SHANGHAI and HONG KONG, Aug. 25, 2025 /PRNewswire/ -- Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) today announced its interim results for the period ending June 30, 2025, along with updates on recent achievements:
- ATG-022 (CLDN18.2 ADC) has shown promising results in the ongoing Phase I/II CLINCH study, demonstrating robust efficacy and a favorable safety profile in gastric/GEJ adenocarcinoma across high, low, and ultra-low CLDN18.2 expression levels.
- In moderate-to-high expressors (IHC 2+ >20%), the 2.4 mg/kg cohort achieved a 40% ORR (12/30, including 1 CR), a 90% DCR, 6.97 months of mPFS, with 6-month PFS at 51.1%, 9-month OS at 82.7%, and 12-month OS at 66.2%; the 1.8 mg/kg cohort achieved 40% ORR (10/25, including 1 CR) and 84% DCR. In low/ultra-low expressors (IHC 2+ ≤20%) treated at 1.8–2.4 mg/kg, ATG-022 achieved 33.3% ORR (6/18, including 1 CR) with 50% DCR.
- Both dose cohorts were well tolerated, with no ophthalmologic toxicities or interstitial lung disease observed, and the 1.8 mg/kg dose showing particularly low rates of Grade ≥3 TRAEs
- In a basket cohort of CLDN18.2-positive tumors, preliminary data showed tumor shrinkage in all 7 evaluable patients with a subtype of gynecologic cancer.
- ATG-022 has also been granted Breakthrough Therapy Designation by China's NMPA for the treatment of CLDN18.2-positive, HER2-negative, unresectable or metastatic gastric/GEJ adenocarcinoma after at least two prior therapies.
- Antengene is advancing a broad development strategy in gastric cancer, including first-line ATG-022 with pembrolizumab and CAPOX/FOLFOX, second-line ATG-022 with pembrolizumab, and third-line ATG-022 monotherapy.
- ATG-037 (oral CD73 small molecule inhibitor) showed robust efficacy in the Phase I/II STAMINA study. In the CPI-resistant melanoma subgroup, results were particularly encouraging, with 36.4% ORR and 100% DCR (1CR, 3PRs), in patients largely double-resistant to both anti-PD-1 and anti-CTLA-4 antibodies. Responses were durable, with the CR patient remaining on treatment for over 32 months, 2 PR patients for more than 15 months, and 1 SD patient for over 28 months. In the CPI-resistant NSCLC subgroup, ATG-037 achieved a 21.4% ORR and 71.4% DCR (3 PRs).
- AnTenGager™ Platform is Antengene's next-generation T-cell engager technology, featuring "2+1" bivalent binding, steric hindrance masking, and proprietary CD3 sequences with fast on/off kinetics to reduce CRS and improve efficacy. Broadly applicable across autoimmune diseases, solid tumors, and hematologic malignancies, the platform is open to global partnerships. ATG-201 (CD19 x CD3), the lead TCE program, expands Antengene's pipeline into autoimmune diseases. Preclinical studies in non-human primates showed repeated dosing at 1mpk, 3mpk, and 6mpk was well tolerated with very low cytokine release, and the surrogate antibody mediated complete B-cell depletion in blood, spleen, and lymph nodes. ATG-201 is expected to enter clinical development in Q4 2025.
To learn more about the 2025 interim financial results, please see the full announcement in the "Investor Relations" section on the company's website.
Forward-looking Statements:
For details on forward-looking statements, please refer to our full Interim Results press release on the Company's website: https://www.antengene.com/newsinfo/442
For more information, please contact:
Investor Contacts:
Donald Lung
E-mail: Donald.Lung@antengene.com
Mobile: +86 18420672158
PR Contacts:
Peter Qian
E-mail: Peter.Qian@antengene.com
Mobile: +86 13062747000
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