Listen to this articleBelow is our recent interview with James L. Sherley, the Founder of Asymmetrex:
Q: What is the mission of Asymmetrex?
A: I founded Asymmetrex with the goal of developing and advancing technologies that are needed to increase the success of stem cell medicine. The most promising stem cell medicine approaches are treatments using non-embryonic stem cells. Embryonic stem cells, of course, have the ethical and moral problem of requiring the deaths of human embryos for their development. In addition, though an often understated fact, embryonic stem cells are biologically incapable of providing the specialized function of tissue stem cells in the mature body. So, Asymmetrex is focused on developing innovative biotechnologies to reduce well known barriers to the medical development of natural tissue stem cells found in the mature body or found in ethically sourced perinatal tissues, like the umbilical cord.
All currently successful stem cell therapies use natural mature tissue stem cells. This approach is not just because mature tissue stem cells have been studied longer than embryonic stem cells. No amount of study is going to fix the biological inadequacy of embryonic stem cells for healing mature organs and tissues. For the same reason, new experimental gene therapies and gene-editing therapies also deploy mature tissue stem cells. The best known examples are blood stem cells found in the bone marrow and in umbilical cord blood.
There are three long-standing challenges that limit stem cell medicine with mature tissue stem cells. Because the cells exist in low numbers in organs and tissues, they are difficult to identify and difficult to count. And a third problem is that due to the same biology that makes them ideal stem cell medicines, they are difficult to produce in larger numbers so that more patients could be treated. Asymmetrex’s mission is to develop new technological solutions for each of these problems.
Asymmetrex was launched in 2013 based on its patented technologies for increasing the number of natural tissue stem cells. It wasn’t long before we recognized that developing a means to count tissue stem cells was a better strategic plan for addressing all three problems limiting progress in stem cell medicine. No method had been developed for counting tissue stem cells since they were first studied 60 years ago. The basic counting problem is that the cells are rare and no specific biomarkers have been discovered that can distinguish them from more abundant short-term committed progenitor cells. Committed progenitor cells do not provide long-term tissue regeneration, which is the special property of tissue stem cells. So, although often mistaken, the highly sensitive method of flow cytometry, which requires specific biomarkers, cannot be used to count tissue stem cells.
Asymmetrex spends considerable effort on educating the stem cell medicine community to the pernicious nature of the current lack of tissue stem cell counting. The quality of approved stem cell treatments and experimental stem cell clinical trials – including natural tissue stem cells and genetically-engineered tissue stem cells – are undermined by the absence of information on stem cell dosage. Early on, we recognized with our own production methods that attempting to optimize the production of tissue stem cells without being able to count them is magical thinking. The ability to count tissue stem cells specifically also enables new approaches to identifying them specifically.
Our latest educational strategy is another step towards achieving Asymmetrex’s mission. Our free stem cell counting website, opening July 5, has the purpose of giving scientists, physicians, tissue stem cell producers, suppliers, and drug developers the opportunity to explore the value of quantifying the number of tissue stem cells that they use in every area of stem cell medicine.
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Q: What made you decide to offer stem cell counting at no charge?
A: I wanted to reduce barriers to trying the new technology. Any new technology can be difficult to get scientists and technologists to try, especially in pharma companies, before they can see the value they will get from it. Having spent 15 years in academic tissue stem cell research before starting Asymmetrex seven years ago, I know stem cell research and stem cell medicine would benefit immensely from moving into a new era of quantitative tissue stem cell science. But getting the stem cell medicine community and the pharmaceutical industry to overcome their inertia of leaving behind a now comfortable old non-quantitative culture is going to take a significant source of new energy. So, by making it easy to try stem cell counting, I am betting on the intellectual energy of discovering the value of stem cell counting throughout stem cell medicine, the stem cell industry, and the pharmaceutical industry to ignite a widespread adoption of tissue stem cell counting as their new normal.
Q: Can you tell us something more about your patents?
A: Asymmetrex holds recently issued patents in both the U.S. and the U.K. for our tissue stem cell counting technology. In particular, the patents cover the use of the technology for drug evaluations. For example, counting can be used to discover drug candidates that promote tissue stem cell expansion for biomanufacturing or that increase their efficacious properties. Another important pharmaceutical application is the use of the counting technology to identify drug candidates that are tissue stem cell-toxic. Stem cell-toxic drugs cost the U.S. pharmaceutical industry $4-5 billion each year due to their late failures in expensive clinical trials. Drugs toxic to tissue stem cells cause chronic organ failure, which signals the death of drugs that have reached late stage clinical trials before their toxicity is discovered in patients. Though some may be discovered earlier in animal studies, failure at this stage of development also occurs with considerable expense. Asymmetrex’s patented tissue stem cell counting technology can identify such future failures much earlier by using human cell culture tests at little expense.
Q: What level of funding are you currently in?
A: Thus far, Asymmetrex has been funded by its founders and, more recently, revenues from our tissue stem cell counting service. Presently, we have several pending grant applications from government funding agencies (e.g., NIH, NSF). We continue to seek opportunities for equity investments to collaborate in the achievement of our industry and commercialization goals.
Q: What can we expect from Asymmetrex in next 12 months?
A: Hopefully, lots of new tissue stem cell counting attributed to our new efforts to introduce the technology more widely. The main thing I can assure you is that Asymmetrex’s push for the adoption of tissue stem cell counting is not going away. I am hopeful that many more leaders in our industry will continue to join us in this important chorus. Knowing how many tissue stem cells are in stem cell research experiments, in stem cell biomanufacturing processes, in drug evaluations, and certainly in stem cell treatments for patients becomes an absolute requirement once you have a means to count the cells.
We are also continuing our ongoing effort to organize and conduct an interlab study, approved by the American Society for Testing and Materials (ASTM), to evaluate the suitability of our counting technology for becoming a cell therapy industry standard. Achieving designation as an ASTM-approved industry standard is an important step for increasing integration of tissue stem cell counting into general academic, medical, and industry practice.
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Q: When you launched Asymmetrex, what made you think it would be successful?
A: We had and have the basic elements for biotechnology business success:
An outstanding and experienced team of biotech entrepreneurs, who own a highly innovative new biotechnology, that is an effective solution for a recognized important unmet medical or industry need, in a way that is attractive for a large and growing marketplace.
Success is on the horizon, and the horizon is getting closer.
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