Qualigen Therapeutics Inc., a California biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, has signed a license agreement for the technology and plans to fund continued development with UofL to ready it for market.

The technology works by targeting the RAS protein, which sends signals that regulate when and where the body produces and grows new cells. When mutated, the protein turns into a “stuck accelerator pedal,” according to UofL researcher Geoffrey Clark, who co-invented the technology with colleagues John Trent and Joe Burlison.

“Normally, it gets pressed when you need to grow and then the foot comes off and the cell slows down,” said Clark, professor of pharmacology and toxicology at UofL. “When it becomes mutated, the accelerator’s jammed on, with cells continuing to grow and ultimately becoming a cancerous tumor.”

The drug targets only the active RAS protein and, so far, has little toxic effect on healthy cells. Many current non-targeted treatments, such as chemotherapy, can hurt both healthy and cancerous cells, leading to painful side effects. By some estimates, targeting this mutation could stop the growth of at least a third of human tumors.

“The patient impact could be extremely broad because RAS is involved in a lot of different cancers,” Trent said. “It’s one of the holy grails that there has been limited success in targeting.”

Trent leads the Molecular Modeling Facility at UofL Health – James Graham Brown Cancer Center and the UofL partnership with , a non-profit with a network of school computers across the state. When the computers aren’t being used by students, they’re connected to act as a distributed supercomputer, allowing researchers to process and analyze huge amounts of data.

Trent used that capability to run through millions of cancer-fighting drug possibilities in a matter of days. The result was a drug that could inhibit the deregulated RAS protein. Development of the technology was supported by the UofL NIH REACH ExCITE program.

Qualigen holds an exclusive license to the technology through the , which works with startups and industry to commercialize university-owned technologies. This license agreement builds on a sponsored research agreement with Qualigen for the development of several small-molecule RAS Inhibitor drug candidates. Qualigen also has licensed and is developing other UofL technologies for fighting COVID-19 and .

“Partnering on this new cancer-fighting technology is another example of the relationship we’ve developed with the University of Louisville,” said Michael Poirier, CEO of Qualigen. “We look forward to working with UofL and to advancing this important clinical program with the goal of developing an effective treatment for this unmet need.”

More information about supporting this cancer research at UofL is available online.����

The four-year Research Evaluation and Commercialization Hub (REACH) grant from the National Institutes of Health will help fund a public-private consortium, the Kentucky Network for Innovation & Commercialization – KYNETIC. The new organization will use NIH funding to advance the most promising biomedical research innovations from the state’s eight public universities and the Kentucky Community & Technical College System. Ultimately, its goal is to create startups that commercialize the technologies for public benefit.

KYNETIC, whose founding members will contribute a $2.56 million direct-cost match, will provide guidance and technical resources to advance the technologies toward commercialization. Additionally, KYNETIC will assist in scaling the resulting startups to help tackle some of the biggest health challenges facing the US population, such as cardiovascular disease, diabetes and cancer.

Innovations that KYNETIC will help bring to market may be new pharmaceuticals, therapies, devices and other health-related technologies. Those products could directly intervene in disease processes and conditions individuals suffer, or they may address health disparities like lack of health care access in rural areas or populations suffering disproportionate rates of disease and premature death.

As resulting startups move into clinical trials phases, many will rely on the strength of Kentucky’s public hospitals and health care systems.

UofL President Neeli Bendapudi said the expanding resources available through UofL Health will further support health care research.

“With the acquisition of Jewish Hospital and other KentuckyOne Health properties, researchers at UofL will have additional opportunities to recruit patients for clinical studies to advance research emerging from KYNETIC,” Bendapudi said. “Projects developed through KYNETIC will have the potential to further existing UofL research efforts in optimal aging, improve access to quality health care in underserved urban and rural regions, and bolster efforts to both attract and retain top faculty and students at UofL.”

In addition to its statewide approach, KYNETIC will intentionally seek both innovations and entrepreneurs from diverse and underrepresented groups.

