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Axcynsis Therapeutics Receives FDA Clearance for AT03-65

Axcynsis Therapeutics Pte Ltd, a biopharmaceutical company specializing in antibody-drug conjugates (ADCs), has recently secured FDA clearance for its Investigational New Drug (IND) application for AT03-65. This groundbreaking therapy is tailored for treating patients with CLDN6-positive solid tumors, indicating a momentous leap in oncology treatment options.

AT03-65 marks the inaugural use of AxcynDOT™, a proprietary technology developed by Axcynsis. This innovative payload entails a distinct mechanism of action aimed at optimizing the efficacy of traditional cancer therapies. The planned Phase 1 multicenter clinical trial is set to commence in the United States in the first quarter of 2025, which will be an exciting development for both patients and healthcare professionals.

The Science Behind AT03-65

AT03-65 functions by targeting CLDN6, a protein that is considerably overexpressed in several malignancies, including lung, ovarian, endometrial, and gastric cancers. It shows negligible presence in healthy tissues, highlighting its potential for selective targeting and minimizing side effects associated with conventional cancer treatments. The drug's ability to deliver targeted therapy aims to enhance patient outcomes, especially for individuals with advanced or metastatic diseases.

Dr. Zou Bin, CEO of Axcynsis, emphasized the significance of this milestone, stating, "This is a transformational event for Axcynsis and speaks volumes about our proprietary ADC platform using AxcynDOT™. We are delighted with the FDA's clearance, which allows us to explore the potential of AT03-65 to changing lives for patients suffering from CLDN6-positive tumors."

Clinical Trial Objectives and Design

The forthcoming Phase 1 clinical trial intends to assess multiple aspects, including the safety, tolerability, and pharmacokinetics of AT03-65. It will also explore the drug's preliminary efficacy in patients afflicted by advanced CLDN6-positive solid tumors, who have had limited success with existing systemic therapies. The goal is to evaluate how well the drug can manage and potentially diminish tumor sizes while gauging its overall impact on patient health.

AT03-65 represents a groundbreaking approach, as the antibody is engineered to possess a high specificity for CLDN6, ensuring it binds effectively to cancerous cells. Once attached, the ADC is internalized into lysosomes, releasing its therapeutic payload to inhibit the tumor growth efficiently. The promising preclinical results underscore not only the agent's capability of directly killing CLDN6-positive cells but also its efficacy in targeting adjacent tumor cells lacking CLDN6, amplifying its anti-tumor impact.

Advancing Oncology through AxcynDOT™ Technology

AxcynDOT™ is a novel payload that derives from trabectedin, an FDA-approved chemotherapy. This technology significantly enhances the potency and safety profile compared to other DNA alkylating agents. It sets a new benchmark, showcasing the innovation that Axcynsis Therapeutics is bringing to the field of oncology.

As Axcynsis continues its commitment to address critical unmet medical needs in the cancer treatment landscape, the potential of AT03-65 could provide hope to patients with limited options. The company's mission remains steadfast: to develop effective, targeted therapies that can transform the future of cancer care worldwide.

Conclusion

Axcynsis Therapeutics' receipt of FDA IND clearance for AT03-65 is a pivotal advancement in cancer treatment, heralding a new era in the fight against CLDN6-positive solid tumors. The upcoming clinical trial is anticipated to yield valuable insights into this promising treatment option, potentially leading to improved outcomes for cancer patients. As the world awaits the initiation of this trial in early 2025, there's optimism that technologies like AxcynDOT™ will pioneer significant breakthroughs in biopharmaceuticals and change the dynamic of oncology treatments.