Can you highlight some milestones Aphios Corporation has achieved over the past few years?
Over the past few years, Aphios Corporation has focused on infectious diseases prevention and cannabinoid therapeutics. We have developed a pathogen reduction technology applicable to blood plasma and biologics, geared towards reducing the risk of viruses and other pathogens that are threats to our health. We are also working on developing a double encapsulated mRNA vaccine for COVID-19 to sustain efficacy over a longer period of time, decrease dosing regimen, and improve room temperature stability. In the double encapsulation process, mRNA is first encapsulated in lipid nanoparticles (nanosomes), which are then encapsulated in biodegradable polymer nanospheres. After injection, the polymer nanospheres degrade, slowly releasing mRNA in nanosomes which will stimulate cells with sustained release over a long period of time.
We are very concerned with influenza and its pandemic potential. Most of the influenza vaccines available today are chemically inactivated and the efficacy is very low (20%-50%), especially in people 65 years of age and older. Our goal is to produce a better vaccine by utilizing our pathogen inactivation technology which is purely physical giving viruses the ‘bends’ while preserving immunogenicity. The inactivated virions are simultaneously nanoencapsulated in biodegradable polymer nanospheres to sustain their release and increase efficacy.
On the therapeutic side, Aphios has focused on cannabinoids from cannabis. Humans have a natural endocannabinoid system that is associated with both our central and peripheral nervous systems. When these systems are unbalanced, they can create imbalances in health or vice-versa. We believe that external cannabinoids can help rebalance our internal endocannabinoid system. Cannabis has been used for centuries, thus there is anecdotal evidence that it works; however, most cannabinoids are very hydrophobic and do not stay in the body for long. We are using nanoparticles to encapsulate the cannabinoids to sustain them in the body longer. Our research targets are cancer pain, generalized anxiety disorder, opioid use disorder, and multiple sclerosis.
Can you tell us about your approach towards HIV?
There are about 38 million people in the world living with HIV. Only five people worldwide have been cured from HIV over the last five decades, and virus latency is the last hurdle towards a cure. We are working on a technology to treat HIV latency. Our patented strategy is to utilize a combination therapy of a Protein Kinase C (PKC) modulator and a histone deacetylase (HDAC) inhibitor in a nanoparticle together with broadly neutralizing antibodies. The PKC modulator accelerates the conversion of latent HIV into pro-HIV particles, the HDAC inhibitor helps relax the chromatin to encourage the release of the pro-virus, and the broadly neutralizing antibody clears it. This combination nanoparticle therapy is designed to both purge and clear or ‘kick and kill’ the virus from the body.
Is Aphios considering listing?
The market is currently in shreds but Aphios will be well positioned when the market rebounds. We are preparing to list when the market comes back, hopefully by 2023 or 2024. We will go to market as a green biotech company, as we have been extremely focused on ESG issues from our inception in that we always minimize the use of organic solvents, replace them by utilizing SuperFluids, and have focus on medicinal products from plants and marine microorganisms as a source of biodiversity.
In terms of the regulatory landscape, what do you find to be the greatest challenge for Aphios’ operations?
The regulatory processes are rigorous and the greatest challenge for our operations is the cost of clinical trials, which is a requirement to get through the process.
The pandemic has led to the rapid approval of some drugs, such as the mRNA vaccine, which was very helpful, but the industry was ready to meet this challenge as they had been working on mRNAs for more than a decade. Looking forward, I believe it is important for the biotechnology industry to try to look into the future and see what we can do to meet headwinds such as climate change.
Post-pandemic, have you felt a palpable change in public perception in terms of investment, funding, and general attitude towards the industry?
From a public standpoint, the pharma/biotech industry is still the ‘bad boy’, because the public perceives that they generate too much revenue, but what people do not realize is that there are a lot of failures. When you look at the cost of drug development, it is not necessarily the cost of developing of one drug, but rather the cost of the failure of 10,000 sometimes 100,000 candidates before getting to that one that works. Although investors sometimes understand this, the public is not educated on or made aware of it.
What would Aphios like to achieve within the next two to three years?
Aphios means ‘virus free’ in Greek. We plan to complete the development of our pathogen reduction and vaccine technologies, continue clinical development of our lead candidates for chemotherapy induced nausea and vomiting (CINV), HIV latency and Alzheimer’s disease, and launch several QOL medicines to maintain health and improve quality of life.
