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Moleculera Labs to Receive Patent

Moleculera’s new patent is a success for OU’s Office of Technology Development and helps researchers protect their discoveries.

Oklahoma City (Oct. 6, 2017) -- In spring 2015, Kate was an easygoing, friendly second-grader who did well in school and loved to play with her friends.

Aside from several strep infections, she had never really been sick. But in one week’s time, that began to change drastically. She began to feel sick to her stomach and, more disturbingly, she became extremely anxious. She was suddenly afraid of fires and tornadoes, and she feared that someone was poisoning her food. She developed an extreme fear of thunderstorms and bugs, and she became petrified to go to school. She once tried to jump out of a moving car.

“It was horrible. Literally from one week to the next, our daughter changed from a normal child into someone completely different,” said Kate’s mother, Meg Reynolds.

That was just the beginning of a difficult journey for the Reynolds family, but as tough as it was, they were among the lucky ones. Kate’s doctor told the family about something called Pediatric Autoimmune Neuropsychiatric Disorder Associated with Streptococci (PANDAS), an autoimmune condition initially triggered by strep infections, which disrupts normal neurologic activity. PANDAS and a related condition, PANS, Pediatric Acute-Onset Neuropsychiatric Syndrome, are a major focus for Madeleine Cunningham, Ph.D., a researcher at the University of Oklahoma College of Medicine.

Children suffering from PANDAS/PANS often are misdiagnosed for years, or treated with anti-psychotics, which aren’t effective for autoimmune-based disorders. But the Reynolds family was fortunate. When Reynolds was talking with her parents about the dramatic change in Kate’s behavior, she told them that their doctor mentioned PANDAS. As it turned out, Reynolds’ father, Robert Calcaterra, Ph.D., sits on the board of directors for Moleculera Labs, the Oklahoma City-based company that has licensed Cunningham’s clinical assays used by

physicians to help diagnose PANDAS/PANS. Kate was indeed diagnosed with PANDAS. She started antibiotics and began cognitive behavioral therapy to learn coping techniques for her obsessive thoughts; about nine months later, she was mostly back to normal.

“It was a long road, but from what I’ve heard, our experiences were minor even though our lives were turned upside down,” Reynolds said. “We could have been like some other parents who went years before someone mentioned it or they finally found a doctor who knew about it.”

Those are the stories that spur Cunningham to continue her research, and for Craig Shimasaki, Ph.D., president and CEO of Moleculera Labs, to continue building the company. This year, Moleculera has reached a significant milestone: In the next few months, it anticipates being awarded a patent that protects the panel of five blood tests used as an aid in diagnosis. The company also trademarked the name “Cunningham Panel.” In the difficult journey of commercializing research, the patent is a major achievement.

“We are the only laboratory in the world that provides this panel,” Shimasaki said. “The patent not only protects our intellectual property, but it attributes value to what we’re doing as unique.”

Moleculera has grown significantly since it began. Physicians in 49 of the 50 states, as well as countries around the world, have ordered more than 5,000 tests to aid in the diagnosis of PANDAS/PANS, Shimasaki said. The company’s office receives countless letters and pictures from grateful parents, some of whom were close to institutionalizing their children until they discovered the underlying cause was an autoimmune problem. Cunningham, too, advocates for the families who have not yet received the answers that her tests can potentially provide.

“I am so pleased at this next stage of growth for Moleculera Labs,” said Cunningham, who is co-founder and chief scientific officer for the company. “My hope has always been that my research would be able to help patients and families who are suffering. My work is built on the success of many others in the field, including Dr. Susan Swedo of the National Institute of Mental Health, and I am grateful to be a part of this important field of study.”

Moleculera’s new patent also is a success for OU’s Office of Technology Development (OTD), which helps researchers protect and commercialize their discoveries. OTD officials, along with James Tomasek, Ph.D., vice president for research at the OU Health Sciences Center, have worked diligently for years to turn Cunningham’s academic research into a commercial company that can help patients. Although the process is long and fraught with potential pitfalls, Moleculera has grown into a solid company that is helping people worldwide while also contributing to Oklahoma’s economy.

“Starting a new company is never easy,” said Jim Bratton, executive director of OTD and OU assistant vice president for economic development. “But, when the university has the right partner, it can be one of the most effective ways to transfer innovation from the lab to the

marketplace. Dr. Shimasaki has done a great job leading the Moleculera team to commercialize this technology and help the university fulfill its mission to create positive impact from research.”

Commercialization of research is one of the aims of an academic medical center like OUHSC, Tomasek said. In 1998, Oklahoma State Questions 680 and 681 passed, allowing university research to be transformed into start-up companies. Cunningham’s research and Moleculera’s launch is one of several success stories for the university.

“Our mission at OUHSC is not only to conduct groundbreaking research, but to take those findings out of the laboratory and into the commercial realm, where they can begin helping patients,” Tomasek said. “It requires a team of people to make this happen, and the patent award is a significant step in Moleculera’s growth as a company.”