KYNETIC is a National Institutes of Health (NIH) funded Research Evaluation and Commercialization Hub (REACH) and part of the national NIH Proof-of-Concept Network.

The program offers entrepreneurial education and proof-of-concept/product development grants to accelerate the translation of academic innovations into biomedical products by investigators throughout the Commonwealth of Kentucky.ĚýĚý

KYNETIC awarded grants to the following applicantsĚýor teams, three of which are from UofL:

• Andrea Behrman, University of Louisville
• Levi BeverlyĚý(PI), Robert Buchanan (Co-PI), Craig Grapperhaus (Co-PI), University of Louisville
• Christina Ralph-NearmanĚý(PI), Cheri Levinson (Co-PI),ĚýUniversity of Louisville
• Daniel BoamahĚý(PI), Kimberly Green (Co-PI),ĚýWestern Kentucky University
• Andrew LongĚý(PI), Steven Wilkinson (Co-PI),ĚýNorthern Kentucky University
• Mark Fritz, University of Kentucky
• Kip Guy, University of Kentucky
• Jill Kolesar, University of Kentucky

The KYNETIC program is led by the University of Louisville, the University of Kentucky, the Kentucky Cabinet for Economic Development and Kentucky Commercialization Ventures.

The pre-application window for KYNETIC’s Cycle 7 is currently open. The deadline is 5 p.m., Tuesday, Feb. 13. Pre-applications can beĚý.

KYNETIC Project Managers are available for consultation before you submit your pre-application and throughout the application process. You can find more informationĚý.

That funding, an increase of more than $30 million over the previous record set a year earlier, supported work to address some of the biggest global problems of our time, including climate change and battling the COVID-19 pandemic.

“UofL is truly a research powerhouse, continuously blazing new trails and seeking answers to important questions,” said UofL President Neeli Bendapudi. “This record-breaking year for funding is proof of that fact, but it also shows our research and scholarship are a great investment — that UofL is a great place to invest.”

The value of that investment is especially apparent in the university’s work to combat COVID-19. In the past year, researchers investigated innovative new treatments, led widespread community testing and developed new methods that could revolutionize how we track and contain future disease outbreaks.

“The research we do here at UofL has real impact — it can improve the way we live and work, spur economic development, and in some cases, it literally saves lives,”Ěýsaid Kevin Gardner, UofL’s executive vice president for research and innovation. “This funding makes that important work possible.”

The 2021 fiscal year was also far-and-away the university’s best year on record for commercialization income. UofL earned $26.7 million from license royalties and other related income from university research-born intellectual property, nearly triple the previous record set just a year before, and was awarded 80 new patents.

The increased income was propelled by strong deals and development funding, including the license of UofL-born drugs to fight cancer and other conditions. UofL also received grants to develop new technologies, including those addressing societal problems caused by COVID-19.

The past fiscal year also saw the launch of two new startups based on university-born technology. One, iTolerance Inc., signed an exclusive license for a UofL therapy that helps people with Type 1 diabetes stay off immunosuppressants, and is now developing it for clinical use.

To support the launch of more startups based on university technology, UofL recently launched UofL New Ventures, within the . UofL New Ventures is dedicated to broad entrepreneurial support, from forging connections with experienced and potential company founders to helping the resulting startups attract funding and market share.

“It’s important for people to know that our research doesn’t end with a paper or manuscript,” Gardner said. “It ends in getting our research out into the world in the form of innovative new companies, partnerships and technologies. Our goal is innovation with impact.”

The company, Talaris Therapeutics Inc., has listed its shares on the NASDAQ Stock Market exchange under the ticker symbol “TALS.”Ěý

Talaris is working to develop and market , which is intended to help transplant recipients to stay off immunosuppression drugs they would otherwise need for the rest of their lives. The therapy was invented at UofL by researcher and innovator Suzanne Ildstad, who founded the company and now serves as its chief scientific officer.

The therapy is designed to prevent organ rejection without the morbidity and mortality that has been associated with the use of lifelong anti-rejection medicines. Talaris has an exclusive license to the technology, which was developed by Ildstad’s lab at UofL, through .

Immunosuppressants help prevent rejection of the transplanted organ, but can cause serious side effects, including high blood pressure, diabetes, high cholesterol, neurological effects, increased risk of infection and decline in kidney function over time.

