#Shanghai #Antengene #ATG-022 #TCE Platform

Antengene Reports Strong Interim Results for 2025

Antengene Corporation Limited recently unveiled its interim results for the period ending June 30, 2025. The report reflected notable advancements in its clinical program, particularly focusing on the promising outcomes of its investigational products, ATG-022 and ATG-037, as well as innovations from its T-cell engager (TCE) platform.

Key Highlights from the Results

Promising Data from ATG-022

ATG-022, also referred to as the CLDN18.2 ADC, exhibited encouraging results in the ongoing Phase I/II CLINCH trial. The drug demonstrated significant efficacy and a favorable safety profile in patients suffering from gastric and gastroesophageal junction adenocarcinoma.

In moderate to high expressors of CLDN18.2 (IHC 2+ >20%), the trial's 2.4 mg/kg dose cohort achieved a remarkable 40% objective response rate (ORR), which included one complete response (CR). Furthermore, the study recorded a 90% disease control rate (DCR) and an impressive median progression-free survival (mPFS) of 6.97 months. The 1.8 mg/kg cohort echoed these results, achieving a similar ORR of 40% and an overall DCR of 84%. In patients with low and ultra-low expression levels of CLDN18.2 (IHC 2+ ≤20%), the drug still held promise, registering a 33.3% ORR and a 50% DCR when dosed at 1.8-2.4 mg/kg.

Exceptional Tolerability

Both dosage cohorts of ATG-022 were well tolerated, with no reported ophthalmologic toxicities or instances of interstitial lung disease. Notably, the 1.8 mg/kg dose showed particularly low rates of severe treatment-related adverse events.

In addition, preliminary results from a basket cohort studying CLDN18.2-positive tumors demonstrated tumor shrinkage in all evaluable patients with a specific subtype of gynecologic cancer, underscoring the drug's potential as a multi-cancer treatment.

Breakthrough Therapy Designation

Adding to the promising news, ATG-022 has recently been granted Breakthrough Therapy Designation by China's National Medical Products Administration (NMPA). This designation applies to its use in treating CLDN18.2-positive, HER2-negative, unresectable, or metastatic gastric or gastroesophageal junction adenocarcinoma after prior therapies.

Broader Development Strategy

Antengene's strategy for advancing gastric cancer treatments is thorough. The company is progressing with ATG-022 in various combinations, including first-line treatment with pembrolizumab and CAPOX/FOLFOX, second-line therapy with pembrolizumab, and third-line monotherapy.

Efficacy of ATG-037

Shifting focus to another investigational drug, ATG-037, an oral CD73 small molecule inhibitor, it also showed strong efficacy results in the Phase I/II STAMINA study. Particularly in a subgroup of patients with melanoma who were resistant to checkpoint inhibitors, the trial noted a 36.4% ORR and a 100% DCR. The durability of the responses was remarkable, with one complete response lasting over 32 months.

Insights into the AnTenGager™ Platform

One of the most exciting aspects of Antengene's strategy is its next-generation T-cell engager platform, AnTenGager™. This innovative technology employs a