On March 21, 2022 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, reported that it has established a global clinical collaboration with Bristol Myers Squibb to evaluate the combination of TST001, an investigational humanized monoclonal antibody targeting Claudin18.2 developed by Transcenta, with Opdivo (nivolumab), Bristol Myers Squibb’s anti-PD-1 therapy, for the treatment of patients with unresectable locally advanced or metastatic gastric cancer or gastroesophageal junction cancer (GC/GEJ) (Press release, Transcenta, MAR 21, 2022, View Source;gastroesophageal-junction-cancer-301507217.html [SID1234610496]).

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This collaboration includes two global phase I/II open-label, multi-center studies, one to be held in the U.S. and one to be held in China, to evaluate the safety, tolerability, and anti-tumor efficacy of TST001 in combination with Opdivo in patients with unresectable locally advanced or metastatic Claudin18.2 expressing gastric / gastroesophageal junction cancer with or without previous treatment.

Under the terms of the agreement, Transcenta will be the sponsor of the trials and Bristol Myers Squibb will supply Opdivo to Transcenta for use in its combination therapy studies with TST001.

Metastatic GC/GEJ is one of the highly prevalent cancer types globally and there is urgent need for new therapies that can improve patients’ survival. Claudin18.2 is a pan-cancer target and is highly over-expressed in gastric cancer, pancreatic cancer, gallbladder and biliary tract cancer, esophageal cancer, and other tumor types. TST001 is a high affinity humanized antibody developed by Transcenta in house, specifically targeting Claudin18.2 expressing tumor cells and can elicit strong NK cell mediated antibody dependent cellular cytotoxicity. The combination of TST001 with checkpoint inhibitor such as Opdivo could provide greater clinical benefits to patients with locally advanced or metastatic gastric /gastroesophageal junction cancer.

"TST001 is a high affinity humanized monoclonal antibody targeting Claudin18.2. It has shown to be safe in ongoing trials as monotherapy or in combination with chemotherapy and displayed encouraging anti-tumor activity signals in gastric cancer and other solid tumor patients expressing Claudin18.2. TST001 works through NK cell mediated antibody dependent cellular cytotoxicity to exert its anti-tumor activity, and the addition of PD-1 inhibitor and chemotherapy have resulted in synergistic effects in preclinical models. We are excited to test the combination of TST001 with Opdivo for the treatment of metastatic gastric / gastroesophageal junction cancer as a new potential treatment option for these patients." said Dr. Michael Shi, EVP, Head of Global R&D and CMO of Transcenta.

Opdivo is a trademark of Bristol-Myers Squibb Company.

About TST001

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 Claudin18.2 targeting antibody therapeutic candidate being developed globally. TST001 is generated using Transcenta’s Immune Tolerance Breaking Technology (IMTB) platform. TST001 kills Claudin18.2 expressing tumor cells by mechanisms of antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). Leveraging advanced bioprocessing technology, the fucose content of TST001 was significantly reduced during the production, which further enhanced NK cells mediated ADCC activity of TST001. Clinical trials for TST001 are ongoing in China and US (NCT04396821, NCT04495296/CTR20201281). TST001 was granted Orphan Drug Designation in the US by FDA for the treatment of patients with gastric cancer or gastroesophageal junction (GC/GEJ).