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Immunogen seeking phase I trial permission for antibody drug conjugate
Cambridge, Mass. biotech firm Immunogen has requested clearance from the FDA to launch Phase I clinical trials for the company's first fully-owned cancer product, currently known as IMGN529.
IMGN529 will be tested as a potential therapy against both non-Hodgkin's lymphoma and chronic lymphocytic leukemia if the FDA gives the company the green light.
IMGN529 is an antibody drug conjugate (ADC), bringing together a monoclonal antibody, which will do the work inside the body of tracking down specific B-cells that express the CD37 protein on the cell surface, and an anticancer agent called DM1 maytansinoid, which is attached to the antibody as a killer payload and, on delivery, kills the B-cells.
DM1 maytansinoid is the same anticancer agent used in trastuzumab-DM1, an ADC that uses trastuzumab (i.e. Herceptin) as its antibody and is currently in clinical trials as a treatment against breast cancer.
Immunogen is claiming that IMGN529 outperformed Genentech's blockbuster drug Rituxan—in animal studies.
Immunogen IMGN529 FDA press release
Immunogen's IMGN529 poster at the 2011 meeting of the American Association of Cancer Research.