I-Mab (NASDAQ: IMAB) has announced that China’s National Medical Products Administration’s Centre for Drug Evaluation has approved its IND application to start the second phase study of enoblituzumab (TJ271) combination with KEYTRUDA (pembrolizumab) in solid tumors that include urothelial carcinoma (UC), non-small cell lung cancer (NSCLC) and other cancers in China. In addition, the company has obtained exclusive rights from MacroGenics (NASDAQ: MGNX) to develop and commercialize enoblituzumab across greater China.
Phase 2 to evaluate enoblituzumab combination with pembrolizumab
The efficacy of the combination of enoblituzumab and pembrolizumab will be evaluated in phase 2 clinical trial in China. Based on earlier MacroGenics investigations, the trial has been designed as a “basket” clinical trial in patients with UC, NSCLC, and other cancer types. In prior trials, combined therapy has been shown to have anti-tumor activity in recurrent or metastatic NSCLC and squamous cell carcinoma of the head and neck.
The company’s president Dr. Andrew Zhu said, “The initiation of the phase 2 clinical trial will accelerate the clinical development of enoblituzumab in China. Enoblituzumab has become a key player against various advanced cancers and one of the company’s core clinical assets. We are excited about the initiation of this clinical study and expect to bring this valuable compound to cancer patients with critical unmet medical needs.”
MacroGenics evaluating enoblituzumab with retifinalimab
MacroGenics is now evaluating enoblituzumab in conjunction with retifanlimab (PD-1 antibody) or tebotelimab (PD-1 & LAG-3 bispecific DART® molecule) in patients with recurrent or metastatic SCCHN in a phase 2 study.
B7-H3, a member of the B7 family of immune regulator proteins, is the target of Enoblituzumab, an experimental Fc-optimized monoclonal antibody. Many distinct tumor forms express B7-H3, which could play a function in modulating the immune response to different types of cancer. In patients with B7-H3-expressing malignancies, enoblituzumab has been or is currently being studied in clinical studies as a monotherapy or in combination with anti-PD-1-based treatments. MacroGenics sold I-Mab the development and marketing rights for Greater China.