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product, rituximab (Rituxan), according to Junius. Rituxan, first approved by the FDA in 1997, is a so-called “naked” antibody, which zeroes in on cancer cells, but which isn’t attached to a more potent toxin.
“We do think we have attributes with this [ImmunoGen] antibody that would potentially make it superior as a naked agent,” Junius says. And the company is boosting its compound’s cancer-killing ability further with its technology that links the toxin to the antibody.
ImmunoGen plans to file an Investigational New Drug (IND) application with FDA for permission to begin its first clinical trial of the compound by the middle of this year in patients with non-Hodgkin’s lymphoma, according to Junius. He declined to disclose the specific molecular target that the compound is supposed to home in on to treat lymphomas.
Yet Junius did say that the target for the other compound, IMGN853, is a protein known as folate receptor 1 that is found in breast, lung, and ovarian tumors. One thing he highlighted was that the compound’s linker component not only keeps the antibody and the toxin intact in the circulation but also might play a role in preventing cancer cells from developing resistance to the treatment over time. The plan is to begin initial human testing of the compound next year in patients with a variety of tumor types, as is common in Phase I trials for cancer drugs.
While Junius is emphasizing the firm’s internal programs, Roche/Genentech’s T-DM1 is much further along in clinical development than ImmunoGen’s wholly-owned compounds. And Roche is now planning to apply for marketing approval of T-DM1 in the U.S. and Europe in mid-2012 for patients who have breast cancer that expresses HER2 gene and who have failed to respond to a previous therapy, according to ImmunoGen. The compound would provide ImmunoGen, which has no products on the market, its first major revenue from drug sales.
Yet the company’s analysts are quite familiar with the T-DM1 story by now, and already have sketched out how much money ImmunoGen stands to collect from royalties of T-DM1 sales around the world. Today, ImmunoGen wants to tell them about its younger prospects, which could generate a lot of money for ImmunoGen if they can prove over time they offer as much benefit to patients as T-DM1.