Asana BioSciences Announces Dosing of First Patient in Phase 1 Trial of ASN004, a Novel 5T4-Antibody-Drug-Conjugate

On April 8, 2022 Asana BioSciences, LLC, a clinical stage biopharmaceutical company, reported that the first patient has been dosed in a Phase 1 trial for ASN004, an antibody drug conjugate (ADC) targeting the 5T4 oncofetal antigen (trophoblast glycoprotein), that is expressed in a wide range of malignant tumors but shows very limited expression in normal tissues (Press release, Asana BioSciences, APR 8, 2022, View Source [SID1234611757]). Higher 5T4 expression is associated with worse clinical outcome in non-small cell lung, head and neck, gastric, pancreatic, colorectal, and ovarian cancers.

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ASN004 incorporates a novel single-chain Fv-Fc antibody linked to a clinically validated Auristatin F hydroxypropylamide cytotoxic payload, and drug to antibody ratio (DAR) of approximately 10-12. In preclinical cancer models, a single dose of ASN004 achieved complete and durable tumor regression leading to tumor-free survivors.

"5T4 is an ideal antigen target for payload delivery to tumor with high internalization rate dynamics combined with the high DAR and represents a clear opportunity for precision guided therapy as needed" said Dr. Anthony Tolcher, Director of Clinical Research, Next Oncology, San Antonio, Texas and the Principal Investigator of the Phase 1, multicenter, dose-finding study, designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of ASN004, in patients with advanced solid tumors in the US (NCT04410224).

"We are delighted to initiate the clinical development of ASN004. The broad tumor expression profile of 5T4 qualifies it as a promising target for cancer therapies, with potential to be the best-in-class ADC," said Sandeep Gupta, PhD, Founder, President and Chief Executive Officer at Asana BioSciences. "ASN004 is the 6th novel program that Asana has successfully brought into the clinic, affirming our mission to provide new and better treatment options to patients," added Dr. Gupta.