Suzhou Transcenta Therapeutics Co., Ltd.

SUZHOU, China, Aug. 15, 2023 /PRNewswire/ -- Transcenta Holding Limited ("Transcenta") (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, announces that it is going to present three posters highlighting study results from ongoing trials related to Osemitamab (TST001) at the 2023 European Society of Medical Oncology (ESMO) Congress including updated efficacy and PK/PD analysis data from the phase 2 study of Osemitamab (TST001)/CAPOX in CLDN18.2 positive first line G/GEJC as well as preclinical data on the combination study of Osemitamab (TST001) with PD1 inhibitor. A brief summary of the presentations is as follows: Title: First-line Osemitamab (TST001) plus Capecitabine and Oxaliplatin (CAPOX) for Advanced G/GE Cancer with CLDN18.2 Positive - Overall Survival data from Study TranStar102-Cohort C Abstract#: 4038 Type: Abstract Category: Oesophagogastric cancer First Author: Prof. Lin Shen, Beijing Cancer Hospital Title: Pharmacokinetics, Pharmacodynamics and Exposure Response Analyses of Osemitamab (TST001) in Patients with Locally Advanced or Metastatic Solid Tumors Abstract#: 1556P Type: Abstract Category: Oesophagogastric cancer First Author: Prof. Lin Shen, Beijing Cancer Hospital Title: Osemitamab (TST001)，an ADCC Enhanced Humanized Anti-CLDN18.2 mAb, Demonstrated lmproved Efficacy in Combination with anti-PD-L1/PD-1mAb and Oxaliplatin/5-FU in Preclinical Tumor Models Abstract#: 1570P Type: Abstract Category: Oesophagogastric cancer First Author: Dr. Xueming Qian, Suzhou Transcenta Therapeutics Co., Ltd. The ESMO Congress is the most influential oncology platform for clinicians, researchers, patient advocates, journalists and healthcare industry representatives from all over the world. ESMO 2023 will disseminate the latest cutting-edge data, provide high quality education and unparalleled networking opportunities for oncologists and other stakeholders from all around the world. This year, the ESMO Congress will take place on October 20 to October 24, local time, in Madrid, Spain. About Osemitamab (TST001) Osemitamab (TST001) is a high affinity humanized anti- CLDN18.2 monoclonal antibody with enhanced antibody-dependent cellular cytotoxicity ("ADCC"). It has shown potent anti-tumor activities in tumor xenograft models. Osemitamab (TST001) is the second most advanced CLDN18.2 targeting antibody being developed globally. Osemitamab (TST001) was generated using Transcenta's Immune Tolerance Breaking Technology (IMTB) platform. Osemitamab (TST001) kills CLDN18.2 expressing tumor cells by mechanisms of ADCC. Leveraging advanced bioprocessing technology, the fucose content of Osemitamab (TST001) was significantly reduced during the production, which further enhanced NK cells mediated ADCC activity of Osemitamab (TST001). Clinical trials for Osemitamab (TST001) are ongoing in the U.S. and China (NCT05190575, NCT04396821, NCT04495296, NCT05608785 / CTR20201281). Osemitamab (TST001) was granted Orphan Drug Designation in the U.S. by FDA for the treatment of patients with gastric or gastroesophageal junction (G/GEJ) and pancreatic cancer. About Transcenta Holding Limited Transcenta (HKEX: 06628) is a clinical stage biopharmaceutical company with fully integrated capabilities in antibody-based biotherapeutics discovery, research, development and manufacturing. Transcenta has established global footprint, with Headquarters and Discovery, Clinical and Translational Research Center in Suzhou, Process and Product Development Center and Manufacturing Facility in Hangzhou, and Clinical Development Centers in Princeton, US and in Beijing, Shanghai and Guangzhou of China, and Business Development Center in Boston and Los Angeles, US. Transcenta has also initiated the construction of the Group Headquarters and the second high-end biopharmaceutical facility with HiCB as its core technology in Suzhou Industrial Park. Transcenta is developing 13 therapeutic antibody molecules for oncology and selected non-oncology indications including bone and kidney disorders. For more information, please visit and . Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Transcenta, are intended to identify certain of such forward-looking statements. Transcenta does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Transcenta with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Transcenta's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Transcenta's competitive environment and political, economic, legal and social conditions. Transcenta, the Directors and the employees of Transcenta assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect. SOURCE Transcenta Holding Limited

