• 64 patients with CLDN18.2 positive G/GEJ cancer were enrolled in cohort C of TranStar102 (TST001-1002). CLDN18.2 positivity is defined as ≥10% tumor cells with ≥1+ intensity. These patients represent approximately 55% of all G/GEJ adenocarcinomas. The overall median PFS was 9.5months. with no differences according to the CLDN18.2 expression.

• The addition of Osemitamab (TST001) to chemotherapy provides benefit to patients with CLDN18.2 positive tumors, including the low expressors (≥10% tumor cells with ≥1+ intensity but <40% tumor cells with <2+ intensity).

SUZHOU, China, June 30, 2023 -- 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, has presented progression free survival (PFS) data by CLDN18.2 expression level from phase I/II study of Osemitamab (TST001) plus Capecitabine and Oxaliplatin (CAPOX) as the first-line treatment of advanced gastric/gastroesophageal junction (G/GEJ) cancer at ESMO World Congress on Gastrointestinal Cancer 2023

These data will support the upcoming global Phase III pivotal trial to be initiated in the second half of 2023.

Study Design

The efficacy and safety of Osemitamab (TST001) plus CAPOX as the first-line treatment for patients with advanced G/GEJ cancer was explored in a dose escalation and expansion phase 1/2 study in China (Cohort C of TranStar102, NCT04495296). In the expansion phase (except 8 patients from a safety run-in), CLDN18.2 positive was required, which is defined as IHC membrane staining ≥10% tumor cells with ≥1+ intensity per LDT assay, selecting approximately 55% of the screened patients.

Study Results

• As of Apr. 21, 2023, a total of 64 patients were dosed with Osemitamab (TST001) in combination with CAPOX, 15 patients received Osemitamab (TST001) at doses ranging from 1 to 8 mg/kg Q3W in the dose escalation and 49 patients at 6 mg/kg in the dose expansion. The median follow-up was 195 days.

• 41 out of 49 patients in the dose expansion at 6mg/kg had CLDN18.2 positive tumor (High: n=9, Medium: n=13, Low: n=19), 8 patients didn’t get their tumor tissue tested (unknown CLDN18.2 expression). The baseline demographics of this dose expansion are similar to that of the overall population published on 2023 ASCO (abstract 4046*). There are no clinically significant differences in baseline characteristics across different CLDN18.2 expression levels.

• The safety profile of Osemitamab (TST001) is mainly characterized by manageable on-target off-tumor effects and has been presented at ASCO 2023 (abstract 4046*). Most of these AEs are of grade 1 or 2 and occurred during the first 2 cycles.

• Among the 49 patients at 6mg/kg in the dose expansion, 42 patients had measurable lesions and at least one post treatment tumor assessment,28 (66.7%) achieved partial response, At the cut-off date of April 21, 2023, 26 out of the total 64 patients enrolled in this cohort had progressive disease or death, with an estimated median progression-free survival (PFS) of 9.5 months. There was no clear trend of correlation between progression-free survival and the CLDN18.2 expression levels.

“Appropriately selecting patients is critical to optimize the benefit/risk of treatment with Osemitamab. Using our proprietary CLDN18.2 assay, we have selected 55% of the G/GEJ cancer patients and shown that the lower expressors amongst these patients derive the same level of durable benefit than the higher expressors. This is a key differentiation and a significant dataset supporting our phase 3 design.” said Dr. Caroline Germa, Transcenta’s Executive Vice President, Global Medicine Development and Chief Medical Officer.

About Osemitamab (TST001)

Osemitamab (TST001) is a high affinity humanized anti- CLDN18.2 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 CLDN18.2 targeting antibody being developed globally. Osemitamab (TST001) was generated using Transcenta's Immune Tolerance Breaking Technology (IMTB) platform. Osemitamab (TST001) kills CLDN18.2 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) was 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 Holding Limited

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 Business Development 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 HiCB 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.

For more information, please visit www.transcenta.com and https://www.linkedin.com/company/transcenta.