Boundless Bio (NASDAQ:BOLD) said it has received clearance from the Food and Drug Administration for its investigational new drug application covering BBI-940, paving the way for a clinical trial of the experimental therapy. The company plans to initiate the KOMODO-1 study in the first half of 2026, enrolling patients with metastatic breast cancer.
The San Diego–based biotech also said it has halted enrollment in its POTENTIATE study, which was testing a combination of BBI-355 and BBI-825 in cancers driven by oncogene amplification. The move followed a strategic review of its pipeline that took into account market considerations and emerging clinical evidence.
BBI-940 is designed to degrade a kinesin protein that plays a key role in DNA segregation during cell division. In preclinical testing, the orally administered candidate demonstrated anti-tumor effects across multiple cancer cell lines and led to 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.
Boundless Bio said an updated operating plan has extended its cash runway into the second half of 2028, giving the company sufficient resources to reach initial clinical proof-of-concept data from the BBI-940 program, including the expected readout from the forthcoming trial.
The company’s research focuses on extrachromosomal DNA biology, which it says is present in roughly 14% to 17% of cancer patients. This approach targets oncogene amplification, a process that can fuel tumor development and progression.