Sesen Bio Announces Commercial Manufacturing and Global Supply Partnership with Qilu Pharmaceutical

IndustryPRwire -- Sesen Bio announced that the Company entered into a commercial manufacturing and supply framework agreement (the “CMO Agreement”) with the Company's partner in China, Qilu Pharmaceutical Co., Ltd. (“Qilu”).

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 United States (“US”) 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 Dr. Thomas Cannell, president and chief executive officer of 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 $2M 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.

About Vicineum™

Vicineum, a locally administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of high-risk non-muscle invasive bladder cancer (NMIBC). Vicineum is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicineum is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently conducting the Phase 3 VISTA trial, designed to support the registration of Vicineum for the treatment of high-risk NMIBC in patients who have previously received a minimum of two courses of bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. Additionally, Sesen Bio believes that cancer cell-killing properties of Vicineum promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. The activity of Vicineum in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.

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