The therapies developed by Immunis represent the less well trodden path when it comes to the ongoing but still early stages in the replacement of stem cell therapies. This replacement is possible because the benefits provided by presently widespread forms of stem cell therapy result from the signals secreted by those cells in the short period of time before they die. Few such therapies have demonstrated any meaningful degree of long-term engraftment and survival of transplanted cells. Benefits are thus a matter of signals from the stem cells favorably adjusting the behavior of native cells for some extended period of time. The most reliable beneficial outcome of such therapies is a reduction in chronic inflammation.
Most efforts to replace stem cell therapies with a logistically simpler approach have focused on harvesting extracellular vesicles from stem cell cultures. Much of the signaling between cells is carried in these vesicles, and in animal studies the delivery of vesicles instead of stem cells has produced broadly similar benefits. Extracellular vesicles are more easily stored and transported than is the case for cells, and their use offers the vision of a future industry in which the challenging and expensive parts of the manufacturing process, meaning the establishment, maintenance, and quality control of stem cell lines, can be centralized.
Instead of extracellular vesicles, Immunis focuses on harvesting soluble molecules secreted by stem cells – the rest of the panoply of intracellular communication. This is an important difference, but, downstream of the fork in the road that is the choice of soluble molecules or extracellular vesicles, all of the consequent logistical benefits appear similar. The therapeutic product becomes more easily stored and transported, while the thorny challenges inherent in managing a high quality production process that relies upon the incompletely understood, highly complex biochemistry of living cells can be centralized.
Immunis, a clinical-stage biotech company pioneering multi-active secretome-based biologics, today announced positive topline interim results from STEM-META, a double-blind placebo-controlled study of the IMM01-STEM secretome in overweight seniors experiencing muscle loss and metabolic dysfunction. The study offers some of the first Phase 2 data on a class of drugs known as “secretome-based biologics.” Secretomes, like IMM01-STEM, are derived from secreted stem cell factors that have the natural ingredients known to stimulate various cell signaling pathways simultaneously, influencing immune regulation and promoting healing. A strong body of preclinical and Phase 1 evidence shows these “cell-free cell therapies” deliver the therapeutic benefits of stem cell molecules without the risk of administering stem cells, and has contributed to high demand in the class.
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. IMM01-STEM improved gait speed by 26% compared to placebo controls. Gait speed, or the average speed at which an individual walks, is a measure of mobility, and a summary measure of physiologic reserve across multiple systems.
Immunis’ Phase 2 data follows preclinical placebo-controlled studies of muscle and metabolism, demonstrating IMM01-STEM increased whole-body lean mass, reduced fat mass and decreased muscle fat while increasing muscle fiber area and the number of muscle stem cells, and enhancing collagen turnover, grip strength, and overall physical activity in mice. Together, these data provide a basis for future clinical research studies of IMM01-STEM.
