Successful Development to Commercial Excellence
AVM Biotechnology is a clinical stage company actively enrolling oncology patients in an adaptive-design expansion cohort clinical trial. The Company is focused on the US approval process; global regulatory submissions; executing additional clinical trials; and ultimately making AVM0703 available to as many patients as possible via strategic partnerships. The company is currently preparing for commercial launch in the US.
AVM developed a unique and robust patenting strategy resulting in patents that have withstood third party challenges. The company holds seven protected worldwide patent families directed to AVM0703. Currently granted claims and patent protection should extend through 2040.
The NIH awarded AVM two Phase I Small Business Innovation Research (SBIR) grants in 2019 (National Institute of Diabetes and Digestive and Kidney Disease [NIDDK]and the National Cancer Institute [NCI]), which are supporting additional AVM0703 research. In 2022, AVM received two Phase II SBIR grants; $2 million from NCI to further the NHL/Leukemia clinical study and $1.6 million from the NIDDK to pursue additional research in the use of AVM0703 to reverse recent onset and established Type I Diabetes. Receipt of an NIH grant is an acknowledgement of good science and management, and the alignment of the awardee’s goals with the “NIH mission to enhance health, extend healthy lives, and reduce the burdens of illness and disability”.
AVM0703 is a highly concentrated and proprietary reformulation of the existing small molecule dexamethasone for injection. AVM researchers discovered that this molecule, when administered at very high doses, induces and mobilizes a subset of unique and highly active endogenous bispecific gamma delta TCR+ invariant TCR+ Natural Killer T-like (NKT) immune cells. These AVM-NKT immune cells have a rapid onset of action in response to a single dose of AVM0703.
Scientific collaborations, global strategic development and commercial partnerships, as well as out-licensing opportunities continue to be identified and explored. AVM0703 has the potential for multiple indications in several therapeutic areas such as oncology, and infectious and autoimmune diseases. AVM also holds additional IP regarding the novel AVM-NKT cells as an ‘off- the-shelf’ cell therapy product that could have broad applications.