Mountain View, Calif.-based Aditx Therapeutics (NSDQ:ADTX) has recently introduced an offering known as AditxtScore, a lab-developed test that provides a comprehensive profile of the immune system. An initial focus area for the technology will be monitoring COVID-19 immunity.
The technology could also help inform the development of immunotherapies and reduce organ transplant rejection. One of the company’s cofounders, the late Dr. Leonard Bailey, was best known for transplanting a baboon’s heart into a human infant in 1984.
When the company was founded in 2017, the company set out immune monitoring and reprogramming. In addition to organ transplants, autoimmune disorders and allergies were focus areas. “All of them have one thing in common,” said the company’s CEO and cofounder, Amro Albanna. “They’re generally caused by our immune system overreacting.”
But with the rise of COVID-19, much of society is worried about the possibility of the immune system not mounting a sufficiently robust response to the SARS-CoV-2 virus.
In the following Q&A, Albanna touches on the company’s history and explains how its technology can shed light on vaccine efficacy.
What led you to co-found the company?
Albanna: We wanted to commercialize the new class of therapeutics, which we called “ADI” —Apoptotic DNA Immunotherapy. But we realized we also needed to understand patients’ immune status as we develop the drugs. And we need to continue monitoring the immune system during clinical trials and post-clinical trials.
We needed to have a new technology platform that does a couple of things. One, it allows us, with very high sensitivity and specificity, to identify immune analytes, whether they’re antibodies or cellular immunity or some cytokines we needed to understand and identify those analytes again with very high sensitivity. And we also needed to quantify with very high precision those analytes.
A couple of years ago, we partnered with Stanford University. We licensed an initial technology for what became AditxtScore. Right now, we’re using blood samples, but we’re looking at saliva and other samples, where we can analyze them, test them and be able to identify the various analytes depending on the application.
How did COVID-19 change your company’s direction?
Albanna: As COVID-19 emerged, we realized that we could apply this AditxtScore technology platform to understand people’s immunity status relative to the virus.
We need to begin looking at infection and protection together. We need to not only look at the infection status of who’s around us, but also we need to understand who is protected.
Let me give you an example. Let’s say you needed to fly somewhere. Even if everybody on that flight got tested 72 hours ago before the flight and got negative results, which is practically impossible, that doesn’t guarantee you that everybody on that flight is negative.
As we begin deploying vaccines, it will become more critical for us to understand the protection level, whether people were exposed naturally or were vaccinated. We need to understand that protection level and then the durability of that protection. That’s how AditxtScore applies to COVID-19.
How do you see the role of AditxtScore evolving as more vaccines become available?
Albanna: We need more data to reach conclusions about the disease and the protection from individual vaccines. As more vaccines are coming that are mechanistically different, we need to understand what type of immunity level they create depending on age and other factors.
AditxtScore looks at three types of antibodies. Each is measured against three types of antigens. So, we have a total of nine analytes. We add neutralizing antibodies, and we’re working on cellular immunity. Each analyte is measured from 0 to 216,000 units. You can get a picture of high resolution.
We take the data from a single test cycle, run algorithms and come back with guidelines. If someone thinks they were naturally exposed, we can provide data on what we believe their immunity level is.
We’re very conservative with the date, but we’re seeing some patterns that we believe will be helpful as we move forward in the months and years to come.
How might the technology affect efforts to use vaccines to generate herd immunity and better understand the role of COVID-19 variants?
Albanna: We have to leave it to the vaccine manufacturers to address how variants and mutation will impact their vaccine’s efficacy.
Monitoring will be critical to understanding what type of immunity people have against various variants.
We can modify our application to target specific analytes. Let’s say we need specific analytics for a newly mutated virus, or we need to look at different analytes for the immune system. We will be able to more rapidly figure out what effect new variants have on people — especially with vaccines rolling out.
How can your technology help bridge the gap between clinical trials for COVID-19 and the real world?
Albanna: Let’s say you have 30,000 subjects in a clinical trial for a COVID-19 vaccine and have 95% efficacy. Does that mean that someone is protected 95% of the time? We know that’s not true. You’re either protected or not.
Think about protection in nursing homes. Again, even if everyone there got tested 48 hours or 72 hours ago, it’s almost impossible to ensure that no one is infected. Ultimately, it comes down to the combination of managing the risk of infection and looking at protection.
You constantly hear about COVID-19 infection numbers. The U.S. recently surpassed 25 million confirmed cases. You have to believe that we have had a lot more than 25 million people infected. Imagine all the asymptomatic people who had no idea they were infected.
If 50 million people in the U.S. were infected, many would have some level of immunity against the virus. If we knew who they were, we could save millions of vaccine doses.
What data do you think are needed to understand the durability of immunity from COVID-19 vaccines?
Albanna: There’s a progression in immunity of starting with antibodies and later moving toward cellular immunity. Generally speaking, you develop antibodies, and then the level of antibodies will go down, and then you switch over to immunological memory.
A possibility with COVID-19, because it’s a pandemic, is that we’re all getting exposed. The level of antibodies could thus continue to be elevated during a pandemic.
We’ve been looking at people who have been vaccinated — after the first dose and after the booster shot. We see interesting data, but we’re not ready to make any conclusions yet.
How has COVID-19 affected your business?
Albanna: The pandemic has created tremendous awareness, which is an understatement. Before COVID-19, how many people were keenly aware of our immune system and even referencing cytokine storms or antibodies. It created global awareness about how critical it is to understand our immune system.
The first application of AditxtScore is COVID-19, but as a platform, we’re looking to apply it to organ rejection and other diseases.
What do you think is needed to prepare for the next pandemic?
Albanna: We need to change our mindsets from testing reactively to proactively. In the past, when something goes wrong, you go to the doctor. They give you an order, and you go to the lab.
But you need to do proactive monitoring. This is why I don’t like to use the word ‘patients.’ It’s people. We need to monitor the immune system ahead of time, and as we move forward and switch to that mindset and transitioning to that mindset, we will be critical.
Think about your credit score. You don’t want to wait until something bad happens to it before you can do something about it. You want to be able to monitor it so you can be proactive. That’s the paradigm that we’re transitioning to is the proactive monitoring of the immune system.