NEW YORK—A cross-Atlantic partnership is underway between Amarantus Bioscience Holdings Inc. (AMBS) and Germany’s Leipzig University. The organizations have inked an exclusive option agreement under which Amarantus will license rights to LymPro Test 2.0, which combines LymPro Test results with amyloid PET imaging results to aid in diagnosing Alzheimer’s disease.
The LymPro Test is “a diagnostic blood test that determines the ability of peripheral blood lymphocytes (PBLs) and monocytes to withstand an exogenous mitogenic stimulation that induces them to enter the cell cycle,” according to an Amarantus press release. Some diseases, such as Alzheimer’s disease, result from compromised cellular machinery causing neurons to reenter the cell cycle abnormally, which in turn leads to cell death.
Per the agreement, Amarantus has an exclusive option to access data produced from the LymPro PET 1 clinical study, which ran from 2016 to 2017 and was supervised by Dr. Thomas Arendt, who invented the LymPro Test. (Arendt is Professor of Neuroscience at Leipzig University and head of the Paul Flechsig Institute of Brain Research.) Amarantus was provided with a summary of the trial data on May 2, and once it exercises its option, Amarantus and Leipzig will finalize negotiations to license LymPro intellectual property and data from LymPro PET 1 to Amarantus. In addition, the parties will also undertake a confirmatory trial of 20 participants—LymPro PET 2—which is currently undergoing enrollment.
Amarantus noted in a business overview that the LymPro PET 1 study, which was financed by Leipzig, was the result of an effort to address concerns from potential partners that “what was missing from our initial dataset [for LymPro Test] was the use of a reference standard that incorporated newly available biomarkers, such as PET imaging.” The resulting LymPro PET 1 study was intended to “overcome those previous shortcomings by evaluating LymPro’s ability to discriminate patients with dementia of the Alzheimer’s type from patients who suffer from other forms of dementia using clinical diagnosis in addition to various biomarkers, such as amyloid PET imaging.”
“Given the continued high failure rates in Alzheimer’s clinical trials, major uncertainties emerging regarding the amyloid therapeutic hypothesis of Alzheimer’s disease and the wealth of scientific data, the company believes LymPro puts Amarantus squarely back in the center of emerging technologies that have the potential to make a significant impact in the development of new treatment paradigms for Alzheimer’s,” Amarantus noted in its overview. “AMBS intends to bring in seasoned management to build a business around LymPro.”
The company reacquired the rights to LymPro Test on April 6, 2018, from Avant Diagnostics Inc. Per the terms of the deal, Amarantus agreed to cancel all liabilities it was owed by Avant—roughly $722,500—and issue one million shares of Amarantus common stock to the latter company. For its part, Avant agreed to issue an additional 30,092,073 Avant common shares to Amarantus to satisfy certain amounts owed under the original acquisition deal. Amarantus also reacquired rights to MSPrecise and NuroPro. Avant acquired Amarantus Diagnostics Inc., a wholly owned subsidiary of Amarantus Bioscience, and with it the LymPro Test, in 2016.
Amarantus plans to have these diagnostics handled by a new subsidiary, with Gerald Commissiong, president and CEO of Amarantus, noting that “The science underpinning the LymPro Test for Alzheimer’s disease has continued to mature during the intervening period of our ownership by virtue of the improved understanding of the immune system’s involvement in the underlying mechanisms of cell death in Alzheimer’s disease. Going forward, we believe there is an opportunity to move the neurology assets via a focused subsidiary and key additions to management with experience to take it forward.”
The Alzheimer’s Association estimates that more than 5.4 million individuals in the United States have Alzheimer’s disease, while the World Health Organization (WHO) estimates that global incidence is at 35.6 million—a number that WHO expects to double every 20 years to reach 115.4 million by 2050.