#China #Shanghai #gastric cancer #Antengene #ATG-022

Antengene's Breakthrough Therapy Designation for ATG-022

Antengene Corporation Limited, a prominent global biotech company focusing on innovative treatments, has achieved a significant milestone with its investigational drug ATG-022, a CLDN18.2 antibody-drug conjugate (ADC). Recently, the drug received Breakthrough Therapy designation from the National Medical Products Administration (NMPA) in China. This designation specifically targets the treatment of patients with unresectable or metastatic gastric and gastroesophageal junction adenocarcinoma who have already undergone at least two prior lines of therapy.

What Does This Mean for Patients?

The Breakthrough Therapy designation is part of the NMPA's initiative to expedite the development and approval process for medicines demonstrating significant clinical benefits. With this status, ATG-022 will enjoy prioritized reviews, which could mean quicker access for patients in need of effective treatments. Previously, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to ATG-022, recognizing its potential in treating gastric and pancreatic cancers.

Efficacy and Safety Insights

Current findings from the ongoing CLINCH Phase I/II trial indicate that ATG-022 shows promising antitumor activity alongside a favorable safety profile for gastric or gastroesophageal junction adenocarcinoma patients. The study results highlight:

• - In the cohort administered with 2.4 mg/kg of ATG-022, an objective response rate (ORR) of 40% was recorded, including one complete response (CR). The disease control rate (DCR) was impressive at 90%, with a median progression-free survival (mPFS) of 6.97 months.
• - Another cohort receiving 1.8 mg/kg also showed similar ORR, emphasizing the reliability of the treatment across different dosage levels.
• - Notably, patients with low and ultra-low CLDN18.2 expression levels also benefitted from the treatment, together with some patients achieving CR despite having expression levels below 5%. This broad-spectrum efficacy positions ATG-022 uniquely among existing CLDN18.2-targeted therapies.

Future Development Plans

Antengene is currently advancing the Phase II dose-expansion phase for ATG-022 within China and Australia, setting the stage for critical clinical validation. The ongoing strategy includes exploring ATG-022's applications in multiple treatment settings:

• - First-line Treatment: ATG-022 is combined with pembrolizumab and chemotherapy specifically for patients exhibiting CLDN18.2 IHC 1+ (≥1%) and PD-L1 CPS ≥1%.
• - Second-line Treatment: This involves ATG-022 with pembrolizumab for a similar patient profile.
• - Third-line Treatment: Targeting patients who express moderate to high levels of CLDN18.2 exclusively using ATG-022.

Moreover, a phase II study also encompasses a basket trial evaluating multiple tumor types. Some patients from a particular gynecological tumor subtype have experienced significant tumor shrinkage, showcasing ATG-022's versatile potential.

About Antengene

Antengene Corporation Limited, listed on the Hong Kong Stock Exchange (SEHK: 6996.HK), is driven by research and development in order to deliver transformative therapeutics across several critical health issues. Their extensive pipeline includes a variety of innovative treatments and also features proprietary platforms designed to enhance drug efficacy and minimize adverse effects.

As Antengene continues to make strides in its R&D efforts, the future looks promising for ATG-022 as a valuable addition to gastric cancer treatment options. With ongoing clinical trials and new study designs, the medical community eagerly anticipates more data that could support ATG-022's potential across multiple tumor types.

In summary, Antengene's ATG-022 not only exemplifies hope for improved treatment avenues for gastric cancer but also reflects the broader commitment to addressing significant unmet medical needs. The continued insights from ongoing studies could potentially reshape therapeutic strategies in oncology, particularly for patients suffering from challenging forms of cancer.