▎WuXi AppTec Content Team Report

On July 12, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced,ImmuXell Biotech's applicationIX001 TCR-T InjectionClinical Trial Application (IND) Accepted for Review. According to ImmuXell Biotech's public reports, this is the company’s first product under development to enter the registration clinical trial stage.TargetingKRAS  G12VMutant TCR-T Cell Therapy,This product is being developed for the treatment of pancreatic cancer, known as the "king of cancers."

Screenshot source:CDE Official Website

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 develop a series ofTCR Products for the Treatment of Recurrent and Refractory Malignant Tumors such as Pancreatic Cancer. The company announced in November 2023 that it had completedOver 100 Million Yuan in Series A Financing。

Public information shows,IX001 TCR-T Injection isThe fastest progressing product in ImmuXell Biotech's R&D pipeline.This novel TCR-T cell therapy product has previously completed TCR screening, in vitro functional validation, and in vivo efficacy testing, and has been advanced across multiple clinical centers forAdvanced Pancreatic Ductal AdenocarcinomaThe investigator-initiated clinical study (IIT). This clinical application in China marks a significant advancement for this innovative therapy.

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, persistence, and tumor infiltration capabilities of cytotoxic cells in vivo, holding the potential to improve survival time and quality of life for patients with solid tumors. Therefore, the development of targetedKRASMutated TCR-T therapy is expected to bring an effective treatment for refractory solid tumors such as pancreatic cancer.

It is reported that the main indications targeted by ImmuXell Biotech's products arePancreatic Cancer, initially focusing on the KRAS target, and in the future, it hopes to develop new cell processes to improve the accessibility of cell therapies. In additionIn addition to TCR-T cell therapy, ImmuXell Biotech's product pipeline also includes allogeneic cell therapy products.TCR-NK Product, as well as being suitable for mass production and immediate supply.TCR Fusion Protein (TCR-ICE) Product。

It is worth mentioning that,Following the emergence of KRAS G12C inhibitors, scientists have also shifted their focus and interest to otherKRASMutant.And the study found that,KRAS G12VIt is the most common type of mutation in pancreatic cancer, providing a breakthrough for scientists to crack the "king of cancers."According to public information,Currently, globally targetingKRAS G12VThere are at least 20 drug projects under research for mutations, of which only six have entered the clinical stage, and all are TCR-T cell therapies.Other preclinical projects also include drug types such as small molecules, targeted protein degradation chimeras, and fusion proteins.

The research field of TCR-T cell therapy is also developing rapidly. In February this year, the U.S. FDA granted Adaptimmune's investigational TCR-T therapy afami-celPriority Review Eligibility, if approved, is expected to become the first treatment for solid tumorsTCR-T Cell Therapy. In addition, there are more than a hundred TCRs worldwide-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