Junshi Biosciences Announces First-in-Human Dosing of Global First Anti-BTLA Monoclonal Antibody JS004 in Phase I Clinical Trial

Recently, Junshi Biosciences announced that the first patient has been dosed in the Phase I clinical study (NCT04137900) of its independently developed global first-in-class anti-tumor BTLA monoclonal antibody (project code “TAB004/JS004”). This study aims to evaluate the safety, tolerability, and pharmacokinetics of JS004 in patients with advanced unresectable or metastatic solid tumors (including lymphoma) and in patients who are resistant to PD-1 antibodies.

TAB004/JS004, a recombinant humanized anti-BTLA monoclonal antibody injection independently developed by Junshi Biosciences, is the first anti-tumor BTLA monoclonal antibody globally to receive clinical trial approval. It is also the second independently developed investigational product with full proprietary intellectual property rights from Junshi Biosciences to obtain Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA), following its anti-PD-1 monoclonal antibody, toripalimab.

Studies have shown that JS004 can promote the proliferation of tumor-specific T lymphocytes and enhance lymphocyte function, reducing tumor burden and improving survival rates in BTLA-humanized mouse tumor models. It is expected to be used in combination with the company’s independently developed toripalimab to further enhance the proliferation of tumor-specific T cells and the production of anti-tumor cytokines, providing more combination therapy options for a broad patient population.

NCT04137900 is a multicenter, open-label, Phase I clinical study conducted in the United States to evaluate the safety and tolerability of an anti-BTLA monoclonal antibody injection in patients with advanced unresectable or metastatic solid tumors (including lymphoma) and in patients with resistance to PD-1 antibodies. The study plans to enroll 144 subjects.

Dr. Yao Sheng, Vice President of Junshi Biosciences, stated, “There are numerous unmet clinical needs in the field of oncology treatment. We look forward to bringing more possibilities to cancer immunotherapy through our anti-BTLA monoclonal antibody. Meanwhile, we plan to apply for clinical trials of this drug in China, so that this ‘global first-in-class’ medicine can benefit Chinese patients as soon as possible.”

About the Anti-BTLA Monoclonal Antibody TAB004/JS004

BTLA is an important immune checkpoint molecule discovered in 2003 that is expressed on activated T and B lymphocytes. In tumors such as lung cancer, melanoma, colorectal cancer, and lymphoma, tumor cells can inhibit the immune function of lymphocytes by highly expressing HVEM (the ligand for BTLA), which then binds to BTLA expressed on tumor-specific cytotoxic lymphocytes. Studies have found that blocking the BTLA immune checkpoint molecule can further improve lymphocyte function. Especially when used in combination with anti-PD-1 monoclonal antibodies, it may further enhance the efficacy of immune checkpoint blockade therapy and expand the population benefiting from immunotherapy. The clinical trial application for TAB004/JS004 in patients with advanced unresectable or metastatic solid tumors (including lymphoma) and patients resistant to PD-1 antibodies was approved by the U.S. Food and Drug Administration in April 2019.

Regarding the NCT04137900 Study

NCT04137900 is a multicenter, open-label, Phase I clinical trial conducted in the United States to evaluate the safety and tolerability of recombinant humanized anti-BTLA monoclonal antibody injection in patients with advanced unresectable or metastatic solid tumors (including lymphoma) and in patients with PD-1 antibody resistance. The study plans to enroll 144 subjects. The primary endpoints are safety and adverse events; secondary endpoints include objective response rate, disease control rate, duration of response, and pharmacokinetics.

About Junshi Biosciences

Junshi Biosciences (NEEQ: 833330, HKEX: 01877) was founded in December 2012 by a team of graduates from prestigious universities in China and the United States, with extensive experience in cross-border technology transfer and industrialization.

Junshi Biosciences focuses on the development of therapeutic antibodies, specializing in the research, development, and industrialization of innovative monoclonal antibody drugs and other therapeutic protein drugs. The company boasts a robust pipeline of products under development, including 17 innovative drugs and two biosimilars. It is the first Chinese company to receive marketing approval from the National Medical Products Administration (NMPA) for an anti-PD-1 monoclonal antibody. Additionally, it was the first domestic company to obtain NMPA approval for Investigational New Drug (IND) applications for anti-PCSK9 and anti-BLyS monoclonal antibodies. Furthermore, Junshi Biosciences secured the world’s first FDA IND approval for an anti-BTLA blocking antibody for cancer treatment. Currently, the company employs over 1,000 people worldwide, with offices in San Francisco and Maryland in the United States, as well as Shanghai, Suzhou, Beijing, and Guangzhou in China.