TRANSCENTA HOLDING - A Global Fully Integrated Biotherapeutics Company

Transcenta, Biologics, Antibody, Claudin 18.2

TRANSCENTA HOLDING - A Global Fully Integrated Biotherapeutics Company

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Press Release

Transcenta Announces Collaboration with Agilent to Develop a Claudin 18.2 Companion Diagnostic to Support Osemitamab (TST001) Global Phase III Trial

2024 - 04 - 09

PRINCETON, N.J. and SUZHOU, China, April 9, 2024 -- 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, and Agilent Technologies , announce a collaboration to develop a Claudin 18.2(CLDN 18.2) companion diagnostic to support TranStar301 global Phase III pivotal trial of Osemitamab (TST001) in combination with Nivolumab and chemotherapy as first-line treatment in patients with CLDN 18.2 expressing locally advanced or metastatic gastric or gastroesophageal (G/GEJ) adenocarcinoma.

Transcenta has developed a mouse anti-CLDN 18.2 monoclonal antibody, clone 14G11 which specifically binds to CLDN 18.2 but not CLDN18.1. This antibody, generated against a linear epitope located on the extracellular domain of loop1, has a binding site that overlaps with the binding site of therapeutic antibody Osemitamab (TST001).

Transcenta has been collaborating with Agilent, a world leader in CDx development, to further develop this antibody for use in a companion diagnostic assay. Agilent is developing Claudin 18.2 IHC 14G11 pharmDx, an immunohistochemistry (IHC) assay for the detection of CLDN 18.2 protein in gastric and gastroesophageal junction (GEJ) adenocarcinoma with the potential for other indications. Agilent and Transcenta presented the early results of the Claudin 18.2 IHC 14G11 pharmDx assay at AACR Annual Meeting. Claudin 18.2 IHC 14G11 pharmDx for Investigational Use Only/for Performance Evaluation Only will be used for patient selection in the phase III trial of gastric/GEJ adenocarcinoma where applicable ethics committee and regulatory approvals have been granted.

“Agilent’s expertise in the development of companion diagnostics is impressive, as is their strong track record of developing companion diagnostics across the precision oncology sector,” said Dr. Caroline Germa, Transcenta’s Executive Vice President, Global Medicine Development and Chief Medical Officer. “We are excited about the collaboration and look forward to working together to pave the way for enhanced patient health outcomes.”

“We are excited to be working with Transcenta on the development of the Claudin 18.2 IHC 14G11 pharmDx companion diagnostic assay,” said Dr. Paul Beresford, VP/GM of CDx, Agilent. “This partnership with Transcenta will further pave the way for enhanced precision medicine products for those with gastric and gastroesophageal junction adenocarcinoma, and continue transforming diagnostics, treatments, and patient health outcomes.”

About Osemitamab (TST001)

Osemitamab (TST001) is a high affinity humanized anti-CLDN 18.2 monoclonal antibody with enhanced antibody-dependent cellular cytotoxicity ("ADCC"). It has shown potent anti-tumor activities in tumor xenograft models. Osemitamab (TST001) is the second most advanced CLDN 18.2 targeting antibody being developed globally. Osemitamab (TST001) was generated using Transcenta's Immune Tolerance Breaking Technology (IMTB) platform. Osemitamab (TST001) kills CLDN 18.2 expressing tumor cells by mechanisms of ADCC. 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 (NCT05190575, NCT04396821, NCT04495296, NCT05608785 / CTR20201281). Osemitamab (TST001) has been granted Orphan Drug Designation in the U.S. by FDA for the treatment of patients with gastric or gastroesophageal junction (G/GEJ) and pancreatic cancer.

About Transcenta

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 13 therapeutic antibody molecules for oncology and selected non-oncology indications including bone and kidney disorders.

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