Laureate Pharma, Inc. has entered into a biopharmaceutical development and manufacturing agreement with Bradmer Pharmaceuticals, Inc. for process development and cGMP manufacture of the monoclonal antibody precursor of Neuradiab, Bradmer's candidate for treatment of brain cancer. The project is well underway and Laureate expects to supply Bradmer with product by the end of this year. Terms of the agreement were not disclosed.
"We are excited to apply our experience and expertise in monoclonal antibody development and production to Bradmer's important new clinical candidate for patients that suffer from brain cancer," said Robert J. Broeze, Ph.D., president and chief executive officer of Laureate Pharma. "Our relationship with the management of Bradmer and its potential new cancer therapy meets our strategic objective of working with innovative partners and products."
"Neuradiab has been evaluated in multiple Phase I and Phase II trials conducted by Duke University for the treatment of GBM. More than 160 patients have safely received Neuradiab treatment and the results have clearly demonstrated the important clinical benefit of this product," said Mark C. Rogers, M.D., chief executive officer of Bradmer. "Our partnership with Laureate Pharma is a crucial step in our manufacturing strategy and our plans to initiate a multi-center clinical trial over the next year."
Neuradiab is a monoclonal antibody used to treat glioblastoma multiforme (GBM), the most common and deadly form of brain cancer. In a recent Phase II trial of newly diagnosed GBM patients, Neuradiab used in combination with the current standard therapy, extended median survival by 42% to 91 weeks compared with 64 weeks for a historical control group. Bradmer intends to initiate a multi-center clinical trial at U.S. GBM treatment sites across the country late this year or early in the first quarter of 2007.