Respiratory disease therapeutics

National Research Council of Canada (NRC) is seeking potential therapeutics (ideally sub-micromolar potent) to treat respiratory disease by targeting viral infection, replication and/or address associated co-morbidities.

Challenge sponsor:
National Research Council of Canada (NRC)

Funding mechanism:
Grant

Opening date:
July 18, 2022

Closing date:
August 29, 2022 14:00 Eastern Time

Prospective applicants should refer to the Innovative Solutions Canada Grant Instructions and Procedures document.

Challenge

Problem statement

The COVID-19 pandemic response has led to the development of multiple vaccines and advancement of platforms for the future which will be important part of the medical counter-measure. The development of effective therapeutics to address severe cases of disease in the early stages of the pandemic were limited and took time to develop. The national response to future pandemics would be greatly aided by the development of a broad range of effective therapies that either directly address viral infection or address the severe complications of respiratory disease such as of inflammation, blood clots, edema or fibrosis.

NRC is seeking therapeutics that could be positioned to address respiratory disease either through preventing viral infection/replication or can treat the associated complications such as inflammation, edema, blood clots, pneumonia or fibrosis. Potential therapeutics could have utility in other disease indications which could be extended for use in respiratory disease


Desired outcomes and considerations

Essential (mandatory) outcomes

The proposed solution must:

Phase 1 essential outcomes:

  1. Demonstrate that the therapeutic is orally bio-available;
  2. Provide background on the disease/indication and mechanism of action of the innovation that it is intended to address. This would include:
    • Background information on the therapeutic and its potential range of utility in various indications;
    • Description of the disease pathophysiology that the therapeutic currently addresses how it would impact the respiratory disease or associated complications;
    • Description of the actionable results that would be possible to inform the next stage of preclinical development.
  3. In vitro assays evaluation in appropriate surrogate screening assays to confirm:
    • Sub micromolar potency in cell-based assays against pathogen;
    • Activity in surrogate markers of efficacy in cell or tissue-based assays.
  4. Preliminary evidence of efficacy in animal models of disease:
    • Demonstrate therapeutic efficacy in relevant model of disease either alone or in combination with standard of care agents.

At the end of Phase 2:

  1. Establish broad safety and efficacy data package on the therapeutic:
    • Establish safety of the therapeutic through standard non-GLP safety studies;
    • Generate broad efficacy data in additional relevant disease models along with dose-response data.
  2. Analytical method development for drug substance and drug product:
    • In support of IND (Investigational New Drug) enabling toxicology studies;
    • In support of IND enabling CMC (Chemistry Manufacturing Controls), demonstrate development of suitable, qualified analytical methods for drug assay and impurities for drug substance and drug product.
  3. Suitable formulation developed for intended route of administration:
    • Based on pharmacokinetic data, develop prototype drug product formulation intended to be used in advance GLP toxicology studies and informing product development for clinical trials;
    • Demonstrate initial stability of drug substance and drug product (e.g.: 3 to 6 months under appropriate normal and accelerated storage conditions).

Additional outcomes

The proposed solution should:

  1. Address wide range of potential respiratory pathogens and/or associated complications;
  2. Demonstrate the ability, drug substance and product, to be manufactured on scale.

Background and context

The COVID-19 pandemic has revealed gaps in Canadian bio-manufacturing capabilities. The development of domestic vaccines was limited prior to the pandemic. Thus, the development and manufacturing of COVID-19 vaccines has been driven largely by non-Canadian large pharmaceutical/biotechnology companies. Similarly, the development of therapeutics to address SARS-CoV-2 viral infections has been carried out by US firms that have the resources and expertise in infectious disease. Canada has responded to the emergency situation with a national COVID-19 pandemic response to drive vaccine and therapeutics development to address the current pandemic which has advanced a number of domestic vaccines and therapeutics down the clinical and regulatory development path. Despite this support and progress, domestic drug and vaccine development to address the current pandemic is still expected to take a significant period of time before these innovations reach commercial readiness.

The current pandemic has enabled the emergence of a number of novel technologies and allowed the rapid advanced and development of vaccines with unprecedented speed and reduced time to market. That being said, the speed of the global spread of the virus and the dire emergency medical situation where there has been a lack of effective treatments for infected patients showed that there is critical need to develop, advance and build an inventory of effective therapeutics to address these active infections to save lives while buying time until pathogen-specific vaccines and therapeutics can be developed and manufactured.

