Immunis, Inc., a clinical-stage biotechnology company focused on developing multi-active biologics for age and disease-related immune dysregulation, has announced the closing of a $25 million Series A-1 financing round. The funding will be used to advance IMM01-STEM, Immunis's lead candidate, through two Phase 2 clinical trials targeting muscle loss and metabolic dysfunction in elderly populations.
The Series A-1 round saw follow-on investments from existing investors, including Remiges Ventures, Continuum Health Ventures, and BOLD Capital Partners, along with new investments from LifeSpan Vision Ventures, JLS Fund, and a global insurance company.
IMM01-STEM: Addressing Unmet Needs in Age-Related Muscle Atrophy
Mitigating muscle loss and improving metabolic function in aging individuals represent significant unmet medical needs. IMM01-STEM is a novel, stem cell-derived multi-active biologic being developed to address these challenges. The FDA has granted permission for Immunis to proceed with a Phase 2 clinical trial to assess the efficacy of IMM01-STEM in ameliorating muscle loss and reversing metabolic dysfunction in sarcopenic, overweight, and obese elderly individuals.
Promising Phase 1/2a Results
Previously, a Phase 1/2a clinical trial demonstrated the safety, tolerability, and suggestive efficacy of IMM01-STEM in individuals with age-related muscle atrophy. According to Mark Cabato, Chief Business Officer of Immunis, the Phase 1/2a data in nine elderly patients showed the therapy to be safe, with no serious adverse events reported. Furthermore, patients experienced improvements in quality-of-life measures related to physical function and pain, as well as a clinically relevant increase in gait speed.
"By running randomized, controlled studies in elderly populations with degenerative disease and metabolic dysfunction, we hope to demonstrate IMM01-STEM’s broad applicability in multiple medical conditions," Cabato stated.
Preclinical Evidence Supports Therapeutic Potential
Preclinical studies of IMM01-STEM in aged mouse models of muscle disuse atrophy and metabolism, published in GeroScience and Aging Cell, have shown that the therapy can reverse muscle atrophy, improve muscle function, enhance metabolism, and decrease body and liver fat. Immunis highlights that it is currently the leading biotech with the most advanced stem cell-derived multi-active biologic in human clinical trials.
With the completion of this financing round, Immunis is poised to further investigate the potential of IMM01-STEM to address critical unmet needs in age-related muscle and metabolic dysfunction.
