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AVM Biotechnology Team Hopeful Their Unique Dexamethasone Formulation Will Have Greater Impact Than Oxford’s Standard Dexamethasone

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NEWS PROVIDED BY AVM Biotechnology, LLC  Jun 17, 2020, 13:08 ET

SEATTLE, June 17, 2020 /PRNewswire/ — Oxford University announced yesterday that dexamethasone could reduce deaths in the sickest COVID-19 patients. The World Health Organization (WHO) and others from around the world are looking closely at this generic corticosteroid as a global treatment for those severely ill with COVID-19.

AVM Biotechnology’s lead molecule is a purified loaded formulation of dexamethasone. AVM is actively studying dexamethasone and has found that in higher, single doses, it can be safely administered and appears to have a different Mechanism of Action (MOA) than chronic, repeat, lower doses. AVM has seen some success in cancer models and the Oxford study reinforces what we already know about dexamethasone. Based on its MOA in preclinical models, we have reason to believe it will have an even greater impact in COVID-19 patients than standard dexamethasone. The information coming from Oxford University solidifies our hypothesis that AVM0703 could prove effective against COVID-19.

We are filing with the FDA to proceed with clinical trials against this virus. AVM0703 has already been approved for clinical trials in treating terminal no option non-Hodgkins lymphoma. The Oxford research further underscores the need for testing of AVM0703 at higher doses in COVID patients. AVM0703, a repurposed formulation of an active ingredient, dexamethasone, that is already FDA approved for other uses, used at supra-pharmacologic doses has a novel mechanism of action (MOA) to uniquely mobilize supercharged immune cells that are 10X more efficient than normal immune cells. These supercharged immune cells include a novel Natural Killer T (NKT) cell, novel cytotoxic T lymphocytes and a CD11b very high dendritic cell, which invade and destroy tumors more effectively than untreated immune cells, than PD-1 or PD-L1 inhibitor treatments (checkpoint inhibitors), and standard of care chemotherapy.

Long term immunity is triggered and when mice are re-challenged with the same tumor over 100 days later, memory immune cells attack and kill the tumor. NKT cells and cytotoxic T lymphocytes are by nature programmed to kill viruses and bacteria as well as cancer. The combination of these three mobilized supercharged immune cells could kill the COVID-19causing virus (SARS CoV2) and induce long-term immunity. AVM0703, a purer, enhanced formulation of dexamethasone enables single acute doses to replace chronic repeat dosing. This dosing could potentially save more lives than repeat 10-day dosing and could also reduce ICU days from 10+ days to 2-3 days, which would be a significant financial impact benefiting healthcare systems and patients.

AVM0703 can be manufactured in seven hours, is produced for AVM Biotechnology by a global contract development and manufacturing organization (CDMO) and is stable even at temperatures of 40degC (104degF) and high humidity, which make it a potential global solution for the current pandemic and for possible future pandemics.

“Drugs such as AVM0703 that mobilise endogenous supercharged natural killer cells, cytotoxic T cells and dendritic cells provide a potential solution for the treatment of seriously ill COVID19 patients, are available, have safety data, and are registered for the treatment of other diseases. It is in this area that large scale studies should be undertaken as they can be used to immediately treat patients together with other interventions. Such drugs are also potentially useful in other infectious disease settings where vaccines and antiviral drugs are ineffective or unavailable.”   Dr. Gary Grohmann, Former WHO Advisor & Consultant, former Director of Immunobiology and the WHO ERL at the TGA, Director of the Immunisation Coalition and Director/Founder of Environmental Pathogens.

Contact Jena Dalpez Jdalpez@avmbiotech.com

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