CSL and Vitaeris have entered into a strategic collaboration and purchase option agreement to expedite the development of clazakizumab (an anti-IL6 MAB, formerly ALD518) as a therapeutic option for solid organ transplant rejection.
Clazakizumab is a humanized, monoclonal antibody that binds to and inhibits Interleukin-6 (IL-6). IL-6 is an important driver of the inflammatory response and is known to play a key role in transplant rejection.
According to the terms of the agreement, Vitaeris will retain control of projects through end of Phase III. The organization will receive an upfront cash payment of US$15 million from CSL, followed by R&D milestone payments from CSL spanning several years. The agreement grants CSL an exclusive option to acquire Vitaeris, and includes future sales-related payments to Vitaeris, as well as a royalty to Alder BioPharmaceuticals, the innovator of clazakizumab.
"CSL is committed to developing therapies for patients with rare and life-threatening conditions. Vitaeris' transplant rejection program is complementary to CSL's current development activities in solid organ transplant. This is an exciting strategic alliance in an important area of unmet clinical need," Professor Andrew Cuthbertson, Chief Scientific Officer, CSL Limited, said.
Clazakizumab has been specially engineered to remove antibody-dependent cell- mediated cytotoxicity and complement-dependent cytotoxicity. Clazakizumab has been administered in clinical trials involving over one thousand patients and has performed well against safety and efficacy criteria with acceptable tolerability in autoimmune diseases.