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.

“Innovation is absolutely critical to UofL’s mission,” said UofL President Neeli Bendapudi. “It’s what drives us and inspires us. Our three most important goals as a university are to be a great place to learn, to work and to invest, and the work of these innovators contributes to all three.”Ěý

The second annual event, hosted virtually this year by the and its technology transfer arm, the honored UofL innovators who had recently been awarded a patent or whose technology had been licensed to a company for commercialization in fiscal year 2020, which ended June 30, 2020.Ěý

Two large awards were also presented: Paula Bates was given the Innovator of the Year Award, and Theo Edmonds, Brad Shuck and Laura Weingartner all accepted Trailblazer awards on behalf of their teams. Each was delivered a red-and-black glass flame — the symbol for the event.

“Our office, and UofL as a whole, are committed to taking the brilliant, groundbreaking research happening on our campus out of the lab, out of the classroom, and translating it into inventions and products that improve the way we work and live,” said Executive Vice President for Research and Innovation, Kevin Gardner. “And, this past year, our researchers worked tirelessly to develop innovations that in a very real way, may save lives — all while dealing with the added challenges of COVID-19.”Ěý

Innovator of the Year, Bates, is a serial inventor and , known for a long track record of developing strong partnerships with industry to commercialize her technologies. In 2020, she partnered with other UofL innovators to develop a potential breakthrough in our fight against COVID-19 that is believed to block the virus from infecting human cells. The technologyĚý to a now publicly-traded biomedical company, which is working with UofL to further develop it for market.

As for the Trailblazers, who are awarded for work in new areas of innovation for UofL, Edmonds accepted the award for the Cultural Wellbeing Index, a tool that helps companies improve corporate culture and organizational wellbeing. To commercialize the technology, Edmonds launched , UofL’s .

Shuck accepted for the Employee Engagement Scale, a software that helps companies measure workforce engagement. The technology’s non-exclusive license to startup Unitonomy marks the — followed by the second and third, also secured by Shuck, when the technology was licensed to two other companies in the same year.

Lastly, Weingartner accepted the award for “,” a first-of-its-kind manual aimed at better-training future medical professionals on caring for LGBTQ and other non-normative patients. The manual is meant to provide resources and guidance so that medical schools, residencies and continuing medical education programs across the country are able to implement training and provide better resources for more equitable care.

All told, fiscal year 2020 was the at UofL, with a total income of $9.4 million driven by a strong year for startups and deals. It also was UofL’s best year on-record for competitive research funding, with total new awards of $170 million.

“This was a great year for innovation and research — also our best year on record,” said Allen Morris, executive director of the Commercialization EPI-Center. “Our innovators all share in that success, and I look forward to continuing that work together in 2021.”

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 company, Talaris Therapeutics Inc., plans to use the series B funding to support a Phase 3 clinical trial — the last step before applying for FDA approval. This series A funding round announced last year to hire staff and initiate the trial.

Talaris recently began in that trial of the unique cell therapy, called FCR001, which 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, increased risk of infection and decline in kidney function over time.

“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 investors, is a big step in advancing our health.”Ěý

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.

The new funding also will advance aĚýplanned Phase 2 trial of FCR001 in diffuse systemic sclerosis, a severe form of the rare autoimmune disease scleroderma.

Talaris, formerly known as Regenerex LLC, was founded by UofL researcher and innovator Suzanne Ildstad to commercialize the pioneering work of her team at the university. She now serves as Talaris’ chief scientific officer.

“This financing moves us one step closer to helping organ transplant recipients no longer be dependent on immunosuppressive drugs, resulting in a greatly improved quality of life,” Ildstad said of the earlier Phase 3 trial financing. “The support and research infrastructure at UofL have been invaluable in our journey to this important juncture.”

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 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.

The effort, (KCV), is a collaboration between UofL, the University of Kentucky and Kentucky Science and Technology Corp. (KSTC). Together, they will provide expertise, training and other support to help Kentucky colleges and universities get their inventions off campus and into the hands of entrepreneurs and industry.

“The University of Louisville has long been a leader in driving innovative, research-backed technologies to the marketplace,” said UofL President Neeli Bendapudi. “Through this new venture, we can extend our vast proven experience, knowledge and success to institutions around the Commonwealth, working with them to accelerate economic development and the commercialization of technologies that could save lives and improve the way we live and work.”

