Tianjing Bio-B7-H3 monoclonal antibody was approved for Phase 2 clinical trials in China

Tianjing Bio (NASDAQ: IMAB) announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China has formally approved ebrotuzumab (also known as TJ271) and pembrolizumab (Keytruda) Phase 2 clinical trial of combined treatment of solid tumors (including non-small cell lung cancer, urothelial cancer and other tumor types)
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According to the agreement reached between the company and MacroGenics (Nasdaq stock code: MGNX), Tianjing Biotech has the exclusive rights to develop and commercialize ebrotuzumab in Mainland China, Hong Kong, Macau, and Taiwan
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Ebutuximab is a differentiated monoclonal antibody targeting B7-H3 with Fc optimization function
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B7-H3 is widely expressed in many different types of tumors and plays a key role in regulating the anti-tumor immune response.
Its high expression is associated with poor tumor prognosis
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Preclinical studies have shown that Ebutuximab achieves anti-tumor effects through dual mechanisms of antibody-dependent cell-mediated cytotoxicity and enhanced T cell immune response
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Dr.
Zhu Xiuxuan, President of Tianjing Bio, said: "Ebrtoximab is China's first B7-H3 antibody in the clinical development stage.
As one of the core clinical pipeline products of Tianjing Bio, it has the potential to treat a variety of advanced cancers
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The approval of the Phase 2 clinical trial is exciting.
We will quickly advance its clinical development and expect this innovative drug to bring breakthroughs to the current status of cancer treatment and benefit the majority of cancer patients as soon as possible
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” This Phase 2 clinical trial is one This "basket->
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Previous clinical studies carried out by MacroGenics showed that the combination of Ebutuximab and PD-1 monoclonal antibody for the treatment of recurrent/metastatic non-small cell lung cancer and head and neck squamous cell carcinoma has good anti-tumor activity
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At present, MacroGenics is also carrying out a phase 2 phase 2 of ebrolizumab combined with retifanlimab (PD-1 monoclonal antibody) or tebotelimab (PD-1 x LAG-3 double antibody) for the first-line treatment of head and neck squamous cell carcinoma Clinical research
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About Ebutuximab Ebutuximab is a monoclonal antibody that targets B7-H3 in the B7 family of immunomodulatory proteins and has an Fc-optimized function
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B7-H3 is widely expressed in many different types of tumors and plays a key role in regulating anti-tumor immune response
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Relevant clinical trials have been or are underway to evaluate the efficacy of Ebutuximab as a single-agent therapy or in combination with CTLA-4 or PD-1 in the treatment of tumors with overexpression of B7-H3
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According to the agreement reached between Tianjing Biological and MacroGenics, Tianjing Biological has the exclusive right to develop and commercialize Ebutuximab in Mainland China, Hong Kong, Macau and Taiwan
.