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news.The US Food and Drug Administration (FDA) has cleared the investigational new drug application (IND) of Axcynsis Therapeutics’ antibody-drug conjugate (ADC), AT03-65, targeting CLDN6-positive solid tumours.
The company is set to launch a multicentre Phase I trial in the US in the first quarter of this year. Credit: Lucas Vasques on Unsplash.
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The company is set to launch a multicentre Phase I trial in the US in the first quarter of this year.
Axcynsis Therapeutics CEO Dr Zou Bin said: “This is a transformational event for Axcynsis and a significant milestone for our proprietary ADC platform using AxcynDOT. We are pleased that the FDA has cleared AT03-65 which leverages our AxcynDOT technology for this first-in-human study.
“We are very excited with the potential of offering a transformative therapeutic option for patients with CLDN6-positive tumours as well as advancing our pipeline with differentiated and effective ADCs using AxcynDOT to improve the lives of cancer patients worldwide”.
AT03-65 binds specifically to CLDN6, which is overexpressed in various malignancies such as lung, gastric, and ovarian while maintaining the ‘minimal’ presence in healthy tissues.
Once bound to CLDN6-expressing tumour cells, the ADC is internalised and releases its payload in the lysosomes, inhibiting tumour growth.
The therapy is poised to enhance outcomes for individuals with advanced or metastatic CLDN6-positive cancers. Its antibody component is tailored for high specificity and affinity to CLDN6.
The upcoming trial will assess the therapy’s tolerability, safety, pharmacokinetics, preliminary efficacy, and pharmacodynamics.
According to preclinical studies, AT03-65 eliminates CLDN6-positive malignant cells as well as exhibits a bystander effect. Promising results from multiple tumour mouse models and a ‘favourable’ safety profile in non-human primates have been demonstrated.
AxcynDOT, the company’s payload, is a derivative of trabectedin, a chemotherapy approved in the US, Europe, and certain Asian countries.
Headquartered in Singapore with operations in the US, Axcynsis Therapeutics develops targeted therapies for cancer treatment.
