit its website at www.immunomedics.com. The information on its website does not, however, form a part of this press release.
This release, in addition to historical information, may contain forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Such statements, including statements regarding clinical trials (including the funding therefor, outcomes, timing or associated costs), out-licensing arrangements (including the timing and amount of contingent payments), forecasts of future operating results, potential collaborations, and capital raising activities, involve significant risks and uncertainties and actual results could differ materially from those expressed or implied herein. Factors that could cause such differences include, but are not limited to, new product development (including clinical trials outcome and regulatory requirements/actions), our dependence on UCB for the further development of epratuzumab for non-cancer indications, risks associated with the outcome of pending litigation and competitive risks to marketed products, and availability of required financing and other sources of funds on acceptable terms, if at all, as well as the risks discussed in the Company’s filings with the Securities and Exchange Commission. The Company is not under any obligation, and the Company expressly disclaims any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise.
CONTACT: For More Information: Dr. Chau Cheng Senior Director, Investor Relations & Corporate Secretary (973) 605-8200, extension 123 ccheng@immunomedics.com
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