Transcenta Holding Limited (HKEX: 06628), a clinically-advanced biopharmaceutical company with capabilities spanning from discovery to manufacturing of antibody-based therapeutics, is proud to announce the successful study results of their CLDN18.2-targeting Immuno-PET probe [89Zr]Zr-DFO-TST001 for non-invasive imaging in gastrointestinal tumors. Results of the study have been published in the Journal of Pharmaceutical Analysis, marking a major breakthrough in the field of cancer imaging.
Professor Hua Zhu and his team from Beijing Cancer Hospital have achieved a major breakthrough in the field of molecular imaging. They have successfully prepared and evaluated the 89Zr labeled GMP grade anti-CLDN18.2 recombinant humanized antibody TST001 as a novel imaging probe. The probe was found to possess excellent specificity and rapid tumor accumulation, with positive results being observed from 24 to 96 hours. This marks a major advance in non-invasive imaging, providing a promising tool for the detection of therapeutic antibody treatment effects, as well as screening and efficacy evaluation of patients targeted for CLDN18.2 therapy.
Immunohistochemistry (IHC) is currently the main method used to detect the expression of CLDN18.2 protein in tumors. However, IHC is invasive and limited in its sampling sites and number. To overcome this, molecular imaging can be used as a non-invasive diagnostic tool to detect the expression and distribution of CLDN18.2 in the lesion using the radioactive signal emitted by the radiotracer. This can help to screen patients who may benefit from CLDN18.2-targeted therapies, accurately evaluate the efficacy of those therapies, and ultimately aid in the accurate diagnosis and treatment of tumors. Clinical studies have already indicated that CLDN18.2 expression level is correlated with drug efficacy, making the use of molecular imaging in patient selection all the more crucial.
The groundbreaking study conducted by Prof. Hua Zhu from Beijing Cancer Hospital has successfully developed, quality controlled, and clinically evaluated GMP-grade monoclonal nuclide probes to target CLDN18.2. This new discovery provides a promising avenue for the development of ZR-89-labeled tumor-targeting monoclonal antibodies. In cell and animal models, [89Zr]Zr-DFO-TST001 demonstrated remarkable specificity in recognizing and targeting the CLDN18.2 receptor/tissue. With the proliferation of PET/CT examination equipment, this probe is anticipated to be used for screening patients and may potentially bring about therapeutic benefits. It can also be used for localizing systemic lesions and assessing treatment efficacy.
Transcenta is thrilled to be partnering with esteemed colleges and institutes to develop an advanced Immuno-PET Probe for gastrointestinal tumors, targeting CLDN18.2. This innovative non-invasive approach has the potential to revolutionize the selection of patients and monitoring of treatment outcomes, optimizing the benefit-risk ratio of CLDN18.2 targeted treatments. We are excited to see this project come to fruition and utilize it in the clinical setting.
About TST001 (Osemitamab)
TST001 (Osemitamab) is a revolutionary humanized anti-CLDN18.2 monoclonal antibody that has been developed using Transcenta’s Immune Tolerance Breaking Technology (IMTB) platform. This antibody possesses enhanced antibody-dependent cellular cytotoxicity (“ADCC”) and complement-dependent cytotoxicity (“CDC”) activities, and has been proven to possess potent anti-tumor properties in tumor xenograft models. To further enhance its NK cells mediated ADCC activity, the fucose content of TST001 (Osemitamab) was significantly reduced during the production. Clinical trials for this cutting-edge antibody are currently underway in the U.S. and China, and it has been granted Orphan Drug Designation by the FDA for the treatment of gastric or gastroesophageal junction (G/GEJ) cancer.
About Transcenta Holding Limited
Transcenta (HKEX: 06628) is a revolutionary biopharmaceutical company that has the capacity to develop, research, and manufacture antibody-based biotherapeutics. With a clinical stage focus, they are paving the way in cutting-edge biologic treatments.
Transcenta is a global biopharmaceutical leader, with its headquarters and Discovery, Clinical and Translational Research Center in Suzhou, Process and Product Development Center and Manufacturing Facility in Hangzhou, Clinical Development Centers in Princeton, US, Beijing, Shanghai and Guangzhou of China, and External Partnering Center in Boston and Los Angeles, US. What’s more, the construction of the Group Headquarters and the second high-end biopharmaceutical facility with ICB as its core technology has already been initiated in Suzhou Industrial Park. With its advanced technology, Transcenta is committed to developing 10 therapeutic antibody molecules for oncology and selected non-oncology indications including bone and kidney disorders, making it a much-needed and valuable asset to the pharmaceutical industry.