D3 Bio’s D3S-001 Receives U.S. FDA Fast Track Designation for the Treatment of Colorectal Cancer with KRAS G12C mutation

Shanghai, China—D3 Bio (Wuxi) Co. Ltd (“D3 Bio” or “Company”), a biotechnology company that focuses on discovery, development, and registration of innovative medicines in the fields of oncology and immune-oncology, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to D3S-001 for the treatment of advanced unresectable or metastatic colorectal cancers harboring KRAS G12C mutation that have relapsed and/or are refractory to approved therapies. The mechanistic rationale and pharmacologic data presented in the FTD application provided strong evidence of superior activity of D3S-001 in multiple CRC in vitro and in vivo cell line-derived and patient-derived xenograft models. The FTD from FDA reflects D3S-001’s potential to address the unmet medical need for colorectal cancer patients worldwide. "We feel very excited about obtaining FTD to D3S-001 and we will leverage the advantage of FTD and speed up the global clinical development of D3S-001 to better serve our patients’ needs.” said George Chen, Chief Executive Officer, and Chairman of the company.

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About colorectal cancer

Colorectal cancer (CRC) is the third most common and the second most deadly cancer worldwide. About 3% CRC carries KRAS G12C mutation. CRC with KRAS G12C mutation lacks efficacious therapy and has poor prognosis. Although KRAS G12C inhibitors have demonstrated encouraging early clinical activity in CRC with KRAS G12C mutation, no KRAS G12C inhibitor is currently approved for this indication.

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About D3S-001

D3S-001 is a selective and covalent KRAS G12C small molecule inhibitor designed to enhance KRAS G12C target engagement. In preclinical investigation, D3S-001 has demonstrated high potency, CNS penetration property and capability to achieve complete KRAS G12C target engagement at predicted clinically relevant dose. It is currently in global phase 1 development as an oral therapeutic agent for the treatment of patients with advanced solid tumors harboring KRAS G12C mutation, including Non-Small Cell Lung Cancer (NSCLC) and CRC. For detailed information about D3S-001, please refer to our recent publication at the 34th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics.

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About US FDA Fast Track Designation

According to the FDA, granting a Fast Track Designation means the US FDA determines that an investigational drug is intended to treat a serious condition, and nonclinical or clinical data demonstrate the potential to address unmet medical need.

An investigational drug that receives Fast Track designation may become eligible for more frequent meetings and written communications with FDA regulators. The investigational drug may also become eligible for other FDA Expedited Programs such as Accelerated Approval, Priority Review, and Rolling Review, if relevant criteria are met.

About D3 Bio

D3 Bio is a globally orientated, clinical stage biotechnology company that focuses on the discovery, development, and registration of new medicines in oncology and immunology. At D3 Bio, we fully leverage our clinical insight and biomarker strategy to guide our discovery effort and compound development, aiming to create novel and clinically meaningful new therapies for patients in need.  

D3 Bio is funded by globally renowned investors, including Boyu Capital, Matrix Partners China, Sequoia Capital China, Temasek, and WuXi AppTec's Corporate Venture Fund.

For inquiries, please contact:
bd@d3bio.com