In getting university-born technologies to market, KCV’s goal is to boost Kentucky’s position as a technology hub, spurring economic development and new tech-backed startups. Connecting all the state’s schools also is expected to strengthen the state’s position to compete for grants and other federal funding that support innovative companies.

“We all want to grow Kentucky’s tech sector and create the high-paying, knowledge-based jobs that follow,” Beshear said. “A big part of doing so is turning Kentucky’s own academic research and development capabilities into commercially viable products and startups. By partnering to create Kentucky Commercialization Ventures, we will provide the infrastructure to commercialize our own best ideas, build the commonwealth’s tech industry and distinguish Kentucky as a national model in innovation.”

Under recently signed contracts, Kentucky will pay $200,000 to each of UofL’s and UK’s research foundations over the next two fiscal years, and $755,000 to KSTC this fiscal year.

At UofL, KCV will be led by the Office of Research and Innovation’s , which works with startups and industry to commercialize university-owned technologies. Kevin Gardner, UofL’s executive vice president for research and innovation, said KCV is an opportunity to expand on other UofL efforts in this area, such as its suite of innovation grant and training programs that support technology and product development.

“This builds on UofL’s existing work to boost entrepreneurship and get cutting-edge, university-born technologies to market,” Gardner said. “With KCV, we can leverage those past successes and earned expertise to help other Kentucky colleges and universities do the same, driving economic development across the Commonwealth.”

The EPI-Center will have an in-house KCV commercialization manager, Megan Aanstoos, who will work directly with inventors and institutions across the state to develop innovative ideas and inventions into marketable products with established business models. UofL also will have a faculty or administration champion who will work directly with the faculty, staff and students at large.

“We are very excited to work with our sister institutions to drive commercialization in Kentucky,” said EPI-Center executive director Allen Morris.

The California biomedical company Qualigen Therapeutics Inc. has signed a license agreement for the technology, and plans to fund continued development with UofL to ready it for market.

The technology, first announced in April, is based on a piece of synthetic DNA — an “aptamer” — known as AS1411, which targets and binds with a human protein called nucleolin. Early tests show AS1411 may stop viruses, including coronavirus, from “hijacking” nucleolin to replicate inside the body.

UofL researchers Paula Bates and Kenneth Palmer partnered to apply the AS1411 technology to coronavirus. Bates co-discovered the base aptamer technology with researchers John Trent and Don Miller and has applied it a variety of ways, including to .ĚýThe cancer application of the technology also is in development with Qualigen.

“This new use of the AS1411 technology, to fight coronavirus, is another example of the relationship we’ve developed with UofL and how we can work together at a high level,” Qualigen CEO Michael Poirier said. “Because of our outstanding partnership in the cancer area, we believe that our combined effort will be up to the enormous challenge with COVID-19. This is a critically important effort that could provide much needed help to COVID-19 patients worldwide. It is imperative that we do everything we can to succeed.”

Palmer, who is director of UofL’s Center for Predictive Medicine and Regional Biocontainment Laboratory, conducted proof-of-concept experiments showing the aptamer was effective against the virus at doses shown to be safe in humans by previous research.

The lab is one of only 12 regional and two national biocontainment labs in the United States and the only one in Kentucky. Established with support from the NIH to conduct research with infectious agents, the lab includes Biosafety Level 3 facilities built to the most exacting federal safety and security standards. The stringently secure facilities protect researchers and the public from exposure to the pathogens being investigated.

“This has been a true collaborative effort — everyone at UofL has rallied together to take on this big global challenge,” Bates said. “I am fortunate to be at UofL, which is one of the few places in the country where we have the facilities to do this important work.”

Both AS1411 applications — to fight cancer and coronavirus — are licensed to Qualigen through the , which works with startups and industry to commercialize university-born technologies.

The work so far on the technology’s COVID-19 application has been partially supported by a gift from shipping giant UPS, which in early May to fund trials and test materials.

The startup — called , for “Underestimated People Of Purpose” — is built around a new cultural well-being survey and predictive analytics framework developed by UofL researchers Theo Edmonds, Cameron Lister, Molly O’Keefe and Sonali Salunkhe, along with Xian Brooks from the UofL Office of Diversity and Inclusion.Ěý

The framework, Edmonds said, can help companies understand and improve their cultural well-being, which can be a critical advantage in recruiting, retaining and motivating top talent, driving innovation and surviving rapid, unexpected changes.

