SARS-CoV-2 Prevention and Treatment Tech

There are currently few effective therapies for SARS-CoV-2, with very few therapies that directly target the viral life cycle after infection. NANO RED is developing a new platform that is capable of simultaneously 1) preventing SARS-CoV-2 cell entry; 2) delivering a preventive cocktail to cells at risk for infection to prevent infection; and 3) delivering an effective genomic therapeutic to interrupt the SARS-CoV-2 life cycle. Our approach delivers a therapeutic to interrupt SARS-CoV-2 elements specifically to cells at risk for infection. We are cognizant and conscious of the global scale of the current pandemic. Our delivery platform can be re-purposed and re-designed rapidly to include genomic cargo targeting other emerging respiratory viruses. In addition, this platform has the potential to be economically deployed in low-resource settings, where the need for both preventive strategies as well as cost-efficient therapeutics is particularly acute, especially in settings where ICU level care is challenging. 

NANO RED is developing an equitable treatment and preventive against SARS-CoV-2 for use in immunocompromised patients using a therapy that directly competes with SARS-CoV-2 for cell entry and delivers key interrupters of SARS-CoV-2 life cycle proteins to at-risk cells.

1. Technology: Current SARS-CoV-2 therapeutics are focused on attenuating the host response to infection. This strategy is insufficient in immunocompromised populations (particularly those with HIV/AIDs, or TB). Our approach directly interferes with the viral lifecycle, which is more likely to be effective in individuals with underlying immune compromise who are unable to generate strong immune responses and are less likely to respond to vaccination. In this way, we provide a SARS-CoV-2 prevention and treatment solution for those with HIV/AIDS and TB, while doing so in a cost-efficient manner with an easily delivered aerosolized solution. Our therapeutic cocktail also means broad efficacy across variants with less potential for development of resistance SARS-CoV-2 variants.

2. Preventing future pandemics: Our platform can be used to deliver customized cargoes to both prevent and treat emerging respiratory viruses. In addition, the same approach could be used to treat existing respiratory viruses, particularly those that have a disproportionate impact on vulnerable pediatric populations.

NANO RED is building a non-infectious particle optimized to carry degraders of key proteins that SARS-CoV-2 requires in order to survive inside of human cells. An immunocompromised patient with HIV/AIDS, for example, receives a dose of our therapy from an inhaler. The therapy travels to lung cells that express ACE II, the same key protein that SARS-CoV-2 uses to enter human cells. Our therapy prevents SARS-CoV-2 from entering the cell. At the same time, the genomic therapy is released into the cell where they degrade and destroy any SARS-CoV-2 proteins. This works as a treatment or as a means to "up armor" cells that are at risk for infection. In the face of other emerging respiratory viruses with pandemic potential, the cargo can be rapidly adapted to target the key proteins necessary for the virus in question to survive. Our approach is both a treatment and prevention strategy in at-risk immunocompromised individuals for the current pandemic and a downpayment on a new strategy that could be rapidly deployed to ward off future pandemics, particularly in low-resource settings with many immunocompromised patients.

Our solution is designed to turn the tide in the fight against SARS-CoV-2. Although many well-resourced nations are widely vaccinating their populations, SARS-CoV-2 deaths are rising in lower resourced nations. In addition, there are a large number of individuals who are chronically immunocompromised who are less likely to be protected by vaccination who are remarkably vulnerable to SARS-CoV-2--no solution exists to protect their health. Our approach is scaleable, functions in low resource environments and is designed to protect the most vulnerable. 

The founder of our team completed a portion of his internal medicine residency working in the intensive care unit as SARS-CoV-2 was cresting in the United States; he witnessed first hand the lack of effective therapies for the severely ill and the impact this has on patients who suffer immensely and their families. He has also seen how cancer patients (training as an oncology fellow) and those with hematologic malignancy (leukemias, lymphomas) are uniquely vulnerable and suffer substantially from SARS-CoV-2 infection. We have worked with critical care physicians, infectious disease physicians, hematologists, oncologists, rheumatologists, and directly cared for patients suffering from SARS-CoV-2 who needed a better solution that was not available to them.

Our approach uses resilient biotechnology that can be rapidly scaled to provide new protection to vulnerable patient populations throughout the world, regardless of local resources; our solution is temperature stable and easily produced with existing technology in a resource efficient manner.

Global health means the health of all. Current pandemic therapeutics and vaccines are less effective in individuals with HIV/AIDS and conditions that compromise immunity. We are building a solution for the present moment that will protect these uniquely vulnerable individuals while also establishing a prototype of an entirely new technology platform that can be rapidly iterated to respond to emerging respiratory virus pandemics which are likely to threaten the world again, disproportionately impacting the global poor. Our solution can stave off future pandemics and provide physicians and patients with an actionable therapy and prevention strategy for the present and future.

NANO RED has received funding through an NSF SBIR to generate a prototype of our dual therapeutic/preventive platform. We have developed prototype sequences and have begun packaging them in our delivery vehicle, with plans to test these in a SARS-CoV-2 challenge model within the next 3 months. 

