RemeGen Announces US FDA Clearance of IND Application to Initiate Phase II Clinical Trial in Urothelial Cancer
The IND announcement marks an important milestone for the first US-based trial for RemeGen’s leading ADC treatment
YANTAI, China, (April 29, 2020) – 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.
RC48 was developed to treat HER2 expressing solid tumors. It has a novel antibody with a higher affinity to HER2 compared to standard of care, and superior anti-tumor activity compared to other treatments in animal models. RC48 was the first ADC drug approved for human clinical trials in China and favorable safety profile has been observed in clinical trials. It is currently being studied in multiple late-stage clinical trials across solid tumor types.
RemeGen, Ltd. (“RemeGen”) is a leading biopharmaceutical company in China dedicated to fulfilling unmet medical needs for patients with life-threatening conditions. RemeGen's main focus is research and development, manufacturing and commercialization of novel biologics, most notably monoclonal antibodies (mAb) and antibody-drug conjugates (ADCs). Headquartered in Yantai, Shandong Province, China, RemeGen has labs/offices in Beijing and California. Since its inception in 2008, RemeGen has created more than 10 novel drug molecules that are in various stages of clinical development. Currently, there are two products in late stage clinical development in China to treat autoimmune and oncology indications.
For more information about RemeGen, please visit: www.remegen.com
Certain of the statements made in this press release are forward-looking, such as those, among others, relating to the possible utility or application of the Company's technologies to develop therapeutic agents, therapeutic potential of investigational agents, and future development activities including clinical trials. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the difficulty and uncertainty of pharmaceutical product development, including the risks that RemeGen, Ltd. may experience delays in its planned clinical trial initiations or otherwise experience failures or setbacks in its preclinical and clinical development programs due to the potential lack of efficacy or risk of adverse events as RemeGen, Ltd.'s product candidates advance in development or other factors. These factors include those discussed in RemeGen, Ltd.'s public reports are available by contacting Dan Ross at firstname.lastname@example.org. RemeGen, Ltd. disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
i Nagayama, A., Ellisen, L.W., Chabner, B. et al. Antibody-drug conjugates for the treatment of solid tumors: clinical experience and latest developments. Targ Oncol. 2017;12:719-739.
ii National Cancer Institute. Cancer Stat Facts: Bladder Cancer. 2020. Available at https://seer.cancer.gov/statfacts/html/urinb.html
iii Nature.com. Scientific Reports. The Global Epidemiology of Bladder Cancer. 2018. Available at https://www.nature.com/articles/s41598-018-19199-z.pdf?origin=ppub