Boundless Bio gets FDA clearance for cancer drug trial

Boundless Bio (NASDAQ: BOLD) received FDA acceptance of its investigational new drug application for BBI-940, a kinesin degrader targeting cancer cells. The company plans to begin the KOMODO-1 trial for metastatic breast cancer patients in the first half of 2026.

The San Diego-based oncology company discontinued enrollment in its POTENTIATE trial, which was evaluating the combination of BBI-355 and BBI-825 in oncogene-amplified cancers. The decision followed a strategic portfolio review considering market factors and clinical data.

BBI-940 targets a kinesin protein involved in DNA segregation during cell division. In preclinical studies, the oral drug showed anti-tumor activity across cancer cell lines and caused tumor regression in mouse models.

"The acceptance of the BBI-940 IND marks an important milestone for our first-in-class Kinesin oral degrader program," said Zachary Hornby, president and chief executive officer.

The company's revised operating plan extends its cash runway into the second half of 2028, allowing it to reach initial clinical proof-of-concept data for BBI-940. The timeline covers the expected data readout from the upcoming trial.

Boundless Bio focuses on extrachromosomal DNA biology, which the company states is observed in 14% to 17% of cancer patients. The approach targets oncogene amplification, a mechanism that can drive tumor growth.

The information is based on a company press release.

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