A New Approach to Cancer Treatment
AVM0703 Induces & Mobilizes Endogenous Gamma Delta+ NKT-like Cells
AVM0703 rapidly triggers the production and release of endogenous bispecific gamma delta TCR+ invariant TCR+ Natural Killer T-like cells (AVM-NKT). These supercharged immune cells have unique properties and appear rapidly in the blood following a single dose of AVM0703. They home to abnormal cells including cancer, infected cells and autoreactive lymphocytes. It is clear that these cells could play a significant role in addressing several serious conditions.
The proprietary AVM0703 formulation is based on dexamethasone (DP), approved by the FDA at much lower doses since 1958. AVM0703 has been engineered to permit very high doses of dexamethasone to be administered without concerning side-effects. The unique, higher dose AVM0703 formulation is required to deploy activated AVM-NKT cells into the bloodstream for targeted delivery to abnormal cells.
Current Cancer Treatment Approaches Leave an Unmet Need
Despite recent clinical advances, cancer continues to take a tremendous toll on life, society, and medical resources. There remains a clear unmet need for more effective cancer therapies that are kinder and gentler. A treatment cannot ultimately work if the patients cannot tolerate the side effects. New therapies must have tolerable and manageable side-effect profiles so as to maximize the therapeutic benefit. The emerging safety profile of AVM0703 is encouraging.
AVM Biotechnology’s Solution: AVM0703
AVM0703 is a clinical stage product with a novel mechanism of action. Based on a proprietary, suprapharmacologic dexamethasone dose, this drug product could offer a kinder and gentler, yet equally effective treatment option for patients and their oncologists.
A New Approach
Conventional therapies, such as radiation and chemotherapy can require numerous cycles over weeks or months. These and newer cell, i.e., CAR-T and gene therapies can also have significant side effects and costs.
The novel immune cells mobilized by AVM0703 have been shown to target leukemia/lymphoma while sparing normal lymphocytes, unlike other therapies which are known to cause lymphocyte reduction. Following AVM0703 administration, platelets, red blood cells, and stem cells are also spared. This could reduce the need for transfusion(s) and other supportive care.
To date, AVM0703 has been well-tolerated with minimal and generally mild and self-limiting side effects both in compassionate use and in the ongoing clinical study. Preclinical data indicate that AVM0703 could be synergistic with other chemotherapy regimens, resulting in a reduction in the number of chemotherapy cycles needed for a complete response. This could result in a lower total exposure to chemotherapy and subsequent toxic side-effects while maintaining efficacy
Patients who have received AVM0703 reported that they felt “great” and side effects have been predominantly grade 1.
Requesting Access
AVM0703 is accessible through clinical trial AVM0703-001 (NCT04329728) or the expanded access / compassionate use program.