D3 Bio closes $108M Series B to propel KRAS inhibitor into global Phase 3 trials

On December 10, D3 Bio, a global clinical-stage biotechnology company focused on developing innovative medicines for oncology, announced the successful completion of a $108 million Series B financing round. The proceeds will be used primarily to advance the global Phase 3 pivotal clinical study of its lead candidate, elisrasib (D3S-001).

The study is designed to evaluate elisrasib both as a monotherapy and in combination regimens for patients with tumors harboring KRAS G12C mutations. The trial will be conducted across key regions, including the United States, China, and the European Union, to support subsequent global registration filings.

In addition to funding the pivotal trial for elisrasib, the capital will be deployed to advance the company's pipeline of innovative drug candidates, which is centered on targeted therapy and tumor immunology.

According to publicly available information, D3S-001 is a next-generation KRAS G12C inhibitor capable of rapid and complete inhibition of the KRAS G12C target. Preclinical studies have demonstrated that D3S-001 exhibits high covalent binding efficiency, achieves complete target inhibition at clinically relevant doses, and possesses central nervous system (CNS) penetration properties.

Previously, the U.S. FDA granted Breakthrough Therapy designation to D3S-001 for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) who have previously received chemotherapy and immunotherapy but have not been treated with a KRAS G12C inhibitor. Additionally, D3S-001 has received Orphan Drug designation from the FDA for the treatment of KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC).