2023 - 03 - 29
SUZHOU, China, Mar. 29, 2023, 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 that monotherapy 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)
Osemitamab (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.
For more information, please visit www.transcenta.com and https://www.linkedin.com/company/transcenta.
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Transcenta Announces the Publication of Preclinical Results of [177Lu]Lu-TST001 Radionuclide Antibody Conjugate as Potential Novel Treatment Option for Metastatic Gastric Cancer in the European Journal of Nuclear Medicine and Molecular Imaging
Transcenta Unveils Updated Efficacy Data from Osemitamab (TST001) Plus CAPOX as First-Line Treatment for G/GEJ Cancer Study at ESMO 2023
FDA Grants Transcenta Clearance to Proceed with Global Phase III Trial of Osemitamab (TST001) as First-Line Treatment for Gastric/Gastroesophageal Cancer Patients
Transcenta Anti-sclerostin Monoclonal Antibody TST002 (Blosozumab) Received Approval from China CDE to Initiate Phase II Clinical Trial in Patients with Reduced Bone Mineral Density
Transcenta Received Approvals from China CDE and South Korea MFDS to Initiate TranStar 301 Global Phase III Pivotal Trial of Osemitamab (TST001)
Transcenta Presented PFS Data by CLDN18.2 Expression Level from Phase I/II Study of Osemitamab (TST001) plus CAPOX as the First-Line Treatment of Advanced G/GEJ Cancer at 2023 ESMO GI Annual Congress