D3 Bio Receives FDA Breakthrough Therapy and Orphan Drug Designations for D3S-001 in KRAS G12C-Mutated Cancers
Friday, August 29, 2025
D3 Bio, a clinical-stage oncology company developing precision cancer therapies, has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to D3S-001, its next-generation KRAS G12C-selective inhibitor. The designation covers adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) who have previously received chemotherapy and immunotherapy but not a KRAS G12C inhibitor.
In addition, D3S-001 has been awarded Orphan Drug Designation for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC).
These designations are supported by data from an ongoing Phase 1/2 trial (NCT05410145) assessing D3S-001 in advanced solid tumours carrying the KRAS G12C mutation. The study has shown encouraging and durable efficacy under RECIST criteria, with a favourable safety and tolerability profile.
KRAS mutations are among the most common oncogenic drivers, occurring in up to 30% of cancers. The KRAS G12C mutation is present in around 12% of NSCLC cases and 3–4% of CRC cases. Patients with these mutations typically face more aggressive disease and limited response to current treatment options.
D3S-001 is designed to achieve rapid and complete engagement of the KRAS G12C target. It selectively and irreversibly binds to the inactive RAS G12C protein, blocking its switch between active and inactive states. Preclinical studies have demonstrated strong potency, full target engagement at clinically relevant doses, and central nervous system penetration.
The candidate is being evaluated as both a monotherapy and in combination regimens in a global Phase 2 trial for advanced solid tumours harbouring KRAS G12C mutations, including NSCLC, CRC and other cancer types.
Source: prnewswire.com
