Transcenta Releases Phase I Clinical Data of TST001 in Combination with CAPOX as First-Line Treatment for Advanced and Metastatic G/GEJ Cancer at ASCO 2022
SUZHOU, China, June 1, 2022 /PRNewswire/ — Transcenta Holding Limited (“Transcenta”) (HKEX:06628), a clinical-stage biopharmaceutical company with fully integrated capabilities in the discovery, research, development and manufacturing of antibody therapies, announces that the clinical data for the dose-escalation portion of the Phase I study of TST001 in combination with CAPOX as first-line treatment for advanced and metastatic G/GEJ cancer has been published on the website of the ASCO: https://conferences.asco.org/am/attend.
The data showed that TST001 in combination with CAPOX as first-line treatment of patients with advanced and metastatic G/GEJ cancer is well tolerated and encouraging preliminary anti-tumor activities were observed. Recruitment for the current cohort is ongoing, and the safety and efficacy of TST001+CAPOX as a first-line treatment for patients with advanced and metastatic G/GEJ cancer will be further evaluated.
Abstract number: 4062
Session date and time: June 4, 2022, 8:00-11:00 a.m. CDT
Title: A Phase I Study of TST001, a High-Affinity Humanized Anti-Claudin18.2 Monoclonal Antibody, in Combination with Capecitabine and Oxaliplatin (CAPOX) as First-Line Treatment for Advanced G/GEJ Cancer
First author: Teacher Jifang GongPeking University Hospital and Cancer Research Institute
Presentation format: Attach
The study aimed to assess the safety, tolerability and preliminary efficacy of TST001 in combination with CAPOX as first-line treatment for patients with advanced G/GEJ cancer. (ClinicalTrials.gov ID: NCT04495296). Chinese patients with advanced G/GEJ cancer who had not received prior systemic therapy were recruited whatever the expression of Claudin18.2 in the dose escalation phase following the 3+3 design; the safety and efficacy profile was further evaluated in the dose expansion phase.
From April 5, 2022, 14 patients had received TST001 at 1, 3, 6 or 8 mg/kg plus CAPOX Q3W in the dose escalation phase, and 12 patients at 6 mg/kg Q3W in the expansion phase. No subject experienced dose limiting toxicity. Treatment-related adverse events (TEAEs) were mainly fatof 1-2, including nausea, hypoalbuminemia, anemia, vomiting and increased AST. Of the 9 subjects in the dose-escalation phase without Claudin18.2 selection who had measurable lesions and had received at least one post-treatment tumor evaluation, 5 achieved a partial response and 3 achieved stable disease as best global response according to RECIST1.1.
“Claudin18.2 has been validated as a novel target and promising anti-tumor activity was observed in the Phase II FAST clinical trial of IMAB362.” says the teacher Lin Shen from Beijing Cancer Hospital. “Based on efficacy and safety results from trials to date, TST001 has shown a manageable safety profile and encouraging anti-tumor activities in Claudin18.2 expressing treatment-naïve gastric cancer patients. center registration phase III trial in patients with Claudin18.2 positive gastric cancer.”
“From the dose escalation phase, we are very pleased to show that TST001 is well tolerated and shows an encouraging clinical response in combination with chemotherapy in first-line gastric cancer patients not selected by Claudin18.2.” says dr. Michael Shi, EVP, Head of Global R&D and CMO of Transcenta. “We will continue to evaluate the safety and efficacy of this combination and plan to initiate a global, multi-center trial enabling registration in Claudin18.2-positive first-line gastric cancer patients. Development will be supported by our proprietary Claudin18.2 companion diagnostic kit. being developed in parallel and strong in-house CMC capabilities. We believe that TST001 in combination with chemotherapy could provide a new option for the treatment of patients with Claudin18.2 positive gastric cancer worldwide.
TST001 is a high affinity humanized anti-Claudin18.2 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 is the second candidate therapeutic antibody targeting Claudin18.2 developed worldwide. TST001 is generated using Transcenta’s Immune Tolerance Breaking Technology (IMTB) platform. TST001 kills Claudin18.2 expressing tumor cells through antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) mechanisms. Through advanced bioprocessing technology, the fucose content of TST001 was greatly reduced during production, which further enhanced the NK cell-mediated ADCC activity of TST001. Clinical trials for TST001 are underway in China and United States (NCT04396821, NCT04495296/CTR20201281). TST001 has received orphan drug designation in the United States from the FDA for the treatment of patients with gastric or gastroesophageal junction (GC/GEJ) cancer.
About Transcenta Holding Limited
Transcenta (HKEX: 06628) is a clinical-stage biopharmaceutical company with fully integrated capabilities in the discovery, research, development and manufacturing of antibody-based biotherapeutics.
Transcenta has established a global footprint, with headquarters and a clinical and translational research center in Suzhou, a process and product development center and a manufacturing facility in Hangzhouand clinical development centers in beijing, Shanghai and Canton in China and in Princetonin the United States and at the external partnership center of Boston and Los Angeles, WE. Transcenta also launched the construction of the group headquarters and the second high-end biopharmaceutical facility with ICB as the core technology in Suzhou Industrial Park. Transcenta is developing ten therapeutic antibody molecules for oncology and certain non-oncology indications, including bone and kidney disorders.
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