-A Potential Global First-in-Class Long-Acting Recombinant IL-7 Immunotherapy
SHANGHAI, China, Mar. 5, 2019 – I-Mab Biopharma (I-Mab), a China-based clinical stage biopharmaceutical company exclusively focused on the development of innovative biologics in immuno-oncology and autoimmune diseases, today announced that the first patient has been dosed in a phase 1b/2a clinical study in China to evaluate TJ107 (HyLeukin), a long-acting Interleukin-7 fusion protein, in patients with advanced solid tumor. I-Mab in-licensed HyLeukin from Genexine Inc. (KOSDAQ: 095700) and has exclusive rights to TJ107 for development and commercialization in China, Hong Kong, Macao and Taiwan.
The phase 1b trial is a multi-center, dose escalation study to investigate the safety, tolerability, pharmacokinetic and pharmacodynamic properties of TJ107 as a monotherapy in approximately 58 patients with advanced solid cancers . In addition to the anti-tumor activity, the effect on the generation and the function of the lymphocytes will be evaluated in the study.
The cytokine IL-7 plays a critical role in hematopoiesis and the immune system. It is expected to be a promising companion with the available T-cell related cancer immunotherapy as well as an efficient solution to correct the status of lymphopenia seen in a majority of cancer patients undergoing chemotherapy and radiotherapy. Currently there is no FDA-approved drug for lymphopenia. According to Frost & Sullivan, more than 85% of all cancer patients typically adopt chemotherapy and radiotherapy, which may translate into potentially substantial unmet medical needs.
“With the initiation of this phase 1b study of TJ107 to treat cancer patients, we now have seven clinical stage programs, which demonstrated our clinical development capabilities,” said Dr. Joan Shen, M.D., Head of R&D at I-Mab. “By leveraging Genexine’s ongoing clinical efforts in TJ107, we expect to rapidly advance the development of TJ107 for Greater China markets.”
“After determining the appropriate doses in the phase 1b trial, we expect to start a phase 2a trial on TJ107 in combination with anti-PD-1 or anti-PD-L1 antibodies in cancer patients who do not respond adequately to immune checkpoint inhibitors, due to its immuno-boosting property,” Shen said.
Genexine has conducted a first-in-human phase 1 trial in South Korea, in which TJ107 demonstrated excellent safety and pharmacological effects. I-Mab received the investigational new drug (IND) approval from the China National Medical Products Administration in October 2018 to initiate clinical studies in China mainland.
I-Mab is a dynamic and fast-growing China-based global player exclusively focused on developing potential first-in-class and/or best-in-class biologics in the areas of immuno-oncology and autoimmune diseases through internal R&D capabilities and global partnerships. I-Mab’s pipeline is driven by the company’s development strategy to address unmet needs in China and to bring innovative assets to the world. The company is prepared to submit additional INDs in order to initiate clinical trials in China and the U.S., including multiple Phase 2 and Phase 3 studies. I-Mab is on a fast track toward becoming an end-to-end fully integrated biopharma company. The company has been well-recognized by capital markets by successfully raising approximately USD 370 million within 12 months, with its USD 220 million Series C financing in July 2018 representing one of the largest amounts ever raised by an innovative biotech company in China. www.i-mabbiopharma.com