US-based clinical stage biopharmaceutical company Asana BioSciences has begun its Phase I trial of ASN003 to treat patients with advanced solid tumours.
ASN003 selectively inhibits B-RAF and phosphoinositide 3-kinase (PI3K), while demonstrating wider anti-proliferative activity against tumour cell lines.
Activation of the two signalling pathways triggers abnormal cell growth in a range of cancers such as melanoma, colorectal, breast and lung.
ASN003 can treat or prevent resistance to selective B-Raf inhibitors.
The Phase I trial is being conducted as a multicentre, dose-finding, cohort expansion study, which will include patients with advanced solid tumours with B-RAF V600 mutation or PI3K pathway alterations, including those with metastatic colorectal cancer (CRC) or advanced non-small-cell lung cancer (NSCLC).
The study is intended to establish the safety, tolerability and determine pharmacokinetics, pharmacodynamics profile and anti-tumour activity of ASN003.
Asana BioSciences founder, president and CEO Sandeep Gupta said: “We are delighted to initiate the clinical development of ASN003, which is a first-in-class, highly selective B-RAF / PI3K inhibitor designed to delay or treat acquired resistance observed in patients treated with current therapies targeting these individual pathways.
“The dosing of the first cohort in the trial has been completed, and the drug was well tolerated.
“ASN003 is our third clinical stage programme in less than two years, affirming Asana’s efficiency and dedication to provide new and better treatment options to cancer patients.”
ASN003 has also demonstrated anti-tumour activity when administered in combination with immune checkpoint and IDO inhibitors.