Boundless Bio has initiated patient enrollment in a Phase 1/2 clinical trial (STARMAP) to investigate BBI-825, a novel therapy targeting resistance gene amplifications in cancer.

BBI-825 is an oral ribonucleotide reductase (RNR) inhibitor, designed to inhibit the formation and repair of extrachromosomal DNA (ecDNA). EcDNA plays a crucial role in amplifying genes that drive cancer growth and resistance to targeted therapies.

Preclinical studies have shown that BBI-825 effectively suppresses tumor growth and induces tumor regression in models of resistance mediated by MAPK pathway-activated tumors.

• Phase 1/2 study involving patients with locally advanced or metastatic cancer
• Evaluation of BBI-825 as a single agent and in combination with select targeted cancer therapies
• Initial focus on patients with colorectal cancer harboring KRASG12C and BRAFV600E mutations and resistance gene amplifications

Resistance to targeted therapies is a significant challenge in cancer treatment, particularly in colorectal cancer. The development of MAPK pathway and receptor tyrosine kinase gene amplifications often drives treatment resistance, leading to poor outcomes.

The STARMAP trial aims to address the unmet need for therapies that can prevent or overcome amplification-driven resistance in cancer. BBI-825, as a novel ecDTx, targets a fundamental mechanism of resistance, providing a potential breakthrough in oncogene amplified cancer treatment.

The positive results from this trial could support the expansion of BBI-825 into broader patient populations, including those with pan-tumor, pan-RAS, and pan-RAF indications.

Source link: http://www.businesswire.com/news/home/20240410633469/en/Boundless-Bio-Announces-First-Patient-Dosed-in-First-in-Human-Phase-12-Clinical-Trial-of-BBI-825-in-Cancer-Patients-with-Resistance-Gene-Amplifications

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Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.