The SARS-CoV-2 pandemic has shown that there is a lack of robust, effective therapies that can be rapidly deployed to treat infected, hospitalized patients. There is a need to build out the toolbox of available therapies to treat the complications associated from respiratory infections, such as cytokine-mediated inflammatory response, pneumonia, pulmonary edema, clotting, etc. for the current, as well as future pandemics. Non-pathogen specific therapeutic agents would have a broad utility in a pandemic emergency while having commercial potential beyond just the pandemic response. NRC is seeking proposals from innovative firms to develop and test new therapeutic agents. Development of these therapeutics with enable Canada to build out its arsenal of effective treatments to deal with future pandemics.

Maximum grant value and travel

Multiple grants could result from this challenge.

Phase 1:

  • The maximum funding available for any Phase 1 Grant resulting from this challenge is : $150,000 CAD
  • The maximum duration for any Phase 1 project funded by a grant resulting from this challenge is up to 6 months
  • Estimated number of Phase 1 grants: 2

Phase 2:

  • The maximum funding available for any Phase 2 Grant resulting from this challenge is : $1,000,000 CAD
  • The maximum duration for any Phase 2 project funded by a grant resulting from this challenge is up to 2 years
    • Note: Only eligible businesses that have completed Phase 1 could be considered for Phase 2.
  • Estimated number of Phase 2 grants: 1

Note: Selected companies are eligible to receive one grant per phase per challenge.

This disclosure is made in good faith and does not commit Canada to award any grant for the total approximate funding. Final decisions on the number of Phase 1 and Phase 2 awards will be made by Canada on the basis of factors such as evaluation results, departmental priorities and availability of funds. Canada reserves the right to make partial awards and to negotiate project scope changes.

Travel

No travel is anticipated. The kick-off meeting and final review meeting will have the flexibility of being a video or teleconference.

Eligibility

Solution proposals can only be submitted by a small business that meets all of the following criteria:

  • for profit
  • incorporated in Canada (federally or provincially)
  • 499 or fewer full-time equivalent (FTE) employeesFootnote *
  • research and development activities that take place in Canada
  • 50% or more of its annual wages, salaries and fees are currently paid to employees and contractors who spend the majority of their time working in CanadaFootnote *
  • 50% or more of its FTE employees have Canada as their ordinary place of workFootnote *
  • 50% or more of its senior executives (Vice President and above) have Canada as their principal residenceFootnote *

Evaluation criteria

The applicant must complete the Challenge Stream Electronic Submission Form with a degree of information sufficient to enable Canada's assessment of the proposal against the criteria and the Evaluation Schema. The information must demonstrate how the proposal meets the criterion.

Part 1: Mandatory Criteria

Proposals must meet all mandatory criteria identified by achieving a "Pass" in order to proceed to Part 2. Proposals that do not meet all mandatory criteria will be deemed non-responsive and given no further consideration.

Mandatory Criteria

(Applicant's proposal must address)

Question 1 a: Scope

Describe the proposed solution and demonstrate how it responds to the challenge. Include in your description the scientific and technological basis upon which the solution is proposed and clearly demonstrate how the solution meets all of the Essential (Mandatory) Outcomes (if identified) in the Desired Outcomes section in the Challenge Notice.

Evaluation Schema (Mandatory - Pass/Fail)

Pass

The Applicant's proposed solution is clearly articulated, within the scope for the challenge and addresses all Essential (Mandatory) Outcomes (if identified) in the Challenge Notice.

Fail

The proposed solution is articulated as out of scope for the challenge.
OR
The proposal does not clearly demonstrate how the proposed solution addresses all Essential Outcomes listed in the challenge.
OR
The proposed solution is poorly described and does not permit concrete analysis.
OR
There is little to no scientific and/or technological evidence that the proposed solution is likely to meet the challenge.

Question 2: Current Technology Readiness Level (TRL)
  • Indicate the current TRL of the proposed solution. (Drop Down Menu of the Challenge Stream Electronic Submission Form)
  • Describe the research and development activities that have taken place to bring the proposed solution to the stated TRL.
Evaluation Schema (Mandatory - Pass/Fail)

Pass: The Applicant has demonstrated that the proposed solution is currently between TRLs 1 and 6 (inclusive), and provided justification by explaining the research and development (R&D) that has taken place to bring the solution to the stated TRL.

