On September 19, 2020, stem cell biotechnology company Asymmetrex was awarded a research and development grant from the NIH-NHLBI. The $0.42 million grant was awarded to support the company’s technical development and commercialization of its first-in-kind technology for specific and accurate counting of therapeutic tissue stem cells.
On the heals of Asymmetrex’s recently published peer-reviewed report describing its development of a method for quantifying therapeutic tissue stem cells, on Saturday September 19, the company received a Notice of Award of its first Phase I Small Business Innovation Research (SBIR) grant from the U.S. National Institutes of Health. Sponsored by the National Heart, Lung, and Blood Institute, the $0.42 million 1 year award recognizes the potential major impact of Asymmetrex’s first-in-kind technology in the stem cell medicine and drug development industries.
Asymmetrex founder and director James L. Sherley, M.D., Ph.D. spent most of Saturday contacting collaborators, contract service providers involved in the project, corporate partners, and industry colleagues who endorsed the grant application to share the news of the award. “I couldn’t wait until Monday to share this news. No one does biotechnology development and commercialization successfully alone; and Asymmetrex is fortunate to have the kind of support that gets a company to important milestones like this one.”
The new funds will accelerate the technical and business development of two applications of the company’s AlphaSTEM Test™ tissue stem cell counting technology. One goal is to evaluate in a head-to-head comparison how the company’s computational counting technology relates to the only existing method for specific estimation of the dosage of a therapeutic tissue stem cell.
Human blood stem cells can be estimated specifically by transplanting cells into mice. This test method is expensive, slow (taking 12-16 weeks), and variable. Asymmetrex already established – reported in the recent publication – that its technology compares well to the published literature for the mouse test, but has significantly less variability. The direct comparison will increase industry confidence and pave the way to raising more financing for advancing the AlphaSTEM Test™ to clinical evaluations. The company’s first clinical application target is determining the dose of stem cells in umbilical cord blood to identify which units will be lifesaving for children after leukemia treatment. In current clinical practice, 15-18% of children receive an ineffective transplant, because the stem cell dose was not known.
The second major milestone accomplished with award funding will be measurement of how well the AlphaSTEM Test™ identifies drug candidates that are toxic to tissue stem cells, like those in the liver and bone marrow. Drugs that are toxic to tissue stem cells cause chronic organ failure, a life-threatening event for clinical trial patients and a financial catastrophe for a drug development program. Such failures in Phase II and Phase III clinical trials cost the U.S. pharmaceutical industry $4-5 billion in losses each year. Currently, besides these late costly failures, the only way to identify tissue stem cell-toxic drug candidates is with expensive animal toxicology evaluations. Animal evaluations are notorious for their poor ability to predict human toxicities.
The company’s seminal report contains preliminary evidence of the AlphaSTEM Test™‘s ability to identify either tissue stem cell-toxic or tissue stem cell-activating compounds inexpensively in cell culture. The latter ability has application for discovery of new compounds that accelerate wound healing and combat effects of aging, including cosmetics. With the new award, Asymmetrex will extend the preliminary studies to the full-scale analyses needed by pharmaceutical companies for their evaluations.
Asymmetrex, LLC is a Massachusetts life sciences company with a focus on developing technologies to advance stem cell medicine. The company’s U.S. and U.K. patent portfolio contains biotechnologies that solve the two main technical problems – production and quantification – that have stood in the way of effective use of human adult tissue stem cells for regenerative medicine and drug development. Asymmetrex markets the first technology for determination of the dose and quality of tissue stem cell preparations (the “AlphaSTEM Test™”) for use in stem cell transplantation therapies and pre-clinical drug evaluations. Asymmetrex is a member company of the Advanced Regenerative Manufacturing Institute BioFabUSA (https://www.armiusa.org/).