New startup Elevian has launched with $5.5 million in backing to develop drugs based on GDF11, a Harvard University-discovered protein that it says is linked to age-related diseases.
GDF11 (growth differentiation factor 11) hit the headlines a few years back when researchers led by Harvard cell biologist Amy Wagers, Ph.D., published studies suggesting the protein was behind research dating back decades which shows that blood taken from young mice and administered to older animals could help rejuvenate organs.
Their work on GDF11—which involved a technique called parabiosis in which the circulatory systems of young and old mice were combined to allow blood to flow between the animals—suggested that injecting the protein into old mice regenerated cardiac, brain and muscle tissue. It was named Science’s breakthrough of the year in 2014.
The hypothesis quickly became controversial, however, when another research group from the Novartis Institutes for Biomedical Research (NIBR) tried and failed to reproduce the findings, and in fact concluded that GDF11 increases with age and inhibits skeletal muscle regeneration. Since then, the two groups have traded blows over the integrity of their studies and research methods, but Elevian says it has data coming out that will firm up evidence that the protein plays a key role in anti-aging.
Wagers is one of the scientific founders of San Francisco-based Elevian, which is led by Mark Allen, M.D., who was most recently CEO of business decision-making software company Corticon Technologies before its sale to Progress Software in 2011.
“Elevian’s therapeutic strategy is to modulate upwards active GDF11 levels, which can be achieved by exogenous administration of recombinant protein as well as by targeting natural regulation mechanisms of GDF11,” Allen tells FierceBiotech.
The new company is pursuing preclinical programs in cardiovascular disease, Alzheimer’s disease, Type 2 diabetes and age-related muscle dysfunction (sarcopenia). Elevian’s CEO says, “we expect to have completed preclinical efficacy and safety studies in multiple therapeutic indications and initiate our first human clinical studies in 2-3 years.”
He goes on to say that the company reckons it can achieve a successful human proof-of-concept relatively quickly in each of these indications.
“Our cardiovascular program, in particular, is supported by human clinical data from the laboratory of Peter Ganz at UCSF, demonstrating that patients with low levels of a measure of GDF11 have significantly increased mortality rates,” says Allen.
Getting approval in those lead indications would require expensive large-scale, time-consuming studies, however, so the company “is also considering additional indications that may provide a faster regulatory path,” according to Allen.
He also notes that Elevian is currently pursuing a much bigger funding round to raise capital to take “two or more different product candidates” through the Investigational New Drug (IND) application stage.
Elevian’s other co-founders include scientists from Harvard’s stem cell and regenerative biology group who have been involved in work on GDF11, notably Lee Rubin, Ph.D., who has looked at the protein’s effects on brain vasculature and neurogenesis, and Rich Lee, M.D., who specializes in heart failure and metabolic diseases that accompany human aging.
“Elevian has exclusive worldwide rights under a portfolio of patent families licensed from Harvard and its research partners broadly claiming methods and compositions for modulation of GDF11 to treat diseases and conditions related to aging,” says Allen.
“Our scientific co-founders are in the process of publishing new data that we believe will help to elucidate some of the open questions regarding GDF11 biology, as well as its therapeutic effects in various disease models.”
The round was led by Bold Capital, the investment firm of Peter Diamandis, and included WTI, Stanford StartX fund, Longevity fund, Kizoo Ventures, Thynk Capital and others.