Immunis Announces Preliminary Results from First-Ever Phase 2 Study of a Secretome-Based Biologic Showing Weight Loss with Preserved Muscle and Improved Gait Speed in Obese Sarcopenic Seniors

Interim Phase 2 IMM01-STEM data pioneers a class of cell-free multi-active secretomes, showing clinically significant improvements in a key vital sign of health

IRVINE, Calif.--(BUSINESS WIRE)--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. In recognition of the news, Immunis Chairman, Dr. Hans Keirstead, will be speaking at Biotech Showcase on a panel about cutting-edge immune-based therapeutics.

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.

“Most diseases arise from dysregulation of complex cellular signaling pathways that are too intricate to correct with a single agent; yet scientists have been largely focused on single-target therapeutic approaches. The time has come to disrupt traditional paradigms in regenerative medicine," said Dr. Hans Keirstead, Chairman of Immunis. “With the most advanced data yet on multi-active secretome-based biologics, we’re thrilled to validate the promise of our unique approach, which harnesses the power of the secretome to more effectively address the underlying cellular intricacies that drive disease. Immunis aims to deliver secretome therapies that safely and effectively overcome the most prevalent and disruptive conditions of our time.”

In the study of 47 obese seniors with loss of muscle functionality, IMM01-STEM demonstrated clinically relevant improvements to functionality, including 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:

• IMM01-STEM improved gait speed by 26% compared to placebo controls.
• 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.

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, including balance and coordination, musculoskeletal integrity, lower-extremity strength, and neurological, cardiovascular, and pulmonary function. Improving gait speed functionally benefits independence, quality of life, physical fitness, cognitive and cardiovascular health, and reduces the risk of falls, disability, hospitalization, institutionalization, and all-cause mortality.

“These highly encouraging findings suggest IMM01-STEM offers significant improvements in overall physical function and health with gait speed being a key metric predicting biological age, physical and cognitive status, risk of hospitalization, disability and death,” said Dr. Nicole Berchtold, Principal Scientist at Immunis. “We hope to build on these insights to explore stand-alone and combinatorial treatment approaches that can transform mobility, quality of life, and overall health. This research tackles a pressing challenge for the expanding older-adult population, a demographic that is shaping the future of healthcare, the economy, and society at large.”

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.

STEM-META is an ongoing clinical trial. Immunis is concurrently exploring the potential of IMM01-STEM in other populations with musculoskeletal and metabolic diseases as well as companion animals such as canines.

About STEM-META

STEM-META is a Phase 2, placebo-controlled, dose expansion study of the safety and efficacy of IMM01-STEM on muscle strength and physical function in seniors with obesity and muscle weakness. The study targets safety parameters, body composition, and muscle function. Additional metabolic, inflammatory and muscle-adipose crosstalk markers are also monitored. To learn more about the trial, click here.

About IMM01-STEM

IMM01-STEM is a novel, multi-active biologic derived from the secretome of partially differentiated stem cells. It is designed to deliver a naturally balanced set of regenerative and immunomodulatory molecules to improve immune health and function, with the goal of mitigating muscle loss, improving muscle regeneration and bettering metabolism in patients suffering from age- and disease-related muscle atrophy or metabolic decline.

About Immunis

Immunis is a clinical-stage biotechnology company developing multi-active stem cell-derived secretome-based biologics to treat the various manifestations of age-related diseases and immune dysregulation. The investigational product line leverages Immunis’ leading-edge capabilities in stem cell secretome technology to deliver a product of all natural, all human immune modulators in their natural physiological concentrations. For additional information about Immunis’ programs, please visit Immunisbiomedical.com.