Paula Bates, PhD, professor of medicine at UofL and co-principal investigator on the grant, said the state will benefit from broader collaborations facilitated by KYNETIC.

“When you get people from different backgrounds working together, you see innovation blossom,” Bates said. “I am looking forward to seeing some new collaborations, being able to share what we have learned and learn from other people in Kentucky. I think this is a really powerful way to reach everybody in Kentucky and get some great knowledge transferred and some great new ideas.”

Linda Dwoskin, PhD, UK professor of pharmaceutical sciences and co-principal investigator on the grant, said KYNETIC will benefit researchers, institutions and communities across Kentucky including underserved communities and populations.

“It is an honor to work with the University of Louisville, C3 and public academic institutions across the state to advance and accelerate innovative ideas that could lead to new products and technologies,” Dwoskin said. “Throughout the state we have untapped resources of inventive and entrepreneurial individuals and groups whom we hope to provide opportunities that will aid in transforming ideas and discoveries to tangible health benefits.”

“Kentucky’s ability to win this grant — one of only a handful ever awarded nationwide — was made possible in large part because of the unprecedented collaboration between our economic development cabinet, public universities and technical colleges in creating our non-profit commercialization center, C3,” said Governor Matt Bevin. “This grant further validates the significance of C3’s public-private structure and our decision to revitalize Kentucky’s innovation and entrepreneurial support system. Together, we can have a truly positive impact on the health of Kentuckians and people around the world.”

KYNETIC will leverage commercialization resources led by co-investigators Allen Morris, PhD, executive director of the UofL Commercialization EPI-Center, Ian McClure, executive director of the UK Office of Technology Commercialization, and April Turley director of C3’s Commercialization Core. It also will build on the experience brought by a current REACH hub at UofL () and other existing tech-transfer programs at UofL, as well as the regional IDeA biomedical technology transfer accelerator hub at UK 

Check out more in the video below: 

The companies, and , were favorites in audience voting, respectively placing first (34 percent) and second (32 percent). Innovative Therapeutix also won the shark-judged competition.

“This win is huge for us,” said Michael Detmer, Innovative Therapeutix co-founder and UofL adjunct professor of music therapy. “We are in a very exciting but daunting phase of our startup.”

Innovative Therapeutix produces LullaFeed, a musical baby bottle to help reinforce infant feeding. DesiCorp has a to extend its shelf-life, which could have many applications, including in the military or humanitarian aid.

Detmer’s partner, Rebekah Gossom, is a Norton Healthcare speech-language pathologist. Their backgrounds — music and medicine — were perfect for creating the product, but they had less experience in entrepreneurship and commercialization.

For that, both teams worked with the UofL (EVPRI), which has offices to help researchers translate their ideas from lab to the marketplace.

The teams, for example, worked with the EVPRI’s for advice, help securing the intellectual property and connections to funding and training opportunities.

“Our goal is to help our inventors to turn their ideas into real products, and sometimes, turn them into real entrepreneurs,” said OTT director, Dr. Allen Morris. “It’s a proud moment when you see them fully come into that, as these teams have.”

The teams also participated in other programs, including the site program at UofL; , a local business accelerator and UofL partner; and with , an NIH-backed program that helps researchers commercialize healthcare-related technologies.

“Both of these teams are great illustrations of how the University of Louisville ecosystem nurtures budding entrepreneurs and helps them to develop products that will positively impact human health,” said ExCITE program director, Dr. Paula Bates.

She said ExCITE now works with 19 projects from diverse disciplines across campus. ExCITE projects are led by students, faculty and staff from a range of departments and backgrounds, including medicine and music.

“Seeing what was once our silly clipart drawing of the device go through multiple iterations in the lab and then end up in our hands was one of the most rewarding moments,” Detmer said.

Detmer said Innovative Therapeutix is planning to launch the product in early 2019. Right now, they’re beta testing the bottles with real parents, talking to manufacturers, and trying to raise additional funding.