Can you speak to how Aphios’ Critical Fluid Inactivation (CFI) technology can help provide convalescent plasma as a disease treatment?                                                         

Aphios has been conducting research in this area for several years now, but in 2020 we accelerated our research program to clear convalescent plasma of potential viruses including coronavirus. The key is to utilize the technology for units of plasma so it is traceable, rather than pool plasma. Currently, we are designing equipment to deploy in hospitals, as well as remote settings around the world.

People in West Africa may be facing an Ebola outbreak, where you may have areas of localized flare-up. When you have patients who are recovered, you can treat the plasma from that patient, and reintroduce it into a patient who has been infected with the disease. This can act as a very quick therapeutic, rather than having to develop a new monoclonal antibody or vaccine.

Aside from CFI, what area of the business has been the biggest focus for Aphios over the past year?

An area that is of keen interest remains cannabis and cannabis-related products. We are focused on establishing partnerships to develop therapeutics for cannabidiol in the area of cancer-induced peripheral neuropathic pain (CIPNP), as well as substance use disorder (SUD) and opioid use disorder (OUD).

Do you see the changing of the political guard in the US as being more encouraging of those pursuing the therapeutic potential of cannabis?

The regulatory barriers to development have been challenging from a combination of the Drug Enforcement Agency, FDA and NIH. They all work together to regulate the utilization of cannabis-based products on a national basis. I think with the new administration there will be some deregulation, which will allow more research, more clinical development, and more products in the marketplace.

Another trend we are anticipating is that as a result of more cannabis use being permitted in different states, there is going to be a greater focus on addiction prevention. About 30% of people in the United States have issues with alcohol, with 10% strongly addicted. You are inevitably going to get a significant portion of the population who is addicted to marijuana. There is going to be an additional level of therapeutic intervention that is required and Aphios is investigating this as a potential therapeutic target area.

Fortunately, some of the studies can be accelerated through a 505b(2) pathway because some of the drugs have been approved by the FDA. In the case of Marinol and Epidiolex, you can accelerate the development of their APIs – Δ9-THC and CBD, avoiding phase one and get into phase two proof of concept. In our case, we are very interested in neuropathic pain, for which more than 50% of cancer patients suffer. You have no interdictions and no therapeutic modalities that work right now. Anecdotally CBD works, but it is an acute-type response, and we are planning to move forward with our program to do more on nanoencapsulation to sustain the release of CBD in the body. This will give patients a better therapeutic effect.

This past year, you received a patent on “Combination therapeutics and methods for the treatment of neurodegenerative diseases.” What is the significance of your research on this topic?

We believe that for most modalities, combination therapeutics are needed. I call it a whack-a-mole theory. As you whack one particular pathway, another pathway pops up. Combinations allow us to have therapeutic solutions, whereas a single therapy may not work. Case in point is in HIV. There was a very high amount of single therapy failures caused by resistance being developed by HIV mutations, and it was a problem until Dr. Ho came up with the idea to use a triple drug therapy to prevent the virus from mutating. That combination therapy, which is the basis for current antiretroviral therapy in the HIV world, is what made HIV a chronic disease rather than a killing disease.

The problem in neurodegenerative diseases like Alzheimer's is that we have no single therapy that has been effective in either suppressing or curing the disease. People ask, why use a combination therapy when we have not gotten the single therapy to work? The problem with a single therapy is that you hit only one target in a very complex biological system. For example, you inhibit one enzyme like beta secretase, and alpha secretase pops up as a contributing factor to Alzheimer’s disease. It is important to start thinking about how we can combine therapies that can impact different pathways simultaneously in treating Alzheimer's disease.

What are some key milestones Aphios is looking to achieve in 2021?

One of our key goals is to conduct clinical trials, which are capital intensive. Therefore, we have an A strategy and a B strategy for fundraising. Our preferred strategy is to do a mezzanine round of financing and then an IPO to generate the capital necessary to execute clinical trials. Our plan B is to spin off companies, special purpose vehicles (SPVs), which are focused on both product or technology in different areas of our platform or product pipeline. For example, Aphios Pharma LLC is a spin off of all our cannabis-related drugs, where we can finance that to develop capital for clinical trials. Aphios International is focused on our CFI technologies for convalescent plasma and other pathogen clearance technologies. Amylon LLC is another SPV that is focused on our CNS Alzheimer's disease program. Those are the two strategies we have going forward for the next 12 to 18 months.