Transcenta Holding Limited ("Transcenta") (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics,announces that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Osemitamab (TST001), its high affinity humanized ADCC-enhanced anti-Claudin18.2 monoclonal antibody, for the treatment of patients with pancreatic cancer. This is the second Orphan Drug Designation for Osemitamab (TST001), following its designation in 2021 for the treatment of gastric cancer and gastroesophageal junction cancer. Orphan drugs are used for the prevention, treatment, and diagnosis of rare diseases. The ODD granted by the US FDA is applicable to drugs and biologics for rare diseases with less than 200,000 patients in the United States each year. The drugs that have been certified can potentially enjoy tax incentives in the United States, a seven-year market exclusivity period after listing, as well as other policy incentives. Pancreatic cancer is one of the most challenging cancers to treat, as it is often diagnosed at an advanced stage with typically poor outcomes to available therapies. The 5-year survival rate at diagnosis is around 10% and the median overall survival barely exceeds 9 months for advanced or metastatic disease. According to the data from National Institutes of Health, it is estimated that in 2022 approximately 62,200 people will be diagnosed with pancreatic cancer and approximately 50,000 will die from the disease. Previously Transcenta presented preliminary anti-tumor activity data in pancreatic cancer of Osemitamab (TST001) at the 2022 International Gastric Cancer Congress, the data indicated thatmonotherapy treatment with Osemitamab (TST001) led to a prolonged partial response in a Claudin18.2 low expressing pancreatic cancer patient who progressed from multiple cycles of chemotherapy. In preclinical studies, Osemitamab (TST001) has shown potent anti-tumor activities in Claudin18.2 expressing pancreatic cancer tumor models independent of Kras mutation status. "Osemitamab (TST001) is currently being evaluated for the treatment of different Claudin18.2 positive indications. We believe it also has the potential to be transformative for advanced pancreatic adenocarcinoma who lack effective therapeutic options. We look forward to progressing our program in this indication." said Dr. Caroline Germa, Transcenta's Executive Vice President, Global Medicine Development and Chief Medical Officer. About Osemitamab (TST001) semitamab (TST001) is a high affinity humanized anti- CLDN18.2 monoclonal antibody with enhanced antibody-dependent cellular cytotoxicity ("ADCC") and complement-dependent cytotoxicity ("CDC") activities and potent anti-tumor activities in tumor xenograft models. Osemitamab (TST001) is the second most advanced CLDN18.2 targeting antibody being developed globally. Osemitamab (TST001) is generated using Transcenta's Immune Tolerance Breaking Technology (IMTB) platform. Osemitamab (TST001) kills CLDN18.2 expressing tumor cells by mechanisms of ADCC and CDC. Leveraging advanced bioprocessing technology, the fucose content of Osemitamab (TST001) was significantly reduced during the production, which further enhanced NK cells mediated ADCC activity of Osemitamab (TST001). Clinical trials for Osemitamab (TST001) are ongoing in the U.S. and China (NCT04396821, NCT04495296/CTR20201281). Osemitamab (TST001) was granted Orphan Drug Designation in the U.S. by FDA for the treatment of patients with gastric or gastroesophageal junction (G/GEJ) cancer. About Transcenta Holding Limited Transcenta (HKEX: 06628) is a clinical stage biopharmaceutical company with fully integrated capabilities in antibody-based biotherapeutics discovery, research, development and manufacturing. Transcenta has established global footprint, with Headquarters and Discovery, Clinical and Translational Research Center in Suzhou, Process and Product Development Center and Manufacturing Facility in Hangzhou, and Clinical Development Centers in Princeton, US and in Beijing, Shanghai and Guangzhou of China, and External Partnering Center in Boston and Los Angeles, US. Transcenta has also initiated the construction of the Group Headquarters and the second high-end biopharmaceutical facility with ICB as its core technology in Suzhou Industrial Park. Transcenta is developing ten therapeutic antibody molecules for oncology and selected non-oncology indications including bone and kidney disorders. SOURCE Transcenta Holding Limited

