Events:

The company has released the latest data on Osemitamab (TST001) combined with capecitabine and oxaliplatin (CAPOX) as advanced gastric or gastroesophageal junction (G/GEJ) cancer at the American Society of Clinical Oncology (ASCO) Annual meeting and the World Congress of Gastrointestinal Oncology (ESMO) in 2023.

Comments and viewpoints:

Osemitamab has excellent data and will successfully enter the third phase of the trial:

Osemitamab (TST001) is the second Claudin18.2 targeted antibody therapy candidate worldwide, developed by the company through its independently developed immune tolerance Breakthrough (IMTB) technology platform. Of the 49 patients in the 6mg/kg Q3W dose expansion group, 42 had measurable lesions and received at least one post-treatment tumor evaluation, of which 28 (66.7%) achieved partial remission, according to data presented at the ASCO annual meeting. The median duration of remission for 34 responders in all dose groups was 9.9 months, and the median progression-free survival was 9.5 months. Most of the adverse events (TEAE) occurred during the treatment were grade 1-2. Data at the annual meeting of ESMO: of the 49 patients who received 6 mg/kg dose treatment during the dose expansion phase, 41 patients were CLDN18.2 positive (9 high expression, 13 moderate expression, 19 low expression) and 8 patients did not have tumor detection (CLDN18.2 expression unknown). Of the 49 patients who received 6mg/kg dose treatment during the dose expansion phase, 42 patients had measurable lesions and received tumor evaluation after at least one treatment, and 28 patients (66.7%) achieved partial remission. As of April 21, 2023, 26 of the 64 patients developed disease progression or died, and the median progression-free survival (PFS) was 9.5 months.

Most of the adverse reactions were grade 1 to grade 2, which occurred in the first two courses of treatment. The data of efficacy and safety are excellent.

Osemitamab R & D progress is the first in China and the second in the world:

Osemitamab is expected to become the first Claudin18.2 targeted antibody therapy in China and the second in the world, covering gastric cancer or gastroesophageal junction cancer, pancreatic cancer, cholangiocarcinoma and other indications. Osemitamab was certified as an orphan drug for gastric cancer by FDA in July 2021. With excellent clinical data, we will successfully enter the phase III clinical trial. It is estimated that the market size of Claudin 18.2 inhibitors in the United States and China will reach US $1.8 billion and US $1.7 billion respectively in 2030, and US $4 billion and US $3.7 billion respectively in 2035. TST001 is a candidate drug for the second generation of Claudin18.2 targeted antibody therapy. With its high affinity, stronger ADCC effect and declaration in China and the United States, it has a broad market prospect in the treatment of gastric cancer, pancreatic cancer and cholangiocarcinoma.

The company's R & D strength is outstanding, and the product pipeline differentiation is obvious:

In the tumor pipeline, Osemitamab is a potential homologous optimal humanized antibody targeting Claudin18.2. TST005, a dual-functional humanized antibody targeting PD-1/PD-L1 and TGF- β pathway, is currently in clinical trials, showing better anti-tumor activity and tolerable safety in preclinical studies. TST003 is the first anti-Gremlin1 monoclonal antibody in the world to enter the clinic and is expected to become a first-in-class product. MSB0254 is a humanized VEGFR2 monoclonal antibody, which has completed the phase I study; in non-tumor pipeline, TST002 (Blosozumab) is used to treat osteoporosis. The company has outstanding R & D capability and rich pipelines, and is optimistic about the long-term development of the company.