On August 29, 2024 Transcenta Holding Limited ("Company"; stock code: 6628.HK) reported the unaudited consolidated results of the Company and its subsidiaries (collectively, the "Group") for the six months ended June 30, 2024 (the "Reporting Period") (Press release, Transcenta, AUG 29, 2024, View Source [SID1234646217]).

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In the first half of 2024, the Company continued to accelerate clinical progress across both the oncology and non-oncology pipelines.

For company’s lead oncology asset, the Claudin18.2-targeting antibody osemitamab (TST001, A Humanized ADCC Enhanced Claudin18.2 mAb for Solid Tumors), reached key milestones for the treatment of gastric or gastroesophageal junction (G/GEJ) cancer. Company published the encouraging Phase II data of osemitamab (TST001) in combination with checkpoint inhibitor and standard chemotherapy as first-line treatment of G/GEJ cancer at American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting (ASCO) (Free ASCO Whitepaper), showing that high/medium Claudin18.2 expression is associated with a median PFS of 12.6 months. At the same period, Company published the safety and PK data of TranStar101 study at the 2024 AACR (Free AACR Whitepaper) annual meeting. The safety and pharmacokinetic profile of osemitamab (TST001) in the U.S. patients, is consistent with the profile reported in Chinese patients from TranStar102 study.

Worked with Agilent Technologies, Inc. (Agilent), a world leader in CDx development, and developed a Claudin18.2 companion diagnostic test that can fully support the global pivotal trial of osemitamab (TST001). Successfully received regulatory clearances from the U.S. Food and Drug Administration (FDA), China Center for Drug Evaluation (CDE) and South Korea Ministry of Food and Drug Safety (MFDS). All the achievements validate and further support strategy for the Global Phase III trial (TranStar301). Osemitamab (TST001) is on track to become the first global therapy that delivers the next wave of innovation in the first-line treatment of patients with Claudin18.2 expressing locally advanced or metastatic G/GEJ cancer. Company also plans to explore several Claudin18.2 expressing advanced solid tumors other than G/GEJ cancer.

For lead non-oncology asset, the anti-sclerostin antibody blosozumab (TST002, A Humanized Sclerostin mAb for Osteoporosis), published Single Ascending Dose (SAD) study result in the 2024 World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (WCO-IOF-ESCEO Congress) in April. After a single dose of blosozumab (TST002) up to 1,200 mg, the average increase of lumbar spine BMD at day 85 (D85) ranged from 3.52% to 6.20% and total hip BMD from 1.30% to 2.24% across dose cohorts. The lumbar spine BMD increase exceeded the least significant difference level (2.77%) and was clinically meaningful.

In addition, Company has completed the enrolment of patients in the dose-escalation part for the First-in-Human (FIH) trial of first-in-class anti-GREMLIN-1 antibody TST003 and the trial is ongoing at multiple clinical centers in the U.S. and China. Have presented one Trial in Progress (TiP) poster of TST003-1001 study at the 2024 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in April.

Furthermore, progress had been made in improving the continuous bioprocessing platform technology HiCB (Highly Intensified Continuous Bioprocessing) and the technology was successfully implemented in the GMP manufacturing of osemitamab (TST001).

Research/Early Development Update:

TST013 (An ADC Candidate Targeting a Validated Tumor Antigen)- TST013 displayed significantly improved anti-tumor activity relative to benchmark ADC and improved tolerability profile which warrants further development
TST808 (A Humanized Antibody Neutralizing One of the Validated Key Targets Regulating B/Plasma Cell Proliferation and Survival) – TST808 has the potential to treat multiple autoimmune renal disorders including IgA nephropathy. Company has obtained the lead molecules and initiated the IND-enabling studies
Business Development Achievements:

Company has continued the collaboration with Agilent for the Claudin18.2 specific IHC CDx Assay to support TranStar301 global Phase III pivotal trial of osemitamab (TST001) in combination with checkpoint inhibitor and chemotherapy
Company has continued the clinical trial collaboration with BMS, and completed the enrolment with osemitamab (TST001),checkpoint inhibitor and chemotherapy combination in TranStar102 in China and in TranStar101 in the U.S.
Technology Partnership & Advancement:

Company has formed a strategic alliance with a company specialized in siRNA drug substance synthesis, to provide CDMO services in siRNA formulation development and F&F
Company’s in-house cell culture media ExcelPro CHO are being evaluated for its performance against market standards for fed-batch, intensified fed-batch and perfusion processes by several external partners including a global leading company of media. This is part of potential collaboration for global commercialization of ExcelPro CHO