Immunis

Immunis, Inc. is a private, clinical-stage biotechnology company founded in 2018 and based in Irvine, California. The company focuses on developing secretome products to combat age and disease-related immune decline. Its establishment is credited to Dr. Hans Keirstead, who serves as the Chairman and is an internationally recognized expert in stem cell research and regenerative medicine. Dr. Keirstead has a significant background in founding and successfully exiting multiple biotech firms, bringing extensive experience in cultivating specific cell types and harnessing their secretomes for clinical use.

The company operates in the biotechnology and life sciences sectors, specifically within the field of regenerative medicine. Immunis' business model centers on the research, development, and eventual commercialization of its proprietary secretome-based therapies. Its primary source of funding comes from venture capital investments, having raised a total of \$55.4M in funding over 3 rounds. A significant Series A financing round in August 2022, which raised \$10 million, was led by Remiges Ventures and other healthcare investment firms to support clinical trials.

Immunis' core product is a line of investigational secretome therapies, with its lead candidate being IMM01-STEM. This product is a cell-free, multi-active biologic composed of natural, human immune modulators secreted by stem cells. The secretome contains a complex mixture of proteins, lipids, growth factors, and other molecules that work to modulate the immune system and address cellular senescence. A key benefit of this approach is minimizing the risk of immune rejection and tumorigenicity associated with direct stem cell-based therapies. The initial clinical focus for IMM01-STEM is on treating muscle atrophy (sarcopenia) in elderly patients, particularly those with knee osteoarthritis and sarcopenic obesity. The company has completed a Phase 1/2a clinical trial to assess the safety and tolerability of IMM01-STEM and is conducting a Phase 2 placebo-controlled study. Preclinical studies in aged mouse models have shown that the therapy can increase lean mass, reduce fat mass, improve muscle strength, and increase physical activity.

Keywords: regenerative medicine, secretome therapy, immune modulation, age-related diseases, muscle atrophy, sarcopenia, biotechnology, clinical-stage, stem cell secretome, immunomodulatory, Hans Keirstead, knee osteoarthritis, sarcopenic obesity, biologics, immune decline, human healthspan, cell-free therapy, longevity, IMM01-STEM, venture capital-backed