Antengene Receives IND Approval for Advancing ATG-022 Study

Antengene's Exciting Development with ATG-022

Antengene Corporation Limited, a prominent name in innovative biotechnologies, is making significant strides in the field of oncology. Recently, the company celebrated a major milestone with the approval of its investigational new drug (IND) application by China's National Medical Products Administration (NMPA) for their Phase Ib/II study, focusing on the innovative treatment ATG-022. This therapy is poised to be combined with KEYTRUDA® (pembrolizumab) and chemotherapy, marking a significant advancement in the fight against cancer.

Understanding the Study: What Is CLINCH-2?

The study, known as CLINCH-2, will be spearheaded by Professor Lin Shen at Beijing Cancer Hospital. It aims to explore the efficiency of two distinct combination treatment regimens targeting patients afflicted by unresectable or metastatic gastric cancer or gastroesophageal junction adenocarcinoma. This patient group has been categorized as CLDN18.2-positive, HER2-negative, and PD-L1-positive (CPS?1).

The two regimens being evaluated are ATG-022 combined with pembrolizumab, and the same combination further augmented with the CAPOX chemotherapy regimen. This comprehensive study's primary objective is to ascertain the safety and tolerability of these combinations, while the secondary aims delve into their preliminary antitumor activity, the immunogenic properties of ATG-022, and its pharmacokinetic profile.

Clinical Insights from the CLINCH Study

Recent data from Antengene indicated promising results from the earlier Phase I/II CLINCH study of ATG-022, which focuses on advanced gastric cancer. This pivotal information was shared at the European Society for Medical Oncology Congress 2025 (ESMO 2025). The results pinpointed significant safety and efficacy patterns, showcasing that in the 1.8 mg/kg dose group, a mere 18.2% experienced grade 3 or higher treatment-related adverse events.

Additionally, researchers noted no instances of ocular toxicity or interstitial lung disease, emphasizing ATG-022's relatively low associated peripheral neuropathy incidence. Importantly, both the efficacious doses of 1.8 mg/kg and 2.4 mg/kg illustrated an objective response rate (ORR) of 40%. This robust performance reinforces ATG-022's applicability alongside pembrolizumab and chemotherapy in initial treatment settings.

What makes this study particularly noteworthy is that antitumor activities have been observed across varying levels of CLDN18.2 expression. This versatility hints at a broader eligibility spectrum for patients compared to existing CLDN18.2 targeting treatments.

The Future of ATG-022 and Antengene

Antengene is committed to propelling both the ongoing CLINCH study and the newly approved CLINCH-2. They plan to present updated findings at upcoming medical conferences, further underscoring ATG-022's clinical promise. The anticipation surrounding these developments illustrates the company's dedication to its revolutionary therapies and underscores their vital role in addressing critical unmet medical needs.

The Significance of CLDN18.2-targeted Treatments

ATG-022 stands out due to its targeted action against the CLDN18.2 protein, showcasing remarkable affinity and rapid cellular internalization. This ADC utilizes a VC-MMAE linker-payload, achieving profound effectiveness across a spectrum of tumors exhibiting various CLDN18.2 expression levels. Additionally, ATG-022 has earned two Orphan Drug designations by the FDA for treating gastric and pancreatic cancers, emphasizing its potential in the clinical landscape.

The therapy has also received Breakthrough Therapy Designation from the NMPA in China targeting specific gastric cancer categories, highlighting its importance in treating patients who have previously undergone multiple therapies. This acknowledgment showcases Antengene's commitment to innovative and next-generation cancer treatments.

About Antengene Corporation

Antengene Corporation Limited is a globally recognized R&D-driven biotech company. It strives to develop first-in-class and best-in-class therapeutics for conditions with significant unmet medical requirements. Antengene's diverse pipeline encompasses a range of researched and commercially viable programs. Their lead project, XPOVIO® (selinexor), has already gained approvals across several markets and has been incorporated into national insurance schemes in multiple regions.

Ultimately, as Antengene continues to evolve and expand its influence, the future looks bright for both the company and those reliant on advanced therapeutic solutions in the arena of cancer treatment.

Frequently Asked Questions

What is ATG-022?

ATG-022 is an antibody-drug conjugate targeting the CLDN18.2 protein, specifically designed for treating certain types of cancers.

What does the CLINCH-2 study aim to achieve?

The CLINCH-2 study seeks to evaluate the safety and effectiveness of combining ATG-022 with KEYTRUDA® and chemotherapy for treating gastric and gastroesophageal cancers.

Who is leading the CLINCH-2 study?

Professor Lin Shen is the principal investigator, overseeing the trials conducted at Beijing Cancer Hospital.

Is ATG-022 currently available for patients?

ATG-022 remains in clinical trials, and results from these studies will determine its future availability for patients.

What milestones has Antengene achieved?

Antengene has received 32 IND approvals and has introduced its lead asset into multiple international markets, reflecting its growth and commitment to innovative therapies.

About The Author

Olivia Taylor here, a 26-year-old writer and financial advisor. After earning a degree in finance, I worked in the sector for years. I've always loved numbers and had a talent for simplifying difficult financial ideas so that anyone could understand. I wrote my first book because of this passion; it helps readers take charge of their financial futures by fusing real-life stories with useful financial advice.

Whether they are just beginning their careers, preparing for significant life events, or seeking to invest wisely, my goal with my writing is to enable people to make educated financial decisions. The foundation of my work is the conviction that security and freedom of the individual are largely determined by financial literacy. To further financial education, I run workshops and frequently write for financial blogs in addition to my books.

I like to travel, experience other cultures, and find inspiration in daily life when I'm not writing or examining market trends. My passion is utilizing sound financial practices to help people reach their financial objectives and lead the best lives possible.

Contact Olivia Taylor privately here. Or send an email with ATTN: Olivia Taylor as the subject to contact@investorshangout.com.

About Investors Hangout

Investors Hangout is a leading online stock forum for financial discussion and learning, offering a wide range of free tools and resources. It draws in traders of all levels, who exchange market knowledge, investigate trading tactics, and keep an eye on industry developments in real time. Featuring financial articles, stock message boards, quotes, charts, company profiles, and live news updates. Through cooperative learning and a wealth of informational resources, it helps users from novices creating their first portfolios to experts honing their techniques. Join Investors Hangout today: https://investorshangout.com/

The content of this article is based on factual, publicly available information and does not represent legal, financial, or investment advice. Investors Hangout does not offer financial advice, and the author is not a licensed financial advisor. Consult a qualified advisor before making any financial or investment decisions based on this article. This article should not be considered advice to purchase, sell, or hold any securities or other investments. If any of the material provided here is inaccurate, please contact us for corrections.