Fail: The Applicant has not provided sufficient evidence to demonstrate that the current TRL is between 1 to 6 (inclusive) including:

  • There is insufficient/no evidence provided for TRL judgment.
  • The solution involves the development of basic or fundamental research.
  • The solution is demonstrated at TRL 7 or higher.
  • Insufficient/unclear/no justification explaining the R&D that took place to bring the solution to the stated TRL.
  • The explanation simply paraphrases the description of a given TRL level.
Question 3a: Innovation

Demonstrate how the proposed solution meets one or more of the ISC definitions of innovation below:

  • An inventionFootnote *, new technology or new process that is not currently available in the marketplace.
  • Significant modifications to the application of existing technologies/components/processes that are applied in a setting or condition for which current applications are not possible or feasible.
  • An improvement in functionality, cost or performance over an existing technology/process that is considered state-of-the-art or the current industry best practice.
Evaluation Schema (Mandatory – Pass/Fail)

Pass:

The Applicant has demonstrated that the proposed solution meets one or more of the ISC definitions of innovation.

Fail:

  • Applicant has not provided sufficient evidence to demonstrate that the proposed solution meets any of the ISC definitions of innovation; OR
  • Applicant has demonstrated that the proposed solution is an incremental improvement, "good engineering", or a technology that would go ahead in the normal course of product development (i.e. the next version or release).
Question 3b: Advance on State of the Art

Describe in detail the competitive advantages and level of advancement over existing technologies. Where appropriate, name existing technologies as well as potential substitutes or competitors.

To demonstrate this, proposals should include the following information:

  • Improvements (minor or major) over existing technologies or substitutes. Use direct comparison.
  • How the proposed innovation will create competitive advantages in existing market niches or market spaces.
Evaluation Schema (Mandatory Criteria – Pass/Fail + Points)

0 points/Fail:

  • The Applicant has not demonstrated that the proposed solution advances the state-of-the-art over existing technologies, including available competing solutions; OR
  • The proposed solution improves minimally upon the current state of the art, though not sufficiently enough to create competitive advantages in existing market niches; OR
  • The stated advancements are described in general terms but are not substantiated with specific, measurable evidence.

5 points/Pass:

  • The Applicant has demonstrated that the proposed solution offers one or two minor improvements to existing technologies, including available competing solutions, that have potential to create competitive advantages in existing market niches.

12 points/Pass:

  • The Applicant has demonstrated that the proposed solution offers three or more minor improvements to existing technologies, including available competing solutions, that together are likely to create competitive advantages in existing market niches; OR
  • The Applicant has demonstrated that the proposed solution offers one significant improvement to existing technologies that is likely to create competitive advantages in existing market niches

20 points/Pass:

  • The Applicant has demonstrated that the proposed solution offers two or more significant improvements to existing technologies, including available competing solutions that are likely to create competitive advantages in existing market niches and could define new market spaces; OR
  • The Applicant has demonstrated that the proposed solution can be considered a new benchmark of state of the art that is clearly ahead of competitors and that is likely to define new market spaces

Part 2: Point-Rated Criteria

Proposals must meet the overall minimum pass mark of 50% to be deemed responsive. Proposals that do not achieve the minimum pass mark will be declared non-responsive and given no further consideration.

Point-Rated Criteria

(Applicant's proposal to address)

Question 1b: Scope

Demonstrate the scientific and technological basis of how the proposed solution addresses the Additional Outcomes (if identified) in the Desired Outcomes section in the Challenge Notice. If no Additional Outcomes are identified in the Challenge Notice, text entered in this section will not be considered.

If no Additional Outcomes are identified in the Challenge Notice, Applicants will receive 10 points.

Evaluation Schema (Point-Rated)
  1. Insufficient or no information provided to demonstrate that the solution will address any of the Additional Outcomes. 0 points
  2. Information provided clearly demonstrates that the solution will address some (<50%) of the Additional Outcomes. 3 points
  3. Information provided clearly demonstrates that the solution will address most (50% or more) of the Additional Outcomes. 6 points
  4. Information provided clearly demonstrates that the solution will address all (100%) of the Additional Outcomes. 10 points
Question 4: Phase 1 Science and Technology (S&T) Risks

Describe potential scientific and/or technological risks to the successful development of the proof of feasibility and how they will be mitigated in Phase 1.

Evaluation Schema (Point-Rated)
  1. Insufficient or no information provided to demonstrate that the Applicant has considered potential risks and mitigation strategies and/or information provided contains significant gaps. 0 points
  2. Information provided demonstrates that the Applicant has considered some potential risks and associated mitigation strategies but there are minor gaps in risks and/or associated mitigation strategies. 5 points
  3. Information provided clearly demonstrates that the Applicant has sufficiently considered the risks and defined associated mitigation strategies. 10 points
Question 5: Phase 1 Project Plan

Demonstrate a feasible Phase 1 project plan by completing the table.

