Aphios International is developing a pathogen reduction technology platform, CFI™ for human plasma, plasma products, immunoglobulins, recombinant biologics, monoclonal antibodies and medical devices such as PPEs, N95 masks and single use devices.
Our management team consists of Dr. Trevor P. Castor, President & CEO, with 30+ years of experience in the biotechnology industry, has managed collaborations with multinational companies such as Lilly, Novartis, Pfizer and Sigma; Dr. Judith L. Palmer-Castor, Director, Clinical & Regulatory Affairs with 20+ years of experience in industry and academia; and Ms. Catherine Prillo, Controller with 30+ years financial and accounting experience.
Our business advisors include Dr. Val Livada, Business; and Mr. Joseph F. Faris, CPA, Financial. Our Scientific Advisors include Dr. Arthur D. Lander, MD, Ph.D.; Dr. Gordon M. Cragg, PhD.; Dr. Glenn T. Hong, ScD; and Dr. Jonathan Steven Alexander, PhD.
The periodic emergence of novel coronavirus which is the etiologic agent of the current worldwide COVID-19 pandemic, recurrent outbreaks of potentially pandemic strains of influenza (e.g., H5N1), the rapid spread of the Zika virus, recent outbreaks of the extremely virulent Ebola virus and the worldwide HIV/AIDS pandemic have highlighted a persistent concern in the healthcare community and our economy — the need for effective pathogen inactivation and removal techniques for human blood plasma, biologics and medical devices. Current screening does not take into account the regular emergence of novel pathogens, which are increasing in frequency due to deforestation, species overlap, urbanization and rapid global travel.
Human plasma, biologics and medical devices are at significant risks from virus and bacterial pathogens. Both the FDA and EMA have in place rigorous guidelines for pathogen reduction and product safety. A number of approaches have been employed for the reduction of pathogens in human plasma, therapeutic proteins derived from human plasma, recombinant biologics and medical devices. Current approaches are not always effective against a wide spectrum of human and animal viruses, are sometimes encumbered by process-specific deficiencies, and often result in denaturation of the biologics and devices that they are designed to protect. Currently, there is no commercially available, FDA-approved technology for the inactivation of non-enveloped viruses in pooled human plasma and biologics, and only one method has been approved for units of plasma that inactivates some but not all known non-enveloped viruses.
Technology: CFI™ pathogen inactivation technology works, in part, by first permeating and inflating virus particles with the selected SuperFluids™ under pressure. The overfilled particles are then quickly decompressed, and the dense-phase fluid rapidly changes into a gaseous state rupturing the virus particles at their weakest points — very much like the embolic disruption of the ear drums of a scuba diver who surfaces too rapidly. The disruption of viral structure and release of nucleic acids prevent infectivity and replication of the CFI™ treated viral particle.
CFI™ technology is purely physical and has significantly less adverse impact on the biological activities of blood products and biologics than competing technologies that utilize heat, chemicals and irradiation. CFI™ inactivates both classes of viruses and bacterial pathogens, and is applicable to pooled human plasma, units of plasma, biologics and medical devices. CFI™ technology is covered by 9 US and International Patents and 5 pending patents.
Octapharma utilizes the solvent-detergent (SD) technique that is effective against enveloped viruses such as HIV, but is ineffective against non–enveloped viruses such as HAV. Residual organic solvents and detergents must be removed before therapeutic use. Creus and Terumo utilize photochemical reactions with chemicals that are both carcinogenic and teratogenic and must be removed. They are not scalable to pools and cannot be used for biologics and medical devices. For medical devices, Battelle and Steris utilize hydrogen peroxide which is toxic, has several limitations when applied to PPEs and cannot be used for biologics and plasma.
The marketplace for CFI™ technology is large and expanding, and consists of three major segments – human blood products, biotechnology products and medical devices. All these segments require pathogen inactivation, clearance and reduction mandated by the FDA in US and the EMA in Europe. The potential market is $5B with the current market around $500M; thus, there is a high growth opportunity. Our target market is growing at a rate of 21.7%.
Products and Services
We will manufacture and sell standardized CFI™ units for processing units of biologics that will be fully automated, mobile and about the size of a washing machine. It will have the capability to process about 100 units of plasma per day and reduce pathogen levels by > 4 logs per mL with > 90% retention in biological activity. Customized CFI™ units will have the capability to process 1,000 to 10,000 liters per day with similar pathogen reduction and biological retention levels.
Our targeted customers include blood banks and plasma processing companies, hospitals and healthcare centers as well as small biotechnology companies such as Cambium Medical Technologies and large multinational pharmaceutical corporations such as Pfizer. Other potential customers include the American Red Cross, CSL Behring, Grifols, DOD, Amgen, Baxter, Bayer, Genentech, Roche, Millipore Sigma, Merck, AstraZeneca, J&J, Moderna and Sanofi-Pasteur.
Marketing and Sales Strategy
Our customer archetype are physicians, plasma processors and biologics manufacturers. We will persuade these customers to acquire CFI™ technology through rigorous clinical trials, FDA approval, publications, and a direct sales force. We will retain customers by continued education, research and periodic contacts. Market outreach will be supported by print ads and internet advertisements with presentations at relevant conferences and trade shows.
We plan to license CFI™ technology and equipment to customers. Licensing agreements will include royalties on a per product use basis, CFI™ equipment and raw materials (SuperFluids™), and service and maintenance contracts. CFI™ equipment will be standardized for certain operations such as blood plasma process and PPEs, and customized for high throughput manufacturing of pooled plasma, fetal bovine serum, immunoglobulins, monoclonal antibodies and recombinant therapeutics.
Funding History and Request
Aphios has invested $7.2M to-date on developing CFI™ pathogen reduction technology and will spend an additional $700K in 2021 with funding from a Phase II SBIR grant from NHLBI, NIH to develop “CFI™ Pathogen Inactivation of Human Plasma Units” for a total investment of $7.9M We are seeking $5M to spin-off Aphios International and to file an IND with the FDA to conduct a Phase 1 clinical trial on virus clearance of human plasma units utilizing CFI™ technology.
Commercialization and Exit Strategies
We will establish a strategic corporate partnership with a multinational pharmaceutical company to develop and commercialize CFI™ on a worldwide or regional basis. Alternatively, we will raise $25M in a B round with a strategic partner and $100M in an IPO to complete development of CFI™. Investors will be able to exit at an M&A that may be coincident with a strategic corporate partnership, the B round or the IPO planned in 2024.
Cerus is publicly traded on the NASDAQ, has a current market cap of $1.1B and had revenues of $91M in 2020.