When we interviewed Clarkson University alumna Amy Jenkins ' 02 (chemistry and biomolecular science) in spring 2020, she was working on an antibody therapeutic that acts as a “temporary vaccine” to prevent infection in individuals exposed to COVID-19. The antibody, which would create an immunity that lasts for several months, was still in the production stage then.
Jenkins is a program manager in the Biological Technologies Office of the Defense Advanced Research Projects Agency (DARPA), a research and development agency of the U.S. Department of Defense. There she manages three programs focusing on medical countermeasures -- both vaccines and therapeutics -- and how to develop and manufacture them faster to combat infectious disease threats.
We recently caught up again with Amy.
What's the latest on the antibody therapeutic you were working on in spring 2020? Did it go into use?
Yes. We're very excited to report that two of the products from the portfolio that I manage are now either in late-stage clinical trials or have emergency use authorization (EUA) and are being utilized. These were the first leads that came out of this program and I think are on a record development time.
The first is bamlanivimab from Eli Lilly/AbCellera. That antibody, as it stands right now, has an indication for treating patients who are very early in their course of COVID disease. So, while the use of monoclonal antibodies can prevent disease -- an application that we are absolutely interested in within the Department of Defense -- Eli Lilly entered into those studies to see if they could use it to treat COVID patients and obtained an emergency use authorization for it. It is now being distributed and used around the country to prevent people who are infected and have symptoms, from progressing to severe disease and needing to be put into the hospital.
The second product, AZD7442, is a combination product. This monoclonal antibody cocktail -- two antibodies being used in one product -- is in late-stage clinical trials with AstraZeneca. This antibody was fully discovered, characterized and developed as part of DARPA's P3 (Pandemic Prevention Platform) program and went on to additional U.S. Government funding to do the late-stage clinical trials. They are currently in a phase-three clinical study with two arms.
The first takes healthy people and sees if this can act as a preventative -- what we call pre-exposure prophylaxis. You're walking around, you know you haven't been exposed to COVID and you try to prevent that -- similar to a vaccine.
The second is a clinical trial in a post-exposure prophylaxis setting. So, you may not be symptomatic, but you know you've been exposed to it, you could enroll in this trial. It's looking to see why people do not then become symptomatic with COVID disease and preventing disease in that setting where people know they've been exposed.
What's your role in these two products?
The companies and academic groups we work with – we call them performers - did all this incredible work. Granted, I was there alongside them on the phone many times, but they do the hard work of actually finding the antibodies. But what we do as program managers is to envision what we think is needed -- establishing if we were to ever encounter this type of situation, how would we solve this problem?
We try to envision the types of technology investments that need to be made to make it a reality. And that's what I've been managing. Investing in those. Pushing these groups. Keeping them focused. Having many technical calls to make sure that they're making the progress we anticipate. And if they're not making the progress, we brainstorm on what we can do to fix it.
And then also on the much less exciting, but absolutely necessary side: ensuring that we're doing everything on the up-and-up from a U.S. Government taxpayers' dollars perspective.
Are you working on any new projects?
I am very excited that we have recently been able to launch a follow-on program. The aim of the NOW (Nucleic acids On-demand Worldwide) program is to actually make the capability to manufacture vaccines and nucleic acid-based countermeasures -- think the Moderna mRNA vaccine -- in a distributed setting.
So, rather than having to manufacture things in one large building in one place in the country and then ship the vaccines around the country, imagine a situation where you could have a fairly small manufacturing device -- think tractor-trailer-sized or half-of-a-tractor-trailer-sized devices or room. And you could have this on-site device that essentially makes thousands of antibody doses every couple of days.
When we devised the program, we were largely thinking about the Ebola crisis in both West Africa and in the Democratic Republic of the Congo, and how useful it would be to be able to have on-site manufacturing in some of these far-forward remote settings. But I think even in the context of the current COVID response, if we didn't have to ship and we didn't have all the logistics and distribution that comes along with centralized manufacturing, and we could manufacture things where we need them, it might relieve some of the pressure on the system.
DARPA is always very interested in looking at high-risk-high-reward technologies. Another program that I manage is called the PREPARE (PReemptive Expression of Protective Alleles and Response Elements) program. It's a very high-risk, very early-stage R&D effort to develop a whole new modality for fighting infectious diseases and viruses using the newly emerging CRISPR-Cas technology.
These are enzymes that can very specifically cut DNA, and there have been newly discovered versions of this that are enzymes that can very specifically cut RNA. The thought was if you have an enzyme that can very specifically cut an RNA, could we design it to very specifically cut the RNA of, for example, Coronavirus or influenza virus, and essentially shred that virus up before it makes us sick?
This is a very early R&D stage program. We're just doing lab-based type experiments right now, but it has promise in the early stages that you could use these newly emerging modalities for fighting infectious diseases as well.
Did Clarkson play a role in the success you have today?
Absolutely. It really set me up for success in graduate school. I came to Clarkson as a first-generation college student. I didn't even know how to get a Ph.D. I had professors and advisors at Clarkson that helped walk me through that process. I'd attribute Clarkson 100 percent as laying the foundation for my success.
I was able to move between chemistry and biomolecular science and had daily conversations with professors and advisors about my interests. They helped me think about taking classes like medical microbiology and classes that I think traditional chemistry majors don't take.
It allowed me to get a very interdisciplinary background. That's one reason why DARPA's so successful -- we bring together people of such varying backgrounds to solve problems and I think it helps when you have that varying background.
Professors Phil Christiansen and Jim Peploski were really instrumental in helping me prepare for thinking critically as part of a Ph.D. program. They said, "You're smart, use your brain, and think about it. You'll figure it out. That's what graduate students do." And I used what they told me many times. Use rational thinking and that's your job as a graduate student. I very much accredit them with providing me with that advice.
Any advice for current Clarkson students?
Clarkson has a very well-renowned program and the opportunities are there. Take advantage of them and use them to get where you want to go. And if you don't know how to get where you want to go, ask people. Because there are people there that help and can get you there.