Sesen Bio Announces Conference Call with Neal Shore, M.D., FACS to Provide Clinical Perspective on the Company’s Lead Product Candidate Vicineum™
Sesen Bio (Nasdaq: SESN) announced a conference call on March 15, 2021, at 8:00 a.m. ET to discuss Vicineum, its drug for high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). Dr. Neal Shore, an expert in Urologic Oncology, will provide insights on Vicineum's clinical perspective. The FDA accepted Sesen's BLA for Vicineum and granted it Priority Review, with a PDUFA date set for August 18, 2021. Sesen Bio retains global rights to Vicineum, except in Greater China and MENA. The company is monitoring potential COVID-19 impacts on operations.
- FDA granted Priority Review for Vicineum's BLA, enhancing prospects for regulatory approval.
- Dr. Neal Shore's involvement brings credibility and expertise to Vicineum's clinical perspective.
- Sesen Bio retains worldwide rights to Vicineum outside of Greater China and MENA, allowing for broader market potential.
- Uncertainty exists regarding the potential impact of COVID-19 on business operations and commercialization efforts.
Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, today announced 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). 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.
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.
About Sesen Bio
Sesen Bio, Inc. is a late-stage clinical company advancing targeted fusion protein therapeutics for the treatment of patients with cancer. 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 non-muscle invasive bladder cancer (NMIBC). 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. Sesen Bio retains worldwide rights to Vicineum with the exception of Greater China and the Middle East and North Africa (MENA), for which the Company has partnered with Qilu Pharmaceutical and Hikma Pharmaceuticals, respectively, for commercialization. Vicineum is a locally administered targeted fusion protein composed of an anti-EpCAM antibody fragment tethered to a truncated form of Pseudomonas Exotoxin A for the treatment of high-risk BCG-unresponsive NMIBC. For more information, please visit the company’s website at www.sesenbio.com.
COVID-19 Pandemic Potential Impact
Sesen Bio continues to monitor the rapidly evolving environment regarding the potential impact of the COVID-19 pandemic on our Company. The Company has not yet experienced any disruptions to our operations as a result of COVID-19, however, we are not able to quantify or predict with certainty the overall scope of potential impacts to our business, including, but not limited to, our ability to raise capital and, if approved, commercialize Vicineum. Sesen Bio remains committed to the health and safety of patients, caregivers and employees.
Cautionary Note on Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for the Company, the Company’s strategy, future operations, and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the timing for the FDA’s decision on the Company’s BLA for Vicineum for the treatment of high-risk, BCG unresponsive NMIBC based on the FDA granting the BLA Priority Review and the PDUFA date of August 18, 2021, the impact of COVID-19 on the Company, including its ability to raise capital, and, if approved, its ability to commercialize Vicineum for the treatment of high-risk, BCG unresponsive NMIBC, and other factors discussed in the “Risk Factors” section of the Company’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other reports filed with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company’s views as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof.
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