  • Indicate if any milestones and activities will be completed concurrently
  • Indicate the estimated exit TRL at the completion of Phase 1. (Drop Down Menu of the Challenge Stream Electronic Submission Form)
Evaluation Schema (Point-Rated)
  1. Insufficient or no information provided to demonstrate a feasible project plan for Phase 1 and/or the project plan exceeds the maximum duration indicated in the Challenge Notice. 0 points
  2. Project plan for Phase 1 is conceivably feasible but not clearly demonstrated and/or includes gaps. 10 points
  3. Information provided clearly demonstrates a feasible project plan for Phase 1. 20 points
Question 6: Phase 1 Project Risks

Describe potential project risks to the successful development of the proof of feasibility and how they will be mitigated in Phase 1.

Applicants should address the following risks, as applicable:

  • Human Resources
  • Financial
  • Project Management
  • Intellectual Property
  • Other project-related risks

Note to Applicants: S&T risks should not be included in this section. Question 4 addresses S&T risks.

Evaluation Schema (Point-Rated)
  1. Insufficient or no information provided to demonstrate that the Applicant has considered potential risks and mitigation strategies and/or information provided contains significant gaps. 0 points
  2. Information provided demonstrates that the Applicant has considered some potential risks and associated mitigation strategies but there are minor gaps in risks and/or associated mitigation strategies. 5 points
  3. Information provided clearly demonstrates that the Applicant has sufficiently considered the risks and defined associated mitigation strategies. 10 points
Question 7: Phase 1 Implementation Team

Demonstrate how the project implementation team has the required management and technological skill sets and experience to deliver the project plan for Phase 1 by completing the table. A member of the implementation team can have more than one role.

Evaluation Schema (Point-Rated)
  1. Insufficient or no information provided to demonstrate that the project team has the required management and technological skill sets and experience to deliver the Phase 1 project plan. 0 points
  2. Information is provided but there are minor gaps in required management and/or technological skill sets and/or experience to deliver the Phase 1 project plan. 10 points
  3. Information provided clearly demonstrates that the project team has the required management and technological skill sets and experience to deliver the Phase 1 project plan. 20 points
Question 8: Inclusivity

If your business were to receive funding from Innovative Solutions Canada, describe what actions (e.g., recruitment strategy, internships, co-op placements, etc.) might be taken in Phase 1 to support the participation of under-represented groups (e.g., women, youth, persons with disabilities, Indigenous people, visible minorities) in the research and development of the proposed solution. Each Applicant in their response to this question must focus only on describing relevant programs, policies, or initiatives that it currently has in place or would put in place to support the R&D effort in Phase 1.

Note: Do not provide any personal information of individuals employed by your company or that of your subcontractors in the response.

Evaluation Schema (Point-Rated)
  1. No description and/or concrete examples of actions provided that would be taken to encourage greater participation of under-represented groups. 0 points
  2. A description and concrete examples of actions to encourage greater participation of under-represented groups provided.5 points
Question 9: Phase 1 Financial Proposal

Demonstrate a realistic financial proposal for the Phase 1 project plan by completing the table.

Evaluation Schema (Point-Rated)
  1. Insufficient information provided and/or information provided significantly lack credibility. Does not demonstrate a realistic financial proposal for the Phase 1 project plan. 0 points
  2. Information is provided but some costs lack credibility and/or are unclear for the Phase 1 project plan. 7.5 points
  3. Information provided contains credible elements to clearly demonstrate a realistic financial proposal for the Phase 1 project plan. 15 points
Question 10: Phase 1 Financial Controls, Tracking and Oversight

Describe the financial controls, tracking and oversight that will be used to manage the public funds throughout Phase 1. Applicants should indicate if an individual or firm will be managing the public funds and provide their credentials and/or relevant experience.

Evaluation Schema (Point-Rated)
  1. Insufficient or no information provided to demonstrate the Applicant's ability to manage public funds in Phase 1. 0 points
  2. Information provided is vague and/or contains gaps. The Applicant has some controls, tracking and/or oversight in place to manage the public funds in Phase 1. 5 points
  3. Information provided clearly demonstrates that the Applicant has strong financial controls, tracking and oversight to manage public funds in Phase 1. 10 points
Question 11: Phase 2 Overview

Demonstrate a realistic overview for the prototype development plan if selected to participate in Phase 2.

