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).
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.
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.