Asana BioSciences has dosed the first subject in a Phase I clinical trial of antibody drug conjugate (ADC) ASN004 for the treatment of advanced solid tumour patients in the US. 

ASN004 acts on the 5T4 oncofetal antigen (trophoblast glycoprotein). 

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This antigen is expressed in a broad range of malignant tumours but in a limited manner in normal tissues. 

Increased 5T4 expression is linked to worse clinical outcome in non-small cell lung, head and neck, pancreatic, gastric, ovarian and colorectal cancers.

Furthermore, ASN004 has a new single-chain Fv-Fc antibody associated with a clinically established Auristatin F hydroxypropylamide cytotoxic payload.

The drug to antibody ratio (DAR) of ASN004 is nearly ten to 12. 

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The multicentre, dose-finding trial will analyse the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumour activity of ASN004 in advanced solid tumour patients. 

One dose of ASN004 offered complete and durable tumour regression resulting in tumour-free survivors, in preclinical cancer models.

Asana BioSciences founder, president and CEO Sandeep Gupta said: “We are delighted to initiate the clinical development of ASN004. 

“The broad tumour expression profile of 5T4 qualifies it as a promising target for cancer therapies, with the potential to be the best-in-class ADC. 

“ASN004 is the sixth novel programme that Asana has successfully brought into the clinic, affirming our mission to provide new and better treatment options to patients.”

The clinical-stage biopharmaceutical company discovers and develops new targeted investigational medicines in the fields of immunology/inflammation and oncology.

Apart from ASN004, Asana has other assets in the pipeline, Gusacitinib (ASN002), ASN003, ASN008 and ASN009. 

Gusacitinib is being studied to treat moderate-to-severe atopic dermatitis and chronic hand eczema.

ASN003 was analysed in Phase I trial for metastatic melanoma, colorectal and advanced non-small cell lung cancer, and other advanced solid tumours patients harbouring BRAFV600 and PI3K pathway mutations. 

ASN008 completed the Phase I trial and ASN009 is in the preclinical stage.