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Olson received help from the Gates Grubstake Fund, which provides three or four annual awards up to $350,000 to support the translational development of regenerative medicine projects into patented, clinic-ready products. AmpVision has employed some of that funding for a regulatory consultant to navigate FDA procedures, and to investigate how to start up clinical- grade manufacturing if the device is approved for human trials.
The presentations and persuasion that come with fundraising are “not my favorite part,” Olson said. “Gates Grubstake has really gotten us through some of that.” The Gates funds are less restricted, for example, and therefore easier to direct where needed, than other sought-after funding such as federal Small Business Innovation Research grants, Olson said.
Through Grubstake and the Startup Toolbox, Callahan said, the variety of assistance available for researchers is unparalleled. “We connect them to law firms, lawyers who are used to working with inventors who help them form a company and license the technology; we help them assemble a management team; we help them obtain non-dilutive funding...those are the things that make a difference in the success of a company.”
Gates Center research members have launched a number of promising startups to help translate their discoveries into products for treating patients. Each is at a different stage of fundraising, regulatory approval, and steps remaining to clinical trial. Here is a partial list:
Allander Biotechnologies, LLC – Gates member Xiao-Jing Wang, M.D., Ph.D.,
leads this startup bringing to the clinic a protein-based therapeutic that can be topically applied to treat inflammatory disorders with unmet medical needs such as oral mucositis (a side-effect of cancer treatment) and chronic non- healing wounds (frequently seen in diabetics). Allander has received one of the first Grubstake Awards, two Phase 2 NIH Small Business Innovation Research (SBIR) awards and investment funding. Allander’s goal over the next year is to file for pre-Investigational New Drug (IND) status, a critical step in the FDA approval process for new drug therapies.
Ceria Therapeutics, Inc. – Ken Liechty, M.D., has received two Grubstake Awards to develop a therapeutic cerium oxide nanoparticle conjugated to miRNA (CNP-miR146a) designed to treat inflammatory disorders with unmet medical needs such as diabetic ulcers and acute lung injury. Dr. Liechty’s startup, Ceria Therapeutics, Inc., filed a pre-IND through the University of Colorado before the company was even formed. Ceria has received investment funding from Children’s Hospital. Ceria is currently assessing whether its therapeutic, CNP-miR146a, might be helpful in treating acute respiratory distress symptoms in patients with serious cases of COVID19.
Omix, LLC – is led by Kirk Hansen, Ph.D., an associate professor at the School of Medicine. Omix has technology that characterizes the tissue scaffolds that allow regeneration to happen in situ. Such tissue scaffolds require meticulous FDA approvals of their manufacturing for safety and efficacy.
Op-T, LLC – David Wagner, Ph.D., an Associate Professor in the Department
of Medicine and Department of Neurology at the School of Medicine, is developing diagnostics for autoimmune disease and therapeutic approaches to control autoimmune inflammation. Op-T plan to file an IND for a drug product in early 2020 and to start clinical trials later in the year. Their focus is on the immune cascade, useful for type 1 diabetes, atherosclerosis and multiple sclerosis
SummitDx, LLC – Shi-Long Lu, M.D., Ph.D., an Associate Professor at the School of Medicine, is developing saliva liquid biopsy tests for the early detection of Head and Neck cancer. The company is built on the research discoveries of Dr. Lu and John Song, M.D., from the University of Colorado Anschutz Medical Campus. The company’s lead product in development is HNKlear, the first saliva test for Head and Neck cancer recurrence following front-line treatment.
Validus Cellular Therapeutics, Inc. –
Validus researchers, including Steve Dow, Ph.D., Director of the Center for Immune and Regenerative Medicine at Colorado State University, have discovered that through special activation of mesenchymal stem cells, drug resistant infections become more treatable. In clinical veterinary studies to treat animal infections, activated cells seek out resistant infections and enhance the body’s natural immune system. Validus has a new CEO, Ethan Mann, and is applying for SBIR funding as well as investment capital.
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