14 May How Cancer Agent Might Be Utilized To Combat COVID-19
Dr. Deisher discusses AVM Biotechnology’s plan to study the immune stimulator AVM0703, developed for it’s anti-tumor effects, as a potential agent to combat COVID-19.
MedicalResearch.com: What is the background for this study? What is AVM0703 currently being studied to treat?
Response: Our lead small molecule, AVM0703, is a novel, patent-pending repurposed formulation of an active pharmaceutical ingredient that has been U.S. Food and Drug Administration (FDA)-approved since 1961. AVM0703 works by supercharging and mobilizing immune cells, including a novel natural killer T-cell (NKT), novel cytotoxic T lymphocytes and a CD11b very high dendritic cell, which invade and destroy tumors more effectively than untreated immune cells. AVM Biotechnology has received clinical trial approval from the FDA to begin Phase I/II trials to characterize the safety, tolerability, pharmacokinetics, and antitumor activity of AVM0703 administered as a single intravenous infusion to pediatric and adult patients (≥12 years old) with terminal, no-option lymphoid malignancies.
In addition, we are planning to study AVM0703 in Phase I/II trials in patients with severe or life-threatening COVID-19 infection. The proposed study is a randomized, double-blind, placebo-controlled, single-ascending dose study of AVM0703 administered as a single intravenous infusion. The study’s objective is to evaluate the safety and efficacy of AVM0703 in patients with COVID-19, as well as assess pharmacokinetics and dosing, including the maximum tolerated dose and the recommended Phase II dose. We hope to begin recruiting patients next month (June 2020).
MedicalResearch.com: How might AVM0703 be utilized in combating COVID-19?
Response: COVID-19 patients have been shown to have lower lymphocyte counts and below normal T-cells. We are testing the hypothesis that AVM0703 supercharged immune cell mobilization will reduce lung inflammation, kill SARS-Cov-2, the novel coronavirus that causes COVID-19, and induce long-term immunity. The ability of AVM0703 to mobilize supercharged immune cells is not compromised in disease models, and thus should compensate for the diminished regular immune cells in patients who develop severe cases of COVID-19.
Additionally, AVM0703 may have endogenous vaccine-like properties given its ability to mobilize NKT cells while also activating dendritic cells. By itself, AVM-NKT mobilized by AVM0703 could kill COVID-19 and provide memory via the T-cell character of the NKT cells. The addition of activated dendritic cells could provide memory through other T and B (antibodies) lymphocytes by presenting antigens.
MedicalResearch.com: What should readers take away from your report?
Response: If the results of our study are positive, we would have an encouraging signal that AVM0703 has the potential to be a viable treatment for COVID-19 that could be studied and brought to market quickly. Our research shows it has an onset of action as early as six hours from dosing. The GMP drug is manufactured in seven hours, produced domestically, and is stable at high temperature and humid conditions, making it a potential global solution for the current pandemic and possible future pandemics.
MedicalResearch.com: Is there anything else you would like to add?
Response: Our clinical team is dedicated to addressing unmet needs for which AVM0703 may provide real-world, real-time solutions to patients. AVM Biotechnology has made researching AVM0703’s efficacy in COVID-19 patients, along with our cancer-specific research, our concurrent priority.
Theresa A. Deisher, Founder and CEO, Ph.D., graduated from Stanford University School of Medicine with a doctoral degree in Molecular & Cellular Physiology. She has 35+ issued US/EU/Japan patents and three discoveries in clinical trials. Dr. Deisher has more than 30 years of pharmaceutical leadership experience at Genentech, Repligen, ZymoGenetics, Immunex and Amgen. AVM0703 is a personal mission for Dr. Deisher as she lost her 14-year-old son to Burkitt’s lymphoma.
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Eur. J. Immunol. 2009. 39: 3283–3291 DOI 10.1002/eji.200939800
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