MedImmune Inc. said Monday that it acquired worldwide rights to ananti-T cell monoclonal antibody that has been through Phase II trialsfor use in solid organ and bone marrow transplantation. The antibody,T10B9, was developed by the University of Kentucky ChandlerMedical Center.David Mott, vice president, business development and planning forMedImmune, told BioWorld that his company will make certainmilestone payments to the University of Kentucky, as well as payingroyalties on sales of any products. He said MedImmune, ofGaithersburg, Md., also will fund an ongoing research collaboration atthe university focusing on work related to T10B9 and on a second-generation humanized form of the molecule.In May, Phase II results of a 76-patient, four-year, blinded trial werepresented at the annual meeting of the American Society of TransplantPhysicians. The trial showed that T10B9 compared favorably to theonly commercially available monoclonal antibody for treatment ofgraft rejection in kidney transplant patients, Orthoclone OKT3, aproduct of Ortho Biotech Inc., of Raritan, N.J.MedImmune said it hopes to enter Phase III trials with the molecule fortreatment of kidney graft rejection in the second half of 1995."It [T10B9] complements both our scientific and medical expertise inthe monoclonal antibody field, where we have other products underdevelopment," Mott said. "In addition, it builds on our existing salesand marketing presence in the organ transplant center, where wecurrently market CytoGam," MedImmune's first product, which is usedfor the prevention of cytomegalovirus disease in kidney transplantpatients.The molecule currently is being evaluated in a Phase I trial as animmunosuppression induction agent in heart transplants, and has beenevaluated in clinical trials for treatment of graft rejection episodes inheart and liver transplant recipients. There also was a small Phase Istudy done with T10B9 as therapy for acute graft versus host disease,Moss said.Another MedImmune product being tested is RespiGam, which is inPhase III trials for the treatment and prevention of respiratory syncytialvirus (RSV) disease in children. Moss said MedImmune hopes to fileinvestigational new drug applications later this year for three potentialproducts _ a recombinant vaccine for Lyme disease, a humanizedmonoclonal antibody for RSV and a recombinant subunit vaccine forparvovirus B19 infection.In addition to CytoGam, MedImmune markets Zosyn in a co-promotional effort with Lederle Laboratories of Wayne, N.J., whichdeveloped the anti-infective. n
-- Jim Shrine
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