Could you provide some highlights of Aphios’ operations throughout 2021?
In 2021, we focused on introducing our green pathogen reduction technology to biotechnology and pharmaceutical companies. We developed a technique called critical fluid inactivation (CFI) to ensure that biologics and blood products critical for patient care are free of harmful viruses and other pathogens. CFI disrupts these particles by giving them the “bends”, meaning it inactivates them without destroying the underlying biologic material.
We also focused on developing cannabis-based, pharmaceutical grade therapeutics utilizing proprietary manufacturing and nanotechnology platforms for disease states such as chemotherapy-induced peripheral neuropathic pain (CIPNP), substance use disorders, anxiety, and multiple sclerosis. Our goal is to mitigate physical and mental intrusions like pain, anxiety, and depression that destabilize our internal endocannabinoid system. This is done by introducing external cannabinoids from cannabis or hemp to rebalance the system pharmaceutically. Moreover, we are nanoencapsulating specific pharmaceutical grade cannabinoids so they can be sustained in the body longer and released over time to change acute treatment by cannabis and cannabinoids to address chronic conditions such as CIPNP and anxiety.
How would you assess the regulatory posture towards cannabis products under the Biden administration?
It is too early to tell given the challenge of passing comprehensive legislation around cannabis. Congress will likely legalize the use of marijuana, but this will probably trigger significant senatorial pushback, to say nothing of securing presidential assent. Nevertheless, the overall tenor has been more mature than last year.
What are the highlights of Aphios’ current product pipeline?
Our current pipeline includes our lead product, Zindol, used for chemotherapy-induced nausea and vomiting (CINV). We are expanding that pipeline to include products for first trimester pregnancy and anemia. The second major product is APH-0812 for HIV latency towards an HIV cure.
The third major clinical program centers around Alzheimer’s disease where we are developing a compound that we believe works because it satisfies both the necessary and sufficient conditions to manage amyloid plaques and stimulate synaptic regrowth. We also have several preclinical programs in prostate, breast and pancreatic cancer. Furthermore, we have good preclinical data and intellectual property coverage for kidney and liver transplantation as well as for diabetes through oral insulin.
Can you elaborate on your different types of nanotechnologies for enhanced delivery?
One aspect of the nanotechnology platforms is for the encapsulation of therapeutics including small and large molecules (small interfering RNA and mRNA) into lipid nanoparticles utilizing our green technology platform. This will typically be used for either intravenous or topical applications. Moreover, we can encapsulate both materials in the lipid bilayer and the aqueous core, as we have demonstrated in our HIV cure therapeutic.
The second of our nanotechnology capabilities entails the encapsulation of molecules into biodegradable polymer nanospheres, which degrade over time to release bioactive molecules in a sustained manner. This technology can be utilized mainly for oral delivery of proteins, intranasal delivery of compounds, and the intramuscular or subcutaneous delivery of vaccines. We are currently developing a combination technology to encapsulate lipid nanoparticles into polymer nanospheres for a single shot mRNA vaccine with improved shelf-life that will be capable of being stored at refrigerator or room temperature.
The third type of nanoparticle technology Aphios offers creates nanoparticles by, for example, taking an insulin crystal and breaking it up into smaller components. By creating a larger surface-to-volume area, we have enhanced insulin’s efficacy as more active sites are exposed. This technology is applicable to both organic and inorganic molecules as we have shown for insulin and paclitaxel, improving the delivery of nanoparticles for sustained release.
How have you found market reception for products that are more environmentally sustainable?
The individual consumer loves these products, which is in stark contrast to big pharma companies who are against the implications these products have on their business model. Big pharma companies prefer to use synthetic roots because they can scale rapidly. We prefer to work with plants and microorganisms because they provide ecological balance and sustainability.
Do you anticipate Aphios’ approach towards more naturally derived products to become a trend within society at large?
I believe it will. Food is a natural source of enzymes and nutrients, and dietary supplements and nutraceuticals are upgraded foods. It comes down to different volumes and concentrations of these products and how they impact our bodies. Thus, as more people become invested in managing their physical and mental health, there will be a higher utilization of natural products.