Virus Agnostic Protection Against Respiratory Infection
Ness Therapeutics Inc. is developing N001, a self-administered intranasal prophylactic that acts at the upper airway. N001 is host-directed and virus-agnostic, designed for prevention and early post-exposure use across known and emerging respiratory threats.
A Major Gap Remains at First Contact
Respiratory viruses continue to impose an enormous clinical and economic burden globally. Yet no approved intervention stops transmission at the point of entry. Current approaches are largely pathogen-specific and designed to respond after infection has already occurred. The first-contact window remains unaddressed.
Vaccines
• Requires prior knowledge of the virus.
• Delayed immunity, not deployable in real time.
• Efficacy varies across strains.
Antivirals
• Treats infection rather than avoiding.
• Virus-dependent.
• Effectiveness contingent on early diagnosis.
mAb Therapies
• Virus and strain-specific by design.
• Rapidly undermined by viral mutation.
• High cost, limited scalability and access.
No scalable solution exists to block respiratory virus infection and transmission at the point of first contact.
Annual URTI cases
(North America)
Annual URTI cases
(Global)
Annual burden
(health + productivity)
Designed to Protect From Infection.
Not After It.
Ness is developing N001 to address the first-contact gap with an airway-first prophylactic designed to act early, locally, and broadly across known and emerging respiratory virus threats.
First-contact protection.
Self-administered.
Host-directed immune response.
Virus-agnostic.
An Intranasal, Host-Directed Approach to Respiratory Protection.
N001 is a virus-agnostic intranasal prophylactic that activates innate antiviral defences directly at the upper airway, the primary point of entry for respiratory viruses. Unlike treatment-focused approaches, N001 is centred on prevention and early post-exposure use.
Intranasal Delivery
Administered directly to the upper airway, N001 delivers protection exactly where it's needed. No clinical setting, no injection, and no systemic exposure. Simple, self-administered, and designed for real-world use.
Virus-Agnostic Protection
N001 is not designed around a specific virus or pathogen. By working through the body's own immune defences rather than targeting a known pathogen, N001 is designed to offer protection across known respiratory viruses and newly emerging threats.
Early Protection
Designed to intervene before infection takes hold, N001 targets the critical first-contact window, activating innate immunity at the upper airway to stop transmission and reduce the risk of progression to serious disease. Where current vaccines and antivirals cannot reach.
Stop Infection Where It Starts
The nasal cavity and upper airway are the body's first point of contact with respiratory viruses. Yet they remain the most overlooked target in respiratory drug development.
N001 is administered directly to the upper airway, delivering protection at the exact site of viral entry. Targeted and immediate, with no systemic exposure or clinical administration required.
By acting at the point of entry, N001 is designed to activate innate antiviral defenses before the virus can replicate, spread, or progress to the lower respiratory tract.
Built on Clinical and Translational Precedent
The rationale for N001 is supported by a body of preclinical and clinical work showing broad antiviral protection, reduced lung disease severity, accelerated viral clearance, and lower inflammatory and pathological signals in respiratory virus settings.
A household randomized clinical trial involving 1,172 participants across 341 households also showed a transmission signal, with lower viral burden observed in exposed contacts.
Together, these findings provide a strong translational basis for advancing N001 as an airway-focused prophylactic.
Preclinical protection against serious respiratory viral infections.
N001 demonstrated protection in multiple preclinical models of serious respiratory viral infection, supporting the rationale for airway-directed prophylaxis.
Clinical precedent showing reduced lung disease severity.
Clinical precedent demonstrates that N001 reduces lung pathology and disease progression in human respiratory tissue models exposed to respiratory viruses.
Accelerated viral clearance and reduced inflammatory biomarkers.
N001 demonstrated broad protection across multiple preclinical models of serious respiratory viral infection, establishing the scientific foundation for airway-directed prophylaxis. These results support advancement toward human studies.
Reduced transmission and lower viral burden in exposed contacts.
Human lung tissue exposed to respiratory viruses showed reduced pathology and slower disease progression when treated with N001. This clinical precedent validates the approach in relevant biological systems.
Advancing Toward First-in-Human Readiness
N001 is in IND/CTA-enabling development. Ness and its collaborators have established recombinant production, completed pilot-scale manufacturing, confirmed product identity and integrity analytically, and demonstrated strong in vitro antiviral activity. The program is now advancing through formulation development, preclinical safety and efficacy studies, toxicology, and regulatory preparation, supported by Government of Canada funding and Canadian development partnerships.
Progress to Date
• Recombinant production established
• Pilot-scale manufacturing completed
• Analytical confirmation of product identity and integrity completed
Q1 2026: IND/CTA-Enabling Work
• Formulation development
• Preclinical safety and efficacy studies
• Toxicology and regulatory preparation
2026: Regulatory & Clinical Readiness
• Regulatory package completion
• Clinical readiness activities
• First-in-human preparation
Clinical Objective
• First-in-human study
• Advancement toward a Phase 2-ready asset
One Lead Program.
Disciplined Platform Expansion
N001 is Ness Therapeutics Inc. lead program in respiratory virus protection. In parallel, Ness is evaluating broader platform potential, including a preclinical oncology program exploring N001 as a tumor-priming agent in combination with checkpoint blockade.
The company's strategy is to advance the respiratory program rigorously while developing expansion opportunities where the biology supports them.
Designed for Preparedness and Broad Respiratory Relevance
Because N001 acts through host antiviral defences at the airway, it is intended to complement vaccines and pathogen-specific therapeutics, not replace them. This positions N001 as relevant across a broad range of settings: seasonal respiratory infections, outbreak response, frontline environments, vulnerable populations, and preparedness contexts where rapid deployment is critical.
Led by Deep Scientific and Development Experience
Ness Therapeutics Inc. brings together expertise in immunology, virology, biologics development, manufacturing, and regulatory translation. The company is advancing N001 through a development model built on scientific depth, focused execution, and external collaboration.
- Dr. Fish is a leading academic in immunology and infectious diseases, recognized internationally for her scientific and policy contributions.
- She was appointed as a Member of the Order of Canada and a Tier 1 Canada Research Chair in Women’s Health & Immunobiology.
- Dr. Fish is a Professor in the Department of Immunology at the University of Toronto and Scientist Emerita at the Toronto General Hospital Research Institute at the University Health Network.
- She is a Fellow of the Canadian Academy of Health Sciences, the American Academy of Microbiology and the African Academy of Sciences.
- Dr. Fish has also served on the Expert Science Panel to the Chief Scientific Advisor to the Government of Canada, and the COVID-19 Therapeutics Task Force of the Government of Canada.
- Dr. Rahbar is a biopharmaceutical executive with extensive experience in therapeutic development, manufacturing, and technical strategy.
- He has nearly two decades of experience in process development, technology transfer, clinical manufacturing, and regulatory CMC for biologics, vaccine candidates, and nucleic acid-based products.
- Dr. Rahbar has held senior leadership roles in the sector and is recognized for his expertise in translational development across diverse platforms.
- He has also authored numerous peer-reviewed publications.
- At Ness Therapeutics Inc., Dr. Rahbar leads the company’s technical strategy and development programs.
Meet the Full Leadership and Advisory Team
Learn more about the scientific and clinical expertise guiding N001's development.
