EXUMA Biotech Is 'Revolutionizing CAR-T Therapy,' Increasing Patient Access, CEO Says

EXUMA Biotech is focused on developing a Chimeric Antigen Receptor (CAR)-T cell product for liquid and solid tumors.

Chairman and CEO Dr. Greg Frost spoke with Benzinga about patient access to CAR-T therapies, the technology behind the company's two tumor platforms and the impact the coronavirus pandemic has had on the company.  

Benzinga: Dr. Frost, you co-founded Halozyme Therapeutics, Inc. HALO, where you led research and development efforts as a board member and CEO. What inspired you to start EXUMA Biotech?

Frost: Halozyme was an experience for me early on after working as a scientist at Sidney Kimmel Cancer Center in San Diego.

My interest in EXUMA was a culmination of looking at the adoptive cellular therapy space and seeing the great progress that was happening in tumors and really thinking about the culmination of both efficacies and having CAR-T more accessible.

In addition, working with a great group of researchers and having them spread across the globe has allowed us to move quickly to leverage the capabilities for tumor biology and apply the best discovery efforts for building new platforms and engagement systems.

Our goal was to make CAR-T much easier and less complicated for the health care system, which was something very appealing to me. We can make these therapies with safety and with increased speed for patients to get access to them. This significant contribution in the field and for patients is what inspired me.

Benzinga: How does EXUMA’s CAR-T therapy treat liquid and solid cancers, and how is it different from other companies' CAR-T therapies?

Frost: The first priority is of course efficacy in oncology. Designing a CAR-T cell that can stay on the track without causing on target off tumor toxicity is absolutely crucial for systemic therapies to target solid tumors. We want to make sure that patients have the specific target antigen and in high enough amounts, so it can ensure we can achieve adequate tumor cell elimination.

Another important thing is patient access. My personal belief is that it doesn’t matter how effective your product is if patients that need it the most can’t get it.

When we look at those elements, what we did differently is that we started with that in mind, and I believe that we are revolutionizing CAR-T therapy.

In addition, the training and patient management is very specialized. So, what we have been able to do with this platform is effectively take that vein to vein process of several weeks down to a process where the product never needs to leave that patient's side. We are able to do that by eliminating a lot of the core complexities in CAR-T. In the end, it's simply the gene factor that needs to get distributed.

Benzinga: EXUMA is developing two types of platforms: the rPOC, meaning rapid point of care, and the logic-gated technology. Can you tell us about each of those?

Frost: The rPOC can dramatically reduce the cost of CAR-T production and lower the burden on the health care system. We took the process of drawing blood from the patient and using that blood to make CAR-T. Then we reintroduce it to the patient and the blood never needs to be sent away from the hospital. We're compressing the time frame down and the complexity involved, which has significant benefits.

The logic-gated process is a program and technology which uses two decision points for a CAR-T on whether or not it will engage and kill a target cell. There are two requirements for the CAR-T cells to engage and kill the target. First, it must be present on the target tumor cell, and second, it must be in a tumor environment. If the CAR-T sees the target in a normal tissue, it will not recognize it.

Benzinga: The only FDA approved CAR-T therapies are Novartis AG's NVS Kymriah and Gilead Sciences, Inc.'s GILD Yescarta, which can be expensive. Although CAR-T therapies can be viewed as game changers, how valuable are CAR-T therapies if patients in need can’t afford them?

Frost: The benefit of the Kymriah and Yescarta should not be ignored. They have demonstrated cost effectiveness in a number of different settings and patient populations. The struggle we had with these products are in fact the implementation of them as it relates to patient access. The challenge with these products is because of the chain of custody required of obtaining blood samples, sending them to a central facility, returning them to the patients and coordinating those activities. That in itself introduces both cost and complexity.

It’s remarkable that we have been able to genetically modify the immune system and re-harness it to target these types of malignancies. These products use the patient’s own derived material. The same principle applies by using the patient’s own white blood cells, but instead what we focused on is how to make that occur at the points of delivery.

When the gene factor is distributed, it's able to reduce the complexity. If CAR-T is in the right setting we can reduce cost, complexity and really work toward patient access.

Benzinga: How has the coronavirus impacted your work in the United States and in China?

Frost: Looking at the optimistic side and being grateful of our locations around the globe, we were able to adjust our activities. We probably lost 2 1/2 months in Asia in late January through March, but now those areas are fully back and operational and going in full speed.

During that same period, our U.S. operations were still working full time. Now that most of our U.S. team is working remotely, our Asia team is back working. Nothing is ever shut down completely, and that is an advantage we had.