ANTENGENE-B Shares Surge Over 5% Following Clinical Approval for Key Phase III Study of ADC Therapy ATG-022 in Gastric Adenocarcinoma

Stock News05-29

ANTENGENE-B (06996) rose more than 5%. As of the time of writing, the stock was up 5.33% to HK$4.35, with a turnover of HK$3.2719 million.

The company announced that it has received approval from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) to initiate the pivotal Phase III CLINCH-3 study. This study will evaluate ATG-022, a Claudin 18.2 (CLDN18.2) antibody-drug conjugate (ADC), for the treatment of CLDN18.2-positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma.

The trial is expected to commence first in China and is planned as a multi-regional clinical trial (MRCT). It is a randomized, controlled, open-label, multicenter Phase III study designed to assess the efficacy and safety of ATG-022 compared to investigator's choice of therapy in patients with CLDN18.2-positive advanced gastric or GEJ adenocarcinoma.

As a key registration study, CLINCH-3 aims to support a future marketing authorization application for ATG-022 as a monotherapy for CLDN18.2-positive advanced gastric or GEJ adenocarcinoma. The primary endpoints are progression-free survival (PFS) and overall survival (OS), as assessed by an independent review committee. Secondary endpoints include objective response rate (ORR), duration of response (DOR), disease control rate (DCR), safety, and other measures.

The company noted that it cannot guarantee the successful development or eventual marketing of ATG-022.

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