Guoxin Pharma Supports Yimufeng Bio's Pivotal Phase III Clinical Trial of IMC002 for Advanced Gastric Cancer
Immunofoco
Developer of Novel Therapeutics for Solid Tumors
Recently, the National Investigator Meeting for Phase III Clinical Study of Immunofoco's IMC002 in the treatment of advanced gastric cancer and gastroesophageal junction adenocarcinoma was successfully held. As the full-process outsourcing service provider for this project,Song Wei, CEO of Guoxin Pharmaceutical Technology (Beijing) Co., Ltd. ("Guoxin Pharmaceutical"), was invited to attend the meeting.。
This meeting brought together clinical experts, institutional and ethical representatives from more than thirty participating centers across China, as well as the collaborating teams, to engage in an in-depth discussion on the efficacy and safety of IMC002 in patients with advanced gastric cancer or gastroesophageal junction adenocarcinoma. The aim is to promote the comprehensive launch of high-quality clinical research and the patient enrollment process.
As the core service provider for this project, Guoxin Pharmaceutical Technology (Beijing) Co., Ltd. fully undertakes the execution of key aspects such as medical monitoring, project operation management, data management and statistical analysis, and pharmacovigilance (PV). Relying on extensive experience in the cell and gene therapy (CGT) field, Guoxin Pharmaceutical Technology has formed a professional, cross-functional service team. Through scientific protocol support, meticulous operational management, and a strict quality control system, they effectively address multiple challenges in highly complex clinical trials, ensuring that the research proceeds in a standardized, efficient, and compliant manner.
This deep involvement fully demonstrates Guoxin Pharmaceutical Technology (Beijing) Co., Ltd.'s full-process service capabilities and comprehensive competitive advantages in Phase I-III pivotal clinical research of cell therapy, further consolidating the company's leading position in the high-barrier innovative drug and device R&D services field.
IMC002 is a self-developed autologous CAR-T product targeting CLDN18.2 by Immunofoco, designed with high-specificity VHH nanobodies. It is expected to enhance tolerance, expand the clinical dosage range, and extend its application to front-line and combination therapies, aiding in overcoming the challenges of solid tumor treatment. CLDN18.2 is highly expressed in various tumors such as gastric cancer and pancreatic cancer, making it an ideal target for CAR-T therapy. The Phase I registrational clinical trial of IMC002 has been successfully completed, with preliminary data demonstrating excellent safety and efficacy.
CR Case Highlights IMC002 Clinical Potential
At the meeting,Dr. Lin Xiuyun from Fujian Cancer Hospital shared a case that achieved sustained complete remission (CR).The patient had advanced HER2-positive gastric cancer with liver metastasis. After multiple lines of targeted immunotherapy and chemotherapy, the disease continued to progress, and HER2 expression turned negative, leaving very limited subsequent treatment options. Ten months after a single infusion of IMC002 in the IMC002 clinical study, the patient achieved sustained complete remission (CR).
Since receiving treatment after enrollment, the patient has not undergone any other anti-tumor therapies. The efficacy improved continuously from partial response (PR) to complete response (CR). Endoscopic diagnosis and gastroscopic biopsy showed pathologically negative results, and the quality of life has significantly improved.The tumor assessment one year after the recent infusion showed sustained complete remission.
National Expert Consensus Clarifies, Jointly Promoting High-Quality Clinical Enrollment
Professor Xu Jianming, the national leader of this study and the First Medical Center of Chinese PLA General HospitalFully affirmed the positive data from the preliminary research of IMC002, emphasizing the significant importance of this clinical project in meeting patient needs. As the leading expert, Professor Xu Jianming stated that he will collaborate with all participating research centers to strictly enforce the study protocol, ensuring compliance and scientific integrity of the clinical trial, jointly promoting high-quality development in China's cell therapy field.
Dr. Sun Minmin, Founder, Chairman and CEO of ImmunofocoIt was pointed out that IMC002, as an innovative therapy with independent intellectual property rights, has demonstrated significant potential in the field of advanced gastric cancer. The company will fully incorporate expert recommendations, deepen clinical collaborations, and make every effort to advance the efficient completion of the IMC002-RT02-RCT study, bringing new hope to gastric cancer patients worldwide.
The successful convening of this launch meeting marksIMC002-RT02-RCT Phase III Confirmatory Clinical Study Officially Enters a New Stage of Full Acceleration, will provide strong momentum for the smooth progress of the research and rapid patient enrollment.
Currently, the patient recruitment work is proceeding in an orderly manner. The following is the list of sites that have been initiated for this Phase III confirmatory clinical study.PartCenter List:
Serial Number | Center Name | Department | PI |
1 | ChinaFirst Medical Center of Chinese People's Liberation Army General Hospital | Medical Oncology | Xu Jianming |
2 | The First Affiliated Hospital of Anhui Medical University | Medical Oncology | Wei Wei |
3 | Jinan Central Hospital | Oncology Department | Sun Meili |
4 | Shanghai Changhai Hospital | Gastrointestinal Surgery | Luo Tianhang |
5 | Gulou Hospital Affiliated to Medical College of Nanjing University | Oncology Department | Wei Jia |
6 | Shanxi Cancer Hospital | Medical Oncology | Ying Zhitao |
7 | The Second Affiliated Hospital of Soochow University | Oncology | Zhuang Zhixiang |
8 | Peking Union Medical College Hospital, Chinese Academy of Medical Sciences | Department of Gastrointestinal Oncology | Ba Yi |
9 | Jiangsu Provincial People's Hospital | Oncology | Gu Yanhong |
10 | Shandong Cancer Hospital | Oncology Department | Liu Bo |
11 | Fujian Cancer Hospital | Medical Oncology | Yang Jianwei |
As a clinical CRO deeply engaged in the cell and gene therapy (CGT) field, Guoxin Pharmaceutical Technology (Beijing) Co., Ltd. has successfully undertaken multiple "global firsts" and "China's first" innovative projects, fully demonstrating its clinical development capabilities for complex mechanism-based innovative therapies. In the CGT sector, the company has established an end-to-end service chain encompassing product strategy, regulatory submissions, and the integration of pharmaceutical policy and academic resources. It has taken on groundbreaking projects such as the world’s first TCR-T therapy carrying PD-1, China’s first CAR-NK cell therapy approved for IND, registration clinical trials for autologous RAK in solid tumor treatment, and clinical programs utilizing RAK cells and stem cells to treat hepatitis B, gastrointestinal diseases, and more. These cover various categories of CGT registration and clinical projects, including iPSC, CAR-T, mRNA, DC, MSC, and AAV gene therapy products, accumulating extensive experience in nationwide regulatory submissions. Leveraging its broad regulatory submission expertise and deep understanding of regulatory pathways, Guoxin Pharmaceutical Technology continues to accelerate the translation of innovative therapies.
Looking ahead, Guoxin Pharmaceutical Technology (Beijing) Co., Ltd. will leverage its extensive full-process service experience in the CGT field to collaborate with Immunofoco, jointly accelerating the implementation of cutting-edge therapies and advancing China's pharmaceutical innovation to new heights.
