Transcenta Announces Global Clinical Collaboration with Bristol Myers Squibb to Evaluate TST001 (Osemitamab) in Combination with Opdivo® for Locally Advanced or Metastatic Gastric/GEJ Cancer

Suzhou, March 22, 2022 /PRNewswire/ -- On March 22, 2022, Transcenta Holding (06628.HK), a clinical-stage biopharmaceutical company with fully integrated capabilities in biologics discovery, research and development, process development, and production, announced a global clinical research collaboration agreement with Bristol-Myers Squibb. The collaboration will explore the combination of Transcenta's investigational product, TST001, a humanized monoclonal antibody targeting Claudin18.2, with Bristol-Myers Squibb’s PD-1 inhibitor, Opdivo.^®(Nivolumab) Global clinical trial for the treatment of patients with unresectable locally advanced or metastatic gastric cancer and gastroesophageal junction cancer.

This collaboration includes two open-label, multi-center global clinical studies in Phase I/II, conducted separately in China and the U.S. The aim is to evaluate TST001 in combination with Opdivo.^®Safety, Tolerability, and Antitumor Efficacy in Patients with Unresectable Locally Advanced or Metastatic Gastric Cancer and Gastroesophageal Junction Cancer Expressing Claudin18.2, Regardless of Prior Treatment.

According to the terms of the agreement, Transcenta Holding will act as the sponsor of the clinical study, while Bristol-Myers Squibb will provide Opdivo to Transcenta Holding.^®, for the clinical research related to the combination therapy with TST001.

Metastatic gastric cancer and gastroesophageal junction cancer are among the most prevalent cancers globally, and there is an urgent need for new treatment modalities that can improve patient survival rates. Claudin18.2 is a pan-cancer target that is highly overexpressed in gastric cancer, pancreatic cancer, gallbladder and biliary tract cancer, esophageal cancer, and other tumor types. TST001 is a high-affinity humanized antibody independently developed by Transcenta Holding, which specifically targets tumor cells expressing Claudin18.2 and can induce potent tumor-killing activity mediated by NK cells. TST001 and Opdivo^®Combination therapy with checkpoint inhibitors may offer greater clinical benefits for locally advanced or metastatic gastric cancer/gastroesophageal junction cancer.

Dr. Shi Ming, Executive Vice President of Global R&D and Chief Medical Officer of Transcenta Holding, stated: "TST001 is a high-affinity humanized monoclonal antibody targeting Claudin18.2. In ongoing clinical trials, TST001 has demonstrated good safety whether used as a monotherapy or in combination with chemotherapy, and it has shown encouraging anti-tumor activity signals in patients with Claudin18.2-expressing gastric cancer and other solid tumors. TST001 exerts its anti-tumor activity through NK cell-mediated antibody-dependent cellular cytotoxicity. In preclinical models, the addition of a PD-1 inhibitor and chemotherapy produced a synergistic effect. We are encouraged by the combination of TST001 with Opdivo (nivolumab).^®The trial for the treatment of metastatic gastric cancer/gastroesophageal junction cancer is highly anticipated, with the potential to become a new treatment option for patients with gastric cancer."

Opdivo^®Is a trademark of Bristol-Myers Squibb Company.

About TST001

TST001 is a high-affinity humanized monoclonal antibody targeting Claudin18.2 with enhanced ADCC and CDC activity, demonstrating potent antitumor activity in xenograft models. This drug is the second Claudin18.2-targeted antibody therapeutic candidate globally developed by Transcenta Holding through its independently developed Immune Tolerance Breakthrough (IMTB) technology platform. TST001 kills tumor cells expressing Claudin18.2 via antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) mechanisms. Using advanced bioprocessing technology, the fucose content of TST001 is significantly reduced during production, further enhancing its NK cell-mediated tumor-killing activity. Since August 2020, clinical trials of TST001 have been ongoing in both China and the United States (NCT04396821, NCT04495296/CTR20201281). The U.S. Food and Drug Administration (FDA) has granted TST001 Orphan Drug Designation for the treatment of gastric cancer and gastroesophageal junction cancer.

About Transcenta Holding

Transcenta Holding is a clinical-stage biopharmaceutical company with fully integrated capabilities in biologics discovery, research and development, process development, and manufacturing.

Transcenta Holding, headquartered in Suzhou, has successfully established a global business layout: a drug discovery, clinical and translational research center is located in Suzhou, while the headquarters of Transcenta Holding and a production base with continuous perfusion production technology as its core are under construction. A process and product development center and drug production base are located in Hangzhou, and clinical development centers have been set up in Beijing, Shanghai, Guangzhou, and Princeton, USA, with external cooperation centers established in Boston and Los Angeles, USA. Transcenta Holding's development pipeline includes ten novel therapeutic antibody molecules, covering fields such as oncology, orthopedics, and nephrology.

For more information about Transcenta Holding, please visit the company website:www.transcenta.comOr LinkedIn account: Transcenta.

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