SHANGHAI, China, November 1, 2018 – Asieris Pharmaceuticals, a clinical-stage pharmaceutical company, today announced the appointment of Gail L. Brown, M.D., to the position of Acting Chief Medical Officer. Dr. Brown will be responsible for the clinical development programs for the company’s pipeline of genitourinary oncology and reproductive health products, including the lead product candidate APL-1202 for the treatment of non-muscle invasive bladder cancer.
“Gail has a proven track record of successfully leading the development of a number of drug candidates from phase 1 to pivotal phase 3 studies, both in the US and internationally. Her leadership and extensive experience add breadth and depth to our executive team as we accelerate the global clinical development of products in our pipeline, particularly of APL-1202 under our recently granted IND in the US,” said Kevin Pan, Ph.D., Co-Founder and Chief Executive Officer.
Dr. Brown has 25 years of clinical research and development experience in designing and conducting phase 1 through phase 3 international clinical trials. Most recently, Dr. Brown was Chief Medical Officer at ARMO Biosciences, Inc. (NASDAQ: ARMO), which was recently acquired by Eli Lilly for US$1.6 billion. At ARMO, she built a clinical operations department, advanced their lead product AM0010 from phase 1 to Phase 3 for advanced metastatic pancreatic cancer, and led two successful End of Phase-2 (Type B) FDA meetings. Previously, she served as Chief Medical Officer at Telik, Inc. (NASDAQ: TELK) and a senior medical director at AbbVie. Earlier in her career, Dr. Brown consulted for a number of oncology start-up companies and participated in their scientific and clinical advisory boards. Dr. Brown began her career at Harvard Medical School, where she served on the faculty of the Department of Medicine, Division of Hematology and oncology at Brigham and Women’s Hospital, New England Deaconess Hospital, and Dana Farber Cancer Institute. She holds a M.D. degree from the University of Rochester School of Medicine, and a M.B.A. degree from St. Mary’s College of California Graduate School of Economics and Business Administration.
About Asieris Pharmaceuticals
Asieris Pharmaceuticals was founded in March 2010 at the China Medical City located in Taizhou, Jiangsu Province. It is the only China-based, globally oriented innovative drug research and development company devoted to genitourinary oncology and related diseases. Asieris Pharmaceuticals aspires to becoming the most innovative and influential, most respectable and trustworthy pharmaceutical company in its therapeutic areas of focus. The company has new drug discovery, clinical operations (domestic and international), regulatory affair, CMC, quality, business development, and other departments, as well as proprietary new drug discovery platform for anti-tumor/anti-multidrug resistance. Asieris has staff and operations in Shanghai, Taizhou of Jiangsu, Beijing, and the United States.
Asieris’ strategy is to focus on diseases of the genitourinary system and quickly command a leadership position in this field after laying a solid foundation. Through the “twin engine” of ”proprietary R&D” and “in-licensing”, the company aims to maximize the global values of proprietary and with breakthrough potential first-in-class therapies. This organic growth strategy is supplemented with in-licensing late-stage or marketed products from overseas for the China market. Asieris believes this “twin engine” model will enhance the diversification and synergy of its product pipeline, and accelerate the establishment of its leadership position in the domestic market.
The incidence of bladder cancer ranks first among domestic urological tumor diseases, second only to prostate cancer in western countries, and with an increasing trend. Among bladder cancer patients, about 80% are non-muscle invasive bladder cancer (NMIBC). The current standard of care for NMIBC is Trans-Urethral Resection of Bladder Tumor (TURBT), followed with intravesical chemotherapy or immunotherapy. However, NMIBC has a recurrence rate as high as 70% after surgery, and the intravesical therapies are painful and may result in drug resistance. Radical cystectomy is the standard treatment for high-risk NMIBC patients who have failed intravesical therapies, resulting in significant deterioration of a patient’s quality of life. There has been no new drug approved for this disease for more than two decades; therefore, there is an urgent and highly unmet medical need. Asieris’ proprietary APL-1202 has a novel mechanism of action, thereby holds the promise of filling this therapeutic gap for the treatment of NMIBC.
In the completed Phase II clinical trial, APL-1202 has shown significant efficacy for the treatment of NMIBC patients who have relapsed from intravesical chemotherapy, and with excellent safety profile. The results have been presented at the 2016 European Association of Urology (EAU) Munich Annual Meeting and at the 2017 Chinese Clinical oncology Society (CSCO) Annual Meeting, and received international attentions. APL-1202 is currently in registration trial in China. The global clinical development of APL-1202 has also been initiated following the recently granted IND by the US FDA, which marks an important milestone in Asieris’ path to globalization.
As Asieris’ leading drug, APL-1202 has received a number of government grants, noticeably the “National 12th Five-Year Major New Drug Innovation Programs” and “National 13th Five-Year Major New Drug Innovation Programs”. It is expected to be the world’s first oral medication for the treatment of NMIBC.