Internationally renowned stem cell expert Dr. Hans Keirstead’s latest venture shows promise in reversing age-related muscle loss and metabolic decline.
Irvine-based biotechnology startup Immunis Inc. recently received approval from the Food and Drug Administration to start Phase 2 of a clinical trial for its investigational drug Immuna, which claims to reduce fat while preserving muscle.
“We want to move forward and bring on a partner in order to further develop this and refine it hand-in-hand with a larger pharmaceutical company,” Keirstead, chairman of Immunis, told the Business Journal.
The first phase, set to wrap up next month, tested the safety and efficacy of the drug in patients with muscle atrophy related to knee osteoarthritis at the University of California, Irvine Medical Center.
It had positive results showing that Immuna not only preserved muscle but also helped grow muscle in elderly participants, according to Keirstead.
The second phase will focus on fat reduction in body composition. It’s expected to begin this December or next January and last up to two years.
Secretomes
With age, immune systems deteriorate.
“Age attacks your body in many ways, causing muscular atrophy,” Keirstead said.
Immuna is derived from human cells that are grown by the company.
These cells release proteins, lipids and other growth factors known as secretomes, which help maintain a healthy immune system. Immunis developed a way to stimulate cells to produce secretomes and reinvigorate old immune cells back to their optimal functioning state.
Results from Phase 1/2a, which merges Phase 1 with early Phase 2 trials, reflect the same results seen in a preclinical study that the company performed on aged mice.
The study, published in Aging Cell in March, reported “substantially increased whole-body lean mass and decreased fat mass.”
“That tells us that the drug translates from rodents to humans,” Keirstead said. “It works in both species.” Immunis has also opened an animal health division that will concurrently study the efficacy of Immuna in dogs.
Weight Loss Market
The rapidly growing market for weight loss drugs is expected to reach $150 billion by 2030, according to Reuters.
While GLP-1 drugs like Ozempic and Wegovy may be hacks for weight-loss, “roughly 30%” of that weight loss is due to muscle atrophy, Keirstead said.
“So, these drugs do shrink fat, but they also shrink muscle,” he said. “That’s very bad for any age of human but especially bad for people over 50 years old because your muscles do a lot more than help you to be strong.”
Keirstead said that muscles also contribute to creating new neurons, learning and memory.
Keirstead spent 15 years as a professor at UCI, where he founded, directed and raised $77 million for the Sue and Bill Gross Stem Cell Research Center that was established in 2010.
Keirstead is chief executive of Aivita Biomedical Inc., an Irvine-based stem cell therapy firm focused on developing personalized vaccines for cancer and COVID-19.
