On January 20, 2026 Boundless Bio (Nasdaq: BOLD), a clinical-stage oncology company interrogating extrachromosomal DNA (ecDNA) biology to deliver transformative therapies to patients with previously intractable oncogene amplified cancers, reported that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for its novel Kinesin oral degrader program, BBI-940. The Company also provided updates on the POTENTIATE clinical trial of BBI-355 and BBI-825 and its capital position.
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BBI-940 novel Kinesin degrader program
The acceptance of the BBI-940 IND enables Boundless to advance the program into a first-in-human clinical trial for patients with metastatic breast cancer, KOMODO-1 (Kinesin Oral Molecular Degrader for Oncology-1), which is expected to initiate in the first half of 2026. Boundless’s novel Kinesin oral degrader program targets a previously undrugged kinesin involved in DNA segregation, including ecDNA segregation, during mitosis. BBI-940 has demonstrated potent anti-tumor activity across a range of cancer cell lines as well as in mouse xenograft models, including single-agent tumor regressions. The Company expects to deliver initial proof-of-concept clinical data within its cash runway timeline.
"The acceptance of the BBI-940 IND marks an important milestone for our first-in-class Kinesin oral degrader program, enabling us to advance this differentiated anti-cancer approach into clinical development," said Zachary Hornby, President and Chief Executive Officer of Boundless Bio. "In parallel, our portfolio prioritization and disciplined capital allocation sharpen our focus on BBI-940, maximizing our potential to deliver high-impact therapies for patients with high unmet need cancers."
POTENTIATE clinical trial of BBI-355 and BBI-825
Following a strategic portfolio review, Boundless Bio has elected to cease enrollment of the Phase 1/2 POTENTIATE trial evaluating the combination of BBI-355, its oral, selective CHK1 inhibitor and BBI-825, its oral, selective RNR inhibitor, in oncogene-amplified cancers. This decision reflects market considerations, clinical data, and the Company’s prioritization of programs with the greatest potential to deliver meaningful clinical impact and long-term value.
Financial Update
Based on the revised operating plan, the Company’s streamlined operations will extend its operating runway into the second half of 2028, through the anticipated initial clinical proof of concept readout for BBI-940.
(Press release, Boundless Bio, JAN 20, 2026, View Source [SID1234662100])