Our solution provides an entirely new paradigm to treat and prevent SARS-CoV-2 while also proving the concept that allows for the same platform to be rapidly adapted to prevent and treat emerging respiratory viral illnesses. In addition, our solution is uniquely optimized to work in individuals who are immunocompromised and are least likely to benefit from current vaccines and therapeutics, answering a key unmet need. This type of innovation will unlock an entirely new class of therapies that have never been used before with the potential to treat the current pandemic, future pandemics, and potentially to be adapted to treat other viral pathogens that have long plagued humanity.

Currently, we are developing a prototype which is not currently in clinical use. Within a year, we anticipate clinical trials involving thousands of individuals, before roll out within the next two years, both as a SARS-CoV-2 treatment/prevention strategy and a platform to prevent/treat emerging respiratory viruses, and to potentially treat endemic and life threatening respiratory viruses that are already circulating. Ultimately, we believe this solution will be meaningful for the 37.9 million individuals with HIV/AIDS around the world for whom SARS-CoV-2 prevention strategies are less effective. Our approach will also be materially meaningful to broader communities with a high degree of immunocompromise. 

We understand the significant time pressure that surrounds our efforts and the need to deliver in a rapid, scaleable manner. Ultimately, we aim to start clinical trials within 1 year and to begin clinical roll out within the next 2 years. We also aim to develop therapeutics/preventives against at least 3 separate respiratory pathogens that are endemic and which uniquely impact those who are immunocompromised either due to HIV/AIDS or hematologic malignancy within the next 3 years. Key metrics will ultimately include lives saved, and disease prevented, falling under the guise of the UN Sustainable Development Goal 3 "Ensure Healthy Lives and Promote Well Being for All at All Ages"

Three full time members as well as 2 part time members and an extensive scientific advisory board as well as many ad hoc advisors assist NANO RED in meeting our goals. Should we garner additional funding, we plan to rapidly expand this team on both the scientific and implementation ends.

Our team includes a physician-scientist who has personally worked in the ICU treating SARS-CoV-2 patients. His firsthand experiences, particularly in treating those with immune compromise exposed to SARS-CoV-2 drive significant passion for this work. The scientific team includes a genomic interference expert with a deep well of molecular expertise, as well as a scientist devoted to our vehicle's production. We are a multicultural team with diverse backgrounds; we value equity between all of our team members. Our current team includes individuals with backgrounds in the United States, Canada, China, and India, united in common purpose to solve critical global health needs.

Our leadership team is diverse. We value input from each of our members and strive, whenever possible, to operate by consensus. We believe in active listening and ensuring that all have an opportunity to weigh in on critical decisions. Each of our scientists in particular is empowered to question overarching strategy, ensuring that we are grounded in the science and what it can deliver as well as our purpose to make better therapies and preventions strategies for SARS-CoV-2 globally available. We draw on near gender parity as well as diverse perspectives and backgrounds, with team members born in the United States, Canada, China, and India all united in common purpose.

This opportunity provides an ability to interface with others who have deep international health expertise. We aim to leverage those connections to connect with the communities that we hope to serve. We also aim to cultivate collaborations with like minded investors to accelerate development of our approach.

We aim to rapidly deploy our SARS-CoV-2 prevention and therapeutic strategy. To do this, we require additional human capital by building connections with the communities that we intend to serve. We will also need to build strong connections to those with detailed regulatory and legal expertise at international scale to facilitate clinical trials. Finally, deep financial expertise will be required to drive investor interest in order to attract the capital necessary to enact our vision.

The Bill & Melinda Gates Foundation provides an exceptional example of a science-based organization that aims to understand the needs of individual global communities in order to enact change. We aim to partner with groups such as this to expand our reach and the reach of our technology.

HIV/AIDS afflicts 1.2 million Americans. Nearly 170,000 Americans are diagnosed with leukemias/lymphomas each year. Each of these groups are immunocompromised and less likely to respond effectively to vaccination to prevent SARS-CoV-2. Our approach is targeted to these populations that are underserved by existing medical technology in the current pandemic. We also aim to serve a population that includes many BIPOC and LGBTQ+ members who have historically been medically disenfranchised. We believe that our approach will enhance health equity by provided much needed solutions for those who are immunocompromised and at risk not only from the current pandemic, but also from seasonal, endemic viruses. The Robert Wood Johnson Foundation Prize would allow us to expand connections with these communities and to build the framework for an inclusive clinical trial built on the basis of community input.

Displaced persons are at high risk from SARS-CoV-2. Our approach can operate in low resource medical environments without the need for an ultra cold storage chain, and with the ability to prevent and treat SARS-CoV-2 and to be rapidly adapted to emerging respiratory viruses with pandemic potential. We would use the Andan Prize to connect with refugee communities to understand their unique cultures and medical barriers to ensure inclusion in a global clinical trial.

Too often, the health of women and girls does not receive investment parity. Unfortunately, women and girls globally bear a disproportionate burden of HIV/AIDS. This immunocompromised group is uniquely vulnerable to SARS-CoV-2 infection and is less likely to respond adequately to vaccination. Our strategy prevents and treats SARS-CoV-2 and emerging as well as endemic respiratory viruses in this population. This prize would allow us to connect with channels that would allow us to ensure that our global clinical trial will be inclusive of women and girls and meet their unique needs.