Transcenta Presented Safety/Tolerability and Preliminary Antitumor Activity Data in Gastric and Pancreatic Cancers of TST001 Monotherapy Phase I Clinical Trial in China at the International Gastric Cancer Congress 2022
SUZHOU, China, March 9, 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 Transcenta Presented Preliminary Safety/Tolerance and Anti-Tumor Activity Data in Gastric and Pancreatic Cancers of TST001 China Phase I clinical trial as a poster presentation at the 2022 International Gastric Cancer Congress (IGCC).
The primary objectives of this phase I study (NCT04495296) are to assess the safety and tolerability, identify the BAT and the recommended phase 2 dose (RP2D) in patients with advanced or metastatic solid tumors who have progressed during or after standard treatments. Secondary objectives include evaluation of pharmacokinetic parameters, immunogenicity, and preliminary antitumor activity.
In the dose escalation phase, patients without prescreening for tumor Claudin18.2 expression received increasing doses of TST001 intravenously every 3 weeks (Q3W) using a 3+3 design. November 23, 2021, 11 patients had been treated at doses of 3, 6 and 10 mg/kg Q3W. 9 patients were DLT evaluable with no DLT reported and MTD was not achieved. TST001 demonstrated an approximately linear pharmacokinetic profile as Cmax and AUC increased proportionally across the dose range after the first dose. No drug accumulation was observed in the Q3W cohort. 10 mg/kg Q3W was designated as RP2D for further expansion study and additional patients with Claudin18.2 overexpression were recruited into the expansion phase at 10 mg/kg Q3W. The most common AEs (>20%) included nausea, vomiting, anemia, hypoalbuminemia, abdominal distension, and constipation. In terms of efficacy, one patient in the 6 mg/kg Q3W dose escalation cohort who progressed through multiple lines of chemotherapies, anti-PD1 and anti-VEGF therapies achieved a confirmed partial response at week 12 After the data cut-off date, additional confirmed PRs were observed at the recommended Phase 2 dose in the newly recruited monotherapy expansion cohorts, including patients with gastric cancer and pancreatic cancer with Claudin’s expression18.2. A patient with pancreatic cancer with moderately low expression of Claudin 18.2 achieved an 82% tumor reduction 12 weeks after treatment. Patient recruitment for the monotherapy expansion cohorts is ongoing and full data will be updated and reported at a future medical conference.
In this Phase 1 clinical study, TST001 demonstrated a manageable and tolerable safety profile in patients with advanced solid tumors and preliminary anti-tumor activity in a patient with heavily pretreated Claudin18-expressing gastric and pancreatic cancer. 2.
“Claudin18.2 is an ideal target with great antitumor potential for cancer therapy. TST001, a high-affinity humanized Claudin18.2 antibody, is safe and has shown promising antitumor activity in patients with overexpressing gastric and pancreatic cancer. Claudin18.2.” says dr. Michael ShiEVP, Head of Global R&D and CMO of Transcenta, “We will continue to characterize the safety and anti-tumor activities of monotherapy in various Claudin18.2-expressing solid tumors as well as combination therapy with standard of care for gastric cancer We believe that TST001 could offer new and more effective treatment options for gastric cancer patients.”
“Gastric cancer is one of the most common types of malignant tumors in China. In recent years, Claudin18.2 has emerged as a promising therapeutic target for gastric cancer beyond HER2 and PD-L1. TST001 is the second most advanced global program targeting Claudin 18.2 and has shown promising signals of antitumor activities with a manageable safety profile. I look forward to the start of the global phase III trial enabling registration to test TST001 as a first-line treatment for gastric cancer.“, says the teacher Lin Shen from Beijing Cancer Hospital.
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 antitumor 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.
For more information, please visit www.transcenta.com and https://www.linkedin.com/company/transcenta.
This press 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, with respect to Transcenta, are intended to identify certain of these forward-looking statements. Transcenta does not intend to regularly update these forward-looking statements.
These forward-looking statements are based on Transcenta’s management’s existing beliefs, assumptions, expectations, estimates, projections and understandings regarding future events at the time such statements are made. These statements are not guarantees 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. Accordingly, actual results may differ materially from the information contained in the forward-looking statements due to changes or future developments in our business, Transcenta’s competitive environment and political, economic, legal and social conditions.
Transcenta, the directors and employees of Transcenta assume (a) no obligation to correct or update any forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements do not materialize or prove to be incorrect.
Public relations: [email protected]
Investor Relations: [email protected]
Business development: [email protected]
SOURCETranscenta Holding Limited