#Shanghai #United States #KRAS G12C #D3S-001 #D3 Bio

D3 Bio, Inc. Receives FDA Breakthrough and Orphan Drug Designations for D3S-001

D3 Bio, Inc., a leading clinical-stage oncology firm focused on precision therapies, has made significant strides in cancer treatment with the recent announcement of two pivotal designations granted by the U.S. Food and Drug Administration (FDA) for their drug D3S-001. The product has been awarded the Breakthrough Therapy Designation for adult patients affected by KRAS G12C-mutated non-small cell lung cancer (NSCLC) that is either locally advanced or metastatic. Furthermore, it has also secured Orphan Drug Designation for treating colorectal cancer (CRC) featuring KRAS G12C mutations.

Significance of Designations

The Breakthrough Therapy Designation was conferred following compelling clinical data derived from an ongoing Phase 1/2 study (NCT05410145), where D3S-001 was evaluated among patients with advanced solid tumors carrying the KRAS G12C mutation. Results showcased not just significant efficacy but also a favorable safety profile in this challenging cohort of patients. Specifically, the trial highlighted the drug’s potency in patients who had already undergone treatments like platinum-based chemotherapy and anti-PD-(L)1 antibody therapy but were previously untreated with a KRAS G12C inhibitor.

George Chen, Founder and CEO of D3 Bio, expressed immense pride and excitement regarding the accomplishments of D3S-001, stating that these designations underscore its potential to tackle urgent medical needs in patients with KRAS G12C-mutated cancers, a particularly aggressive form of the disease. The recognition of D3S-001 as a next-generation KRAS G12C inhibitor grants hope for patients needing new therapeutic options.

Understanding KRAS Mutations

KRAS mutations are among the most prevalent oncogenic drivers found in humans, encountered in approximately 25-30% of all cancers. The KRAS G12C mutation plays a critical role, manifesting in about 12% of NSCLC cases and 3-4% of CRC cases. Patients carrying these mutations often face more aggressive diseases, paired with suboptimal responses to standard therapies, including immunotherapy and chemotherapy.

Mechanism of Action of D3S-001

D3S-001 is ingeniously designed as a next-generation KRAS G12C inhibitor, functioning through rapid and complete target engagement. It selectively binds to the oncogenic (Off) conformation of the RAS G12C variant, effectively disrupting the nucleotide cycling between the RAS (Off) and RAS (On) forms of the mutant protein. This action addresses critical shortcomings of earlier therapies by enabling high covalent potency and ensuring total engagement of KRAS G12C at clinically relevant dosages.

Investigation has thus far indicated promising applications not just as a singular therapeutic option but also in combination therapy regimens evaluated within a global Phase II clinical trial context. This trial focuses on advanced solid tumors harboring KRAS G12C mutations, thereby potentially encompassing indications beyond NSCLC and CRC.

D3 Bio’s Commitment to Innovation

D3 Bio’s commitment to leading the way in innovative cancer treatment remains unwavering. The company's global biotechnology approach is centered on discovering, developing, and registering groundbreaking medicines within the realms of oncology and immunology. By leveraging proprietary clinical insights and biomarker strategies, D3 Bio aims to create not just novel therapies but also clinically impactful treatment solutions for patients in critical need.

D3 Bio emphasizes a dual focus on both driver mutations and significant immune pathways contributing to cancer, thereby promising their programs could lead to either first-in-class or best-in-class therapies. With full ownership and global rights across its various programs, D3 Bio stands at the forefront of exciting advancements in the fight against cancer.

For additional insights about D3 Bio and its promising developments, visit D3 Bio's official website.