AVM Biotechnology, based in Seattle, was launched to capitalize on the founder’s knowledge and expertise in developing immunotherapies targeting oncology and viruses. With the advent of COVID-19 and the understanding that serious cases leading to acute respiratory distress syndrome (ARDS) can trigger deadly cytokine storms. This new study will evaluate the safety and efficacy of this advanced novel, patent-pending formulation of a repurposed drug without the toxic excipient, unlike existing formulations.
Founded in 2008 by Dr. Theresa Deisher, PhD (over 35 patents), AVM Biotechnology focuses on researching and developing game-changing stem cell technologies. Their lead molecule, AVM0703, received FDA approval in April 2020 to proceed with Phase I/II clinical trials for the treatment of lymphoid malignancies. Currently, research reveals that AVM0703 may be an effective therapeutic treatment against viruses, including COVID-19. The mechanism of action that makes AVM0703 work against aggressive cancers may also prove effective against COVID-19. AVM Biotechnology has filed with the FDA for approval to proceed with clinical trials against this deadly virus. They have raised at least $8.9 million since inception, including some debt. The company is a small, early-stage upstart with under 20 employees. They are based in Seattle, WA.
Truly a high-powered researcher, Dr. Deisher graduated from Stanford University School of Medicine with a doctoral degree in Molecular & Cellular Physiology. With over 35 issued US/EU/Japan patents and three discoveries in clinical trials, she has diversified experience in the management of prominent biotech’s to startups, including Genentech, Repligen, ZymoGenetics, Derived Stem Cell, and Immunex/Amgen.
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.
A Phase I/II starts with a primary objective to evaluate the safety and efficacy of an experimental therapy called AVM0703 in patients with severe or life-threatening COVID-19 infection. While the second objective of Phase I centers on an evaluation of the pharmacokinetics (PK) of ascending doses of AVM0703. In an exploratory stage, investigators also seek to assess potential biomarkers indicative of natural killer T (NKT) cell activity and biomarkers predictive of response to AVM0703 in peripheral blood and bronchoalveolar lavage. The sponsor seeks a total of 126 participants—the study starts in June 2020 and runs through June 2023.
During Phase II, the investigational team seeks to identify the potential efficacy of AVM0703 when administered at the maximum tolerated dose (MTD)/recommended Phase II dose (RP2D) in patients with severe or life-threatening COVID-19 infection. Key in this second phase is the determination of the potential efficacy of AVM0703 when administered at the MTD/recommended Phase II dose (RP2D) in patients with severe or life-threatening COVID-19 infection. Additionally, the investigators seek to better understand the safety profile of AVM0703 in patients with severe or life-threatening COVID-19 infection. Exploratory objectives include the assessment of possible biomarkers indicative of NKT cell activity and biomarkers predictive of responders to AVM0703 in peripheral blood and bronchoalveolar lavage.
The study arm will receive the experimental drug known as AVM0703 in the form of a single IV infusion at 10 mg/ml in normal saline over 1 hour to patients.
The participants must be 1) ≥18 years; 2) laboratory-confirmed COVID-19; 3) severe, immediately life-threatening COVID-19, based on COVID-19 critical Salvage Criteria including: a) severe acute respiratory distress syndrome and b) refractory hypoxemia on invasive mechanical ventilation despite rescue measures (prone positioning, positive end-expiratory airway pressure ladder, inhaled pulmonary vasodilators, recruitment maneuvers and/or neuromuscular blockade) as demonstrated by either i) PaO2: FIO2 ratio ≤100 mm Hg with PEEP ≥5 cm H2O on more than two arterial blood gases at least 6 hours apart within 24 hours, ii) Persistence of SpO2 ≤87% on room air by pulse oximetry for more than 6 hours, iii) Oxyhemoglobin desaturation to SpO2 ≤80% on room air during and/or following patient position changes in the bed; and 4) females of childbearing age must have a negative serum pregnancy test at screening. Moreover, females of childbearing potential and non-sterile males must agree to use medically effective contraception methods from the time of informed consent through the first month after study drug infusion.
No site is disclosed, but the study is managed by mid-market clinical research organization (CRO) Medpace.
Brandon Franklin, PhD, Clinical Trial Manager