On March 2, 2021 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 will host a conference call with Dr. Neal Shore, medical director of the Carolina Urologic Research Center who will provide a clinical perspective on Vicineum, Sesen Bio’s product candidate for the treatment of high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) (Press release, Sesen Bio, MAR 2, 2021, View Source [SID1234575962]). In addition, members of the management team will provide a corporate update. The conference call is scheduled for Monday, March 15, 2021 at 8:00 a.m. ET.
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Neal Shore, M.D., FACS is the medical director of the Carolina Urologic Research Center and is an internationally recognized expert in Urologic Oncology. Dr. Shore is a practicing Urologist at the Atlantic Urology Clinic and he is the National Director of Urology Research for the 21st Century Oncology. He has conducted more than 350 clinical trials, including over 200 trials in bladder cancer, and serves on the Boards of the Duke Global Health Institute, the Society of Urologic Oncology and the Bladder Cancer Advocacy Network. Dr. Shore has authored over 200 peer-reviewed publications and founded both the CUSP Clinical Trials Consortium and DASHKO, large urology practices data registries. A graduate of Duke University and Duke University Medical School, Dr. Shore completed a 6-month clinical research fellowship in Pretoria, South Africa, and then completed his General Surgery/Urology training at New York Hospital Cornell Medical Center and at Memorial Sloan Kettering Cancer Center in New York City. He is a Fellow of the American College of Surgeons. Dr. Shore is a paid consultant to Sesen Bio and served as a clinical investigator for the Phase 2 and Phase 3 clinical trials of Vicineum for NMIBC.
To participate in the conference call, please dial (844) 831-3025 (domestic) or (315) 625-6887 (international) and refer to conference ID 2441628. The webcast can be accessed in the Investor Relations section of the company’s website at www.sesenbio.com. The replay of the webcast will be available in the investor section of the company’s website at www.sesenbio.com for 60 days following the call.
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 in the follow-up stage of a Phase 3 registration trial in the US 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. 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 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.