Immunis Inc. has struck a licensing deal with Japanese material manufacturer Toray Industries Inc. to develop a potential treatment for Parkinson’s-associated involuntary movement.
The agreement gives the Irvine-based biotechnology company exclusive rights to develop and commercialize Toray’s drug candidate Kora for dyskinesia, a motor complication caused by long-term use of Parkinson’s medication, in the U.S., Canada, the European Union and the European Free Trade Association.
“Immunis is thrilled to expand our research pipeline to include a common and serious complication affecting Parkinson’s disease patients,” Immunis Chief Business Officer Mark Cabato said in a statement.
The drug candidate joins Immunis’ growing pipeline, which includes an investigational drug that claims to reduce fat while preserving muscle. The company in January presented
interim results from a Phase 2 study testing
the drug in overweight seniors experiencing muscle loss and metabolic dysfunction. Topline interim data showed that Immunis’ IMM01-STEM improved gait speed by 26% compared to placebo controls.
“These highly encouraging findings suggest IMM01-STEM offers significant improvements in overall physical function and health with gait speed being a key metric predicting biological age, physical and cognitive status, risk of hospitalization, disability and death,” Dr. Nicole Berchtold, principal scientist at Immunis, said in a statement.
Immunis was founded in 2022 by Hans Keirstead, an internationally known stem cell expert who has founded and sold four biotechnology companies.
Keirstead, a 2022 Business Journal Innovator of the Year Award winner, was a professor at UCI, where he founded, directed, and raised funds to build the $77 million Sue and Bill Gross Stem Cell Research Center.
Drug Candidate Shows Promise in Preclinical Data
Parkinson’s disease progressively impairs movement, and long-term use of Parkinson’s medications like levodopa can result in the development of dyskinesia, adding another layer of difficulty for patients.
Dyskinesia causes involuntary, uncontrollable movements, such as jerking and writhing.
The partnership with Toray comes as Parkinson’s cases continue to rise.
The prevalence of Parkinson’s disease has doubled within the past 25 years, according to the World Health Organization, with an estimated 1.3 million people getting diagnosed annually.
Studies show that between 30% to 50% of patients with Parkinson’s develop dyskinesia after five years of levodopa treatment, with that increasing to 80% after ten years.
Kora has shown promise in reducing levodopa-induced dyskinesia in a rat model of Parkinson’s disease, published in the European Journal of Pharmacology.
Immunis said it has submitted an investigational new drug (IND) application to the FDA in order to initiate a Phase 1 clinical trial.
CEO of Aivita Biomedical
In addition to chairing Immunis, Keirstead is also the chief executive of Aivita Biomedical.
The Irvine-based biotech company, founded in 2016, specializes in stem cell applications to develop personalized vaccines against cancer and COVID-19.
Aivita aims to become a leader in the COVID-19 vaccine space, led by larger competitors Pfizer and Moderna.
Keirstead says the company’s advantage is that it’s made at the point of care and can be stored at 4 degrees Celsius, unlike rival vaccines, which require between minus 60 degrees Celsius and minus 90 degrees Celsius, making them difficult for developing countries to store.
Aivita takes blood from a person and incubates an immune cell. A week later, the person will receive a vaccine injected with that immune cell.
“What we put back into you is your own immune system that is now educated against COVID-19,” Keirstead previously told the Business Journal. “No foreign protein is put into you. That’s why there are virtually no side effects.”
