D3 Bio Receives U.S. FDA Clearance for Two IND Applications, Enabling Phase 1 Trial of D3S‑003 and Phase 2 Combination Study of Elisrasib (D3S‑001) with D3S‑002

SHANGHAI, Jan. 18, 2026 /PRNewswire/ — D3 Bio, a global clinical‑stage biotechnology company focused on developing transformative oncology therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has cleared two Investigational New Drug (IND) applications:

• D3S‑003 — a KRAS G12D inhibitor — enabling the start of a Phase 1 first‑in‑human clinical trial.
• A Phase 2 combination trial evaluating D3S‑001 (elisrasib), the Company’s next‑generation KRAS G12C inhibitor, in combination with D3S‑002, a selective oral ERK1/2 inhibitor.

D3S‑003 is an orally bioavailable, allele‑specific KRAS G12D inhibitor that targets both the GDP‑bound (OFF) and GTP‑bound (ON) conformations. Preclinical data demonstrate a differentiated, best‑in‑class profile with potent anti‑tumor activity, favorable drug‑like characteristics, and a promising safety margin. With FDA clearance received, D3 Bio will advance D3S‑003 into a Phase 1 first‑in‑human study in patients with advanced solid tumors harboring KRAS G12D mutations.

The newly cleared Phase 2 study will evaluate the combination of D3S‑001 and D3S‑002 in patients with KRAS G12C–mutant non‑small cell lung cancer (NSCLC) who have progressed on prior KRAS G12C‑targeted therapies. The trial, expected to begin in the first half of 2026, will investigate safety, pharmacokinetics, and early efficacy signals with the goal of establishing a rational combination strategy to address resistance and deliver more durable benefit in KRAS‑driven cancers.

“We are excited to receive FDA IND clearance for D3S‑003 and to advance a Phase 2 combination clinical trial of elisrasib and D3S‑002,” said George Chen, Founder, Chairman and Chief Executive Officer of D3 Bio. “With D3S‑003, we are bringing a differentiated KRAS G12D inhibitor into the clinic to address one of the most prevalent and challenging KRAS mutations. In parallel, the combination study of elisrasib and D3S‑002 pushes forward our next‑generation KRAS G12C strategy, particularly for patients who have progressed on prior KRAS G12C‑targeted therapies. Together, these milestones underline the momentum of our KRAS franchise and reinforce our commitment to delivering transformative therapies for patients with KRAS‑mutant cancers who urgently need new options.”

About Elisrasib (D3S-001)

Elisrasib is a next‑generation KRAS G12C inhibitor designed for rapid, complete, and selective target engagement. It covalently binds the GDP‑bound (OFF) form of KRAS G12C, effectively blocking nucleotide cycling and suppressing oncogenic signaling. Preclinical studies show robust potency, complete KRAS G12C engagement at clinically relevant exposures, and CNS penetration capability. Elisrasib is currently being evaluated globally in a Phase 2 monotherapy and combination trial across KRAS G12C–mutant solid tumors including NSCLC, CRC, and others.

Key publications:

• Cancer Discovery (2024) 14(9):1675–1698
• Nature Medicine (2025) 31(8):2768–2777

About D3S‑002

D3S‑002 is a selective ERK1/2 inhibitor strategically designed for combination approaches, providing vertical MAPK‑pathway inhibition to enhance efficacy and overcome acquired resistance, particularly in tumors previously treated with KRAS G12C inhibitors.

Key publication:

• Cancer Res 1 April 2023; 83 (7_Supplement): 5501.

About D3S‑003

D3S‑003 is a differentiated KRAS G12D inhibitor targeting both OFF and ON conformations to address one of the most common KRAS mutations. The program aims to broaden D3 Bio’s multi‑allele KRAS franchise and deliver new solutions for the heterogeneous and evolving landscape of KRAS‑driven cancers.

About D3 Bio

D3 Bio is a global biotechnology company focused on the discovery, development, and registration of novel oncology and immunology therapies with first‑ or best‑in‑class potential. Guided by deep clinical insight and biomarker‑driven strategies, the Company is advancing a pipeline of programs targeting key oncogenic drivers and immune pathways. D3 Bio owns global rights to all its programs.

For more information, please visit www.d3bio.com

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SOURCE D3 Bio