D3 Bio Secures FDA Breakthrough Therapy Designation for KRAS G12C Cancer Drug
D3 Bio, Inc., a clinical-stage biotechnology company focused on precision oncology, has received Breakthrough Therapy Designation and Orphan Drug Designation from the US Food and Drug Administration (FDA) for its KRAS G12C-selective inhibitor, D3S-001.
The Breakthrough Therapy Designation applies to adults with KRAS G12C-mutated, locally advanced or metastatic non-small cell lung cancer (NSCLC) who have already been treated with chemotherapy and immunotherapy but not with another KRAS G12C inhibitor.
The Orphan Drug Designation covers adults with KRAS G12C-mutated, locally advanced or metastatic colorectal cancer (CRC).
Both designations are based on data from an ongoing Phase 1/2 clinical study (NCT05410145), which has shown promising and durable anti-tumour activity according to RECIST criteria, alongside a favourable safety and tolerability profile.
KRAS mutations are among the most frequent oncogenic drivers, appearing in approximately 25–30% of all cancers. The KRAS G12C mutation is present in around 12% of NSCLC cases and 3–4% of CRC cases.
Patients with this mutation often face aggressive disease and limited benefit from standard options such as chemotherapy or immunotherapy. D3S-001 has been developed as a next-generation KRAS G12C inhibitor designed for rapid and complete target engagement.
It binds selectively and covalently to the inactive form of the RAS G12C protein, effectively disrupting the switching process between active and inactive states that promotes tumour growth. Preclinical data demonstrated strong covalent potency, complete KRAS G12C engagement at clinically achievable doses, and central nervous system penetration.
The therapy is now under investigation as monotherapy and in combination treatments in a global Phase 2 trial in patients with advanced solid tumours harbouring KRAS G12C mutations, including NSCLC, CRC, and other tumour types.