With this therapy, the goal is “helping organ transplant recipients no longer be dependent on immunosuppressive drugs, resulting in a greatly improved quality of life,” Ildstad said previously. “The support and research infrastructure at UofL have been invaluable in our journey to this important juncture.”

FCR001 consists of stem and immune cells taken from the organ donor and processed at Talaris’ GMP cell processing facility, then infused into the organ transplant recipient. The goal is to create a durable “dual immune system” (part donor-derived and part recipient) in the transplant recipient where these two immune systems coexist, recognizing both the recipient’s own body as well as the donated organ as self.

“This technology could help transplant patients live fuller, healthier lives,”Ěýsaid UofL Executive Vice President for Research and Innovation, Kevin Gardner.Ěý“This UofL research, in the hands of strong industry partners and backed by sophisticated life sciences investors and now public shareholders, is a big step in advancing our health.”Ěý

Talaris has secured significant funding over the past two years. In 2019, the company closed a , which it used to hire staff and initiate a Phase 3 clinical trial for its therapy — the last step before applying for FDA approval.

A year later, it to support that trialĚý as well as two other Phase 2 trials that are expected to begin in the second half of 2021, including a planned Phase 2 trial of FCR001 in diffuse cutaneous systemic sclerosis, a severe form of the rare autoimmune disease scleroderma.

The startup is MAC-BIO, led by MD/PhD student Jordan Noe, which is developing a new cell-based therapy for the treatment of aggressive solid tumors. For winning CardStart, Noe will receive $1,500 to help him get his startup off the ground and his technology to market.

“CardStart has been an amazing experience in refining MAC-BIO’s business pitch and vision as well as helping us connect with potential mentors and investors,” he said. “CardStart’s support will be instrumental in helping us further advance our technology through our current pre-clinical studies.”

is a two-pronged, student-led event. In fall 2020, teams spent a whirlwind virtual weekend finding innovative solutions to health care problems and building startups around them.Ěý

The , including Noe, won mentorship and coaching, modest funding to develop their prototype and free registration (an $895+ value) for theĚý2021 spring cohort of LaunchIt, UofL’s 10-week entrepreneurial training boot camp.

In April, the teams competed again, pitching their ideas to a panel of seasoned judges for a shot at cash prizes.Ěý

Noe took first place, and Vertify, which is commercializing a UofL research-born bone density measurement device for spinal surgery, took second. The Vertify team — MBA student Alex Godfrey and undergraduate business major Connor Cowell — received $1,000 to further their startup.Ěý

CardStart is backed by the ,Ěý, the Louisville Healthcare CEO Council and the , an NIGMS-funded partnership that expands access to and accelerates technology commercialization support to universities throughout the Southeast IDeA state region, which includes Kentucky, West Virginia, South Carolina, Arkansas, Mississippi and Louisiana.

Samantha Morrissey, a medical student and graduate chair of the CardStart student organizing committee, said the event is meant to encourage students to think outside the box and gain hands-on experience innovating.Ěý

“This is a great and unique event at UofL that affords students the opportunity and possible financial support to explore entrepreneurship,” she said. “We wanted students to get creative and transform their ideas into real world technologies that could ultimately be developed into their very own startup, and that’s exactly what these teams did.”

The Pandemic-Related Product Acceleration & Responsive Entrepreneurship Program, or PRePARE, will partner UofL researchers with members of the community to scale up innovative ideas. The end goal is to grow existing companies or spin up new ones to bring those ideas to market.

Innovations boosted through the program might include ways to track viral spread more efficiently, expand access to virtual services or bring employees back to work safely.

“The pandemic has caused so many changes and challenges,” said Paula Bates, professor of medicine and a lead on the grant. “Our hope is that by pairing these bold ideas with UofL’s researchers and innovation expertise, we can make a real impact that not only hastens the end of the COVID-19 pandemic, but also increases resilience against future ones.”

UofL is soliciting ideas for filling unmet needs and solving problems from community partners in the seven-county Kentuckiana Regional Planning & Development Agency economic development district. The district, centered around Louisville, includes Bullitt, Henry, Jefferson, Oldham, Shelby, Spencer and Trimble counties.

Community partners can be individuals, companies or organizations. UofL students, staff and faculty also are encouraged to submit ideas. Ideas may be submitted through the .

