On January 4, 2017 Asana BioSciences, LLC, an oncology focused, clinical stage biopharmaceutical company, reported that the first patient has been dosed in a Phase 1 trial for ASN003, a novel and highly selective B-RAF/phosphoinositide 3-kinase (PI3K) inhibitor (Press release, Asana BioSciences, JAN 4, 2017, View Source [SID1234533384]). Activation of these two major signaling pathways has been implicated in abnormal cell growth in various human cancers including melanoma, colorectal, breast and lung.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"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," said Sandeep Gupta, PhD, Founder, President and Chief Executive Officer at Asana BioSciences. "ASN003 is our 3rd clinical stage program in less than 2 years, affirming Asana’s efficiency and dedication to provide new and better treatment options to cancer patients."
ASN003 has shown broader anti-proliferative activity in tumor cell lines as compared to the B-RAF selective inhibitors, vemurafenib and dabrafenib, and shows robust antiproliferative activity in B-RAF and MEK inhibitor-resistant cell lines. It potently inhibits tumor growth in multiple B-RAF mutant and B-RAF/PI3K double mutant mouse xenograft tumor models. ASN003 also showed greater efficacy in tumor models when administered in combination with immune checkpoint and IDO inhibitors.
The Phase 1, multicenter, dose-finding, cohort expansion study will enroll patients with advanced solid tumors with B-RAF V600 mutation or PI3K pathway alterations, including patients with metastatic colorectal cancer (CRC) or advanced non-small cell lung cancer (NSCLC). The trial is designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of ASN003 (NCT02961283).