#China #Shanghai #Antengene #ATG-022 #Breakthrough Therapy

Antengene's ATG-022 Receives Breakthrough Therapy Designation

Antengene Corporation Limited, a well-known global biotech company committed to developing innovative therapies for serious diseases, has achieved a significant milestone. Their newly discovered drug, ATG-022, a Claudin 18.2 antibody-drug conjugate, has been awarded a Breakthrough Therapy designation by China's National Medical Products Administration (NMPA). This designation is designated for treatments that exhibit substantial clinical advantages in comparison to existing therapies.

A New Hope for Patients

The approval comes as a beacon of hope for patients suffering from unresectable or metastatic gastric and gastroesophageal junction adenocarcinoma, particularly those with CLDN18.2-positive and HER-2 negative status who have already undergone at least two lines of therapy. This Breakthrough Therapy designation signifies a promise for a quicker path to market, enabling faster access to potentially life-saving treatment for those in need.

At a management conference scheduled for August 20, 2025, the company will elaborate on the latest clinical data surrounding ATG-022. Interested parties can join via a webcast or a global teleconference, showcasing Antengene's commitment to transparency and communication with stakeholders.

Clinical Significance of ATG-022

Interim results from the ongoing CLINCH Phase I/II trial highlight ATG-022's promising performance. Patients treated with ATG-022 exhibited notable antitumor responses: 40% of patients in the cohort with moderate-to-high CLDN18.2 expression achieved an objective response rate, and the disease control rate reached 90%. Median progression-free survival was reported at 6.97 months, with a 12-month overall survival rate of 66.2%. These findings reflect a trend towards effective treatment options for harder-to-treat cancers.

Additionally, the drug has shown efficacy even in patients with low-expression levels of CLDN18.2. Some patients in this cohort presented with CLDN18.2 expression below 5%, reinforcing the broad-reaching therapeutic potential of ATG-022. As research continues, the hope is that ATG-022 could revolutionize how gastric and gastroesophageal cancers are treated, expanding treatment options to a wider array of patients.

Future Directions and Expanded Trials

Antengene's forward trajectory includes several exciting developments. With Phase II trials underway in both mainland China and Australia, the focus is on increasing patient access to ATG-022. The therapy is being evaluated not only for gastric cancer but also across various conditions with CLDN18.2 positivity.

The strategic development plan for ATG-022 encompasses multiple treatment lines, including first-line combinations with pembrolizumab and chemotherapy, and monotherapy options for third-line treatment. Such comprehensive planning ensures that as many patients as possible will benefit from this promising new therapy.

Furthermore, the trial also includes a basket cohort for various tumor types, examining the effectiveness of ATG-022 in different cancers - an initiative that could potentially lead to broader applications for the medication in oncology.

Antengene's Commitment to Innovation

Established in 2017, Antengene is at the forefront of biopharmaceutical innovation. The company is dedicated to developing therapies that meet significant unmet medical needs across oncology, hematologic malignancies, and other serious health conditions. The success of ATG-022 not only highlights Antengene's robust R&D pipeline but also demonstrates their capability to bring transformative therapies to market.

With 31 investigational new drug approvals secured in the U.S. and Asia, Antengene continues to thrive in the international biomedical landscape, driven by a mission to enhance treatment options and improve patient outcomes. The future looks promising as further data from ongoing studies emerge, affirming the significant potential of ATG-022 and what it represents for patients worldwide.

In conclusion, the Breakthrough Therapy designation for ATG-022 marks a pivotal moment for Antengene and a new dawn for treatment strategies targeting gastric cancer. As research progresses, the global medical community eagerly anticipates the impact of this innovative therapy on patient lives.