Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, today announced it will be featured as a presenting company at the Canaccord Genuity "Horizons in Oncology" virtual conference on April 15, 2021. Sesen Bio will be represented by Dr. Thomas Cannell, President and CEO of Sesen Bio, who will provide a regulatory and commercial readiness update, and by Dr. Michael Jewett, FRCSC, FACS, a member of Sesen Bio’s CEO Medical advisory board, who will provide clinical insights on the Company’s lead product candidate, Vicineum™, for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).
Michael A. S. Jewett, MD, FRCSC, FACS is a renowned Oncologist who is internationally recognized for his life-saving innovations in surgical oncology, his advocacy of patient-centered clinical care, and his contributions to research in the field of bladder cancer. Dr. Jewett is currently a professor in the Departments of Surgical Oncology and Surgery (Urology) at the Princess Margaret Cancer Centre, University Health Network and the University of Toronto. A graduate of Queen’s University, Faculty of Medicine, Kingston, Ontario, Canada, where BCG for bladder cancer was first prescribed, Dr. Jewett completed his Urology training at the University of Toronto, Canada and Memorial Sloane-Kettering Cancer Center in New York. Dr. Jewett has played a prominent role in national and international consensus statements, including as a committee chair for the International Consultation on Bladder Tumors in 2004 Consensus. He has appeared before the FDA as an expert including the presentation that led to the historic approval of BCG for NMIBC. Dr. Jewett has published more than 400 peer-reviewed papers, mostly in Uro-oncology and in technology assessment and medical informatics. Dr Jewett was a member of the inaugural Medical Advisory Board of the Bladder Cancer Advocacy Network (BCAN). He is an Honorary Member of the American Urological Association (AUA) and the European Association of Urology (EAU) and has been a visiting professor in more than 40 institutions and associations. In December 2020, Dr. Jewett was appointed to the Order of Canada based on his achievements listed above, among others. Dr. Jewett is a paid consultant to Sesen Bio and served as a clinical investigator for the Phase 1 and Phase 2 clinical trials of Vicineum for NMIBC.
Event: Canaccord Genuity "Horizons in Oncology" Virtual Conference
Date: April 15, 2021
Time: 9:00 – 10:00 AM ET
To participate in the event please contact your Canaccord Genuity representative.
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 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 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 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.
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 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 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 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 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 BCG unresponsive NMIBC, and other factors discussed in the "Risk Factors" section of the Company’s Annual Report on Form 10-K, 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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Erin Clark, Vice President, Corporate Strategy & Investor Relations