On December 4, 2019 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, reported the successful completion of a constructive Type B pre-BLA meeting with the FDA regarding the final Chemistry, Manufacturing and Controls (CMC) content of the Company’s Biologics License Application (BLA) for Vicinium (Press release, Sesen Bio, DEC 4, 2019, View Source [SID1234551923]). As previously announced, the Company expects to initiate the submission of the BLA for Vicinium in December 2019.

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"After four highly collaborative and productive meetings with the FDA in 2019, we feel increasingly confident in the regulatory path forward for Vicinium," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio.

Sesen Bio reached agreement with the FDA on the final content of the BLA and no further meetings were requested by the FDA at this time. The Company also gained a clear understanding of the FDA’s requirements for the process performance qualification (PPQ) campaign for bulk drug substance and drug product manufacturing. In addition, the Company continues to work in partnership with the FDA to accelerate the timing of the Pre-License Inspection (PLI) of the drug substance manufacturer, which is anticipated to expedite review of the BLA.

Additional details on regulatory progress in support of the potential approval of Vicinium are expected to be announced this December.

Key December 2019 Events

Anticipated initiation of BLA submission under a Rolling Review
Sesen Bio Regulatory Update
About Vicinium
Vicinium, 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). Vicinium 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. Vicinium 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 Vicinium 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 Vicinium promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. The activity of Vicinium in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.