June 25, 2019，Gaithersburg, MD, I-Mab Biopharma (“I-Mab”), a clinical stage biotech company exclusively focusing on discovery and development of innovative biologics in immuno-oncology and autoimmune diseases, announces on June 24, 2019 that the first patient has been dosed in a Phase I clinical trial of TJC4. The study is known as TJ011133 (NCT Number: NCT03934814). TJC4 is a differentiated fully human CD47 monoclonal antibody internally developed for the treatment of advanced malignant tumors. The study is intended to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of TJC4 in patients with advanced solid tumors and lymphoma when administered as a single agent and in combination with other cancer treatment agent(s).
“TJC4 is the second drug candidate from I-Mab’s proprietary innovative pipeline to enter clinical studies in the US. Compared to other clinical stage CD47 antibodies, TJC4 is designed to improve the hematologic safety profile while exerting strong anti-tumor activities. It has the potential to be a best-in-class drug.” Dr. Joan Shen, Head of R&D at I-Mab noted. “We aim to rapidly advance the clinical development of TJC4 and validate its designed advantages in the treatment of solid tumors and hematological malignancies around the world.”
Horizon Oncology Center dosed the first patient in the Phase 1 clinical trial of TJC4. Wael A. Harb, MD, Chief Medical Officer of Verdi Oncology & Director of Clinical Research of Horizon Oncology Center, commented, “I-Mab’s TJC4 is a promising and differentiated CD47 antibody, which is supported by data from I-Mab’s pre-clinical studies. We are excited to participate in this important clinical study.”
About CD47 and TJC4
CD47 is a glycoprotein over-expressed in a wide variety of cancers and delivers a “don’t eat me” signal to tumor-engulfing macrophage through its ligand known as SIRPα. Blockade of CD47 by TJC4 enables macrophage to engulf cancer cells as a potential treatment option for cancers. TJC4 also known as TJ011133 is a differentiated CD47 monoclonal antibody and designed to minimize inherent binding to normal red blood cells by this class of monoclonal antibodies yet preserve its strong anti-tumor activities. TJC4 recognizes a unique epitope on CD47 and exhibits a minimal binding to red blood cells. The hematologic safety advantage of TJC4 has been demonstrated in a series of robust pre-clinical and toxicological studies including those in cynomolgus monkeys, while it maintains superb anti-tumor activities.
I-Mab is a dynamic and fast-growing global biotech company focusing on developing innovative biologics drugs of first-in-class and best-in-class potential in the therapeutic areas of immuno-oncology and autoimmune diseases. I-Mab’s pipeline of clinical and pre-clinical stage drug candidates is driven by the company’s Fast-to-PoC (Proof-of-Concept) and Fast-to-Market development strategies through internal R&D capabilities and global partnerships. I-Mab’s vision is to address unmet medical need through drug innovation in the target therapeutic areas in China and the world. The company is on track to become an end-to-end fully integrated biopharma and is well-recognized by capital markets to have successfully raised approximately USD 380 million in the past three years. Its recent USD 220 million Series C financing represents one of the largest amounts ever raised by a biotech company in China. For more information, please see the Company's website at www.i-mabbiopharma.com.