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Bj-001 is the world's first tumor targeting IL-15 fusion protein independently developed by Boji biology and has a global patent. Its ingenious design not only overcomes the shortcoming of short half-life of recombinant IL-15, but also enables it to α v β 3, α v β 5 and α v β Integrin 6 is enriched in tumors with high expression, which has the potential to reduce systemic toxicity and enhance curative effect. Many tumors, such as non-small cell lung cancer, head and neck cancer, gastric cancer and pancreatic cancer, have overexpression of these integrins. Therefore, bj-001 is expected to become another rookie in tumor immunotherapy, benefiting many tumor patients with high integrin expression.
"The successful completion of the first patient's first administration of bj-001 in the United States is a small step in the clinical development of bj-001 project, but it is also a key step. It is an important milestone in the global clinical development of bj-001." Dr. zhanghaizhou, co-founder and CEO of Boji biology, said, "our clinical application in China is also proceeding as planned. It is expected that we will soon be approved by China's food and drug administration. Next year, we will carry out clinical trials in China, so as to accelerate the global clinical development of bj-001 and benefit the majority of tumor patients at home and abroad as soon as possible."
The ongoing clinical trial in the United States is an open phase 1A trial in patients with locally advanced / metastatic or recurrent / refractory solid tumors. In the early stage, the accelerated dose escalation design was used, and then the traditional 3+3 dose escalation design was used to evaluate the safety and tolerability of bj-001 to determine the MTD and the recommended phase II clinical trial dose (rp2d).
"We reached the important milestone of the first patient's first administration only about 3 months after receiving the notice from FDA that clinical trials can be carried out. In particular, we screened the first patient 3 days after the center was activated. This speed is still very rare in the industry." Ms. Yu Jing, vice president of clinical development of Boji biology, commented, "This is definitely a successful case of efficient team work. In the past three months, team members from Boji biology, cro and next oncology have worked hard and worked together to ensure the completion of this important milestone. Here, on behalf of the company, I would also like to express my heartfelt thanks to these members, including the patient. Without you, we could not have reached this important milestone."
"So far, we have not seen any adverse events including cytokine release syndrome." Said Dr. Raghad Abdul Karim of next oncology, the main investigator of this experiment.
Bj-001 is the world's first tumor targeting IL-15 fusion protein independently developed by Boji biology and with global intellectual property rights. The domain contains α v β 3、 α v β 5 and / or α v β The IL-15 structure of tumor cells with high expression of integrin such as IL-6 can be compared with that of il-2/15r expressed on immune cells (especially NK and T cells) βγ C receptor complex can activate immune system and kill tumor. This design of bj-001 endows it with the ability of species aggregation in the tumor microenvironment, so that it has the potential to reduce systemic toxicity and enhance curative effect. In addition, the effect of IL-15 on lymphocyte proliferation in the local tumor also has the potential to turn the "cold tumor" that does not respond to the current commonly used immunosuppressants such as anti-PD-1 antibody into a reactive "hot tumor", which will greatly improve the efficiency of existing tumor immunotherapy drugs and benefit more patients. Therefore, the tumor targeting IL-15 of Boji biomedicine is expected to become another rookie in tumor immunotherapy, with huge social and market potential, benefiting patients all over the world.
About cosmopolitan biology
Boji biology is a biotechnology company dedicated to the research and development of innovative drugs. It was founded by overseas experts with many years of experience in the research and development of innovative drugs at home and abroad, including experts in the major special review of national "major new drug creation" science and technology. It has an antibody discovery platform protected by trade secrets and top technologies at home and abroad. At present, it mainly researches and develops biological drugs for tumors and infectious diseases. The main scientific research and management team of the company has many years of experience in R & D and management of antibody drugs in domestic and foreign R & D companies and national key scientific research institutions, especially in European and American multinational companies. With a global view of R & D and based on strong capital support, Boji bio has made a global layout of R & D from a global perspective since its inception. At the same time, it has two R & D laboratories in San Francisco, USA and Hangzhou, China, which enable the company to achieve an all-round collection of talents, technology, management and capital markets at the initial stage of entrepreneurship, laying a solid foundation for the company's global positioning and development. It has been established for only 2 years and has become a cutting-edge biotechnology company in China. For more details, please browse: www.bjbioscience.com