VivoSphere’s Patented Tissue Engineering Technologies Drive Scalable Production of Cancer Tissues for Disease Modeling and Therapeutic Drug Testing
Auburn NVA company creates a cost-effective, precise test bed for high-throughput, pre-clinical evaluation of critical cancer therapy candidates
Pharmaceutical companies around the globe spend billions of dollars each year to discover, develop and test the efficacy of a wide range of promising therapeutic drugs for devastating cancers impacting tens of millions of people. One component of that cost is embedded in the pre-clinical testing process that pharmaceutical companies go through before deciding to advance any promising drug or therapy candidate to human testing. An even larger component of that cost, however, comes from failures of candidates that move on to the clinical trial stage.
The challenge for pharmaceutical companies is determining which candidates will fail as early as possible in the development and testing process – identifying effective, non-toxic drug candidates during preclinical testing stages while also finding out which are either not effective or toxic and eliminating them from consideration for human testing in the clinical trial stage.
That’s critical because according to research published by the National Institute of Health (NIH), less than 4 percent of oncology candidates undergoing clinical testing succeed, meaning that billions of dollars in cancer research funding is written off as part of the cost of doing business in developing those very few, very valuable therapies. As a result, according to NIH, the median cost of developing a single FDA-approved cancer drug was $648 million in 2017 – and rising.
How They Decide
We sat down with the co-founders of VivoSphere – Drs. Elizabeth Lipke and Yuan Tian – to understand how their patented approach to pre-clinical testing of promising cancer treatments is enabling pharmaceutical companies to better assess which candidates warrant human trials and what that could mean for better patient outcomes going forward.
Lipke, the Mary and John H. Sanders Professor in Auburn’s Department of Chemical Engineering at the Samuel Ginn College of Engineering, and Tian, a post-doctoral researcher in the department, co-founded their biomedical company in 2022 following a 2021 National Science Foundation-awarded project, “I-Corps: Spheroidal engineered tissues for more efficient drug discovery.” The start-up won first place and $25,000 in Alabama Launchpad’s Cycle 2 concept stage finals in August at Auburn University’s New Venture Accelerator.
NVA: Let’s start with the problem you are trying to solve – why are current methods for conducting pre-clinical trials of promising cancer drugs inadequate?
Lipke: The challenge is two-fold – create an environment for cancer tissue testing that more closely resembles real-life cancer tissue characteristics while also dramatically expanding the number and types of cancer cells available for testing.
Current approaches are severely limited in terms of both quality and throughput. In today’s two-dimensional test beds, the small sample size in a high throughput setting often offers insufficient number of cells, therefore failing to generate adequate levels of confidence in the results, while existing three-dimensional test beds typically have lower throughput.
Tian: A major cause of this problem is that traditional drug testing methods involve using flat 2D cell cultures in a dish. But here’s the catch: cancers don’t grow in isolation. Tumors exist within complex 3D environments, interacting with neighboring cells and their surroundings.
We utilize tissue engineering technology to replicate these conditions by creating miniature versions of human tissues, allowing researchers to study the intricate interactions between cancer cells, normal cells, and the extracellular matrix. This level of detail is simply impossible to achieve with 2D cultures.
What’s more, our technology also enables rapid and scalable production of these human-mimicking tissues. This enables a large amount of cancer tissues to be tested in a high-throughput manner, helping the candidates that will eventually fail to “fail fast” while moving those most viable to move to human clinical trials.
NVA: Can you walk us through how that scientific research turned into an idea for the practical application of your findings in the real world?
Lipke: To make an impact on the success of cancer therapies, I decided that we should move towards something that was more reproducible. We were looking to develop a way to encapsulate lots of cells at very high density into engineered tissues very, very quickly in order to use them for testing regenerative medicine applications.
Yuan had just joined the lab as a first-year graduate student, and at that time we were testing different designs of our microfluidic system – including the one that we are now using to produce these spheroidal engineered tissues.
Tian: The project I was working on was trying to scale production of cells for injectable cell delivery using our newly designed microfluidic device that leverages a molding approach to generate more flexibility in controlling the final products. We filed a patent on this technology through the IP Exchange in collaboration with Dr. Troy Brady.
The Lipke Lab already has another patented technology related to stem cell-based cardiac tissue generation that has great potential when combined with our patent, so now we have two key technologies that can be integrated, and they’re both patented. That’s a great advantage for us because people are moving from small molecules to biological molecules while cell therapies and regenerative medicine are growing rapidly.
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