OKLAHOMA CITY – In medicine, moving a breakthrough from the lab to the doctor’s office often involves navigating a dizzying maze of bureaucratic and financial obstacles. Most health care startups – 90% by some estimates – fail to find a path to profitability.
But one Oklahoma City-based company is poised to become an exception. Fourteen years after its founding, Moleculera Biosciences is emerging from the startup labyrinth.
“We're transitioning from early-stage angel investments to a sizable institutional investment round, which will fuel our continued growth and expansion of our additional products,” said Craig Shimasaki, Ph.D., president and CEO of Moleculera, a precision medicine company that launched from a University of Oklahoma College of Medicine laboratory. “It’s a potential breakout moment.”
In 2011, Shimasaki and Madeleine Cunningham, Ph.D., a George Lynn Cross Research Professor at the OU College of Medicine, created Moleculera to study the link between infections, the immune system and neuropsychiatric disorders. Cunningham was particularly interested in Pediatric Autoimmune Neuropsychiatric Disorder Associated with Streptococci (PANDAS), an autoimmune disease triggered by group A streptococcal infections that disrupt normal neurologic activity, leading to neuropsychiatric symptoms or even psychosis.
An estimated 1 in 200 children in the United States suffer from PANDAS and a related condition, PANS, Pediatric Acute-Onset Neuropsychiatric Syndrome, caused by many other types of infections. More than 17 million children in the U.S. have experienced or are currently affected by a psychiatric disorder – more than all pediatric cases of cancer, diabetes and AIDS combined.
But a correct diagnosis of PANDAS or PANS can take years. Symptoms – such as mood swings, anxiety and depression – may lead doctors to prescribe antipsychotics, which may be ineffective against autoimmune-based disorders or require lower doses to be tolerated. What patients often need are immunotherapeutic agents along with antibiotics to treat these conditions, which are caused by repeated infections. But while there have been some clinical advancements, many physicians remain unable to recognize PANDAS or PANS or are hesitant to treat them.
“Often, patients will have seen between five and 15 doctors and spent anywhere between $20,000 and $100,000 trying to find answers,” Shimasaki said. “Our diagnostic tests can help clinicians find a proper diagnosis quickly and direct treatment to the underlying root of the disorder.”
In collaboration with the National Institute of Mental Health, Cunningham, co-founder and chief scientific officer of Moleculera, developed a blood test to identify the autoimmune dysfunction in PANDAS and PANS. The panel measures the autoimmune response in PANDAS and PANS by identifying elevated autoantibodies that target dopamine receptors in the brain. In 2017, that test was patented and later renamed the “Autoimmune Brain Panel.” Several studies have verified the test’s accuracy.
Today, the brain panel has expanded its clinical utility to many other neuropsychiatric disorders and has helped properly diagnose more than 16,000 patients from over 50 different countries. Additionally, more than 2,700 physicians and clinicians have ordered the tests, according to Shimasaki. “The most remarkable aspect of what we are doing is seeing the amazing recoveries of these patients we have helped, people who have often been suffering for five, 10 or even 20 years,” he said.
These figures have kicked off a fresh wave of interest in supporting Moleculera’s work. Initial funding was provided by angel investors and patients, Shimasaki said. Plans are now being laid for a Series A funding round, which would propel the company to the next level, he added.
“We’re the only lab in the world that runs these tests because they’re so complex, covered by existing patents, and the Laboratory Developed Test regulatory path only permits our laboratory to perform them,” he said. “The goal is to be an international company that develops and pioneers acutely needed products for multiple, chronic immune-mediated disorders in medicine.”
Moleculera is now expanding its expertise to include autoimmune targets in cardiovascular diseases, with a focus on diagnosing poor outcomes in immune-mediated conditions such as cardiomyopathy, atrial fibrillation, myocarditis and heart failure. Future tests being developed include a panel for early-onset autoimmune Alzheimer’s and dementia.
Shimasaki said many chronic disorders result from infection-triggered autoimmune and inflammatory responses attacking different parts of the body, and Cunningham is even working on a vaccine to protect group A streptococcal infections, the underlying infection that can trigger PANDAS.
Moleculera is also using AI and its 16,000-patient bioinformatic database to develop predictive treatment algorithms that would eliminate the trial and error of prescribing medications once a proper diagnosis is made. That work is supported by a $500,000 grant from the Oklahoma Center for the Advancement of Science and Technology.
Shimasaki added that Moleculera’s growth is also good news for Oklahoma: A robust health-tech ecosystem “can help attract groups from outside the state to consider Oklahoma as a place to put down roots,” he said.
Of course, the biggest winners are patients, millions of whom benefit from the testing and future treatments Moleculera develops. “Over the years there have been so many young people and their families who have come to me, begging for help for these conditions,” Cunningham said. “The next phase of Moleculera’s development will ensure that greater multitudes of patients experience the relief these patients seek.”
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About Moleculera
Moleculera Biosciences, Inc., is a precision medicine company focused on identifying and directing treatment for chronic central nervous system and cardiovascular disorders triggered by inflammation and immune dysfunction. The company’s signature program includes the Autoimmune Brain Panel™ (formerly known as the Cunningham Panel™), a series of five blood tests that identify circulating levels of autoantibodies in serum directed against the brain and central nervous system that may result in neurologic, psychiatric and behavioral symptoms. The company has several additional testing panels in the pipeline targeting cardiovascular, early onset autoimmune Alzheimer’s, and cognitive disorders.
About the University of Oklahoma
Founded in 1890, the University of Oklahoma is a public research university with campuses in Norman, Oklahoma City and Tulsa. As the state’s flagship university, OU serves the educational, cultural, economic and health care needs of the state, region and nation. In Oklahoma City, OU Health Sciences is one of the nation’s few academic health centers with seven health profession colleges located on the same campus. OU Health Sciences serves approximately 4,000 students in more than 70 undergraduate and graduate degree programs spanning Oklahoma City and Tulsa and is the leading research institution in Oklahoma. For more information about OU Health Sciences, visit www.ouhsc.edu.