SUZHOU, China, March 3, 2023 /PRNewswire/ -- Transcenta Holding Limited ("Transcenta") (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, today announces that the study results of its CLDN18.2-targeting Immuno-PET probe [89Zr]Zr-DFO-TST001 for non-invasive imaging in gastrointestinal tumors have been published on Journal of Pharmaceutical Analysis. The study, led by Professor Hua Zhu and his team from Beijing Cancer Hospital. The study successfully prepared and evaluated the 89Zr labeled GMP grade anti-CLDN18.2 recombinant humanized antibody TST001 as molecular imaging probe. [89Zr]Zr-DFO-TST001 exhibited good specificity at the cellular level and rapid tumor accumulation which remained positive from 24 to 96 hours. It provides a promising non-invasive imaging tool for detecting the treatment effects of therapeutic antibodies in humans in real time and for the screening and efficacy evaluation of patients targeted for CLDN18.2 therapy in the future. Clinical studies indicated that the CLDN18.2 expression level was correlated with drug efficacy, showing more clinical benefit in patients with CLDN18.2 high expression in tumors. Therefore, patient selection based on CLDN18.2 expression level becomes critical for CLDN18.2-targeted therapies. At present, the main detection method of CLDN18.2 protein expression is immunohistochemistry (IHC). IHC is invasive, and requires endoscopic biopsy, and the sampling site and number are limited. Due to the heterogeneous nature of tumor, the CLDN18.2 distribution and dynamic changes in expression levels in patients cannot be fully reflected in real-time. 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, thereby help to screen patients with potential benefit to therapy, evaluate the efficacy of CLDN18.2 targeted therapy, and guide the accurate diagnosis and treatment of tumors. "This study successfully achieved the development, quality control and Micro-PET imaging clinical evaluation of GMP-grade monoclonal nuclide probes targeting CLDN18.2, providing a new path for the development of ZR-89-labeled tumor targeting monoclonal antibodies. In cell and animal models, [89Zr]Zr-DFO-TST001 specifically recognizes and targets the CLDN18.2 receptor/tissue. With the increasingly popular PET/CT examination equipment, the probe is expected to be used for screening patients with potential benefit to therapy, localizing of systemic lesions and efficacy evaluation" said Prof. Hua Zhu from Beijing Cancer Hospital. "We are fortunate to have the opportunity to collaborate with leading colleges and institutes on the development of a CLDN18.2-targeting Immuno-PET Probe for gastrointestinal tumors. Optimizing the selection of patients in a non-invasive way is key to improve the overall benefit risk of CLDN18.2 targeted treatments. This technology also opens up innovative ways of monitoring treatment outcomes. We look forward to further development of this approach and potential use in the clinics." said Dr. Xueming Qian, CEO of Transcenta. The study results were jointly carried out by NMPA Key Laboratory for Research and Evaluation of Radiopharmaceuticals, Peking University Cancer Hospital & Institute School of Basic Medical Sciences, Southwest Medical University Suzhou Transcenta Therapeutics Co., Ltd, Suzhou Institute of Biomedical Engineering, Peking University Shenzhen Graduate School Guizhou University Medicine College Original article: About TST001 (Osemitamab) TST001 (Osemitamab) is a high affinity humanized anti- CLDN18.2 monoclonal antibody with enhanced antibody-dependent cellular cytotoxicity ("ADCC") and complement-dependent cytotoxicity ("CDC") activities and potent anti-tumor activities in tumor xenograft models. TST001 (Osemitamab) is the second most advanced CLDN18.2 targeting antibody being developed globally. TST001 (Osemitamab) is generated using Transcenta's Immune Tolerance Breaking Technology (IMTB) platform. TST001 (Osemitamab) kills CLDN18.2 expressing tumor cells by mechanisms of ADCC and CDC. Leveraging advanced bioprocessing technology, the fucose content of TST001 (Osemitamab) was significantly reduced during the production, which further enhanced NK cells mediated ADCC activity of TST001 (Osemitamab). Clinical trials for TST001 (Osemitamab) are ongoing in the U.S. and China (NCT04396821, NCT04495296/CTR20201281). TST001 (Osemitamab) was granted Orphan Drug Designation in the U.S. by FDA for the treatment of patients with gastric or gastroesophageal junction (G/GEJ) cancer. About Transcenta Holding Limited Transcenta (HKEX: 06628) is a clinical stage biopharmaceutical company with fully integrated capabilities in antibody-based biotherapeutics discovery, research, development and manufacturing. Transcenta has established global footprint, with Headquarters and Discovery, Clinical and Translational Research Center in Suzhou, Process and Product Development Center and Manufacturing Facility in Hangzhou, and Clinical Development Centers in Princeton, US and in Beijing, Shanghai and Guangzhou of China, and External Partnering Center in Boston and Los Angeles, US. Transcenta has also initiated the construction of the Group Headquarters and the second high-end biopharmaceutical facility with ICB as its core technology in Suzhou Industrial Park. Transcenta is developing ten therapeutic antibody molecules for oncology and selected non-oncology indications including bone and kidney disorders. For more information, please visit and . SOURCE Transcenta Holding Limited