GTC Biotherapeutics obtained exclusive, worldwide rights to recombinant human alpha-fetoprotein (rhAFP) for the treatment of autoimmune diseases from Merrimack Pharmaceuticals. This includes the nonglycosylated version of rhAFP known as MM-093.
GTC will receive an initial inventory of bulk drug substance for use in clinical studies. It will also assume control of the transgenic goats that express rhAFP in their milk, which were originally developed by GTC for Merrimack. GTC intends to further develop rhAFP through commercial partnering.
“The already established safety data and production capability, the published animal disease models, and access to sufficient drug substance make rhAFP an attractive candidate for partnering discussions to support further development and commercialization, potentially as a Phase II product candidate,” comments Geoffrey F. Cox, Ph.D., GTC’s chairman and CEO.
Published studies of rhAFP and AFP derived from cord blood indicate that the recombinant form could be as effective in treating multiple sclerosis as the native form that occurs during pregnancy, according to GTC. Further studies of rhAFP in multiple sclerosis or myasthenia gravis may begin at the proof of concept Phase II level of evaluation.