Regent bioanty anti-Trap2 monoantial-Tub196 coupled agent JS108 completed the first patient drug

According to Mays Medical, Junshi Bio announced yesterday (November 25) that the first patient administration has been completed in Phase I clinical study (NCT04601285) of its products injected with recombinant humanized anti-Trap2 monoanti-Tub196 coupled agent (project code: JS108).
the study was designed to assess the safety, tolerance, and pharmacodynamic characteristics of JS108 for the treatment of patients with advanced solid tumors.
JS108 is a recombinant humanized anti-Trap2 monoanti-Tub196 coupled agent for injection.
Trop2 is an important tumor development factor, its high expression in a variety of tumors, such as breast cancer, stomach cancer, non-small cell lung cancer, small cell lung cancer, colon cancer, pancreatic cancer, etc., can promote tumor cell proliferation, invasion, metastasis and other processes, its high expression and tumor patients shortened survival and adverse prognostic closely related, so Trap2 as the target of anti-tumor drug research is of great significance.
2020, the JS108 clinical trial application was approved by the State Drug Administration.
years, tumor has become a major threat to the health of our people, so the creation of high-efficiency, low-toxic anti-tumor drugs, the national economy and people's livelihood, the urgent need for major innovation and breakthrough.
antibody drug conjugates (Antibody Drug Conjugates, ADCs), commonly known as "new biological missiles", are conjugated products of monoclonal antibodies and small molecules of anti-tumor toxicity, which form ADCs by chemical bonds to conjugate cytotoxic drugs with monoclonal antibodies, and use antibodies to specifically identify the properties of tumor cells, which can "accurately" transport toxic small molecules to tumor cells.
, antibody drug coupled agent in the tumor site to improve the drug concentration at the same time reduce the normal tissue, organ drug concentration, to achieve high-efficiency and low-toxic anti-tumor effect.
antibody drug association is one of the three frontier anti-cancer technologies, has been included in the National Development and Reform Commission "13th Five-Year Plan" for the development of the biological industry.
NCT04601285 study is an open, first phase I clinical study designed to evaluate the safety, tolerance, PK characteristics and effectiveness of JS108 for the treatment of patients with advanced solid tumors.
study was divided into three stages: dose increment stage, dose expansion stage and clinical development stage, and the three stages were planned to be divided into about 16-36 cases, 12-27 cases and 60-90 patients with advanced solid tumors.
- Complete - About JS108JS108 is an anti-tumor injection recombinant humanized anti-Trap2 monoanti-Tub196 coupled agent, is a recombinant humanized anti-Trap2 monoclonal antibody through the -base connection Tubulysin B analogue formed by the ADC class.
In accordance with the Pharmaceutical Development and Licensing Contract signed between Regency Bio and Hangzhou Multi-Jubilee Biotech Co., Ltd., Regency Bio obtains a license to use JS108 from Jubilee Bio through exclusive licensing and is responsible for its subsequent clinical trials, drug registration, commercial production and sales of JS108 in the licensed areas (all Asian countries and regions except Japan and Korea).
do jubilee creatures provide the necessary support for the subsequent development of monarchic organisms.
NCT04601285 Study NCT04601285 is an open, first phase I clinical study designed to evaluate the safety, tolerance, PK characteristics and effectiveity of JS108 for the treatment of patients with advanced solid tumors.
the study's main study endpoints were maximum to-dose (MTD), dose-limiting toxicity (DLT) events, adverse events (AE) occurrence and severity, and abnormal laboratory indicators.
secondary study endpoints were PK characteristics, immunogenicity, effectiveness, and Trop2 protein expression levels.
study was divided into three stages: dose increment stage, dose expansion stage and clinical development stage, and the three stages were planned to include about 16-36 cases, 12-27 cases and 60-90 patients with advanced solid tumors.
about the Regency Creatures (1877. HK, 688180 .SH) was founded in December 2012 as an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies.
has a wide range of products under development, including 26 innovative drugs and 2 biosypoles, covering five therapeutic areas, including malignancies, autoimmune diseases, chronic metabolic diseases, neurological diseases, and infectious diseases.
By virtue of the core platform technology of protein engineering, Junshi Bio is at the forefront of international large molecular drug research and development, and obtained the first domestic anti-PD-1 monoclonal antibody NMPA listing approval, domestic anti-PCSK9 monoclonal antibody NMPA clinical application approval, the world's first treatment tumor anti-BTLA blocking antibody in China NPA and the United States FDA clinical application approval.
This year, Junshi Bio also joined hands with domestic scientific research institutions to fight the epidemic, jointly developed JS016 as the first anti-neo-coronavirus monoclonal and antibody has entered clinical trials, with local innovation for China and the world's disease prevention and control contribution.
currently employs nearly 2,000 people worldwide in San Francisco and Maryland, Shanghai, Suzhou, Beijing and Guangzhou.
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