SUZHOU, China, June 2, 2021 — Transcenta Holding Limited ("Transcenta"), a global biotherapeutics company with fully-integrated capabilities in discovery, development and manufacturing of antibody-based therapeutics, announced completion of first patient dosing in PET-CT imaging study of radionuclide-labeled CLDN18.2 antibody.

The study was led by Professor Lin Shen and Dr. Hua Zhu, from Beijing Cancer Hospital, the objective of the study is to construct a non-invasive approach of ¹²⁴I-18B10 PET-CT to detect the CLDN18.2 expression of tumor lesions in patients with gastrointestinal and other solid tumors, and to identify patients benefited from CLDN18.2 targeting treatment. The current preclinical findings showed that the antibody probe has high specificity to CLDN18.2 and it was specifically enriched in CLDN18.2 positive tumor site in tumor-bearing mice rather than normal tissues. The results of this study were presented in the form of a poster at the ESMO Targeted Anticancer Therapies 2021 Virtual Congress in March and also the abstract was published in Annals of Oncology, 2021(32). An investigator-initiated clinical trial (NCT04883970) is approved for enrollment. The first subject has received the intravenous injection of ¹²⁴I-18B10 antibody probe last week and completed PET-CT imaging study.

"We are working with Beijing Cancer Hospital to explore the potential of ¹²⁴I-18B10 antibody as a non-invasive diagnostic reagent." said Dr. Michael Shi, EVP, Head of Global R&D and CMO of Transcenta, "In the future, we hope that radionuclide tracer technology can be used in the non-invasive, precise and targeted medical diagnosis and treatment of gastrointestinal cancer."

"As a new imaging agent, the radionuclide-labeled 18B10 antibody has great potential to be further developed as a non-invasive diagnostic technology for CLDN18.2 positive cancer patients, and may provide a new auxiliary tool for the diagnosis of CLDN18.2-expressed tumors and the identification of metastatic sites in the future." said Professor Lin Shen from Beijing Cancer Hospital.