Unicar-Therapy's Innovative Solid Tumor CAR-T Therapy U87 Receives IND Clearance for Trop2-Positive Cancers

Jun 28, 2024 21:56 CST Updated 21:56

Unicar-Therapy

Developer of Immune Cell and Gene Therapy Products

On June 28, 2024, the official website of the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) showed that the Investigational New Drug (IND) application for U87 Injection, independently developed by SHANGHAI UNICAR-THERAPY BIOMED-PHAMACEUTICAL TECHNOLOGY CO., LTD, has officially received tacit approval (Acceptance No.: CXSL2400222). Its indication is Trop2-positive advanced malignant tumors.

U87 Injection is a Class 1 cell therapy product independently developed by SHANGHAI UNICAR-THERAPY BIOMED-PHAMACEUTICAL TECHNOLOGY CO., LTD with complete independent intellectual property rights. Currently, no CAR-T cell therapy drugs targeting Trop2 have been approved for marketing globally. The approval of U87 Injection for clinical trials will bring new hope and treatment options to patients with Trop2-positive advanced malignant tumors.

2022 China National Cancer ReportDisplay,In 2022, an estimated 4.8247 million new cases of malignant tumors were reported in China, with an estimated 2.5742 million deaths due to malignant tumors nationwide. The top five malignant tumors by incidence are lung cancer, colorectal cancer, thyroid cancer, liver cancer, and stomach cancer. The top five malignant tumors by mortality are lung cancer, liver cancer, stomach cancer, colorectal cancer, and esophageal cancer. Research data also indicates that human trophoblast cell surface antigen 2 (trophoblast cell surface antigen 2, Trop2) is specifically overexpressed in the top five deadliest malignant tumors, demonstrating the potential as a "pan-cancer" marker.

Trop2 is encoded by the TACSTD2 gene located on chromosome 1 and consists of 323 amino acids. The Trop2 protein structure includes a hydrophobic leader peptide, an extracellular domain, a transmembrane domain, and a cytoplasmic tail region. Trop2 is a cell membrane glycoprotein that is specifically overexpressed in tumor tissues and lowly expressed in normal tissues. It is overexpressed in most malignant solid tumors and significantly associated with tumorigenesis, progression, invasion, and metastasis.

Currently TargetingThe ADC drug Sacituzumab Govitecan targeting Trop2 has been launched, breaking the long-standing treatment deadlock for triple-negative breast cancer. Several other ADC drugs targeting Trop2 are also under active development, with the hope of providing more treatment options for patients with other tumors such as urothelial carcinoma and non-small cell lung cancer.

U87 Injection as the World's First Fully Human Targeted Trop2 CAR-TThe product is based on UniCAR-THERAPY.The innovative CAR-T products developed through the MADDS antibody technology platform hold promise to bring new hope to patients with advanced solid tumors, including triple-negative breast cancer, lung cancer, pancreatic cancer, colorectal cancer, and thyroid cancer.

About UNICAR-THERAPY

SHANGHAI UNICAR-THERAPY BIOMED-PHAMACEUTICAL TECHNOLOGY CO., LTD (hereinafter referred to as"UNICAR-THERAPY" was established in February 2015 at the Zhangjiang Biotech Incubation Center in Shanghai, China.，It is a biopharmaceutical company dedicated to the innovation and transformation of global cell therapy technology, with multiple products already in its portfolio.first-in-class/first-in-safeThe product is in the clinical trial stage.

UNICAR-THERAPY has several original core technology platforms, includingSMART Small Nucleotide Gene Regulation Empowerment Technology Platform, MADDS Antibody Innovation Drugability Technology Platform, 6H Production Quality Control Platform, etc. Moreover, the company has implemented a closed CAR-T production system in Baoshan, with a construction area of approximately 10,000 square meters, to build an internationally advanced billion-level gene and cell therapy research, industrialization, and commercialization center. This will create a world-class immunotherapy tumor innovation technology transformation center and an advanced, high-end genetically engineered immune cell industry chain center, mainly including the industrial production of CAR-T products and CDMO services for plasmids, viruses, and CAR-T cells.

UNICAR-THERAPY Product Pipeline Layout is Extensive, Including Autologous CAR Technology, Universal CAR Technology, and In Vivo CAR Technology, Covering Indications Such as Hematologic Tumors, Solid Tumors, and Autoimmune Diseases. UNICAR-THERAPY Has Collaborated with Multiple Well-Known Clinical Institutions Both in China and Abroad, Successfully Treating Thousands of Patients with Advanced Cancer. The Company's Innovative Product, ssCART-19 Injection, Can Be Breakthrough Used for the Treatment of CAR-T Contraindicated Central Nervous System Leukemia (Commonly Known as "Brain White"), Included in the CDE Breakthrough Therapy Designation List, Obtained FDA Orphan Drug Designation, and Is Currently in a Pivotal Clinical Stage. Another Innovative Product, U16 Injection, is a Non-CD19 Targeted CAR-T Product for Lymphoma Treatment, Demonstrating Significant Efficacy, and Is Currently in Phase I of the Registration Clinical Trial.