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, Jan. 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, announces that TST003, its first-in-class, high affinity humanized monoclonal antibody targeting Gremlin1, has received IND clearance from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA). Transcenta presented the latest progress of TST003 program at the 10th TEMTIA meeting in October 2022. Preclinical data showed that TST003 blocks EMT and displays potent single agent anti-tumor activities in PDX models of multiple difficult-to-treat solid tumors. TST003 also received its IND clearance from U.S. Food and Drug Administration (FDA) in September, 2022. In May 2022, Nature Cancer published the study results by Transcenta and Shanghai Jiao Tong University scientists on the potential application of the its first-in-class Gremlin1 targeting antibody TST003 in the treatment of androgen receptor-negative/low prostate cancer. The study results revealed that Gremlin1 protein can promote lineage plasticity and drive castration resistance in prostate cancer. Gremlin1-specific antibodies can effectively control tumor growth in androgen receptor-negative/low prostate cancer. The study also demonstrated a synergistic activity between the anti-Gremlin1 antibody and enzalutamide against patient-derived castration-resistant prostate cancer models in vitro and in vivo. "Targeting Gremlin1 with our antibody TST003 has the potential to be transformative in the treatment of high unmet need cancer indications, such as castration resistant prostate cancer. As we get ready to initiate our first time in human clinical study in the U.S., getting the authorization to proceed from the NMPA is a critical step to deliver on Transcenta's ambition to have an international development strategy fulfilling both U.S. and China health authorities requirements." said Dr. Caroline Germa, Transcenta's Executive Vice President, Global Medicine Development and Chief Medical Officer. About TST003 TST003 is a high affinity monoclonal antibody targeting Gremlin1, a member of TGFb superfamily. Gremlin1 protein is a highly conserved secreted protein and has shown to play important roles during development. Gremlin1 is highly upregulated in multiple solid tumors. Gremlin1 protein promotes epithelial mesenchymal transition. TST003 has shown promising single agent activities in patient-derived xenograft tumor models of multiple difficult-to-treat solid tumors resistant to checkpoint inhibitor including castration resistant prostate cancer and microsatellite stable colorectal cancer. TST003 also enhanced the anti-tumor activity of checkpoint inhibitor in syngeneic tumor model. 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 www.transcenta.com and https://www.linkedin.com/company/transcenta.