Targeted Cancer Drug Trial Commences

Asana BioSciences recently announced the dosing of the first patient in a clinical trial for the investigational BRAF/phosphoinositide 3-kinase (PI3K) inhibitor, ASN003. ASN003 is a highly selective drug that simultaneously inhibits both signaling pathways involved with multiple cancers, such as colorectal, breast, lung, and melanoma, according to the press release.

Asana specializes in chemical and biologic drugs for the treatment of cancer, pain, and autoimmune diseases, according to the press release.

In preclinical trials, ASN003 demonstrated more toxic effects in cancer cell lines compared with chemotherapy drugs that only target BRAF, such as vemurafenib and dabrafenib.

Interestingly, the drug also shows similar results in cancer cell lines that are resistant to both BRAF and MEK inhibitors, which could lead to novel treatment options for patients whose cancers have become resistant to first-line treatments, Asana noted.

In mouse models of BRAF and BRAF/PI3K-driven cancers, investigators discovered that ASN003 demonstrated potent action against tumor growth, according to the press release.

Asana also found that ASN003’s anti-cancer activity was amplified by the addition of immune checkpoint and IDO inhibitors. These findings could potentially lead to a novel combination treatment that will improve patient outcomes. Due to the positive outcomes observed in cultured cells and mouse models, the pharmaceutical company initiated clinical trials.

The new phase 1 clinical trial aims to determine the optimal dosage for ASN003 in patients with advanced cancers. The researchers will additionally assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-cancer activity of the drug.

Included in the trial are patients with cancer driven by a BRAF V600 mutation or PI3K pathway alteration, such as those with metastatic colorectal cancer, or advanced non-small cell lung cancer, according to Asana.

The dosing of the first patient is a large milestone for the company, which currently has multiple other cancer treatments in phase 1 and 2 clinical trials.

“We are delighted to initiate the clinical development of ASN003, which is a first-in-class highly selective BRAF/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 in a press release. “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.”