On May 16, 2018 Eleven Biotherapeutics, Inc. (Nasdaq: EBIO), a late-stage clinical company developing next-generation antibody-drug conjugate (ADC) therapies for the treatment of cancer, reported that the company is changing its name to Sesen Bio, Inc. Sesen Bio will trade under the new Nasdaq ticker symbol "SESN," effective on May 17, 2018 (Press release, Eleven Biotherapeutics, MAY 16, 2018, View Source [SID1234526820]). The former ticker symbol "EBIO" will remain effective through the market close on May 16, 2018. The new website for Sesen Bio is www.sesenbio.com.
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Additionally, the company announced the appointments of Hagop Youssoufian, M.Sc., M.D. as senior medical advisor and Madhu Anant M.Sc., Ph.D., RAC as vice president of regulatory affairs.
"Over the last several years, we have undergone an incredible transformation as a company, and our new name, Sesen Bio, reinforces this evolution and our focused commitment to oncology drug development. Sesen, an ancient symbol of the lotus flower, represents life and our mission to bring forward medicines that will improve and preserve the lives of those with devastating cancers," said Stephen Hurly, president and chief executive officer of Sesen Bio. "The additions of Dr. Youssoufian and Dr. Anant further strengthen our leadership team and drug development capabilities as we work to bring our lead asset, Vicinium, through Phase 3 development for high-grade non-muscle invasive bladder cancer and advance regulatory interactions. 2018 is set to be a significant year for Sesen Bio, as we are well on our way to achieving our vision and bettering the lives of people in need."
Dr. Youssoufian joins Sesen Bio as senior medical advisor with more than 25 years of physician and drug development experience. He has spent over a decade serving as a consultant to more than 100 biotech companies and investment funds, acting in various roles including chief medical officer, clinical monitor and regulatory officer. In his career, Dr. Youssoufian has led a successful U.S. Food and Drug Administration advisory committee meeting and worked on numerous approved treatments, including Sprycel, Taxotere, Erbitux, Cyramza and Lartruvo. Prior to Sesen Bio, Dr. Youssoufian served as chief medical officer for Bind Therapeutics, where he was responsible for all clinical and regulatory programs, including interactions with key opinion leaders, investors and analysts; executive vice president of research and development for Progenics Pharmaceuticals; president of research and development and chief medical officer for Ziopharm Oncology; and chief medical officer at ImClone-Lilly. Dr. Youssoufian earned his M.D. and M.Sc. from the University of Massachusetts Medical School. He is a medical oncologist and geneticist and an elected member of the American Society for Clinical Investigation.
Dr. Anant brings more than 35 years of experience to her role as vice president of regulatory affairs at Sesen Bio. Prior to joining Sesen Bio, she served as the vice president, global regulatory affairs, hospital products for Mallinckrodt Pharmaceuticals where she was responsible for all regulatory activities including, strategy, health authority liaisons and regulatory pathways for development of products. Prior to Mallinckrodt, Dr. Anant served as an independent consultant in numerous roles including, head of regulatory affairs and lead strategist in regulatory affairs, clinical development and medical affairs. Earlier, she served as director, global regulatory sciences, geographic optimization for Bristol-Myers Squibb. There, she led the global regulatory strategies for geographic optimization of mature brands in the cardiovascular, metabolic, anti-infective and oncology therapeutic areas. Dr. Anant earned her Ph.D. from the International University for Professional Studies and her M.Sc. from the Institute of Science in Nagpur, India.
About Vicinium
Vicinium, also known as VB4-845, is Sesen Bio’s lead product candidate and is a next-generation antibody-drug conjugate (ADC), developed using the company’s proprietary Targeted Protein Therapeutics platform, for the treatment of high-grade 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 (ETA). Vicinium is constructed with a stable, genetically engineered peptide linker 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 studies 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-grade NMIBC in patients who have previously received two courses of bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. Three-month data from the ongoing trial are planned for presentation at the 2018 American Urological Association Annual Meeting on May 21, 2018, with 12-month data anticipated in mid-2019. Additionally, Sesen Bio believes that Vicinium’s cancer cell-killing properties 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.