Transcenta Announces Positive Interim Results, Highlights Osemitamab and Blosozumab Progress
核心洞察
Transcenta's osemitamab (TST001) demonstrated a median PFS of 12.6 months in G/GEJ cancer (搜索) patients with high/medium Claudin18.2 (搜索) expression when combined with checkpoint inhibitors and CAPOX.
Blosozumab (TST002) showed clinically meaningful increases in lumbar spine BMD, exceeding the least significant difference level, in a single ascending dose study.
Transcenta completed enrollment for the dose-escalation phase of the TST003 FIH trial, an anti-GREMLIN-1 (搜索) antibody, with ongoing trials in the U.S. and China.
Transcenta Holding Limited (搜索) (6628.HK) has announced its unaudited consolidated results for the first half of 2024, showcasing significant clinical advancements in its oncology and non-oncology pipelines. The company's lead oncology asset, osemitamab (TST001), a Claudin18.2 (搜索)-targeting antibody, and its lead non-oncology asset, blosozumab (TST002), an anti-sclerostin antibody, have both achieved key milestones.
Osemitamab (TST001) for Gastric/Gastroesophageal Junction Cancer
Osemitamab (TST001) has shown promising Phase II data in combination with checkpoint inhibitors and standard chemotherapy as a first-line treatment for gastric or gastroesophageal junction (G/GEJ) cancer. The data, presented at the American Society of Clinical Oncology (ASCO) annual meeting, indicated that patients with high/medium Claudin18.2 (搜索) expression had a median progression-free survival (PFS) of 12.6 months. Furthermore, safety and pharmacokinetic (PK) data from the TranStar101 study, presented at the 2024 AACR annual meeting, demonstrated consistency in the safety and PK profile of osemitamab (TST001) between U.S. and Chinese patients from the TranStar102 study.
Transcenta is collaborating with Agilent Technologies (搜索) to develop a Claudin18.2 (搜索) companion diagnostic test to support the global pivotal Phase III trial (TranStar301) of osemitamab (TST001). Regulatory clearances have been successfully obtained 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).
Blosozumab (TST002) for Osteoporosis
Blosozumab (TST002) published Single Ascending Dose (SAD) study results at the 2024 World Congress on Osteoporosis (搜索), Osteoarthritis and Musculoskeletal Diseases (WCO-IOF-ESCEO Congress). The study revealed that a single dose of blosozumab (TST002) up to 1,200 mg resulted in an average increase of lumbar spine bone mineral density (BMD) at day 85 (D85) ranging 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%), indicating clinical significance.
TST003: Anti-GREMLIN-1 Antibody
Transcenta has completed patient enrollment in the dose-escalation phase of the First-in-Human (FIH) trial for TST003, a first-in-class anti-GREMLIN-1 (搜索) antibody. The trial is ongoing at multiple clinical centers in the U.S. and China. A Trial in Progress (TiP) poster of the TST003-1001 study was presented at the 2024 American Association for Cancer Research (AACR) annual meeting in April.
Additional Pipeline Developments
Transcenta is also advancing TST013, an ADC candidate targeting a validated tumor antigen, which has shown improved anti-tumor activity and tolerability. TST808, a humanized antibody neutralizing a key target regulating B/Plasma cell proliferation and survival, is being developed for autoimmune renal disorders, including IgA nephropathy (搜索), with IND-enabling studies underway.
Transcenta's HiCB (Highly Intensified Continuous Bioprocessing) platform technology has been successfully implemented in the GMP manufacturing of osemitamab (TST001).