#China #Shanghai #Antengene #KEYTRUDA #ATG-022

Antengene's IND Approval for ATG-022

Antengene Corporation Limited, a prominent biotech firm listed on the Hong Kong Stock Exchange (SEHK: 6996.HK), has recently announced the approval of their investigational new drug (IND) application by the China National Medical Products Administration (NMPA). This landmark decision paves the way for the Phase Ib/II clinical study, known as the CLINCH-2 study, which focuses on their innovative drug ATG-022, an antibody-drug conjugate (ADC) targeting CLDN18.2, in combination with KEYTRUDA® (pembrolizumab) and chemotherapy.

Study Overview

The CLINCH-2 study will be conducted under the leadership of Prof. Lin Shen at Beijing Cancer Hospital, the primary trial center. The study aims to evaluate two different treatment regimens for patients diagnosed with unresectable or metastatic gastric cancer or gastroesophageal junction adenocarcinoma that is CLDN18.2-positive, HER2-negative, and PD-L1-positive (CPS≥1).

The regimens to be tested include:
1. ATG-022 with Pembrolizumab (A+P)
2. ATG-022 with Pembrolizumab and CAPOX chemotherapy (A+P+C)

The primary objective will focus on assessing the safety and tolerability of both combinations. Additionally, secondary goals include evaluating preliminary antitumor activity, immunogenicity of ATG-022, and characterizing its pharmacokinetic (PK) profile.

Previous Successes

Antengene's previous clinical trial results showcased at the European Society for Medical Oncology Congress 2025 (ESMO 2025) demonstrated promising efficacy and safety of ATG-022 as a monotherapy for advanced gastric cancer. Specifically, data revealed that the occurrence of grade 3 or higher treatment-related adverse events reached only 18.2% at a dosage of 1.8 mg/kg. Notably, no ocular toxicity or interstitial lung disease was observed, and peripheral neuropathy incidents were minimal.

Both efficacious doses of ATG-022 (1.8 mg/kg and 2.4 mg/kg) displayed an objective response rate (ORR) of 40%. These findings support the potential of using ATG-022 in combination therapies and indicate its applicability across various patient populations.

Exploring New Frontiers

Moreover, emerging findings suggested that ATG-022 might exhibit antitumor effects in other CLDN18.2 positive tumor types, including specific gynecological cancers, thereby suggesting avenues for expanding the drug's utility beyond gastric cancer.

Antengene continues to advocate for the advancement of the ongoing CLINCH study and the newly approved CLINCH-2 trial, with their eyes set on presenting further research outcomes at subsequent medical conferences.

About Antengene

Antengene Corporation Limited is dedicated to pioneering cutting-edge therapeutics for significant unmet medical needs. With a robust pipeline that extends across various stages of clinical development, Antengene’s innovations include several promising candidates, among them ATG-022, aimed at treating various cancers. The company is committed to developing first-in-class or best-in-class medicines that address the challenges of autoimmune conditions, solid tumors, and hematological malignancies.

As a forward-looking biotech company, Antengene's endeavors in therapeutic development underscore its mission to transform existing treatment paradigms, offering hope for improved outcomes for patients facing complex health challenges in oncology.

Conclusion

With the IND approval of ATG-022 in China, Antengene takes a significant stride in the landscape of cancer therapy. As they commence this pivotal study, the revelations from the clinical data will be crucial for shaping future treatments and improving patient care in oncology. The combination of ATG-022 with KEYTRUDA® and chemotherapy represents a promising approach that could redefine treatment success in patients with specific cancer types.