Manufacturing of anti-tau Alzheimer’s disease vaccine for clinical trials

The Gates Biomanufacturing Facility (GBF) announced the successful completion of the full cycle manufacturing of the recombinant Bulk Drug Substance (BDS) of the Alzheimer’s disease anti-Tau vaccine, AV-1980R, in collaboration with the Institute for Molecular Medicine (IMM), California.

IMM selected GBF as its cGMP-grade BDS manufacturing partner supporting clinical supply for IMM’s recombinant protein vaccines, including AV-1980R. As a result of this work, AV-1980R Drug Substance can be used for phase I and phase II clinical trials in humans.

Abnormal Tau aggregation into neurofibrillary tangles is the hallmark of different tauopathies – neurodegenerative disorders that include Alzheimer’s Disease (AD).

Until now, AD therapeutics have mostly focused on the treatment of already diseased patients. The AV-1980R vaccine targets Alzheimer’s Disease (AD) and other Tau aggregation-associated neurodegenerative conditions by providing outstanding levels of antibody protection against harmful forms of Tau protein that may lead to disease.

Dr. Michael Agadjanyan, Professor and Vice President of IMM commented: “Once pathology begins and neurons are damaged, it becomes impossible to stop the disease. Now, with the help of cGMP-grade AV-1980R, IMM has a highly immunogenic preventative vaccine that could induce significant levels of antibodies inhibiting aggregation of Tau in cognitively unimpaired people who are at risk of AD and halt the disease onset”.

Dr Huntington Potter, Director of Alzheimer’s Disease Program at the Linda Crnic Institute for Down Syndrome, and Director of the CU Alzheimer’s concluded: “It is becoming increasingly clear that targeting Alzheimer amyloid deposits and their formation is not, alone, an effective approach to halting or reversing Alzheimer’s disease. New therapeutics are needed. The development and manufacture of a Tau vaccine is one of the most promising approaches and might be used either alone or in combination with the anti-amyloid antibodies currently in clinical trials. I congratulate GBF on this important milestone.”

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