Through resources at UCI and UCI Applied Innovation, startup Purist moves research and technology forward to produce low-cost treatments for serious diseases.

Leila Safavi-Tehrani, Ph.D., knew she wanted to save lives from life-threatening diseases like cancer, which is diagnosed in 14.1 million new cases worldwide each year. During the last quarter of her undergraduate work in chemistry through the School of Physical Sciences, a nuclear chemistry class taught by George Miller, UCI professor of chemistry, Ph.D., set in motion what would later become the roots of Safavi-Tehrani’s interest in nuclear and radiochemistry. Alongside Mikael Nilsson, professor of chemical engineering and materials science, Ph.D., she would later move on to develop Purist, a company that focuses on low-cost rapid production and distribution of radioactive supplies for the diagnosis and treatment of cancer and other life threatening diseases.

“It started out as a standard research project,” said Safavi-Tehrani. “We had drawings on the whiteboard that said ‘this is what we want to do’ and at first I couldn’t see the end of it.”

Safavi-Tehrani received immersive research training as a collaborator on one of Nilsson’s funded projects based around the Szilard-Chalmers (S-C) method using small research reactors to produce medical radioisotopes – a scarce resource used in treatments targeting cancer and other life-threatening diseases.

“In my first year at UCI, Dr. Miller was training me to become a reactor operator,” said Nilsson. “Dr. Miller worked together with Nobel Laurate Sherwood Rowland on something called hot-atom chemistry in the 1960’s, which was borne from the S-C method. During our frequent discussions, I was intrigued to try this method myself with some of our new samples to see if it would work.”

Radioisotopes are used for imaging as well as radiation therapy. However, because of the combination of their “half-life” or the time taken for the radioactivity of an isotope to fall half its original value (otherwise known as radioactive decay), as well as their lack of local availability,–time is of the essence.

“Due to heavy dependence on foreign resources and aging nuclear facilities worldwide, there is a huge scramble to develop technologies to produce these materials domestically,” said Safavi-Tehrani.

For a product that has a limited shelf life, Nilsson and Safavi-Tehrani saw a national and international need for their technique to be implemented in reactors to supply pharmaceuticals and hospitals within the limited time frame.

Szilard Chalmers method: a blast from the past

Leo Szilard and T.A. Chalmers highlight a specific technique in “Chemical Separation of the Radioactive Element from its Bombarded Isotope in the Fermi Effect” published in Nature, September 1934. The method is used to separate radioactive products in a nuclear reaction, which involves the isotopes absorption of a neutron, resulting in the recoil and potential for separation of the radioisotope from the target.

This now 84-year-old method laid the groundwork for the project to begin with small scale lab bench top experiments, which led to building the prototype based on the technique. The team primarily focused on samarium and holmium isotopes in the lanthanide element group.

“Our technology enables the separation of the radioisotope from the bulk of the inactive material that it’s produced from,” said Safavi-Tehrani. “The challenging part of applying conventional separation techniques is trying to separate isotopes of the same element with the same chemical methods. That’s where Purist’s method comes in.”

Purist’s technology works with the S-C method to enable smaller scale nuclear reactors to produce medical-grade isotopes for medications so patients can receive treatment in a timely manner.

 

Down Under

In 2015, Safavi-Tehrani took a fellowship with the DOW Centre for Sustainable Engineering and Innovation in Queensland, Australia where she worked with Eric McFarland, M.D., Ph.D., nuclear engineering, who, at the time, was a professor of chemical engineering at UC Santa Barbara and the DOW centre’s director.

The DOW Centre was re-thinking the value proposition of nuclear reactors. At the time, the center was promoting a chemical industry initiative to identify specific opportunities for producing valuable chemical products using nuclear technology, which is where they identified their interest in Safavi-Tehrani’s graduate research studies in the Nilsson Lab at UCI.

During her fellowship, Safavi-Tehrani performed a techno-economic analysis on Purist’s radioisotope production technique.
Dr. McFarland closely examined Nilsson and Safavi-Tehrani’s project for its use in nuclear technology. In addition to the technique’s smaller energy requirement, the center was also interested in analysis of the technology for producing valuable chemical products (radioisotopes) using nuclear technology. Although the center was primarily academically focused, they also determined if the technology would be beneficial from a commercialization perspective.

Dr. McFarland encouraged the team to pursue a patent and to consider isotope production from a commercial standpoint.

To Commercialize or Not to Commercialize, that is the question

In her exploration of commercialization, Doug Crawford, UCI Applied Innovation senior licensing officer, introduced Safavi-Tehrani to the department’s business plan competition specialty award track of the New Venture Competition where she quenched her thirst for all things ‘commercial.’ Additionally, she submerged herself into the business world at the local library, pouring over business plan fundamentals.

“I owe a large part of my success in the business plan competition to [UCI] Applied Innovation,” said Safavi-Tehrani.

