D3 Bio Wins FDA Clearance for Dual KRAS Programs, Expanding U.S. Clinical Footprint

New updates have been reported about D3 Bio.

D3 Bio has secured U.S. FDA clearance for two investigational new drug applications that materially advance its KRAS oncology franchise and U.S. clinical presence: a first‑in‑human Phase 1 trial for D3S‑003, its KRAS G12D inhibitor, and a Phase 2 combination study pairing elisrasib (D3S‑001), its next‑generation KRAS G12C inhibitor, with the ERK1/2 inhibitor D3S‑002. With this regulatory greenlight, the company will initiate a Phase 1 study of D3S‑003 in patients with advanced solid tumors harboring KRAS G12D mutations, a large and difficult‑to-treat segment of the oncology market. Preclinical data indicate that D3S‑003, an orally bioavailable, allele‑specific inhibitor targeting both OFF (GDP‑bound) and ON (GTP‑bound) conformations, has a differentiated, potentially best‑in‑class profile based on anti‑tumor activity, drug‑like properties, and safety margins, positioning D3 Bio to compete in one of the most strategically important mutation classes in solid tumors.

The FDA also cleared a Phase 2 combination trial evaluating elisrasib with D3S‑002 in KRAS G12C–mutant non‑small cell lung cancer patients who have progressed on prior KRAS G12C‑targeted therapies, directly addressing a resistance‑driven segment with high unmet need. The study, expected to start in the first half of 2026, will assess safety, pharmacokinetics, and early efficacy signals to validate a vertical MAPK‑pathway blockade strategy aimed at delivering more durable responses. Elisrasib, already in global Phase 2 monotherapy and combination trials across KRAS G12C–mutant solid tumors, has shown robust preclinical potency, full target engagement at clinically relevant exposures, and central nervous system penetration, while D3S‑002 has been designed specifically for combination use to overcome acquired resistance. CEO George Chen framed these clearances as key milestones reinforcing D3 Bio’s ambition to build a multi‑allele KRAS franchise and to retain global rights across its pipeline, a structure that preserves strategic flexibility for future partnering, financing, or commercialization decisions in the U.S. and other major markets.