On October 19, 2020 Sesen Bio (Nasdaq:SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, reported that the Company has selected Cardinal Health as its exclusive provider for third-party logistics (3PL) and specialty pharmaceutical distribution services related to the commercial distribution of Vicineum in the United States (U.S.) (Press release, Sesen Bio, OCT 19, 2020, View Source [SID1234568654]). The Company’s lead program, Vicineum, also known as VB4-845, is currently in the follow-up stage of a Phase 3 registration trial for the treatment of high-risk, BCG-unresponsive NMIBC. In December 2019, the Company initiated the BLA submission for Vicineum to the U.S. Food and Drug Administration (FDA) under Rolling Review.

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Cardinal Health will provide comprehensive end-to-end 3PL, order-to-cash management and specialty pharmaceutical distribution services to Sesen Bio in support of commercialization in the U.S. The Cardinal Health 3PL Services facility in LaVergne, Tennessee is strategically located on the same site as the company’s specialty pharmaceutical distribution operations and is also in close proximity to a major FedEx shipping hub, which simplifies and mitigates risk in supply chain operations.

Cardinal Health has deep experience in urology, as it currently serves over 10,000 specialty clinics in the U.S. and has relationships with more than 1,600 U.S.-based Urologists, which will bring great value to Sesen Bio.

"Cardinal Health is an industry-leading warehouse operator and distributor of specialty pharmaceuticals with an extensive oncology portfolio, including Uro-oncology," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "Partnering with Cardinal Health for both 3PL and specialty pharmaceutical distribution services provides us with an integrated distribution solution. In addition to Fujifilm and Baxter, the Cardinal Health relationship completes the selection of major supply chain partners in support of the commercial distribution of Vicineum. We are now confident that the supply chain will be ready to support the potential commercial launch of Vicineum in mid-2021."

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.