Federal grant funds research into device that monitors immunotherapy response in real time
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The Advanced Research Projects Agency for Health, or ARPA-H, awarded $45 million to fast track the development of a “closed loop” implant for continuous monitoring of patients with cancer undergoing treatment with immunotherapy.
The implant — called HAMMR, which stands for hybrid advanced molecular manufacturing regulator — is intended to be used for patients with ovarian cancer, pancreatic cancer or other difficult-to-treat malignancies.
The device, implanted via a minimally invasive procedure, will be designed to eliminate the need to tether patients to hospital beds, IV bags or external monitors, according to co-principal investigator Omid Veiseh, PhD, associate professor of bioengineering and CPRIT scholar in cancer research at Rice University.
“The concept of closed-loop therapies for drug delivery and monitoring has existed for management of type 1 diabetes for some time, but such technologies are needed for the delivery of immunotherapy, as well,” Veiseh told Healio. “Dosing can be complicated, and there is a narrow range you need to stay within to achieve efficacy. If you go further, it could be toxic. We were inspired by advances in bioelectronics and cell therapies that could enable such a device to be built.”
Development of the device is part of a larger project called THOR, which stands for targeted hybrid oncotherapeutic regulation.
Veiseh will lead the project with co-principal investigator Amir A. Jazaeri, MD, vice chair for clinical research at The University of Texas MD Anderon Cancer Center’s department of gynecologic oncology and reproductive medicine, as well as director of MD Anderson’s gynecologic cancer immunotherapy program.
Healio spoke with Veiseh and Jazaeri about how HAMMR works, how the device will be evaluated and the potential impact it may have on practice.
Healio: What inspired you to develop this device?
Veiseh: When we looked at the components necessary to build such a device, we saw that the field had advanced to the point where this is possible, but there hadn’t been a focused effort to do this in a way that integrates all these technological pieces together.
The technology is being developed now. We’re fortunate because much of the work has been done in this area in terms of advancing the field — it just has not been targeted toward immuno-oncology and looking at biomarkers specific to immunotherapy monitoring. So, we are leveraging some of that.
At the same time, we and others have innovated in the area of cell-based therapeutics, where we leverage engineered cells to produce biologics in the body. Amir and I led an effort that resulted in an ongoing clinical trial in ovarian cancer for which we engineered cells that produce an immunotherapy. The opportunity to develop an integrated product that monitors as well as produces the therapy were the motivators for this effort.
Healio: What benefits might it provide?
Jazaeri: The analogy to glucose monitoring devices is a good one. However, glucose monitoring devices check one variable — the glucose level — and then they deliver insulin. Imagine how much more complex monitoring cancer is going to be. Cancer is not just one variable but multiple variables. There are differences in biology and heterogeneity between individual cancer cells. That’s the degree of complexity that the THOR project and the HAMMR device try to address, while also delivering useful therapies that can address the high-level data obtained from the tumor environment. That is a very exciting part of it.
Healio: How will you use the ARPA-H funding over the next 5 years?
Veiseh: We have a large team of investigators, with 19 principal investigators across multiple institutions. For the first 2 years, the focus will be on building a prototype of this device and validating it in rodents. We then will have a year to think about and focus on validating safety and efficacy in larger animals. During that time, we’ll also work with partners who will help us work on good manufacturing practice standards — a requirement for evaluating a device in humans. If everything goes well, within year 4 we should be gearing up to start our first-in-human trial, which Amir will lead at MD Anderson.
Jazaeri: We anticipate the device being developed and some of the animal testing being done in the first 3 to 3.5 years, and then beginning the trial in the last year and a half. We think we will have results in about 5 years.
Healio: What do you hope will be the long-term impact of this project?
Jazaeri: Right now, our picture of cancer is very static. We do a biopsy and we learn something about the cancer at that time, or we do a CT scan or other imaging and we see something about the size and shape of the tumor in the body at that time. When patients are treated, maybe 2 or 3 months later, we get another imaging study. It might be years later before we get another biopsy. So, our knowledge of how cancer evolves in living biological systems is incomplete. If you imagine a device that can give you daily — or even more frequent — data on a certain treatment, you can get more information. You can see whether the cancer cells are dying, or whether they are growing and the rate of their growth. I believe the sensing function of this device is going to be very important and will allow us to react to what cancers are doing in the body, on their own and in response to treatment. This will help us determine how to counteract that reaction.
For more information:
Amir A. Jazaeri, MD, can be reached at aajazaeri@mdanderson.org.
Omid Veiseh, PhD, can be reached at omid.veiseh@rice.edu.
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