IMM01-STEM is a multi-active and cell-free biologic derived from the secretome of partially differentiated human stem cells. IMM01-STEM includes a diverse mixture of soluble immunomodulatory proteins, growth factors and cytoskeletal remodeling molecules.

IMM01-STEM is produced following Good Manufacturing Practices (GMP) using human stem cells that are grown in a proprietary cell culture media and partially differentiated. These cells secrete factors and molecules into the media, called the secretome. The secretome is then harvested and processed to ensure standard concentration, composition and potency. This stem cell-derived secretome product is the cell-free, multi-active biologic that is used for clinical testing.

For more information, please see the "Generating Stem Cell-Derived, Multi-active Biologics" resource below.

IMM01-STEM contains a broad repertoire of regenerative factors that could have broad therapeutic benefits in several age-related conditions. Based on our published preclinical research, IMM01-STEM may have a positive impact on people experiencing age-related muscle loss and metabolic dysfunction.

Yes. We have three publications in reputable, peer-reviewed scientific journals detailing the therapeutic impact of IMM01-STEM on muscle atrophy in mice and its beneficial effects on metabolism. Additionally, there is unpublished, positive clinical data from a Phase 1/2a clinical trial run in the USA where IMM01-STEM was administered in elderly individuals with muscle atrophy associated with knee osteoarthritis. Lastly, Immunis announced positive topline interim results from STEM-META Phase 2a clinical trial, a double-blind placebo-controlled study of the IMM01-STEM secretome in overweight seniors experiencing muscle loss and metabolic dysfunction.

PUBLICATION #1: “Reversal of deficits in aged skeletal muscle during disuse and recovery in response to treatment with a secretome product derived from partially differentiated human pluripotent stem cells” (Fix et al., GeroScience, 2021).

The first publication in GeroScience investigates treatment with IMM01-STEM in aged mouse models of disuse atrophy. Compared to control mice, IMM01-STEM treatment increases muscle mass and size, and improves grip strength. Additionally, IMM01-STEM increases collagen turnover and the number of muscle stem cells, indicative of enhanced muscle remodeling. These findings demonstrate that IMM01-STEM promotes muscle size and strength following disuse atrophy.

PUBLICATION #2: “Stem cell secretome treatment improves whole-body metabolism, reduces adiposity, and promotes skeletal muscle function in aged mice” (Fennel et al., Aging Cell, 2024).

Age-related loss of muscle mass and function (sarcopenia) associated with excess body fat, referred to as “sarcopenic obesity,” is a global health concern (Donini et al., 2022). There are no interventions to combat weight gain without compromising muscle mass, creating an unmet clinical need. Immunis’ Aging Cell publication investigates the therapeutic impact of IMM01-STEM on muscle and metabolism in aged mice. Compared to control-treated mice, IMM01-STEM increases whole-body lean mass, reduces fat mass and decreases muscle fat. Additionally, there is an increase in muscle fiber area and the number of muscle stem cells, as well as enhanced collagen turnover. Lastly, IMM01-STEM promoted better grip strength and increased overall physical activity.

PUBLICATION #3: “Stem Cell Secretome Treatment Reduces Adiposity and Improves Glucose Handling During Obesity and Weight Loss in Mice” (Fennel et al., The Obesity Journal, 2025)

The key findings are as follows: 1. IMM01-STEM significantly enhanced weight loss in obese mice by reducing the percentage of whole-body fat while increasing lean mass. 2. IMM01-STEM significantly reversed liver steatosis and fibrosis in aged mice on a high fat diet, to levels similar to that of healthy controls. 3. IMM01-STEM provided major metabolic benefits during weight loss, including better glucose tolerance and lower fasting insulin levels, with treated mice achieving metabolic profiles similar to healthy controls. 4. IMM01-STEM preserves muscle mass and enhances muscle quality by increasing muscle fiber size, increasing blood capillary density, and reducing fibrosis.

Phase 1/2a STEM-MYO Clinical Trial: “An open-label dose escalation study to assess the safety and tolerability of IMM01-STEM in participants with muscle atrophy related to knee osteoarthritis.”

Immunis completed a Phase 1/2a clinical trial examining the safety, tolerability and preliminary efficacy of IMM01-STEM treatment in sarcopenic elderly with knee osteoarthritis. There have been no reports of serious adverse events (SAEs) associated with our IMM01-STEM treatment in humans. Initial analyses show striking improvements in quality-of-life measurements related to pain, stiff, and physical function. In the 6-min walk test, the patients increased their walking distance and achieved a clinically meaningful improvement in gait speed, an encouraging suggested functional efficacy signal. The team is preparing a manuscript detailing the full results of the investigation.

Phase 2a STEM-META Clinical Trial: "Safety and Efficacy of IMM01-STEM Against Placebo on Muscle Performance in Seniors With Obesity and Muscle Weakness"

In the study of 47 obese seniors with loss of muscle functionality, IMM01-STEM demonstrated clinically relevant improvements to functionality, including the walking speed (gait speed), one of the most well-documented, validated indicators of muscle function and overall health. Key interim results from the Phase 2 clinical trial: 1. IMM01-STEM improved gait speed by 26% compared to placebo controls. 2. The absolute change in gait speed for IMM01-STEM-treated subjects exceeded the clinically meaningful Quality-of-Life improvement of 0.1 m/s, reaching 0.12 m/s gained at 4 weeks and 0.16 m/s gained at 3 months post-treatment.

For additional information, please see the publications below.

Our published preclinical data in GeroScience and Aging Cell demonstrate that intramuscular administration of IMM01-STEM increases muscle strength, muscle mass, and improves metabolism in aged mice. Additionally, IMM01-STEM increases the number of muscle stem cells and improves macrophage infiltration in mice treated with IMM01-STEM, suggesting that tissue remodeling and regeneration are core components of the mechanism of action.

For additional information, please see the publications below.