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I-Mab Announces Dosing of First Patient in a Phase I Clinical Trial of TJC4

June 26, 2019 By americanpharmaceuticalreview

I-Mab Biopharma announced 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).

I-Mab Announces Dosing of First Patient in a Phase I Clinical Trial of TJC4

"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," said Dr. Joan Shen, Head of R&D at I-Mab. "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.

"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," Wael A. Harb, MD, Chief Medical Officer of Verdi Oncology & Director of Clinical Research of Horizon Oncology Center, said.

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.

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