International Circuit
RemeGen Announces US FDA Clearance Of IND Application To Initiate Phase II Clinical Trial In Urothelial Cancer
RemeGen today announced that the US Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application to initiate its US-based Phase II clinical trial of RC48 (disitamab vedotin), a novel humanized anti-HER2 antibody drug conjugate (ADC), for the treatment of HER2 positive metastatic or unresectable urothelial cancer (UC).
RemeGen previously presented topline data from its China-based Phase II clinical trial for RC48 at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting. The data showed significant anti-tumor activities in a number of HER2-positive UC cancer patients, making it the first potential targeted, biologic therapy for HER2+mUC in a disease state with no new treatments in nearly 20 years.i
“An estimated 81,400 new cases of urothelial cancer will be diagnosed in the United States in 2020,ii” said Jianmin Fang, Ph.D., founder and CEO of RemeGen. “RemeGen is committed to decreasing this number and helping fulfill the unmet medical need for patients. Thanks to the clearance from the FDA, we are one step closer to providing a novel treatment option for this devastating disease.”
UC is the most common type of bladder cancer, representing the ninth most common cancer worldwide and the fourth most common cancer in men in the United States.iii
The IND clearance for RC48’s first US-based trial arrives on the heels of RemeGen’s recently completed $100 million plus financing, led by Lilly Asia Ventures and Lake Bleu Capital.-PR Newswire
