By Eve Herold – Editor in Chief, Healthspan Action Coalition
Healthspan Compass: In general, how does immune dysfunction affect aging in general and age-related diseases in particular?
Hans Keirstead: With aging, there’s a gradual accumulation of molecular damage to our cells, including our immune cells. Consequently, this results in a decline in immune cell function, termed immunosenescence, which is marked by impaired cellular responsiveness and disrupted inflammatory signaling, in favor of chronic, low-grade inflammation. Whereas a balanced immune system keeps illness at bay, immune dysregulation accelerates tissue injury, weakens systemic defenses, and heightens susceptibility to age-related diseases.
HC: The idea of using biologics to treat age-related changes sounds very promising. Could biologics be the future of extending healthspan—in other words, could they replace many of the medications that now treat age-related conditions?
HK: I believe in the therapeutic potential of multi-active biologics. Unlike traditional drugs that typically target one protein, pathway or mechanism, multi-active biologics can include a diverse mixture of soluble immunomodulatory proteins, growth factors, and cytoskeletal remodeling molecules that can engage many signaling complexes simultaneously. Ultimately, secretomes—factors secreted by cells—can provide a more comprehensive solution to age-related diseases by addressing multiple pathologies, while avoiding the toxicity risks of combinations of single target pharmaceuticals.
HC: Given that the secretomes Immunis develops are derived from stem cells, what’s the source of the stem cells? Are they autologous, specific to the patient?
HK: Immunis’ investigational IMM01-STEM secretome is made by harvesting the secreted factors released by partially differentiated human stem cells. Secretome-based therapies provide a natural, cell-free method to combat disease, thereby minimizing the risk of immune system rejection and avoiding tumorgenicity, the formation of tumors.
HC: Can you briefly describe the project that has become an XPRIZE semifinalist?
Immunis was recognized as a promising healthcare innovator by XPRIZE and received a $250K award as one of the Top 40 Milestone 1 winners. Our promising preclinical data show that our secretome can reverse muscle and metabolic decline in aged mice, and we have supporting preliminary evidence from our Phase 1/2a human clinical trial. Based on these findings, we developed a detailed experimental plan to test our secretome as a novel therapeutic for restoring muscle, cognition, and immune function by at least 10 years, with a goal of up to 20 years, in individuals aged 50–80.
HC: In what ways have you found that your secretomes measurably slow aging and extend the healthspan?
HK: Sarcopenia, or muscle loss from aging, disuse, or disease severely impacts quality of life, yet there are no pharmaceutical treatments. We published two preclinical studies of IMM01-STEM in aged mice that demonstrate a reversal of deficits in skeletal muscle. IMM01-STEM resulted in leaner, higher quality tissue with lower fat and fibrosis, thicker myofibers, greater overall strength, improved whole-body metabolism, reduced adiposity, and better balance and coordination. IMM01-STEM also measurably slows aspects of aging by restoring muscle mass, strength, and function in elderly humans with muscle atrophy. In our Phase 1/2a clinical trial, participants with muscle atrophy related to knee osteoarthritis performed better during a 6-minute walk test, a functional quality of life measurement of gait speed and distance, had reduced inflammation, and reported a decrease in pain, all of which are key indicators of enhanced healthspan. A follow-up Phase 2b study is planned for early 2026, and an ongoing Phase 2a trial in 50 elderly patients with sarcopenic obesity is expected to be completed in the first quarter of 2026.
HC: Out of the several metrics that XPRIZE has established as healthspan criteria, which do your project hope to address?
HK: All of them! IMM01-STEM contains a broad repertoire of regenerative factors that could have broad therapeutic benefits in several age-related conditions. Based on our published research and promising clinical data, IMM01-STEM may have a positive impact on people experiencing age-related muscle loss and metabolic dysfunction, but we are also investigating the potential benefits on cognition and overall immune health.
HC: Let’s discuss the scalability of biologics like secretomes. When do you think that biologic therapies will become available to the average person?
HK: An advantage of our biologic is the ease of manufacturing and scalability, making IMM01-STEM an off-the-shelf-ready therapy. Similarly, stem cell-derived secretomes are more cost-effective than stem cell therapies, while still providing the beneficial stem cell factors. While we are hopeful that secretomes like ours will become readily available at an affordable price, our number one priority is drug safety. At this stage, we are still investigating our secretome for safety, tolerability, and preliminary efficacy in ongoing clinical trials.
HC: What needs to happen for groundbreaking therapies like those currently in Immunis’ clinical trials to move from the discovery and testing phases to marketability?
HK: To become commercial in the US, we would follow the traditional path of conducting a pivotal or Phase 3 trial with IMM01-STEM, followed by a regulatory approval process of 10 months following submission of a Biologics License Application. This would take us to around mid-2030. The Chemistry, Manufacturing, and Controls (CMC) scale-up and commercialization planning are in their early stages but have already started and will continue to evolve concurrently as we move through the clinical development and regulatory process.
HC: Aside from your XPRIZE finalist project, what else is Immunis working on these days?
HK: We have several studies in progress seeking to address various outcomes of age-related health decline, with the overall goal of advancing healthy aging. Our STEM-MYO program is a Phase 1/2a clinical trial investigating whether IMM01-STEM benefits elderly individuals with muscle atrophy related to knee osteoarthritis. A Phase 2b clinical study in a larger patient cohort is currently in preparation.
Our STEM-META program is a Phase 2 placebo-controlled, dose-expansion study of IMM01-STEM in elderly sarcopenic obese individuals, to assess safety, body composition, muscle strength and function, along with metabolic, inflammatory, and muscle-adipose crosstalk markers. The study is in progress and actively recruiting participants.
We’re also conducting safety studies of IMM01-STEM in aged dogs with muscle atrophy through our non-terminal STEM-K9 program.
