Sesen Bio, a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, has entered into a commercial manufacturing and supply framework agreement—CMO Agreement—with the company’s partner in China, Qilu Pharmaceutical.
 
Under the CMO Agreement, Qilu will be part of the contract manufacturing network for global commercial supply of Vicineum. The company’s lead program, Vicineum, is currently in the follow-up stage of a Phase 3 registration trial in the U.S. for the treatment of high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). The company is on track to complete the BLA for Vicineum and submit to the FDA later this month.
 
In July 2020, the company and Qilu entered into an agreement which grants Qilu an exclusive license to develop, manufacture and commercialize Vicineum in China.
 
“NMIBC is a disease area that has chronically suffered from manufacturing and CMC issues with significant impacts on patient care,” said Thomas Cannell, president and chief executive officer, Sesen Bio. “Given this, we have taken a thoughtful approach to our supply chain and partnerships in order to meet the significant anticipated global demand for Vicineum. Qilu has a large and experienced manufacturing team and currently supplies products for commercial sale around the world. The CMO Agreement represents an exciting expansion of our strong partnership with Qilu and will help Sesen Bio to reliably meet the projected global demand, while also creating an opportunity to reduce the cost of goods.”
 
The company believes that the technology transfer to Qilu for manufacturing of Vicineum is on track to be completed in mid-2021. Upon completion of the technology transfer, Sesen Bio is entitled to receive a $2 million milestone payment.
 
In addition to Fujifilm and Baxter, the CMO partnership with Qilu expands the company’s network of world-class partners committed to providing reliable supply of Vicineum around the world.