NBF-006 / Nitto Denko - LARVOL DELTA

A Novel Lipid Nanoparticle NBF-006 Encapsulating Glutathione S-Transferase P siRNA for the Treatment of KRAS-driven Non-small Cell Lung Cancer. (PubMed, Mol Cancer Ther) - "The lead drug product candidate (NBF-006) is a proprietary siRNA-based lipid nanoparticle (LNP) comprising GSTP siRNA (NDT-05-1040). Additionally, in a surgically implanted orthotopic lung tumor model, the survival rate of the NBF-006 treatment group was significantly prolonged (P <0.005) as compared to the vehicle control group. Together, these preclinical studies supported advancement of NBF-006 into clinical studies."

Journal • Lipid Nanoparticle • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS • PARP1 • PCNA

A Study of NBF-006 in Non-Small Cell Lung, Pancreatic, or Colorectal Cancer (clinicaltrials.gov) - P1 | N=49 | Completed | Sponsor: Nitto BioPharma, Inc. | Active, not recruiting ➔ Completed | Trial completion date: Aug 2024 ➔ Mar 2024 | Trial primary completion date: Mar 2024 ➔ Nov 2023

Trial completion • Trial completion date • Trial primary completion date • Colorectal Cancer • Gastrointestinal Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • KRAS

Clinical population pharmacokinetic (popPK) analysis of NBF-006, a novel siRNA inhibitor of glutathione-S-transferase P (GSTP) encapsulated in a lipid nano particle (LNP), for treatment of advanced non-small cell lung cancer (NSCLC) (AACR 2024) - "No covariates were identified that impact NBF-006 exposure. The lack of a relationship of exposure with body weight suggests the potential to use fixed dosing in future clinical studies."

Clinical • Metastases • PK/PD data • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • KRAS

First-in-human dose-expansion study of NBF-006, a novel investigational siRNA targeting GSTP, in patients with KRAS-mutated non-small cell lung cancer (AACR 2024) - "Patient enrichment strategies were evaluated with interesting trends observed.ConclusionNBF-006 is well tolerated up to 1.6 mg/kg dose level for over a year with early signs of efficacy in heavily pre-treated pan-KRAS mutant NSCLC patients. The results suggest that further clinical development of NBF-006, alone or in combination with standard therapy, is warranted."

Clinical • P1 data • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • GSTP1 • KRAS

First-in-human dose-expansion study of NBF-006, a novel investigational siRNA targeting GSTP, in patients with KRAS- mutated non-small cell lung cancer* (AACR-NCI-EORTC 2023) - No abstract available

Clinical • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

Preclinical and clinical safety and tolerability evaluation of NBF-006, a novel siRNA inhibitor of glutathione-s-transferase P(GSTP) encapsulated in a lipid nanoparticle (LNP) for treatment of advanced non-small cell lung cancer (NSCLC). (AACR-NCI-EORTC 2023) - No abstract available

Metastases • Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Preclinical and clinical pharmacokinetics (PK) of NBF-006, a novel siRNA inhibitor of glutathione-stransferase P (GSTP) encapsulated in a lipid nanoparticle (LNP), for treatment of advanced non-small cell lung cancer (NSCLC). (AACR-NCI-EORTC 2023) - No abstract available

Metastases • PK/PD data • Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

First-in-human dose-expansion study of NBF-006, a novel investigational siRNA targeting GSTP, in patients with KRAS-mutated non-small cell lung cancer. (AACR-NCI-EORTC 2023) - No abstract available

Clinical • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

Enhanced growth inhibition in lung cancer cells through NBF-006 combination therapy with chemotherapy or KRAS inhibitors. (AACR-NCI-EORTC 2023) - No abstract available

Combination therapy • Lung Cancer • Oncology • Solid Tumor • KRAS

A Study of NBF-006 in Non-Small Cell Lung, Pancreatic, or Colorectal Cancer (clinicaltrials.gov) - P1 | N=44 | Active, not recruiting | Sponsor: Nitto BioPharma, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Colorectal Cancer • Gastrointestinal Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • KRAS

First-in-human dose-escalation study of NBF-006, a novel investigational siRNA targeting GSTP, in patients with non-small cell lung, pancreatic, or colorectal cancer. (ASCO 2023) - P1 | "This FIM study with NBF-006 demonstrated a favorable safety profile with early signs of antitumor activity in NSCLC. No DLTs or treatment-related SAEs were observed. Dose expansion in NSCLC is ongoing and will not be presented."

Clinical • P1 data • Colorectal Cancer • Fatigue • Gastrointestinal Cancer • Lung Cancer • Musculoskeletal Pain • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • GSTP1 • KRAS

A Study of NBF-006 in Non-Small Cell Lung, Pancreatic, or Colorectal Cancer (clinicaltrials.gov) - P1 | N=44 | Recruiting | Sponsor: Nitto BioPharma, Inc. | Trial completion date: Mar 2023 ➔ Aug 2024 | Trial primary completion date: Aug 2022 ➔ Mar 2024

Trial completion date • Trial primary completion date • Colorectal Cancer • Gastrointestinal Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • KRAS

A Study of NBF-006 in Non-Small Cell Lung, Pancreatic, or Colorectal Cancer (clinicaltrials.gov) - P1; N=44; Recruiting; Sponsor: Nitto BioPharma, Inc.; N=30 ➔ 44; Trial completion date: Aug 2021 ➔ Mar 2023; Trial primary completion date: Feb 2021 ➔ Aug 2022

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Colorectal Cancer • Gastrointestinal Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • KRAS

A Study of NBF-006 in Non-Small Cell Lung,Pancreatic, or Colorectal Cancer (clinicaltrials.gov) - P1; N=30; Recruiting; Sponsor: Nitto BioPharma, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

A Study of NBF-006 in Non-Small Cell Lung,Pancreatic, or Colorectal Cancer (clinicaltrials.gov) - P1; N=30; Not yet recruiting; Sponsor: Nitto BioPharma, Inc.

Clinical • New P1 trial