“As the of COVID-19 has disrupted everything, every company must become an entrepreneurial company again,” said Edmonds, research team leader and a co-founder of UPOP. “Economic resilience depends on cultural well-being and finding new ways to connect and co-create value with all stakeholders — both inside and outside the company.”

The cultural analytics technology measures three key areas: cultural actions (creativity and curiosity of employees); bridging actions (inclusion, hope, trust, belonging and health-related quality of life); and growth actions (social and economic value creation).

UPOP is launching with a national, COVID-19 specific survey, and plans to share results with founders, venture capitalists, industry groups, policymakers, higher education leaders and corporate executives in a series of briefs and webinars in late summer.

“One of the worthiest innovation challenges in the months and years ahead will be in creating new forms of cultural well-being in our places and spaces,” said UPOP Board Chair, Dayna Neumann. “Cultural well-being is not about changing what came before, it’s about creating what comes next, together.”

The Cultural Well-being Index intellectual property is protected through , which works to commercialize university inventions by working with industry and entrepreneurs. UPOP worked with the EPI-Center to obtain an exclusive license.

UPOP is UofL’s first public benefit corporation spin-out. This means that UPOP is organized to devote some of its profits to supporting underrepresented and underestimated public health and humanities entrepreneurs and to supporting advanced research on workforce culture, resiliency and inclusive innovation. Edmonds said the company also is a certified LGBT Business Enterprise through the

And now, Louisville startup Ěýhas licensed the technology from UofL and is working to get it to market.Ěý

The inventor here, , studies organizational culture and applied behavioral economics as an associate professor at the UofL College of łÉČËÖ±˛Ą and Human Development (CEHD). His is the first licensed technology out of CEHD.Ěý

Shuck said organizations are more productive and, often, more profitable when their employees are engaged in their workplace. Engaged employees also have a better overall workplace experience. However, his research suggests there is a more than 60% drop off in levels of engagement in the first six months of an employee’s tenure.

“Globally, employee engagement remains a critical, and sought-after competitive advantage for businesses and organizations of all sizes,” he said. “It is the differentiator between market share, customer experience and quality. Everyone wants more of it.”

His software, the Employee Engagement Scale (EES), helps companies to monitor that engagement, and hopefully improve it, through brief, easy-to-use surveys that gauge how employees think and feel about their work.Ěý

The EES will be a central part of system for businesses that provides a sort of “virtual colleague” — one that keeps track of who and what staff are communicating while analyzing collaboration. CEOĚýCharley Miller said the “colleague”Ěýcould help leaders in the company better understand their employees and make smart decisions on how to improve the work environment.ĚýĚýĚý

“One of the key aspects of a good colleague is that they are great listeners,” Miller said. “Dr. Shuck’s IP enables us to ensure our virtual colleague is great listener when it comes to understanding how to ascertain employee engagement.”Ěý

Not only is Shuck’s technology the first out of CEHD to be licensed to a company, but it’s the first license of the UofL Office of Research and Innovation’s Entrepreneurs-in-Residence, or EIR, program.Ěý

Miller was one of the program’s first EIRs, to help guide UofL research-backed technologies to market in collaboration with the . After Miller’s term ended, he launched Unitonomy around Shuck’s technology.Ěý

“Sometimes all it takes is getting the right mix of people — researchers, entrepreneurs, community members — in the same room,” said Will Metcalf, executive director of , who launched the EIR program. “This is case-in-point, and we’re so excited to see what grows of this partnership between Charley and UofL.”Ěý

Funding for the EIRs comes from the , a public-private partnership led by UofL and backed by the Kentucky Cabinet for Economic Development to grow Louisville’s entrepreneurship ecosystem.

He and 167 other inventors from institutions around the world will be formally recognized as 2019 NAI Fellows at a ceremony in Phoenix, Arizona, in April 2020, according to a .

“It is a great honor for me to be one of the NAI fellows,” said El-Baz, a UofL J.B. Speed School of Engineering alum and chair of bioengineering.

At UofL, El-Baz works at the intersection of computer science and medicine. Many of his inventions use artificial intelligence to analyze medical images, allowing them to very accurately diagnose everything from Ěýto to .

