AVM Planning Clinical Trial to Compare AVM0703 to Dexamethasone in Severe COVID-19 Cases

Jun 29, 2020 | COVID-19, Dexamethasone, News, Regenerative Cell Therapy, Stem Cell

AVM Planning Clinical Trial to Compare AVM0703 to Dexamethasone in Severe COVID-19 Cases

AVM Biotechnology, based in Seattle, is a development-stage biotech venture seeking to ultimately commercialize “game-changing” stem cell technologies for high unmet medical needs in regenerative medicine, cancer treatment recovery, safer iPS cell culturing and treatment, and ultimately, a range of precision medicines. The recent success of Oxford University’s dexamethasone clinical trial has geared up AVM as their lead molecule is a purified loaded formulation of dexamethasone. AVM has investigated dexamethasone and found in higher doses it can be safely administered and appears to have a different Mechanism of Action (MOA) than chronic, repeat, lower doses. Based on the Oxford findings and the existing claims of this commercial sponsor, they believe their investigational product called AVM0703 will have a greater impact on COVID-19 patients than dexamethasone alone. Hence, the company filed with the FDA to proceed with a clinical trial against COVID-19. TrialSite News has offered an overview of AVM previously.

The Investigational Product

AVM claims that AVM0703 has several advantages. For example, it can be manufactured in seven hours by a global contract development and manufacturing organization (CDMO); offers stability at even high temperatures (e.g. 45°C (104°F) in high humidity; and can have a long shelf life of 9 to 24 months, which make it a potential global solution. But what is it?

AVM0703 is a novel patent-pending formulation of a repurposed drug without the toxic excipients, unlike existing formulations. AVM0703 has anti-tumor activity in an immunocompetent mouse model of B-cell lymphoma (A20) as both a stand-alone treatment and in combinations with current therapeutics. 

According to recent literature from the company, AVM0703 is a purer, loaded formulation of dexamethasone that could enable single acute doses to replace chronic repeat dosing. Rapid 6 hour onset of action could eliminate infected monocytes and neutrophils that are driving lung damage. They claim that mobilization of supercharged Natural Killer T and cytotoxic T cells could eliminate the virus and provide long term immunity. AVM touts that supercharged immune cells are 10X more activatable than ordinary immune cells. The dosing could save more lives than repeat 10-day dosing and could reduce ICU data from 10+ days to 2-3 days, hence having enormous potential financial impact. 

AVM reports that regulatory authorities have approved of this investigational product for human trials in several types of blood cancer. The company is dedicated to rigorously testing AVM0703 in a controlled clinical trials involving severely ill COVID-19 patients.

Medpace Partnership

AVM has contracted with contract research organization (CRO) Medpace to conduct a clinical trial targeting severely ill COVID-19 patients. The study will be led by Madhavi Malladi, PhD of Medpace. A mid-sized CRO based in Cincinnati, Ohio, the company provides services for Phase I-IV drug and medical device clinical research as well as other related services from regulatory to central laboratory services. The company went public in 2016.

The Study

This planned Phase 1/2 study NCT04366115 is not yet recruiting; the the primary objective of Phase 1 of this study is to evaluate the safety and efficacy of AVM0703 in subjects with severe life-threatening COVID-19 infection. A secondary objective of the Phase 2 option evaluates the pharmacokinetics (PK) of ascending doses of the investigational product.  AVM seeks to investigate the potential biomarkers indicative of natural killer (NKT) cell activity and biomarkers predictive of response to AVM0703 in peripheral blood and bronchoalveolar lavage.

If the study makes it to Phase 2, the key goal will be to determine the potential efficacy of the investigational product (AVM0703) when administered at the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) in patients with severe or life-threatening COVID-19 infection. A secondary objective includes to gain more information about the safety of AVM0703 while an exploratory objective of Phase 2 centers on the assessment of potential biomarkers indicative of NKT cell activity and biomarker predictive of responders to AVM0703 in peripheral blood and bronchoalveolar lavage.

This randomized, double-blind, placebo controlled trial will involve 126 participants. The study is planned to start in June with an estimated primary completion date of June 2022.

The Company

AVM Biotechnology was founded in 2008 by high powered researcher Theresa A. Deisher. The company has raised $15 million to date. Based in Seattle, WA, the company  is a developer of stem cell technologies designed to offer treatment in the form of regenerative medicine for oncology purposes. The company’s stem cell technologies focus on research, development and commercialization of stem cell technologies for unmet medical needs in regenerative medicine, G-CSF induced stem cell mobilization, GvHD, germinal centre lymphomas and iPS cell lines human biologics, enabling medical practitioners to get medicines with minimum side effects.

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