Boundless Bio announced FDA clearance of an investigational new drug (IND) for BBI‑940, an oral kinesin degrader, enabling a first‑in‑human trial (KOMODO‑1) in metastatic breast cancer slated to start in the first half of 2026. The program targets a novel proteolysis‑based mechanism to degrade kinesin family proteins important for cancer cell division and survival. Proteolysis targeting as a modality (small‑molecule degraders) uses bifunctional molecules to recruit E3 ligases to disease proteins for ubiquitination and degradation; BBI‑940 is designed as an orally bioavailable degrader. Boundless positioned the IND clearance as a key clinical milestone that shifts the program from preclinical to clinical evaluation. The company plans dose‑escalation cohorts to define safety, pharmacokinetics and early signals of activity; IND clearance also supports broader investor and partner engagement ahead of initial human data.
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