Bintie Bio's IX001 TCR-T Injection Receives IND Approval in China for HLA-A*11:01+ KRAS G12V+ Advanced Pancreatic Cancer

Recently, according to the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration, ImmuXell Biotech's Class 1 new drug IX001 TCR-T injection has been granted tacit approval for clinical trials, with the proposed indication for development beingThe genotype isHLA-A*11:01Advanced pancreatic cancer with positive expression of tumor antigen KRAS G12V。

According to data released by the International Agency for Research on Cancer under the World Health Organization, it was estimated that there were over 490,000 new cases of pancreatic cancer globally in 2020, with more than 120,000 estimated new cases in China.In other words, one-quarter of the world's new cases of pancreatic cancer occur in China.

ImmuXell BiotechPublic information shows that IX001 TCR-T Injection is the fastest progressing product in ImmuXell Biotech's R&D pipeline. This product uses gene modification technology to transfer TCR gene sequences capable of specifically recognizing the KRAS G12V mutation into T cells, enabling them to precisely identify and effectively kill pancreatic cancer cells.Compared with traditional therapies, TCR-T therapy has higher specificity and stronger anti-tumor activity, providing low-toxicity and long-lasting treatment options for pancreatic cancer patients.

In August this year, the U.S. FDA approved Adaptimune's TCR-T therapy for clinical trials, becoming the first TCR-T therapy specifically targeting solid tumors, which has shown us more possibilities. In addition, other TCR-T therapies targeting different antigens are also under active development.Covering a variety of hard-to-treat solid tumors, such as nasopharyngeal cancer, liver cancer, etc.

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