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Press Release 2018


Nitto announces Phase I clinical trial of NBF-006 for the treatment of KRAS driven tumors in advanced cancer patients is allowed to proceed by the FDA

Nitto Denko Corporation (Headquarters: Osaka, Japan; President, CEO & COO: Hideo Takasaki; “Nitto”, hereafter) (6988: Tokyo), today announced that the investigational new drug (IND) application for NBF-006, a ribonucleic acid interference (RNAi)-based treatment for KRAS mutant tumors was allowed to proceed by the US Food and Drug Administration (FDA). Nitto BioPharma, Inc. (Headquarters: San Diego, California) is working promptly to initiate the Phase 1 study.

NBF-006 is a novel lyophilized lipid nanoparticle (LNP) formulation which delivers encapsulated small interfering ribonucleic acid (siRNA) active pharmaceutical ingredient designed to inhibit the expression of glutathione-S-transferase P (GST-π) to tumors. GST-π is strongly up-regulated in many cancer types, specifically KRAS-mutant lung, colorectal, and pancreatic cancers and a known regulator of oncogenic pathways. NBF-006 demonstrated significant tumor inhibition in KRAS-mutant non-small cell lung cancer animal models.

In the Life Sciences domains, Nitto has been developing RNAi-based drug since 2008. Nitto signed a license agreement with Bristol-Myers Squibb (“BMS”, hereafter) giving BMS exclusive rights to develop the drug for treating fibrosis in the liver in November 2016, and received an upfront payment. In June 2018, Nitto initiated Phase 2 studies for the treatment of idiopathic pulmonary fibrosis (IPF), which has an exclusive option for additional licenses to BMS. In addition to the fibrosis drug, Nitto is expanding into oncology with the start of our Phase 1 clinical trial.

Under the slogan of “Innovation for Customers”, Nitto plans to continue expanding their business reach in the Next-Generation Mobility / Information Interface / Life Sciences domains in order to contribute to our customer’s value creation.
Nitto continues to make significant effort towards developing new drugs for unmet medical needs.

About KRAS mutant tumors

Intractable cancer which is often present in lung, colorectal, and pancreatic cancers

About Nitto BioPharma, Inc.

Nitto BioPharma’s mission is to develop and deliver innovative life-transforming therapies for patients with unmet medical needs. Leveraging the long-standing success and track record of Nitto Denko Corporation, Nitto BioPharma has created an efficient business unit to enable pharmaceutical products to be brought to market at a fast pace.

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