Under the terms of the licensing agreement, Seattle Genetics will get the exclusive rights develop, manufacture, and commercialize the antibody-drug conjugate sacituzumab govitecan (IMMU-132). Once the agreement is finalized, Seattle Genetics will make an upfront payment of $250 million to Immunomedics, and fund all development, regulatory, and sales-dependent payments up to $1.7 billion.
“After a long and robust process, we concluded that licensing our lead asset, sacituzumab govitecan, to Seattle Genetics, the leading ADC [antibody-drug conjugate] company, would give us the best opportunity to advance this product on behalf of advanced stage cancer patients,” Cynthia L. Sullivan, president and CEO of Immunomedics, said in a news release.
“Sacituzumab govitecan has the potential to drive significant value for patients with multiple types of cancer who are in need of new therapy options, and we look forward to continuing its development with Seattle Genetics,” she said.
IMMU-132 is composed of an anti-TROP-2 antibody linked to an active metabolite of ironotecan, SN-38. TROP-2 is found in many tumor types, including breast, colon, lung and bladder cancers.
Data from a Phase 1/2 trial in metastatic triple negative breast cancer patients showed an objective response rate of 29 percent, with a median duration of response of 10.8 months. In addition, patients lived for a median of 18.8 months after initiating treatment with IMMU-132. The drug was generally well-tolerated, with the most common adverse events including nausea, diarrhea, anemia, vomiting, fatigue, and low numbers of a blood cell type called neutrophils.
Data from this Phase 1/2 trial will now serve as the basis for the submission of a Biologics License application under the U.S. Food and Drug Administration’s (FDA) accelerated approval regulations.
In 2016, the FDA designated IMMU-132 as a Breakthrough Therapy for triple negative breast cancer patients who progressed during or following prior treatment for metastatic disease. It also received Fast Track designation for the treatment of small cell lung cancer and non-small cell lung cancer, and Orphan Drug status for small cell lung cancer.
The European Medicines Agency has also granted IMMU-132 Orphan Drug status for pancreatic cancer.
“This agreement would add a promising late-stage ADC to our pipeline as we continue making progress toward our goal of becoming a global, multi-product oncology company,” said Clay Siegall, PhD, president and CEO of Seattle Genetics. “Sacituzumab govitecan would complement our existing pipeline by providing a potential near-term opportunity to commercialize a second drug in the United States, expand our international capabilities in Europe and elsewhere, and extend our efforts in solid tumors.
“In addition, we believe our expertise in ADCs, including demonstrated success in clinical development, regulatory, manufacturing, and commercialization, ideally positions Seattle Genetics to advance this program globally,” Siegall added. “We look forward to working with Immunomedics to advance this program for patients in need, including those with triple negative breast cancer and other solid tumors.”
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