Actinium Pharmaceuticals, Inc. has entered into a manufacturing supply agreement with Goodwin Biotechnology, Inc., under which Goodwin will oversee cGMP production of Iomab-B, a monoclonal antibody for an upcoming Phase III trial in patients preparing for bone marrow transplant.
“This agreement with Goodwin represents a major risk mitigation step in conducting our Phase III trial of Iomab-B,” said Kaushik J. Dave, president and chief executive officer of Actinium. “Goodwin has significant experience in working with companies like ours and the capabilities to provide the scale-up needed for a late-stage clinical trial. Goodwin’s competencies in process and product implementation, quality assurance, and GMP manufacturing make it ideally suited as a manufacturing partner for Actinium as we look forward to launching this pivotal phase 3 trial later this year.”
“We are very excited to be working with Actinium on Iomab-B, their lead product candidate,” said Karl Pinto, chief executive officer of Goodwin. “Actinium’s cutting edge proprietary platform is able to target different types of cancers that are without any approved treatment options. We look forward to a long-term partnership with Actinium, not only on Iomab-B, but hopefully also on other products in their pipeline such as Actimab-A.”