Boundless Bio Initiates Phase 1/2 Trial with First Patient Dosed for BBI-825 in Cancer Patients with Resistance Genes
Boundless Bio, a clinical-stage oncology firm, has initiated a Phase 1/2 clinical trial for BBI-825, an innovative oral inhibitor of ribonucleotide reductase (RNR), as part of the STARMAP study. This marks the company's second extrachromosomal DNA (ecDNA)-directed therapy (ecDTx) to enter clinical development. BBI-825 has shown promise in preclinical trials by inhibiting tumor growth and tackling resistance in MAPK pathway-activated tumors.
The STARMAP trial will assess BBI-825's safety, pharmacokinetics, and preliminary antitumor activity, either as a single agent or in combination with other targeted therapies. The study will focus on patients with colorectal cancer that has developed resistance to targeted therapies, a significant challenge in cancer treatment. The first patient has already been dosed in the trial, which is an open-label, non-randomized, three-part design.
Boundless Bio's Spyglass platform has identified synthetic lethal targets crucial for ecDNA formation and function in oncogene-amplified cancers. The company aims to expand the application of BBI-825 to broader patient populations if the trial data are supportive. BBI-825 works by depriving ecDNA-reliant cancer cells of the building blocks of DNA, thus inhibiting their growth and survival.
The company is headquartered in San Diego and is developing a new paradigm in cancer therapeutics by targeting ecDNA, a root cause of oncogene amplification found in over 14% of cancer patients. Boundless Bio's first ecDNA-directed therapy, BBI-355, is also undergoing clinical trials.
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