Herbert Loong: Promising data on D3S-001 at AACR25 / AACR, AACR25, American Society of Clinical Oncology, ASCO, cancer, D3 Bio, D3S-001, fight against cancer,

SHANGHAI, Jan. 19, 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 […]

D3 Bio, Inc. has announced that its drug D3S-001 has received FDA Breakthrough Therapy and Orphan Drug Designations for KRAS G12C-mutated cancers, highlighting its potential.

Nature Reviews Clinical Oncology, Published online: 09 May 2025; doi:10.1038/s41571-025-01028-8Next-generation KRAS-G12C inhibitor D3S-001 shows promise

FDA grants D3S-001 treatment breakthrough therapy for KRAS G12C some with lung cancer and orphan drug status for KRAS G12C colorectal cancer in adults.

D3S-001 has received FDA breakthrough therapy and orphan drug designations in KRAS G12C-mutated NSCLC and CRC, respectively.

Das Biotechnologieunternehmen D3 Bio hat eine Series-B-Finanzierungsrunde in Höhe von 108 Millionen US-Dollar abgeschlossen. Die Mittel sollen den Fortschritt der klinischen Programme beschleunigen, insbesondere die geplante globale Phase-III-Studie für das führende Kandidatenmittel Elisrasib (D3S-001). Dieses Medikament zielt auf KRAS-G12C-mutierte Krebsarten ab und wird als Monotherapie sowie in Kombinationstherapien getestet. Die Studien sollen in Schlüsselmärkten wie den USA, China und der Europäischen Union durchgeführt werden, um internationale Zulassungen zu erleichtern.

As presented at the 2025 AACR Annual Meeting, in an ongoing first-in-human phase 1 trial of a next-generation KRAS-G12C inhibitor in patients with solid tumors, encouraging safety and response results...

Elisrasib monotherapy delivers an ORR of 78.0% and median PFS of 12.4 months in first-line KRAS G12C–mutant NSCLC (n=41) across all PD-L1 expression levels Combination of elisrasib with pembrolizumab achieves an ORR of 81.3% in first-line KRAS G12C–mutant NSCLC (n=48) across all PD-L1...

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 —...

Breakthrough Therapy Designation was granted for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) who have had prior treatment with platinum-based chemotherapy and anti-PD-(L)1 antibody but have not been previously...

As presented at the 2025 AACR Annual Meeting, in an ongoing first-in-human phase 1 trial of a next-generation KRAS-G12C inhibitor in patients with solid tumors, encouraging safety and response results were observed, including in patients with non-small-cell lung cancer.

D3S-001 is a next-generation KRAS-G12C inhibitor (G12Ci) designed to enhance target engagement efficiency and overcome growth factor-induced nucleotide exchange. D3S-001 was evaluated in a phase 1a dose-escalation study in patients with advanced solid tumors harboring KRASG12C mutation (N = 42) and a phase 1b expansion cohort of patients with non-small-cell lung cancer (NSCLC) whose disease progressed after prior G12Ci therapy (N = 20). The primary endpoints were safety and determination of the maximum tolerated dose. Secondary endpoints included pharmacokinetics, confirmed objective response rate (ORR) and disease control rate. D3S-001 demonstrated dose-dependent pharmacokinetics and no dose-limiting toxicities, and the maximum tolerated dose was not reached. Grade 3 treatment-related adverse events were reported in seven patients (16.7%) in the G12Ci-naive dose-escalation cohort and two patients (10.0%) in the G12Ci-pretreated NSCLC expansion cohort. There were no grade 4 or 5 treatm