February 10, 2017
By Alex Keown, BioSpace.com Breaking News Staff
MORRIS PLAINS, N.J. – Shares of Immunomedics, Inc. have soared more than 25 percent this morning after the company struck a deal worth up to $2 billion with Seattle Genetics Inc. to develop IMMU-132, Immunomedics’ proprietary solid tumor therapy candidate.
Under terms of the agreement, Seattle Genetics will be responsible for initiating a Phase III trial of IMMU-132 in patients with metastatic triple-negative breast cancer and submit the initial application or approval with the U.S. Food and Drug Administration. The agreement includes the development of additional indications for IMMU-132, including urothelial cancer (UC), small-cell lung cancer (SCLC) and non-small-cell lung cancer (NSCLC), which are currently in Phase II clinical studies, along with other solid tumor indications being studied in ongoing clinical trials.
Immunomedics will receive $300 million in upfront payments and up to $1.7 billion in milestone payments.
IMMU-132, sacituzumab govitecan, is a novel antibody-drug conjugate that binds to a protein found on many cancer cells called TROP-2. By bonding with the cancer cells, IMMU-132 can then deliver a dose of a chemo agent into the cell, hopefully killing it. IMMU-132, its lead investigational antibody-drug conjugate, sacituzumab govitecan, earned a Breakthrough Therapy designation by the U.S. Food and Drug Administration in February 2016.
Clay Siegall, president and chief executive officer of Seattle Genetics, said IMMU-132 will complement the company’s “rich pipeline of late- and early-stage programs” and bring a potential new treatment to triple negative breast cancer patients with few options. Siegall said Seattle Genetics has been successful in developing ADCs in oncology treatments.
“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,” Siegall said in a statement.
Earlier trial data showed IMMU-132, or sacituzumab govitecan, achieved an objective response rate of 29 percent and a median duration of response of 10.8 months.
“In just over three years, we have brought IMMU-132 through clinical developments in multiple indications, and have advanced the TNBC indication to a potential accelerated approval and launch by late 2017 or early 2018, which could make IMMU-132 available to patients dealing with a highly malignant form of breast cancer,” Cynthia Sullivan, president and chief executive officer of Immunomedics said in a statement.
David Goldenberg, chief scientific officer at Immunomedics, said after years of developing IMMU-132, this year was the right time to “out-license” the drug.
While Immunomedics investors are pleased with the deal, Seattle Genetics investors have not responded as enthusiastically. Shares of company stock are down more than 3 percent, trading at $60.52.
