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Drug Delivery Solutions

DDS Platform & Pipeline

Drug Delivery Solutions Platform and Pipeline

Nitto BioPharma (NBPI) is a clinical stage biotechnology company that offers unique drug and nucleic acid delivery solutions by designing novel biodegradable delivery vehicles with the combined ability to target specific cells and efficiently deliver a therapeutic moiety to the cells. Over the past several years, NBPI research has resulted in both lipid and polymer based drug delivery platforms.

DDS Platform Licensing

Consistent with Nitto Denko Corporation’s commitment to “Innovation for Customers” and rooted in our deep R&D efforts to develop proprietary technologies, Nitto BioPharma is leveraging our long long-standing success and expanding our business reach through licensing its proprietary Drug Delivery Solutions (DDS) platform. Nitto takes a tailored approach towards the traditional industry licensing framework with the goal to provide this enabling technology and contribute to our customer’s value creation.

Pipeline Partnering

Nitto has a pipeline of siRNA therapeutics for KRAS Cancers and fibrotic diseases that have progressed to Phase 1 and Phase 2 clinic clinical trials. Nitto is seeking to out-license and partner these clinical assets along with additional preclinical programs.

Indication / Organ Modality Delivery Discovery Pre-Clinical Phase 1 Phase 2 Phase 3
Lung siRNA Systemic (I.V.)
Liver siRNA Systemic (I.V.)
Liver siRNA Systemic (I.V.)
Liver mRNA Systemic (I.V.)
Liver circular RNA Systemic (I.V.)
Lung mRNA Inhalation
Lung Gene Editing Inhalation
Liver DNA Systemic (I.V.)
Indication / Organ:  Lung
Modality siRNA
Delivery Systemic (I.V.)
Discovery Pre-clin. Phase 1 Phase 2 Phase 3
Indication / Organ:  Liver
Modality siRNA
Delivery Systemic (I.V.)
Discovery Pre-clin. Phase 1 Phase 2 Phase 3
Indication / Organ:  Liver
Modality siRNA
Delivery Systemic (I.V.)
Discovery Pre-clin. Phase 1 Phase 2 Phase 3
Indication / Organ:  Liver
Modality mRNA
Delivery Systemic (I.V.)
Discovery Pre-clin. Phase 1 Phase 2 Phase 3
Indication / Organ:  Liver
Modality circular RNA
Delivery Systemic (I.V.)
Discovery Pre-clin. Phase 1 Phase 2 Phase 3
Indication / Organ:  Lung
Modality mRNA
Delivery Inhalation
Discovery Pre-clin. Phase 1 Phase 2 Phase 3
Indication / Organ:  Lung
Modality Gene Editing
Delivery Inhalation
Discovery Pre-clin. Phase 1 Phase 2 Phase 3
Indication / Organ:  Liver
Modality DNA
Delivery Systemic (I.V.)
Discovery Pre-clin. Phase 1 Phase 2 Phase 3

Workflow

Licensing & Partnering

Our in-house analytical group can perform all required testing during development. Our CDMO partners perform all required GMP testing of raw materials, intermediates and crude API including duplexes and conjugates in most cases at the same facility, allowing for rapid turnaround of results during manufacturing campaigns. These partners are experienced in GMP release and stability testing to meet regulatory requirements.

Discussion Under CDA

Signing the CDA (Confidential Disclosure Agreement)

Confirmation  of requirements for LNP

Planning a feasibility study (FS) if necessary

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Feasibility Study

Signing the FSA (Feasibility Study Agreement)

Conduct feasibility studies

Accrual of technical access fees

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CLA Negotiation

CLA (Collaboration and Licensing Agreement) is a definitive agreement

Arrange IP and economic terms in DDS licensing

Signing the CLA

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Co-Development

Execution of product development combining your API and Nitto LNP

IND enabling development activities

Upfront and milestone payments

Program Partner

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Feasibility Evaluation
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Lipid & LNP Material Transfer
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CMC & Manufacturing Support
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IND Support
Program Partner

Feasibility Study

Formulation Screening

Biodistribution

Safety / Tox

Success Criteria

Optimization

Process DOE

Scalability

Stability

Safety / Tox

Manufacturing Support

Method Transfer

Lipid Procurement

IND Support

FDA Submissions

Contact Business Development

To learn more about Nitto BioPharma and our proprietary Drug Delivery Solutions (DDS) and program development capabilities click below.

Contact Business Development

Corporate Deck

Request Nitto BioPharma’s corporate deck that provides an overview of Nitto BioPharma and our parent company Nitto Denko Corporation. Included in the deck is an overview of Nitto BioPharma’s proprietary Drug Discovery Solutions (DDS) Platform and it’s utility for developing genetic medicines, as well as our program and clinical development capabilities.

Request Corporate Deck

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