On March 8, 2021 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, reported that on Friday, March 5, 2021 the Company submitted its Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Vicineum1 for the treatment of high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) under the EMA’s centralized procedure (Press release, Sesen Bio, MAR 8, 2021, View Source [SID1234576243]).
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The MAA is supported by the pivotal Phase 3 VISTA trial data, which the Company believes demonstrates a strong risk-benefit profile. In addition, the Company believes the chemistry, manufacturing and controls (CMC) data confirms the analytical comparability between clinical and commercial supply.
"Europe represents one of the largest regions in terms of unmet need for patients with NMIBC," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "The submission of the MAA in Europe marks an important milestone as we continue toward the goal of making this potential best-in-class treatment available to patients globally. I would like to thank the Sesen Bio team and our regulatory partners for their execution excellence and tireless dedication to help save and improve the lives of the patients we serve. We will continue working collaboratively with the EMA to move Vicineum through the regulatory process as expeditiously as possible."
In Europe, bladder cancer is the fifth most commonly diagnosed cancer with about 124,000 new cases per year, and it ranks ninth in cause of death with approximately 40,000 deaths per year. Approximately 80% of these patients are diagnosed with NMIBC, of which many will initially be treated with BCG and at least 50% of patients will experience disease recurrence. If BCG is not effective or a patient can no longer receive BCG, the recommended treatment option is radical cystectomy, the complete removal of the bladder. If approved in Europe, Vicineum would be the first product approved for patients with high-risk, BCG-unresponsive NMIBC in over 20 years.
1The proprietary brand name, Vicineum is a corporate trademark which has been conditionally approved by the FDA. Final approval of the Vicineum brand name is conditional on FDA approval of the Company’s product candidate, oportuzumab monatox. Sesen Bio is currently going through the tradename approval process with the EMA for oportuzumab monatox.
About Vicineum
Vicineum, a locally administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of high-risk, 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 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 in the follow-up stage of a Phase 3 registration trial in the US for the treatment of high-risk, BCG-unresponsive NMIBC in patients who have previously received a minimum of two courses of bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. In February 2021, the FDA accepted for filing the Company’s BLA for Vicineum for the treatment of high-risk, BCG-unresponsive NMIBC and granted the application Priority Review with a Prescription Drug User Fee Act (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. The activity of Vicineum in high-risk, BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.
About Non-Muscle Invasive Bladder Cancer
There are approximately 440,000 new cases of bladder cancer each year globally, and approximately 80 percent of patients have non-muscle invasive bladder cancer (NMIBC). In NMIBC, cancer cells are in the lining of the bladder or have grown into the lumen of the bladder but have not spread into muscle or other tissue. NMIBC primarily affects men and is associated with carcinogen exposure. Initial treatment includes surgical resection; however, there is a high rate of recurrence and many patients diagnosed with NMIBC will receive bacillus Calmette-Guérin (BCG) immunotherapy. While BCG is effective in many patients, challenges with tolerability have been observed and many patients will experience recurrence of disease. Additionally, there is an ongoing chronic, global shortage of BCG, which puts a tremendous pressure on doctors, patients and the FDA. If BCG is not effective or a patient can longer receive BCG, the recommended option for treatment is radical cystectomy, the complete removal of the bladder.