Frequently Asked Questions (FAQs)
Clinical Trials
1What are the different phases of a clinical trial and what do they mean?
There are several phases (I-IV) of a clinical trial, which represent the progression of testing for a novel drug or therapy. Each phase has specific goals and builds upon the previous one, with increasing numbers of participants and more comprehensive data collection. This progressive research ensures treatments are thoroughly tested for safety and efficacy prior to approval for commercial availability.
A Phase I clinical trial is the first test of a new drug in a small number of humans to determine drug safety and dosage. In a Phase II clinical trial, the treatment is tested in a larger number of participants to measure potential efficacy and side effects, while still observing safety. A Phase III clinical trial compares the safety and efficacy of the new drug against current standard treatments. Phase IV clinical trials are conducted once the drug is approved by the FDA during the Post-Market Safety Monitoring period.
For more information, please see the "Clinical Trial Phases" resource below.
2I am interested in Immunis’ investigational therapy. How do I receive treatment?
Immunis’ investigational therapy (IMM01-STEM) is being studied in a USA FDA clinical trial process and is not commercially available. However, you may be eligible to receive our therapy if you qualify for one of our active clinical trials.
The clinical trials are performed at accredited clinical research facilities that are independent from Immunis Inc. Immunis is not involved with the screening or selection of participants to take part in the clinical trials. If you are interested in participation, we recommend that you first review the inclusion and exclusion criteria (see "Phase 2 STEM-META Inclusion Criteria" resource below), where you will also be able to find a clinical site nearest you to discuss the next steps.
For additional information, please see the "Phase 2 STEM-META Clinical Trial" resource below.
3Do I qualify to participate in the clinical trials?
You might! To ensure patient safety and accuracy of the research data, each clinical trial has a strict set of eligibility criteria to participate. Only participants who satisfy all inclusion criteria and none of the exclusion criteria are eligible. The qualifications are different for each trial so please refer to our "Phase 2 STEM-META Inclusion Criteria" resource below. Also, please note that if you have already participated in one of these trials, you may not participate in a second trial.
4What is the time commitment for the clinical trials?
Clinical trials can range from several months in the early phases to several years in the later phases. The time commitment will vary based on the type of clinical trial, which is designed for a particular disease indication with safety and efficacy in mind.
The clinical trial enrollment process typically begins with a comprehensive pre-screening phase, which includes obtaining the patient's medical history from their primary care physician and conducting additional laboratory tests as needed. The process continues with additional screening, treatment, and safety follow up.
For more information, please see the "Phase 2 STEM-META Clinical Trial" resource below.
5How will my privacy and health information be protected?
The clinical trials are designed in accordance with HIPAA regulations as defined by the U.S. Department of Health and Human Services. Additionally, all collaborating institutions and hospitals researching and testing IMM01-STEM are HIPAA compliant to ensure the safety and privacy of each participant.
6Is there a fee to participate?
No, participation in a clinical trial is free. You may even be reimbursed for your time.
7Do I need insurance to participate?
No. You or your healthcare insurance (including healthcare coverage programs such as Medicare or Medicaid) will NOT be charged for any tests or treatments that are part of the clinical trial. As a result, it is not necessary for you to have healthcare coverage to participate.
8Are there other diseases/conditions/indications that IMM01-STEM is approved to treat?
No. IMM01-STEM is a new treatment that is still being tested in FDA-approved clinical trials to ensure safety and efficacy. It is not available as a commercial product. IMM01-STEM is not approved for any clinical applications.
For more information, please see the "Clinical Programs" resource below.
Multi-active Biologics
1What are multi-active biologics?
A multi-active biologic is a therapeutic with multiple factors that can influence a variety of biological pathways. Unlike traditional drugs that typically target one protein, pathway or mechanism, multi-active biologics can engage multiple signaling complexes simultaneously.
Most diseases are driven by numerous biological factors that are too intricate to treat with a single drug. By targeting diseases with multi-active therapeutics, there is a greater opportunity to address the cellular complexities of disease.
2How are multi-active biologics made?
Multi-active biologics can be produced artificially or naturally.
An example of an artificially produced biologic is a mixture of synthesized small molecules that are screened for their ability to stimulate specific cellular interactions. These molecules are often genetically engineered versions of natural proteins with a known function. Artificially produced biologics have the potential to create targeted therapies that selectively interact with specific cell types (Su et al., 2020).
An example of a naturally produced multi-active biologic is a secretome. A secretome is the total set of substances released by a cell including, but not limited to proteins, lipids and growth factors (Xia et al., 2019). While mature cells have a limited set of substances that they can release, stem cells produce a secretome rich in natural molecules for resolving infections, promoting tissue regeneration and function and maintaining health (Md Fadilah et al., 2022). Additionally, stem cells secrete developmental factors abundant early in life that are also beneficial for regeneration but lacking later in life, making stem cell-derived secretome products promising therapies that can address age-related diseases.
For additional information, please see the publications below.
