First Patient Dosing achieved in Mainland China in a Phase II Multi-regional clinical trial (MRCT)
SHANGHAI, Oct. 12, 2018 /PRNewswire/ -- I-Mab Biopharma ("I-Mab"), a company focusing on innovative biologics in immuno-oncology and immuno-inflammation, today announced that the first patient in mainland China has been dosed in a phase II clinical trial of TJ301 for the treatment of ulcerative colitis (UC) at the Division of Gastroenterology, the First Affiliated Hospital of Sun Yat-sen University in Guangdong, China.
TJ301 is a phase II, randomized, double-blind, placebo-controlled study conducted in multiple sites among Mainland China, South Korea and Taiwan area to evaluate the safety and efficacy of TJ301 administered intravenously in patients with active ulcerative colitis.
TJ301 is a selective IL-6 blocker. It works through a novel trans-signaling mechanism without interacting with either IL-6 or IL-6R individually. This mechanism of action is unique and different from other anti-IL6 or anti-IL6R products that block all actions of IL-6. TJ301 is expected to have a better safety profile as compared to the existing IL-6-based biologics. Through a licensing agreement with Ferring at the end of 2016, I-Mab holds exclusive rights to TJ301 for further development and commercialization in Greater China and South Korea.
Ulcerative Colitis (UC) is a chronic inflammatory bowel disease whose etiology and pathogenesis are unknown. Common clinical symptoms are diarrhea, bloody stools and abdominal pain. Although there are no definitive epidemiological data available for Mainland China, it is believed that the incidence of UC is about 11/100,000. At present, the clinical management of the disease in Mainland China mainly involves glucocorticoids and 5-aminosalicylic drugs.
"UC represents a significant unmet medical need in Mainland China. We are thrilled to test this investigational medicine in the current clinical study which has already enrolled a number of patients in Taiwan and South Korea and now the first patient in Mainland China. It is always our goal to provide better medicines through new drug discovery and development," said Dr. Joan Shen, Head of R&D.
Facilitated by a merger between Third Venture Biotech and Tasgen Bio, which was followed by a Series B financing of USD 150 million in 2017, I-Mab has rapidly built a highly experienced team with world-class R&D capabilities. On June 29, 2018, I-Mab announced that it had successfully raised US$220 million in Series C financing with a group of reputable investors led by Hony Capital, representing one of the largest amounts ever raised in Series C by an innovative biotech company in China.
I-Mab focuses on discovery and development of First-in-Class and Best-in-Class biologics in the areas of immuno-oncology and immuno-inflammation. The company has already initiated a Phase 2 clinical trial and is prepared to submit multiple IND applications for additional clinical trials in China and the US, including Phase 2 and Phase 3 studies. www.i-mabbiopharma.com.
SOURCE I-Mab Biopharma