Responses should include:

  • key tasks
  • estimated cost for materials
  • human resources
  • project risks and mitigation strategies

Note: A more detailed proposal will be requested if selected to participate in Phase 2.

Evaluation Schema (Point-Rated)
  1. Insufficient or no information provided to demonstrate that the Applicant has contemplated a realistic overview for the Phase 2 prototype development. 0 points
  2. Information provided demonstrates a conceivably realistic overview for Phase 2 prototype development, however there are gaps and/or the strategy is vague. 6 points
  3. Information provided demonstrates that the Applicant has a clear and realistic overview. 12 points
Question 12: Commercialization Approach

Demonstrate a realistic overall commercialization approach/business model that can successfully take the technology/service to market, and how the technology/service will help you develop and sell other products.

Responses should include:

  • Target markets (excluding Government of Canada)
  • Non-ISC funding sources
  • Transition to a commercially-ready product or service
  • Any other indicators of commercial potential and commercial feasibility

Note: A more detailed proposal will be requested if selected to participate in Phase 2.

Evaluation Schema (Point-Rated)
  1. Insufficient or no information provided to demonstrate that the proposed solution has commercial potential. 0 points
  2. Some information provided to demonstrate that the proposed solution has commercial potential, however there are gaps in the commercialization approach. 6 points
  3. A realistic commercialization approach is provided that demonstrates that the proposed solution has commercial potential. 12 points
Question 13: Resulting Benefits to Canada

Describe the benefits that could result from the commercialization of the proposed solution. Applicants should consider the potential benefits using the following three categories and provide justification for each claim:

  • Innovation Benefits: Expected contribution towards the enhancement or development of new industrial or technological innovations within your firm. Responses could include: potential spillover benefits, creation of intellectual property, impact on productivity of the new technology, etc.
  • Economic Benefits: Forecasted impact on the growth of Canadian firms, clusters and supply chains, as well as its expected benefits for Canada's workforce. Responses could include: number of jobs created, number of high-paying jobs, investment in Canada's economy, etc.
  • Public Benefits: Expected contribution to the broader public to the degree that the solution is expected to generate social, environmental, health, security or other benefits to Canada. Responses could include: solution-related environmental benefits, solution-related accessibility benefits, and solution-related impact on Indigenous communities.
Evaluation Schema (Point-Rated)
  1. Innovation Benefits

    Benefit not identified or insufficient claim of benefit. 0 points

    Benefit has marginal increment or limited justification. 1 point

    Benefit is significant and well justified. 2 points

  2. Economic Benefits

    Benefit not identified or insufficient claim of benefit. 0 points

    Benefit has marginal increment or limited justification. 1 point

    Benefit is significant and well justified. 2 points

  3. Public Benefits.

    Benefit not identified or insufficient claim of benefit. 0 points

    Benefit has marginal increment or limited justification. 1 point

    Benefit is significant and well justified. 2 points

Questions and answers

Will ISC consider a physical platform for delivering medicine through the nasal cavity?

The focus of this ISC challenge is on orally delivered therapeutics. The development of a physical platform for intra-nasal delivery does not fit this challenge.

Would a novel bacteriophage-based prophylactic vaccine against COVID-19 disease fall under the scope of this challenge?

This ISC challenge is focused on therapeutic agents (ie. drug substances) to address medical conditions/complications stemming from the infection. Vaccines fall outside the scope of the challenge.

Are only ingestible solutions eligible?

If it is an oral liquid that is sprayed for gastro-intestinal delivery, it may still apply. However, it would not be applicable for inhaled lung delivery.

Are only solutions that are for ingestion will be considered?

Yes. This challenge is focused on orally delivered therapeutics to increase the range of therapeutic options that can be scaled and distributed rapidly as part of a future pandemic preparedness plan.

Will you consider inhaled drugs in this challenge?

The Challenge is focused on orally delivered therapeutics to increase the range of therapeutic options that can be scaled and distributed rapidly as part of a future pandemic preparedness plan.

Will nebulisation be acceptable?

Challenge is targeted to therapies that can be delivered by oral dosing, for ease of manufacturing and delivery, to address co-morbidities and disease complications related to respiratory infection that can be part of a future Pandemic preparedness plan. Potential therapeutics can be either repurposing of existing molecules or novel therapeutics.

All incoming questions regarding this specific challenge should be addressed to solutions@ised-isde.gc.ca.

All enquiries must be submitted in writing no later than ten calendar days before the Challenge Notice closing date. Enquiries received after that time may not be answered.

You can also consult the Frequently asked questions about the Innovative Solutions Canada Program.

glossary is also available.