Crawford also introduced the team to the I-Corps program, funded by the National Science Foundation. The UCI Applied Innovation I-Corp program trains individuals to broaden the impact of basic research projects to develop effective solutions to customer problems. In addition to Innovation Node-Los Angeles’ ZAP! and BOOM program’s 15 customer discovery interview requirements, through the I-Corps program, Purist did 50 additional interviews.

“Not only does this program give you a chance to step out of your comfort zone to understand your market and your technology’s commercial potential, but it also provides you with a lot of contacts who can be potential collaborators later on,” said Safavi-Tehrani.

The UCI I-Corps program and Crawford challenged the team to think outside of radiopharmaceuticals and consider different avenues, such as physicians and patients. During the weekly workshop sessions, the team would present to an audience of other teams and program leaders. Safavi-Tehrani credits their now more defined commercialization plan and go-to-market strategy to the positive and constructive feedback they received from the I-Corps program’s workshops.

Safavi-Tehrani also utilized several Experts-in-Residence (EiR) at UCI Applied Innovation, namely John Lasko, whose background is in aerospace, clean technologies, life science, entrepreneurship, and, most importantly, business acceleration.
“I was drawn to the fact that their technology could be produced in a low power research reactor as opposed to a multi-billion dollar commercial reactor,” said Lasko. “It’s my understanding that most radioisotopes are flown in from half way around the world and that Purist’s technique would allow for local production in the 30 plus U.S. research reactors in operation.”
Lasko approached Safavi-Tehrani with the idea of validating both the technology and market potential of Purist’s possibly disruptive intellectual property.

“As an EiR, I not only look at the potential of the business/technology, but I also evaluate the person leading the team,” said Lasko. “If I see leadership qualities, which I did see in Leila, then I will mentor the person on becoming the CEO of their own company and help them navigate the landscape of being a first-time entrepreneur.”

Purist’s Mikael Nilson, UCI professor chemical engineering and materials science, Ph.D., and Leila Safavi-Tehrani, Ph.D., receive a Project Achievement Award from the Orange County Engineering Council at the OCEC Annual Awards Banquet for “High Purity Radioactive Ingredients for Nuclear Medicine” in February 2018.
Photo Courtesy: Purist

In May and June 2017, Purist earned first place in the 2017 School of Medicine competition at UCI as well as placed first in UCI Applied Innovation’s Tech Surge competition, a specialty award track of the New Venture Competition organized by the Beall Center for Innovation and Entrepreneurship at the Paul Merage School of Business. The team took home a grand total of $25,000, which was dedicated to research and development efforts. In February, the team also received a Project Achievement Award from the Orange County Engineering Council at the OCEC Annual Awards Banquet for “High Purity Radioactive Ingredients for Nuclear Medicine.”

With their prize money from the business plan competition and funds from joining UCI’s I-Corps program as well as help from the Wayfinder program, Purist became an official company, was able to fund market research, conduct additional R&D and also attend the European Association of Nuclear Medicine conference in Vienna.

“Professionally, I have gained so much out of all of these experiences,” said Safavi-Tehrani. “By being exposed to the presentations, pitches, [building] all the connections, it has personally made me into a stronger person.”

Helping the Patient

Purist’s vision continues to be local on-demand production of specific radioisotopes used to treat life-threatening diseases, however, nuclear oncology and radiation therapy physicians often do not consider these treatments as options due to inaccessibility.

“We’ve been told one treatment of this specific drug [that involves radioisotopes] is more effective than five treatments of chemotherapy,” said Safavi-Tehrani. “I put myself in the shoes of a loved one or myself dealing with this situation: not having access to a specific material that can effectively treat disease.”

About 16 years ago, Safavi-Tehrani’s grandmother was diagnosed with colon cancer, which Safavi-Tehrani recollects as a painful and frustrating experience based on the lack of available treatment.

“Chemotherapy was the only option available to [my grandmother] and her quality of life at that time period was horrible,” said Safavi-Tehrani. “That’s when I knew I wanted to be in some sort of medical field—to help people avoid what my grandmother had to experience.”

If produced within close proximity to where it’s needed, the radioisotope technology can provide the patient or clinician more effective treatment options.

The Next Steps

After winning first place in the Tech Surge competition, Purist was able to conduct another set of experiments at an increased reactor power level to determine if there would be a break down and a decrease in product purity.

“For a similar 20-minute experiment at 250 kilowatts, we did not notice increased degradation of our targets,” said Safavi-Tehrani.
Purist is currently seeking collaborations with other national laboratories and are hopeful to receive an SBIR grant and other non-dilutive federal funding to carry out further incremental studies to scale up and further stabilize the technology for commercialization.

“If it wasn’t for UCI’s programs and [UCI] Applied Innovation’s resources, I would have taken the normal route of getting my Ph.D., a job and have moved on with my life,” said Safavi-Tehrani. “I’m hopeful for what Purist can offer medical professionals in the future.”