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Mountain Valley MD Files Patent for Novel Vaccine Dose Sparing Adjuvant

Saturday, January 23, 2021 6:04:00 PM

- MVMD immediately proceeding with selection of Contract Research Organization to conduct adjuvant IPV study. -

Mountain Valley MD Holdings Inc. announced about filing a POROUS ALUMINUM NANO-STRUCTURED ADJUVANT ("PANA") patent to protect the Company's advanced work on vaccine dose sparing. The PANA patent includes a novel adjuvant that was invented with the objective to be fully compatible with current vaccine manufacturing methods, a critical element of the Company's strategy to introduce technologies that offer simplicity for partner adoption and enable cost effective solutions that can be quickly brought to market.

Adjuvants are well known pharmacological or immunological agents that improve the immune response of a vaccine. Adjuvants are added to a vaccine to boost the immune response to produce more antibodies and longer-lasting immunity, thus minimizing the dose of antigen needed.

The Company's newly invented PANA process produces a stable nano-particulate adjuvant that does not agglomerate during repeated freeze-thaw cycles, avoiding negative effects on the vaccine strength, and requires only sterile filtration versus damaging high temperature autoclaving processes (sterilization method that uses high-pressure steam) associated with micro-particulate gel-based adjuvants.

Long standing aluminum adjuvants found in the marketplace today have proven dose-sparing characteristics with vaccines such as Inactivated Polio Vaccine ("IPV") but have numerous disadvantages in both manufacturing and stability, thus limiting their relative usefulness. The Company believes its patented PANA process overcomes the limitations of traditional aluminum-based adjuvants while significantly enhancing dose sparing stability and ease of use.

"It is a reasonable scientific objective that our new dose sparing adjuvant will enable us to deliver Inactivated Polio Vaccine with the same effect as a full standard dose that is used today, but using about 20 times less of the vaccine," stated Mike Farber, Director of Life Sciences at Mountain Valley MD. "This is a critical achievement to optimize manufacturing output and dramatically reduce costs."

The Company has worked with its key vaccinology advisor, Dr. John Clements, PHD, Emeritus Professor of Microbiology and Immunology at Tulane University School of Medicine, to design an adjuvant IPV study to determine the exact dose sparing achievement of its patented approach. Dr. Clements has over 35 years of experience in vaccine, immunology and infectious diseases research and development.

MVMD will be proceeding immediately with the selection of a Contract Research Organization to conduct an adjuvant IPV study that compares Alhydrogel adjuvant to the Company's stable nano-particulate adjuvant by both intermuscular injection and intradermal injection immunization, evaluating the antibody responses following vaccination with fractional doses of IPV comparing delivery types with IPV alone or adjuvanted.

"MVMD's newly developed stable nano-particulate adjuvant is a critical piece of our broader vaccine technology strategy and our current focus on completely eradicating Polio," stated Dennis Hancock, President and CEO of Mountain Valley MD. "Linking together all of our leading project work in this space is key. Using a fraction of the Inactivated Polio Vaccine, applying advanced Quicksome™ thin film inside a vial that can be distributed completely outside of the cold chain, and administering through needleless applications is the formula to help us achieve our vision of a world without Polio".

Mountain Valley MD is building a world-class biotech and life sciences company organization centred around the implementation of its patented Quicksome™ oral drug formulation and delivery technologies and its Quicksol™ solubilization technology for macrocyclic lactones, to innovate industry leading products that are sought out globally.

MVMD's proposition for delivering Quicksome™ formulations that have rapid onset, high bioavailability, low variability and precision dosing is core to the Company's success across key health and wellness categories. Consistent with its vision towards "Helping People Live Their Best Life", MVMD applies its Quicksome™ and Quicksol™ technologies to its ground-breaking work for advanced delivery of vaccines and pharmaceutical drugs as well as the development of products for pain management, weight loss, energy, focus, sleep, anxiety, and more.

The Company's patented Quicksome™ desiccation technology utilizes advanced liposomes and other stabilizing molecules to encapsulate and formulate active ingredients into highly efficient product formats that are consumed orally. The result is a new generation of product formulations that are capable of delivering vaccines, drugs and nutraceuticals into the body faster, with greater impact, efficiency and accuracy. The Company's patented Quicksol™ solubilization technology covers all highly solubilized macrocyclic lactones (including the drugs Ivermectin and Selamectin). MVMD's solubility technology applied to the Ivermectin drug is the only form in the world that only uses excipients that are currently approved by the US Food and Drug Administration (FDA), making it a leading candidate for human injection and sublingual applications as well as significantly broader husbandry and companion animal treatments based on its low viscosity.

SOURCE: Mountain Valley MD Holdings Inc.