Bintie Bio's IX001 TCR-T Achieves Partial Response in Just 28 Days in First Patient with Advanced Pancreatic Cancer: Phase I Clinical Data Disclosed

(Source: Arterial New Medicine)

Recently, it was reported that the IX001 TCR-T injection independently developed by ImmuXell Biotech LtD. (hereinafter referred to as "ImmuXell Biotech") received approval from the CDE in October 2024 to conduct a Phase I clinical trial for the treatment of advanced pancreatic cancer. Currently, the first subject has successfully completed enrollment, dosing, and dose-limiting toxicity (DLT) observation.

On March 27, 2025, the Phase I clinical trial of "IX001 TCR-T Injection," independently developed by ImmuXell Biotech, was officially launched. The launch meeting was chaired by President Ruihua Xu of the Sun Yat-sen University Cancer Center. Director Yuhong Li, the principal investigator of the project, and Director Danyun Ruan of the Phase I ward led the professional team members in attendance. In-depth discussions were held on the research protocol, testing, and project plans for the clinical trial of IX001 TCR-T Injection in treating recurrent or refractory pancreatic cancer. Detailed communication took place regarding specific workflows and key considerations in the execution of the clinical trial.

IX001 TCR-T Injection is a cell therapy product independently developed by ImmuXell Biotech, with independent intellectual property rights. It is used to treat advanced pancreatic cancer with the genotype HLA-A*11:01 and positive expression of the tumor antigen KRAS G12V, offering a potential new treatment option for patients with advanced solid tumors.

Currently, the safety data of IX001 TCR-T injection is good and shows very positive preliminary efficacy, laying a solid foundation for the advancement of subsequent clinical trials.

01.

In Just 28 Days! First Patient Achieves Partial Response

The first enrolled patient was a 62-year-old male diagnosed with pancreatic ductal adenocarcinoma in August 2022. After three lines of standard treatments proved ineffective and his disease progressed, he was enrolled in the IX001 TCR-T clinical trial. The research team discovered a KRAS G12V mutation in his tumor and confirmed the expression of a matching HLA subtype through genetic testing technology. After preparing the IX001 TCR-T injection targeting the G12V mutation in a GMP-grade production facility, the patient received a single infusion of TCR-T cells following lymphodepletion.

The patient received a single infusion of TCR-T cells and continuous injection of IL-2, and was discharged smoothly one week later. As of now, the patient has been followed up for two months post-infusion. Clinical results show: good safety, stable vital signs, normal organ function indicators, with only fever occurring during IL-2 injection. The lymphodepletion-induced reduction in blood cells recovered rapidly within one week. No common side effects of cell therapy such as Grade 2 or higher cytokine release syndrome (CRS) or neurotoxicity were observed, and no DLT was noted.

As detected by flow cytometry, TCR-T cells rapidly expanded in the patient's body, reaching a peak on day 7, then gradually declining, with significant cell persistence still detectable on day 56. The tumor marker CA19-9 began to decrease significantly 7 days after infusion and returned to normal levels from a baseline of 889 U/mL within just 28 days.

Imaging examination after one month showed:Significant reduction in target lesions in the hepatic hilar region, and near-complete disappearance of target lesions in the lungs., the sum of target lesion diameters decreased from 67mm at baseline to 43mm (a reduction of 35.8%), which, according to RECIST 1.1 criteria, has reached partial response (PR); imaging examinations after two months showed: the tumor lesion remained at PR, and the sum of target lesion diameters further reduced to 35mm (a reduction of 47.8%).

02.

Higher Specificity + Stronger Anti-Tumor Activity, IIT Clinical Trials Already Show Promise

ImmuXell Biotech Ltd. was founded in 2021 as a biotechnology company focused on TCR-T cell therapy for solid tumors and is currently in the clinical stage. ImmuXell Biotech specializes in the independent discovery of TCRs that recognize tumor gene mutations (KRAS) and promotes the technical optimization and clinical application of TCR-T cell therapy.

The IIT clinical research conducted in the early stage of the company has shown the preliminary efficacy and safety of TCR-T cell therapy for various solid tumors, demonstrating the great potential of TCR-T in the field of solid tumors. The company has a highly skilled team led by several senior experts in the field of cell therapy, with the ability to rapidly develop and translate from basic laboratory discoveries to clinical applications. Since its establishment, the company has applied for several patents related to its core business, been selected as a "National Science and Technology SME," and, as the leader of a sub-project, received the 2023 National Key Research and Development Program.Frontier Biotech"Technology" joint application project, as a corporate partner participating in the 2025 Major Special Project of the National Health Commission of China "Clinical Research on Systemic Treatment Strategies for Liver Cancer Based on Individualized Precision Assessment."

On June 28-29, 2025, the 2nd Huaxia Cancer Immunotherapy New Technology Forum and the 2025 Annual Meeting of the Chinese International Exchange Promotion Association for Medical and Healthcare (CIEPAMH) - Tumor Immunotherapy Branch were successfully held in Zhengzhou. Dr. Hongming Hu, Chief Scientist of ImmuXell Biotech, was invited to attend the forum and delivered a presentation focusing on TCR-T cell therapy technology as the main direction for new technology showcases. Meanwhile, ImmuXell Biotech was awarded the "First Prize" in the 2nd New Technology Showcase for Cancer Immunotherapy.

Dr. Hu Hongming stated that TCR-T therapy has unique advantages in the treatment of solid tumors, targeting intracellular antigens that traditional antibody drugs cannot reach. The "IX001 TCR-T Injection" 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 offers higher specificity and stronger anti-tumor activity.

Shanghai ImmuXell Biotech will adhere to the development philosophy of "innovation, cooperation, and win-win," working hand in hand with global partners in the biopharmaceutical field to jointly promote the innovation and development of tumor cell immunotherapy technologies, extend the survival period of patients with relapsed and refractory tumors, and achieve clinical benefits.

About IX001 TCR-T Clinical Trial

IX001 TCR-T Project is a single-arm, open-label Phase I clinical trial designed to evaluate the safety, tolerability, and preliminary efficacy of IX001 TCR-T injection in patients with advanced pancreatic cancer harboring the KRAS G12V mutation. The trial plans to recruit 9 to 12 advanced pancreatic cancer participants in China.

● Main Inclusion Criteria：

1. Aged 18 to 75 years (inclusive of boundary values);

2. Pancreatic ductal adenocarcinoma confirmed by pathology (histology) or cytology;

3. Patients with locally advanced or metastatic disease who have failed standard treatment;

4. Presence of KRAS G12V mutation and HLA-A*11:01 subtype;

● Contact Information for Enrollment：

Contact Number:18127912755 Mr. Huawu

Contact Address: Yuexiu Branch, Cancer Hospital Affiliated to Sun Yat-sen University

● Warm Tips: To improve the efficiency of the researchers' review, it is recommended to collect and organize the following materials in advance. Once the review is passed, there is an opportunity to quickly enroll and receive TCR-T cell therapy:

1. Recent imaging reports and tumor marker reports;

2. Recent complete blood count, blood biochemistry, and coagulation function reports;

3. Tumor-related gene screening report (must include KRAS);

4. Recent infectious disease reports, past medical history, and treatment history;

5. Human Leukocyte Antigen HLA Typing Report (if available).