How did Aphios navigate macroeconomic challenges in 2022?

We focused on developing solutions for people who need cannabinoid-based therapeutics. Specifically, we concentrated on producing cannabidiol (CBD) and tetrahydrocannabinol (THC) using Good Manufacturing Practices (GMP) and applying nanotechnology platforms to provide sustained release of these products. Our goal was to address unmet medical needs such as chemotherapy-induced peripheral neuropathic pain, substance use disorders (including opioid use disorder, alcohol use disorder, and marijuana use disorder), multiple sclerosis, and anxiety (some of which was caused by the Covid-19 pandemic).

Could you provide an overview of the demand for your key nanotechnologies and how these aid the development of oncology and CNS-related drugs?

The mRNA vaccine could not have been delivered without nanotechnology. Nanotechnology drug delivery allows the reformulation of existing drugs to provide improved and sustained or time-released delivery, often repositioning and/or repurposing the drug and extending its lifecycle. The goal is to develop a therapeutic that can effectively reach the site of action. Our approach is unique because we use SuperFluids to make our nanoparticles. These non-toxic gas-based fluids exhibit enhanced thermodynamic properties of solvation, penetration, selection, and expansion. This allows us to manufacture nanoparticles using an environmental-friendly ‘green’ technology, and avoid using organic solvents that often result in product quality damage and residual toxicity in nanoparticles with concomitant environmental contamination.

We have also used SuperFluids to inactivate viruses and other pathogens in an environmentally friendly, non-toxic manner. This is important for managing emerging viruses in our blood supply and biologic manufacturing trains in the wake of the pandemic.

How do cannabinoid products provide benefits beyond pharmaceutical uses?

We are aware that people are using it and experiencing mixed results due to inconsistencies in the quality and purity of the material. One of the main issues with these products is their instability, as they are known to be highly sensitive to light and oxygen, so the product may degrade before having a chance to use it. To address these challenges, we are working on developing more standardized and stable products with clearly defined dosages. For medical and recreational users, the effects of the product are typically acute and short-lived, but for those suffering from chronic conditions such as pain or anxiety, the symptoms persist even after the initial effects have worn off. We are developing sustained-release products with a clearly defined dosage based on clinical trials so that users can experience consistent efficacy over a longer period of time. And our target market is focused on those who prefer FDA-approved products with clearly defined dosages.

How must the pharmaceutical industry evolve to become more sustainable?

I believe that plant-based products will continue to be a buzzword in the pharmaceutical industry. Many companies prefer synthetic products because of perceived greater control over intellectual property and manufacturing, but plant-based products can be just as effectively covered by IP and manufactured, and be less harmful to the environment. As the world warms up, we may see the emergence of tropical diseases in new areas, such as North America. We need to focus on preventing these diseases and finding sustainable ways to produce pharmaceuticals in a changing climate. The emergence of pathogens from thawing permafrost and zoonotic virus are also concerns that we must address. While there are valid reasons for preferring synthetic products, they can also face supply chain challenges.

What does Aphios expect to achieve in the upcoming year 2023?

We have redirected our focus towards tackling Alzheimer's disease, taking a new approach now that Biogen's drug has been approved for Alzheimer's disease with certain limitations. Instead of focusing on one cause, beta-amyloid plaques, we are looking at all the causes of Alzheimer's disease including beta amyloid, tau entanglement, enzymatic changes, but particularly inflammation in the brain. We are exploring how to address brain inflammation and how our genetic makeup changes as we age promoting more inflammation in the CNS. Additionally, we are using our drug delivery platforms to find ways to get our drugs across the blood brain barrier and into the brain. We are continuing our work from last year on mRNA vaccines, employing double encapsulation to improve their bioavailability, shelf life, stability, and effectiveness.