3What advantages do stem cell-derived secretomes provide over standard stem cell replacement therapies?
An advantage of multi-active biologics derived from secretomes is that they are cell-free. Traditional stem cell therapies involve the administration of live stem cells, but secretomes do not contain cells, thus significantly eliminating the risk of tumorigenicity and immune rejection.
Another advantage is that stem cell-derived secretomes contain all the bioactive components suggested to be involved in the regeneration, maintenance and differentiation of stem cells (Das et al., 2023). These secreted bioactive molecules can yield therapeutic benefits by restoring and maintaining the population of regenerative stem cells in various tissues and organs with potentially long-lasting therapeutic effects.
Other advantages of secretome therapies include: 1. Standardized and controlled manufacturing 2. Reduced manufacturing costs 3. Precise and controlled dosing 4. Versatile routes of administration: injection, inhalation or topical application (Li et al., 2022)
For additional information, please see the publications below.
IMM01-STEM
1What is IMM01-STEM?
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.
2How is IMM01-STEM made?
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.
3What is the therapeutic potential of IMM01-STEM?
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.
4Is there data suggesting IMM01-STEM efficacy?
Yes. We have published preclinical data in two reputable, peer-reviewed scientific journals detailing the therapeutic impact of IMM01-STEM on muscle atrophy in aged 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.
“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., 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.
“Stem cell secretome treatment improves whole-body metabolism, reduces adiposity, and promotes skeletal muscle function in aged mice” (Fennel et al., 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.
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.
For additional information, please see the publications below.
5What is the mechanism of action of IMM01-STEM?
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.
Additional Resources
Publications
Das, M., Teli, P., Vaidya, A., & Kale, V. (2023). Secretome of Young Mesenchymal Stromal Cells Rejuvenates Aged Mesenchymal Stromal Cells by Normalizing Their Phenotype and Restoring Their Differentiation Profile. Stem Cells and Development, 32(1–2), 12–24. https://doi.org/10.1089/scd.2022.0213
Donini, L. M., Busetto, L., Bischoff, S. C., Cederholm, T., Ballesteros-Pomar, M. D., Batsis, J. A., Bauer, J. M., Boirie, Y., Cruz-Jentoft, A. J., Dicker, D., Frara, S., Frühbeck, G., Genton, L., Gepner, Y., Giustina, A., Gonzalez, M. C., Han, H.-S., Heymsfield, S. B., Higashiguchi, T., … Barazzoni, R. (2022). Definition and Diagnostic Criteria for Sarcopenic Obesity: ESPEN and EASO Consensus Statement. Obesity Facts, 15(3), 321–335. https://doi.org/10.1159/000521241
Fennel, Z. J., Bourrant, P.-E., Kurian, A. S., Petrocelli, J. J., de Hart, N. M. M. P., Yee, E. M., Boudina, S., Keirstead, H. S., Nistor, G., Greilach, S. A., Berchtold, N. C., Lane, T. E., & Drummond, M. J. (2024). Stem cell secretome treatment improves whole-body metabolism, reduces adiposity, and promotes skeletal muscle function in aged mice. Aging Cell, 23(6), e14144. https://doi.org/10.1111/acel.14144
Fix, D. K., Mahmassani, Z. S., Petrocelli, J. J., de Hart, N. M. M. P., Ferrara, P. J., Painter, J. S., Nistor, G., Lane, T. E., Keirstead, H. S., & Drummond, M. J. (2021). Reversal of deficits in aged skeletal muscle during disuse and recovery in response to treatment with a secrotome product derived from partially differentiated human pluripotent stem cells. GeroScience, 43(6), 2635–2652. https://doi.org/10.1007/s11357-021-00423-0
Li, F., Zhang, J., Yi, K., Wang, H., Wei, H., Chan, H. F., Tao, Y., & Li, M. (2022). Delivery of Stem Cell Secretome for Therapeutic Applications. ACS Applied Bio Materials, 5(5), 2009–2030. https://doi.org/10.1021/acsabm.1c01312
Md Fadilah, N. I., Mohd Abdul Kader Jailani, M. S., Badrul Hisham, M. A. I., Sunthar Raj, N., Shamsuddin, S. A., Ng, M. H., Fauzi, M. B., & Maarof, M. (2022). Cell secretomes for wound healing and tissue regeneration: Next generation acellular based tissue engineered products. Journal of Tissue Engineering, 13, 20417314221114273. https://doi.org/10.1177/20417314221114273
Su, Z., Wang, B., Almo, S. C., & Wu, Y. (2020). Understanding the Targeting Mechanisms of Multi-Specific Biologics in Immunotherapy with Multiscale Modeling. iScience, 23(12), 101835. https://doi.org/10.1016/j.isci.2020.101835
Xia, J., Minamino, S., Kuwabara, K., & Arai, S. (2019). Stem cell secretome as a new booster for regenerative medicine. Bioscience Trends, 13(4), 299–307. https://doi.org/10.5582/bst.2019.01226