On July 26, 2021 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, reported that it has completed its commercial build phase in preparation for the anticipated launch of Vicineum, if approved, in the US, and has advanced to the implementation phase that will focus on executing the Company’s commercial strategy for Vicineum. The Biologics License Application (BLA) for Vicineum, the Company’s lead program, is currently under Priority Review with the Food and Drug Administration (FDA) for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) in the US, with a target Prescription Drug User Fee Act (PDUFA) date of August 18, 2021.
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"We are thrilled to have this experienced commercial team on board at Sesen Bio to build capabilities as we approach the potential commercial launch of Vicineum in the US market," said Patricia Drake, chief commercial officer of Sesen Bio. "They have made incredible progress across the core functions of sales, marketing and market access. We also believe our network of Urology and Uro-oncology KOL speakers will play an integral role in allowing us to educate their peers about Vicineum, which we believe will be a new tool in their practices to serve a large unmet medical need in NMIBC."
The Company has completed the hiring of ~25 talented internal employees to support the Company cross-functionally, as well as the hiring of 34 of 35 sales representatives as part of the contract sales organization, which will be deployed across four customer-centric regions and will target approximately 2,000 high-prescribers of BCG to drive awareness, trial and adoption of Vicineum for the treatment of BCG-unresponsive NMIBC. If approved, promotional efforts will begin immediately, and the Company expects Vicineum product to be commercially available to physicians and patients in the fourth quarter of 2021.
In addition to building its sales force, as part of Sesen Bio’s national speaker programs, the Company has identified and commenced training of 14 KOL speakers to engage physicians and educate them on Vicineum for the treatment of BCG-unresponsive NMIBC.
Upon product availability, the Company will utilize a two-pronged market access strategy to ensure maximum coverage for Vicineum. The Company anticipates strong product reimbursement achieved through the deployment of a focused team of National Account Executives (NAEs) who will call on key commercial and Medicare payers. The Company will also provide support to eligible patients with a reimbursement services and support center, which will help with benefit investigation, prior authorizations, a co-pay assistance program, and any other support resources they may require along their journey.
The Company believes it remains on track for an FDA decision on its BLA for Vicineum by the target PDUFA date August 18, 2021.
About Vicineum
Vicineum, a locally administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of BCG-unresponsive 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 to the antibody binding fragment until it is internalized by the cancer cell. This fusion protein design 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 in the follow-up stage of a Phase 3 registration trial in the US for the treatment of BCG-unresponsive NMIBC. In February 2021, the FDA accepted for filing the Company’s BLA for Vicineum for the treatment of BCG-unresponsive NMIBC and granted the application Priority Review with a target PDUFA date of August 18, 2021. 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. For this reason, 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.