IRVINE, Calif. — August 8, 2022 — Immunis Inc., a private biotechnology company developing a novel treatment for age and disease-related immune decline, today announced that the U.S. Food and Drug Administration has approved it’s Investigational New Drug application for a Phase 1/2a clinical trial investigating IMM01-STEM in participants with muscle atrophy: www.clinicaltrials.gov/ct2/show/NCT05211986

The open label dose escalation study will enroll up to 18 patients to assess the safety and tolerability of IMM01-STEM in participants with muscle atrophy related to knee osteoarthritis. Muscle atrophy is an immune-mediated condition that affects every person with age and is exacerbated with disease and/or immobilization such as that experienced in knee osteoarthritis. IMM01-STEM is a stem cell-derived secretome that was generated to support immune health. The treatment for this particular indication is administered in a series of injections, twice a week for four weeks.

The Phase 1/2a will be conducted at the University of California at Irvine’s Medical Center, UCI Health, rated amongst the nation’s best hospitals by U.S. News and World Report for 20 consecutive years. UCI Health is part of the California Institute of Regenerative Medicine’s Alpha Stem Cell Clinic Network, which will support Immunis’ Phase 1/2a clinical study.

“Muscle atrophy is a degenerative condition experienced by every aging human but is exacerbated when coupled with immobilization, as it is in patients with knee osteoarthritis,” said Dr. Tom Lane, Chief Science Officer of Immunis. “We hope to alleviate suffering, better KOA disease outcome, and offer a new tool to combat immune-mediated symptoms of aging in general.”

For additional information about Immunis’ IMM01-STEM Phase 1/2a trial please visit: www.immunisbiomedical.com

About Immunis Inc.

Immunis is a private biotechnology company developing a novel immunomodulatory secretome product for the various manifestations of age and disease-related immune decline. The STEM product line leverages Immunis’ leading-edge capabilities in stem cell technologies to deliver a product of all natural, all human immune modulators in their natural relative physiological concentrations.

About STEM-MYO

Immunis’ FDA-awarded Phase 1/2a clinical trial is an open-label dose escalation study to assess the safety and tolerability of IMM01-STEM in elderly participants with muscle atrophy associated with knee osteoarthritis (KOA). Up to 18 patients will be enrolled in the trial and randomly assigned to an IMM01-STEM dose cohort. Treatment will be administered in the form of intramuscular injections twice a week, for four weeks (8 injections total). Male or female patients are eligible for the study if they satisfy the following criteria: (1) 50 to 75 years of age at the time of signing the informed consent, (2) have a grade 2 or 3 knee osteoarthritis as defined by Kellgren-Lawrence analyses, (3) have quadricep weakness (<7.5N/kg), (4) can ambulate >50 feet unassisted, (5) are negative for human immunodeficiency virus, hepatitis B surface antigen (HBsAg), and hepatitis C at the Screening Visit and (6) have a body mass index (BMI) of <40kg/m². For additional information about Immunis’ trial participant qualifications, please visit:  https://immunisbiomedical.com/

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