▎WuXi AppTec Content Team Report

Today (October 9), the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced,ImmuXell Biotech's Class 1 New Drug IX001 TCR-T Injection Granted Clinical Trial Implied Permission, Intended Indication Under DevelopmentThe genotype isHLA-A*11:01Advanced pancreatic cancer with positive expression of tumor antigen KRAS G12V。Pancreatic cancer is known as the "King of Cancers" due to its high mortality rate and difficulty in treatment.According to the public information from ImmuXell Biotech, this is the company's first product under development to enter the registration clinical trial stage.TargetingKRAS  G12VMutant TCR-T Cell Therapy。

Screenshot source:CDE Official Website

Following the advent of KRAS G12C inhibitors, scientists have also shifted their focus and interest to otherKRASMutant.The study found that,KRAS G12VIt is the most common type of mutation in pancreatic cancer, providing a breakthrough for scientists to tackle the "king of cancers."

Public information shows,IX001 TCR-T Injection isThe most advanced product in ImmuXell Biotech's R&D pipeline.This product uses gene modification technology to specifically identifyKRAS G12VMutated TCR gene sequences are transferred into T cells, enabling them to precisely recognize 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-acting treatment options for pancreatic cancer patients.

Previously, Dr. Hu Hongming, founder of ImmuXell Biotech, was interviewed by the content team of WuXi AppTec.InterviewIt was once pointed out,KRAS is an intracellular target, and developing therapies for such targets is extremely challenging.TCR-T, as a novel therapy, can not only recognize surface antigens but also target intracellular antigens that are difficult for antibodies and small molecules to reach.. As an immunotherapy, TCR-T therapy exhibits stronger proliferation and persistence of cytotoxic cells in vivo, as well as enhanced tumor infiltration capabilities. Therefore, the development of targetedKRASMutated TCR-T therapy is expected to bring new effective treatment options for refractory solid tumors such as pancreatic cancer.

ImmuXell Biotech is a clinical-stage biopharmaceutical company with main products being novel immune cell therapies targeting solid tumors. The long-term goal is to developA series of TCR products for treating recurrent and refractory malignant tumors such as pancreatic cancer. In November 2023, the company announced the completion of an over 100-million-yuan Series A financing round. In addition to TCR-T cell therapy, the company's R&D pipeline also includes TCR-NK products under development that can serve as allogeneic cell therapies, as well as TCR fusion protein (TCR-ICE) products under development that can be mass-produced as off-the-shelf therapies.

TargetingKRAS G12VMutation,According to publicly available information,Currently, there are more than ten drug projects targeting this site in clinical research stages globally, most of which are TCR-T cell therapies.Other preclinical projects also include types such as small molecules, targeted protein degradation chimeras, and fusion proteins.

At the same time, the research field of TCR-T cell therapy is also developing rapidly.In August this year, the US FDA granted Adaptimune's TCR-T therapy under researchafami-celFor the treatment of specific adult patients with synovial sarcoma, this is alsoThe First Treatment for Solid TumorsTCR-T cell therapy. Meanwhile, there are multiple TCR-T cell therapy is under development, with advanced products covering targets including HPV E7, MAGEA4, EBV, NY-ESO-1, HBV, etc., and is being developed for the treatment of various solid tumors such as nasopharyngeal carcinoma and liver cancer.

[2] ImmuXell Biotech Official Website.  From https://www.immuxell.cn/Clinicalcenter