Community members whose ideas are selected will be partnered with one or more UofL researchers, who will have up to $75,000 to fund project development at UofL. Teams also will receive project management and entrepreneurial support from PRePARE’s program staff.Ěý

PRePARE is funded through the E.D.A.’s .

PRePARE builds on UofL’s suite of aimed at turning research into viable commercial products, dubbed the “superfecta.” UofL is one of only a handful of universities in the U.S. to receive each of these innovation-associated awards, and it’s the only one to receive all of them.

The PRePARE program will be led by a group of university innovation experts that includes Bates, along with the Office of Research and Innovation’s Holly Clark, Will Metcalf and Jessica Sharon.

“UofL has significant earned expertise in developing and commercializing new technologies that can save and improve lives,” said Kevin Gardner, UofL’s executive vice president for research and innovation. “PRePARE is an extension of that work to empower our communities, advance our health and engineer our future economy through innovation and entrepreneurship.”

The competition, STAT Madness, pits UofL against other biomedical technologies developed by university research teams in a March Madness-style bracket competition. .Ěý

The , invented by a multidisciplinary team that includes researchers from UofL’s School of Medicine and J.B. Speed School of Engineering, helps extend the useful life of heart tissue samples. That means more time for research and improved preclinical testing of new drugs for effectiveness and toxicity.

Biomedical researchers use slices of heart tissue to test new drugs and gene therapies. Currently, those slices only last up to 24 hours, but the UofL system can keep them up to six days.Ěý

“This system will save time and costs of clinical trials during phase one research, which includes testing for toxicity and proof of efficacy,” said Tamer M. A. Mohamed, who led the research. “In addition to drugs, we have demonstrated the system’s effectiveness in testing gene therapy.”

The resulting intellectual property portfolio consisting of 12 patent families, invented by Huang-Ge Zhang, of UofL’s James Graham Brown Cancer Center and Department of Microbiology and Immunology,Ěýhas been licensed to Boston-basedĚýSenda BioSciences, a Flagship Pioneering company.ĚýUofL’s technology is part of Senda’s efforts to develop novel drug delivery platforms to solve the challenges of transferring therapeutics across biological barriers and throughout the body.

The UofL technologies use exosomes, which are very small fragments of living, edible plant cells, to transport various therapeutic agents, including anti-cancer drugs, DNA/RNA and proteins such as antibodies. These exosomes help ensure the drug is properly absorbed by the body.Ěý

Current practice is to useĚýnanoparticles or liposomes made from synthetic materials to deliver these medicines. However, these materials are more expensive to produce in large quantities and can cause adverse health effects, such as cell toxicity and chronic inflammation. The UofL edible-plant-derived exosomes don’t have these problems, Zhang said, since they come from natural, readily available sources. More importantly, these exosomes have anti-inflammatory effects.Ěý

“Our exosomes come from fruit or other edible plants — something good for you, that you buy in the grocery store and that humans have eaten forever,” said Zhang, an endowed professor of microbiology and immunology who holds the Founders Chair in Cancer Research. “And, they don’t require synthetic formulation.”

The exosomes made from fruit lipids also can be modified to target and deliver medications to specific cell types within the body — like homing missiles, Zhang said. For example, the exosomes could be engineered to deliver a cancer therapeutic directly to cancer cells.

Zhang originally experimented with other fruits, including tomatoes and grapes. His epiphany came while eating a grapefruit — he realized his breakfast was chock-full of natural lipids that could be harvested to make exosomes at a larger scale. The results of that work later were published in multiple scientific journals, including , and Cell Host & Microbe, and now are exclusively licensed to Senda Biosciences.

“These technologies could make a real difference in drug delivery, improving access and costs while reducing side effects, ” said Guillame Pfefer, CEO of Senda Biosciences. “We look forward to working with UofL to further develop these innovations and get them to market.”

Senda Biosciences holds an exclusive license to several UofL fruit-based drug delivery technologies, including technologies focused on the regulation of gut microbiota, through the UofL , which works with industry and startups to commercialize university technologies. The EPI-Center team worked closely with Zhang and Senda to develop and grow the partnership.

“This is the kind of outcome we want for all our technologies,” said Holly Clark, deputy director of the Commercialization EPI-Center, who manages Zhang’s intellectual property portfolio. “We’ve built a great working relationship between our innovator and our commercialization partner, Senda, and together, they will advance this suite of technologies for market.”

