InnoCare Pharma's First-in-China Non-Viral, Non-Genetically Modified ACC-NK Therapy IBR854 Receives NMPA Approval for Phase II Clinical Trial in Advanced Renal Cell Carcinoma

Apr 21, 2025 08:27 CST Updated 08:28

iMBioRay

CAR-NK Cell Therapy Drug Developer

April 18, 2025Imbioray (Hangzhou) Biomedical Co., Ltd., which focuses on the field of cell therapy, announced that its proprietaryIBR854 Cell Injection(Target: 5T4) in combination with Pazopanib for the treatment of advanced renal cell carcinomaPhase II Clinical StudyGranted Clinical Trial Approval by the National Medical Products Administration (NMPA)(Notification Code: 2)025LP01104 and 2025LP01105).

A Powerful Combination! Cell Therapy Combined with Anti-angiogenic Drugs Brings New Hope to Patients with Advanced Renal Cell Carcinoma:

Renal cell carcinoma is a malignant tumor originating from the renal tubular epithelium, accounting for 80% to 90% of renal malignancies. The incidence rate of renal cell carcinoma in China is 4.02 per 100,000, with an age-standardized incidence rate of 2.66 per 100,000. Renal cell carcinoma is a highly aggressive malignant tumor with insidious onset and almost no symptoms in the early stages. Statistics show that about 30% of patients with renal cell carcinoma have already developed cancer metastasis at the time of diagnosis, missing the optimal timing for surgery. Among patients who are able to undergo radical nephrectomy, 25% will experience local recurrence or distant metastasis after the procedure, leading to a poor prognosis for patients with recurrent or metastatic renal cell carcinoma. There is an urgent need to design new clinical trials and develop innovative treatment strategies.

Pazopanib is a multi-target tyrosine kinase inhibitor that primarily acts on pathways such as VEGFR, PDGFR, and c-Kit, inhibiting angiogenesis and tumor growth.In 2017, Pazopanib was launched in China and approved for first-line treatment of patients with advanced renal cell carcinoma and for the treatment of patients with advanced renal cell carcinoma who had previously received cytokine therapy. Its serious adverse reaction is hepatotoxicity, which has been included in the black box warning in the package insert.As a "living drug," cell therapy has already achieved cures in certain hematologic malignancies. The scientific basis for the synergistic effect of pazopanib and NK cells mainly comes from earlier studies and some research on renal cell carcinoma (RCC), soft tissue sarcoma, and other cancers. These studies have shown that pazopanib modulates the tumor microenvironment and enhances the anti-tumor effects of NK cells. IBR854 cell injection combined with pazopanib is expected to bring new hope to patients in the treatment of renal cell carcinoma.

About IBR854 Cell Injection:

IBR854The cell injection is a globally innovative product independently developed by Imbioray with proprietary intellectual property.5T4Antibody andNKThe cell complex coupling product is the first non-viral vector and non-gene modification method for solid tumors in China.ACC-NKCell therapy, the core structure of this product is to target tumor antigens5T4Specific antibodies throughlinkerAllogeneicNKCells undergo covalent coupling.5T4Antigen is a highly glycosylated protein on the cell surface, found in human placental trophoblasts and various types of human cancer cells. It is present in multiple solid tumors such as renal cell carcinoma, epithelial ovarian cancer, non-small cell lung cancer, breast cancer, pancreatic cancer, cervical cancer, soft tissue sarcoma, prostate cancer, and colorectal cancer.5T4Both have a relatively high positive expression rate but are not expressed in the normal tissues of healthy adults.5T4The widespread distribution across various malignant tumors has made it a popular target for cancer immunotherapy.

Clinical Research:A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of IBR854 Cell Injection in Patients with Unresectable Locally Advanced or Metastatic Solid TumorsIn Phase I clinical study, 19 patients were actually enrolled, and the dosing regimen was3.0×10⁹Dose Group of Live Cells ~12.0×10⁹A living cell dose. The results of the Phase I clinical study showed that the safety and tolerability of IBR854 cell injection were both good.

About Imbioray

Imbioray is a clinical-stage and venture capital-backed innovative biopharmaceutical company, primarily focusing on the development of cutting-edge immuno-oncology therapies and innovative drugs for non-cancer immunotherapy targeting immune-related diseases, chronic conditions, and CNS disorders. Dr. Zhenwei Miao, the founder of Imbioray, returned to China in 2016 to start the company and established the direction of developing off-the-shelf, universal cell therapeutics based on NK cells. Imbioray has four internationally pioneering core technology platforms to accelerate its original innovations and boasts world-leading large-scale in vitro closed-system NK cell production capabilities.CultivationAdvanced technology. Based on its proprietary antibody-conjugated NK cell platform technology, Imbioray has developed several universal off-the-shelf cell therapy products, including IBR854, IBR733, and IBR822.Currently, the world's first innovative treatment for advanced solid tumorsIBR854Cell InjectionThe Phase II clinical study has received clinical tacit approval from the National Medical Products Administration (NMPA).To be launchedIIPhase Clinical Trial, World's FirstIBR733 cell injection for acute myeloid leukemia has completed the dose escalation trial of three dose groups, demonstrating good safety and efficacy.For advanced solid tumorsIBR822Cell Injection is Imbioray's Third Antibody-NKCell Engager Drugs in 20249MonthEnterIPhase Clinical Trial。IBR900It is the fourth product of Imbioray to obtainCDEClinical Implicit License for Off-the-Shelf Universal TypeNKCell products, the main target population for clinical application is65Years and aboveBPatients with cell lymphoma or tumors who are intolerant to and have failed existing treatments. Imbioray has multiple products at different stages of development.NKCell Products.

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