Aelan, Buck Institute Announce Agreement

Aelan Cell Technologies has announced a licensing agreement with the Buck Institute for Research on Aging (Novato). The agreement gives Aelan world-wide rights to intellectual property describing a novel epigenetic biomarker with a granted United States patent. The Buck Institute filed the patent application on the discovery made in Dr. Victoria Lunyak's laboratory. Dr. Lunyak is currently the Founder, CEO and President of Aelan Cell Technologies. The patent on the discovery was granted in 2015.

The agreement grants Aelan development and commercialization rights to this biomarker, which is linked to DNA damage pathway, cellular senescence and aging. Financial terms of the agreement are not disclosed. This agreement is further evidence of Aelan's commitment to developing novel innovative diagnostics and treatments for important medical conditions, especially age-related pathologies and disorders. Aelan Cell Technologies announced the discovery and potential clinical utility of this novel epigenetic biomarker.

Together with other Aelan's proprietary components this biomarker is used in one of three blood-based tests aimed to diagnose Alzheimer's disease. An early human clinical feasibility study has indicated that serological tests developed by Aelan's researchers are very promising and could help physicians to pin-point Alzheimer's disease (AD) by directly measuring of the biomarker in patient's serum alongside with a measurement of a patient's immunological response to its presence. Aelan plans to initiate additional clinical studies for these novel diagnostic tests in the future.

"Together with other proprietary components developed by Aelan, the licensed biomarker is used in one of our novel and proprietary serological ELISA diagnostic tests intended for confirmatory diagnostics and potentially screening for early onset Alzheimer's disease in the elderly population," said Victoria Lunyak, Ph.D. "We have presented our early results during the Third International European Neurodegenerative Disease, Brain mapping and Optogenetics Meeting at University of Cambridge in 2015." Since then the tests optimization results show top of the level diagnostic accuracy when put to the scrutiny in the different laboratory/operator settings."

"Aelan's strategy is to maximize value for our diagnostic products with a commitment to demonstrate sound scientific evidence of clinical utility and health-economic benefit. This license from the Buck Institute is incremental to the strong IP landscape we have built over the past year by developing affordable and reliable diagnostics for the unmet medical needs in this sector," adds Dr. Lunyak.

"There is an opportunity for Aelan's products to address a large unmet need for early diagnosis of AD and companion diagnostics for AD therapeutics. A non-invasive diagnostic test for AD that could aid in stratifying patients that could benefit from targeted drug therapy has the potential to become a blockbuster product which could ignite the pharmaceutical and IVD markets," said Chester Aldridge, CEO of US Equity Holdings and Chair of Aelan's Board of Directors.

Currently, there are no biological markers available that enable preclinical detection or definitive premorbid diagnosis of AD. Worldwide, nearly 44 million people have Alzheimer's or a related dementia and only 1-in-4 people with Alzheimer's disease have been diagnosed (Alzheimer's Disease International). According to the American Association of Alzheimer's Disease, every 66 seconds someone in the United States develops AD and more than 5 million Americans are living the disease. AD is one of the costliest chronic diseases to society. In 2015, AD and other forms of dementia cost the nation $236 billion.

AD is the sixth leading cause of death in the United States and it's the only cause of death in the Top 10 in America that cannot be prevented, cured, or slowed with currently available therapies. Between 2000 and 2013, deaths attributed to Alzheimer's Disease increased 71 percent. By 2050, the projected cost to the nation could rise as high as $1.1 trillion. This dramatic spike includes a five-fold increase in government spending under Medicare and Medicaid and a nearly five-fold increase in out-of-pocket spending. Nearly one in every three seniors who dies annually has Alzheimer's or another form of dementia.