The unique cell therapy, called FCR001, allows living-donor kidney transplant recipients to stay off immunosuppression drugs they would otherwise need for the rest of their lives.

Immunosuppressants help prevent rejection of the transplanted organ, but can cause side effects, including high blood pressure, diabetes, high cholesterol, neurological effects and increased risk of infection. They also are toxic to the kidneys, causing decline in kidney function over time.

FCR001 consists of stem cells taken from the organ donor and processed at the Talaris facility, then infused into the organ transplant recipient. The goal is to create a durable “dual immune system” (part donor-derived and part recipient) in the transplant recipient. These two immune systems coexist, recognizing both the recipient’s own body as well as the donated organ as self.

Talaris Therapeutics Inc., formerly known as Regenerex LLC, is developing and commercializing FCR001. UofL researcher and innovator Suzanne Ildstad founded the company to commercialize the pioneering work of her team at the university and now serves as Talaris’ chief scientific officer.

“We are very gratified to have reached the milestone of treating the first patient in our pivotal Phase 3 clinical trial as we work to make this therapy broadly available to patients receiving a kidney transplant from a living donor,” Ildstad said. “Thanks to our talented team, investors and the research infrastructure at UofL, we have moved incredibly quickly over the past year to both initiate this trial and to plan additional clinical studies of FCR001 in other indications.”

Last year, Talaris raised $100 million from investors to hire staff and initiate the Phase 3 trial evaluating the safety and efficacy of a single dose of FCR001 in living donor kidney transplant recipients.

In an earlier Phase 2 trial, FCR001 allowed 70% of living donor kidney transplant patients durably to be weaned off all of their immunosuppression treatments. The first patient successfully dosed with FCR001, Robert Waddell, has been off immunosuppressants for a decade with no signs of organ rejection.

“It makes me forget I was ever sick,” Waddell said.Ěý“I feel as healthyĚýas I ever have.”

The Phase 3 trial is expected to enroll 120 adult living donor kidney transplant recipients at multiple sites across the U.S. To date, the trial has been initiated at five clinical sites around the country.

“We are rapidly expanding our network of trial sites, with five sites now active and a planned 10 sites active by the end of this year,” said Scott Requadt, chief executive officer of Talaris. “We look forward to ramping up enrollment across the U.S. as we work to offer living donor kidney transplant patients a future potentially free from chronic immunosuppression.”

More information about the trial is .Ěý

iTolerance Inc., a San Mateo, California-based biotech company, has signed an exclusive license and intends to develop the therapy toward clinical use. The technology was co-invented at UofL and at the Georgia Institute of Technology with support from the National Institutes of Health and , which funds Type 1 diabetes (T1D) research.

“Our goal is to help people with Type 1 diabetes, so they don’t have to suffer the side effects that come with immunosuppressants,” said Haval Shirwan, inventor and gratis professor in the UofL Department of Microbiology and Immunology.

In Type 1 diabetes, a condition affecting some 1.6 million Americans, the body’s immune system attacks cells in the pancreas that produce insulin, a hormone that regulates blood sugar. As a result, patients that receive pancreatic islet transplants need to be placed on immunosuppressants and cope with the possible side effects, including loss of appetite, nausea and increased risk of infection.

The technology works by training the immune system to accept insulin-producing cells through transplanted islets — cells taken from the pancreas. The islets are laced with a recombinant protein pioneered by Shirwan and Esma S. Yolcu, a gratis faculty member at UofL, known as Fas ligand (FasL), which “teaches” the immune system to see new graft as beneficial rather than a threat.

Once the immune system has been re-trained, the idea is to transplant healthy islet cells so the patient again can produce insulin on their own.

The UofL scientists teamed up with researchers at Georgia Tech to generate a to the graft site to ward off rejection. The technology has the potential to be an “off-the-shelf” treatment, and the hydrogels which hold the islets can be prepared up to two weeks ahead of the transplant. The islets also don’t need to be modified for the individual patient.

“We look forward to leveraging the technology to locally and durably induce immune tolerance of organ transplants,” said Cameron Gray, founder and chairman of iTolerance. “We believe the technology has potentially far-ranging implications for engraftment.”

iTolerance holds an exclusive license to the technology through Georgia Tech and theĚý, which works with startups and industry to commercialize university-born technologies.