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The companies have partnered to develop and commercialize vectorized antibodies against tau for Alzheimer's and other neurodegenerative diseases.
On Feb. 20, 2018, AbbVie and Voyager Therapeutics, a clinical-stage gene therapy company, announced that they have entered into an exclusive strategic collaboration and option agreement to develop and commercialize vectorized anti-tau antibodies for the treatment of Alzheimer's disease and other neurodegenerative diseases. This collaboration combines AbbVie's experience with monoclonal antibodies (mAbs), global clinical development, and commercial capabilities with Voyager's gene therapy platform that enables generating adeno-associated viral (AAV) vectors for the treatment of neurodegenerative diseases.
Under the terms of the agreement, Voyager will conduct the research and preclinical development of vectorized antibodies against tau. AbbVie will then have the choice to select one or more vectorized antibodies to advance into IND-enabling studies and clinical development, as stated in the release. Voyager will also handle the research, IND-enabling, and Phase I studies activities and costs.
AbbVie has an option to license the vectorized tau antibody program following Phase I clinical development and would then lead further clinical development and global commercialization for tauopathies, including Alzheimer's disease and other neurodegenerative diseases. To obtain higher royalty rates, Voyager has an option to share in the costs of clinical development.
Voyager will receive an upfront cash payment of $69 million, as well as up to $155 million in potential preclinical and Phase I option payments. Additionally, Voyager is eligible to receive up to $895 million in development and regulatory milestones for each vectorized tau antibody compound and is eligible to receive tiered royalties on the global commercial net sales of the vectorized antibodies for tauopathies, including Alzheimer's disease and other neurodegenerative diseases, according to AbbVie.
Tau, a protein in the brain that promotes cellular stability and function, is altered and accumulated in the neurodegenerative brain, resulting in impaired brain function and neuronal cell loss. According to AbbVie, progressive neurodegeneration and symptom severity are related to the progressive spread of abnormal tau in the brain. The use of weekly or biweekly infusions of biologic therapies for neurodegenerative diseases is limited because only a small amount of drug is able to make its way into the brain. The companies plan to develop a potential single treatment using “Voyager's gene therapy platform to reduce tau pathology through the delivery of an AAV vector antibody that determines the genetic instructions to produce anti-tau antibodies within the brain,” as stated in a company press release.
"AbbVie is focused on developing treatments to meet the crushing public health crisis presented by Alzheimer's and other neurodegenerative diseases," said Jim Sullivan, PhD, vice-president, pharmaceutical discovery, AbbVie, in the release. "Voyager's vectorized antibody platform presents an innovative approach to addressing challenges in treating neurological disorders associated with the administration of biologic therapies. This collaboration has the potential to address the needs of patients who live with conditions such as Alzheimer's disease, progressive supranuclear palsy, and frontotemporal dementia."
"Combining AbbVie's leadership and deep expertise in [mAb] discovery, development, and commercialization and our ability to vectorize monoclonal antibodies is a natural fit, and we are very pleased to collaborate with AbbVie to advance this strategy towards the clinic in an effort to bring innovative treatments to patients," said Steven Paul, MD, president and CEO of Voyager, in the release. "This collaboration also represents an important advance in our strategy to leverage our AAV gene therapy platform and programs through partnerships with biopharmaceutical companies that bring complementary expertise and capabilities, in addition to capital."