El-Baz is the sixth UofL inventor to be inducted into the NAI, following Suzanne Ildstad and Kevin Walsh (2014); William Pierce (2015); Paula Bates (2016); and most recently, Robert S. Keynton (2017).

“We’re very proud of Ayman, and all past UofL inductees, for this huge accomplishment and all the hard work behind it,” said Allen Morris, executive director of the . His office works with UofL researchers, like , to commercialize their inventions.Ěý

“This kind of honor shows our university’s commitment to and leadership in research, invention and technology commercialization,” he said. “These inventions have the power to change and improve the way we work and live.”

Aside from the EPI-Center, El-Baz has also worked with other UofL programs for technology development and commercialization. He was the first researcher to hit a “trifecta” with UofL’s suite ofĚý, having earned entry into the UofL Coulter Translational Partnership, NSF I-Corps and NSF AWARE:ACCESS programs.

“These crucial support mechanisms have enabled me to develop and translate technologies from ideation to commercialization quickly,” El-Baz said.

To date, El-Baz holds eight patents, five copyrights and has had 11 technologies optioned and two have been licensed to companies for further development and commercialization. Some technologies have also resulted in startup ventures like Autism Diagnostics Technologies Inc., which El-Baz co-founded, creating jobs and economic development.Ěý

NAI fellows hold a collective 41,500 issued U.S. patents, resulting in 11,000 licensed technologies and companies, generating more than 36 million jobs and $1.6 trillion in revenue, according to the release.

“I am so impressed by the caliber of this year’s class of NAI Fellows, all of whom are highly-regarded in their respective fields,” NAI President Paul R. Sanberg said in the release. “The breadth and scope of their discovery is truly staggering. I’m excited not only see their work continue, but also to see their knowledge influence a new era of science, technology, and innovation worldwide.”

And it gets sweeter: the process also results in a bio-mass “coal” alternative that burns up to 20 times cleaner than the regular stuff.

The technology was invented at the UofL , biomass conversion and biofuels group in collaboration with Michael Nantz and his team in the UofL chemistry department. The newly-issued patent for the technology is now licensed to Louisville-based startup, BioProducts, which is working to get it to market.

Brian Walsh, the company’s CEO, said the potential environmental benefits of the technology are huge. According to the , burning traditional coal can cause emissions linked to smog, acid rain and other negative environmental and health side effects

“There’s a better way to do it,” he said. “We don’t have to harm the earth. We don’t have to pollute.”

The process isolates xylose – a low-calorie sugar from the biomass. Xylose sugar is widely used as a diabetic sweetener in food and beverage applications. It is also used as a diagnostic agent to observe malabsorption in the gastrointestinal tract.Ěý

Once the xylose is extracted, the team turns the remnant agriculture waste products into a cleaner “drop-in” replacement for coal – a “bio-coal” product.

BioProducts licensed the technology from UofL’s , which handles intellectual property resulting from university research and forges partnerships with companies for commercialization.

“I’m blown away with how well UofL does integrating technology with business leaders,” Walsh said. “I’ve never seen anything like it. I don’t see other universities doing that better.”

Dr. Jagannadh Satyavolu, theme leader for biomass and biofuels research at the UofL Conn Center, led this research effort and is the founder of BioProducts. Energy and value creation from waste products are his specialty.Ěý

In the past, Satyavolu has partnered with industry to accelerate the commercialization of multiple bioproducts made from wood and agricultural biomass materials. His bio-coal work has been partly funded by U.S. Endowment for Forestry and Communities.ĚýDr. Satyavolu is continuing his bio-coal research work with Oregon Torrefaction LLC, John Day, Oregon and other industry partners.

The process technology behind those products, as with the technology licensed by BioProducts, was — essentially, “roasting” the biomass material to remove moisture and certain volatile compounds. A densification step needs to follow torrefaction to make the product denser, turning it into a coal replacement brick that’s easier to store and ship.

He said the xylose work started about seven years ago, after he took on a pilot project to find new uses for spent distiller’s grain — something Kentucky has in spades — and for corn. Walsh said the product could also create an additional revenue stream for farmers who might otherwise lose money on their agriculture waste.

“We’re always looking for new opportunities to add value and lower the cost of biofuels,” Satyavolu said.