Transcenta Holding Limited (6628.HK) Announces 2024 Interim Results

Transcenta Holding Limited, a clinical-stage biopharmaceutical company, has released its unaudited consolidated results for the first half of 2024, showcasing significant advancements in both its oncology and non-oncology pipelines.

A primary focus has been on the company's lead oncology asset, osemitamab (TST001), a Claudin18.2-targeting antibody designed for the treatment of gastric or gastroesophageal junction (G/GEJ) cancer. The company presented promising Phase II data on osemitamab at the American Society of Clinical Oncology (ASCO) annual meeting, highlighting that high to medium Claudin18.2 expression correlates with a median progression-free survival (PFS) of 12.6 months. Additionally, safety and pharmacokinetic (PK) data from the TranStar101 study were unveiled at the American Association for Cancer Research (AACR) annual meeting, showing consistency between U.S. and Chinese patient profiles.

Transcenta continued its collaboration with Agilent Technologies to develop a Claudin18.2-specific companion diagnostic assay, which supports the TranStar301 global Phase III pivotal trial of osemitamab in combination with a checkpoint inhibitor and chemotherapy. This assay has received regulatory clearances from the U.S. FDA, China’s Center for Drug Evaluation (CDE), and South Korea’s Ministry of Food and Drug Safety (MFDS). The company aims to position osemitamab as a pioneering global therapy for first-line treatment of Claudin18.2-expressing locally advanced or metastatic G/GEJ cancer, and plans to investigate its effectiveness in other advanced solid tumors.

In the non-oncology sector, Transcenta's anti-sclerostin antibody blosozumab (TST002) showed promising results in a Single Ascending Dose (SAD) study presented at the 2024 World Congress on Osteoporosis, Osteoarthritis, and Musculoskeletal Diseases (WCO-IOF-ESCEO Congress). Following a single dose of up to 1,200 mg, the lumbar spine bone mineral density (BMD) increased by 3.52% to 6.20%, and total hip BMD by 1.30% to 2.24%, exceeding the least significant difference level and indicating clinical significance.

The company has also advanced the first-in-human (FIH) trial of TST003, an anti-GREMLIN-1 antibody, completing patient enrollment for the dose-escalation phase. This trial is being conducted across multiple clinical centers in the U.S. and China, and progress was showcased through a Trial in Progress (TiP) poster at the 2024 AACR annual meeting.

On the technology front, Transcenta has made strides in enhancing its Highly Intensified Continuous Bioprocessing (HiCB) platform, successfully applying this technology in the Good Manufacturing Practice (GMP) production of osemitamab. The company has also been developing TST013, an antibody-drug conjugate (ADC) targeting a validated tumor antigen, which has shown significantly improved anti-tumor activity and tolerability compared to benchmark ADCs. Additionally, TST808, a humanized antibody for treating autoimmune renal disorders like IgA nephropathy, is in the IND-enabling study phase.

Transcenta has embarked on various strategic collaborations to bolster its technological and commercial capabilities. This includes a partnership with a specialized company for siRNA drug substance synthesis, providing Contract Development and Manufacturing Organization (CDMO) services in siRNA formulation development. The company's proprietary cell culture media, ExcelPro CHO, is under evaluation against market standards by several external partners, including a global leader in media, as part of a potential global commercial collaboration.

Transcenta remains dedicated to advancing its pipeline and technology platforms, aiming to deliver innovative therapies and maintain its position at the forefront of biopharmaceutical development.

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