Minnesota partnership advances potential multiple sclerosis therapy

A production laboratory founded by the Minnesota Partnership has transferred its first potential therapy, a medication for multiple sclerosis, to a processing plant in Minnesota. This step will complete purification of material to fully enable translation from preclinical to clinical development.

The antibody known as rHIgM22, developed at Mayo Clinic, was produced and purified in the Biotherapeutic Protein Production Laboratory created by a Partnership infrastructure award in 2006. This laboratory was developed within the Molecular and Cellular Therapeutics Facility on the St. Paul campus of the University of Minnesota. The therapy is under license to Acorda Therapeutics, Inc. (NASDAQ: ACOR), which is supporting the development of this potential therapy. This includes the Minnesota Partnership’s transfer of remaining production and purification to Biovest, Inc., in Minneapolis.

"The preclinical success and the promise of this program to date have only enhanced our commitment to the continued advancement of this potential new therapy for people with multiple sclerosis," says Ron Cohen, M.D., Acorda president and CEO. "The Partnership has provided a mechanism for academic and commercial institutions to work together effectively in the early stages of developing a promising and innovative therapeutic approach to a very challenging condition."

The importance of the antibody as a promoter of myelin repair (remyelination) was recognised in studies using experimental animal models of multiple sclerosis. The studies were directed by Moses Rodriguez, M.D., a Mayo Clinic neurologist. Multiple sclerosis is a progressive disease, caused by damage to the myelin sheath that surrounds nerves. It can affect the brain and the spinal cord, leaving patients permanently disabled. The rHIgM22 antibody initiates the regrowth or repair of the damaged myelin sheath but has yet to be tested in patients.

The initial synthetic production of the therapeutic antibody was developed in the laboratory of Larry Pease, Ph.D., chair of immunology at Mayo. Early stage process development was also performed in collaboration with Acorda Therapeutics. The Partnership facility subsequently developed production of the antibody into a validated process that can be used to produce antibody for patient studies. John Wagner, M.D., at the University of Minnesota, and Dr. Pease were the principal investigators on the Minnesota Partnership grant. The grant established the protein production facility with the mission of providing good manufacturing technical support to investigators at the University of Minnesota and Mayo Clinic to move laboratory advancements into clinical trials. The developmental work on this antibody at the protein production facility was funded by philanthropic gifts from the Eugene Applebaum Family Foundation, the Conrad N. Hilton Foundation, and anonymous benefactors.

"The Minnesota Partnership was instrumental in providing the infrastructure to develop this monoclonal antibody to this point," says Dr. Pease. "This antibody would not be headed into clinical studies or toward commercialisation otherwise."

"This is exactly what the Partnership is intended to do," says program director Eric Wieben, Ph.D. "That is to promote interactions between the two leading medical research institutions in Minnesota and to accelerate medical discoveries that can be commercialised for the benefit of patients while improving our state’s economy."

(Source: Mayo Clinic: April 2008)