Innovation Pharmaceuticals Inc (IPIX)

[attilathehunt]

I wonder if the 2nd bullet will pertain to us given the push on manufacturing...

Source: NIAID STRATEGIC PLAN FOR COVID-19 RESEARCH
FY2020 – FY2024 April 22, 2020
https://www.niaid.nih.gov/sites/default/files/NIAID-COVID-19-Strategic-Plan-2020.pdf

Objective 3.1: Identify promising candidates with activity against SARS-CoV-2
• Screen protease inhibitor and nucleotide analogue class agents and other small molecules with documented activity against other coronaviruses SARS-CoV-2. Screening drugs that are already licensed by the FDA for other indications and might be efficacious against SARS-CoV-2 infection may provide a route to identifying a therapeutic for use in the current pandemic. Broad-spectrum antivirals that are already FDA approved or in clinical development for other indications—including those previously targeting SARS-CoV-1 and MERS CoV—can be evaluated for their potential activity against SARS-CoV-2 infections. Approved therapeutics for other infectious diseases also are being evaluated as possible treatments for COVID-19. By leveraging their existing efficacy, safety, and manufacturability data, the time to development and production can be reduced. NIAID also will continue working with partners to screen compound libraries for potential activity against SARS- CoV-2. For these studies, priority will be given to compounds based on in vitro screening data and the existence of human
safety data.
• Identify viral targets for
therapeutic development.
Advances in structural biology
technology enable
researchers to map key viral
structures at an
unprecedented level. The Structural Genomics Centers for Infectious Diseases (SGCID) apply state- of-the-art, high-throughput technologies and methodologies, including computational modeling, x- ray crystallography, nuclear magnetic resonance imaging, and cryogenic electron microscopy, to experimentally characterize the three dimensional atomic structure of proteins that play an important biological role in human pathogens and infectious diseases. NIAID will continue to support use of this powerful technology to identify viral targets of SARS-CoV-2 for therapeutics or vaccines.
Box 4
Priority 3: Characterize and test therapeutics
Objective 3.1: Identify promising candidates with activity against SARS-CoV-2
Objective 3.2: Conduct treatment studies to advance high-priority therapeutic candidates
6
• Identify novel mAbs for use as therapy or prophylaxis. Data from early studies indicate that well- characterized convalescent plasma may provide a treatment benefit in COVID-19.4 Therefore, IVIG derived from convalescent plasma may also hold promise for treatment. Moreover, peripheral blood mononuclear cells and plasma are being used to identify novel neutralizing antibodies. Through collaborations with structural biologists, binding properties can be quickly assessed. Paired with assessment of neutralization activity, the most promising mAbs will be identified for further characterization in animal models and human trials.

Objective 3.2: Conduct treatment studies to advance high-priority therapeutic candidates
• Characterize and evaluate host-directed strategies for treatment of disease. Experience with other coronaviruses indicates that infection of the respiratory tract is rapid and damage is primarily mediated by the host inflammatory response.5 These conditions may make it difficult to modify COVID-19 with pathogen-directed therapeutics. Instead, host-directed strategies that target the immune response may exert a beneficial therapeutic effect. Host-directed strategies, including immune-modulating agents, will be investigated as potential therapeutic candidates.

Conduct clinical trials to demonstrate safety and efficacy of lead therapeutic candidates. Many potential therapeutic candidates have been identified and are being tested in clinical trials.
o In March 2020, NIAID launched a multicenter, adaptive, randomized controlled clinical trial to
evaluate the safety and efficacy of the investigational antiviral drug remdesivir (GS-5734) for the treatment of COVID-19 in hospitalized adults with laboratory-confirmed SARS-CoV-2 infection and evidence of lung involvement. The trial builds on recent studies by NIAID scientists showing that remdesivir can improve the disease course in rhesus macaques when administered promptly after viral challenge with the MERS CoV.6 The trial is also adaptive, allowing for additional arms should other therapeutics warrant assessment for efficacy.
o NIAID is finalizing the protocol for the Big Effect Trial (BET), in which putative therapeutics that have existing human data and are readily available will be tested in patients hospitalized with lower respiratory tract disease. Each potential intervention will be given to approximately 75 patients and evaluated for mitigating disease symptoms. Candidate therapeutics that meet the criteria in this initial study will be further evaluated in larger clinical trials for which the infrastructure is already in place.
o As mentioned above, identification of novel mAbs for therapy or prophylaxis is another strategic priority. These mAbs should be safe, highly effective, amenable to fast manufacturing, and easy to administer. They will be tested in clinical trials to develop immunotherapies for the prevention and early treatment of COVID-19, potentially in high-risk populations including healthcare workers.