The goal for the companies is to reach greater levels of anti-tau antibodies in a single treatment that what current weekly or bi-weekly infusions can achieve.
Matt Osborne, MBA
AbbVie has announced a joint strategic collaboration and option agreement with clinical-stage gene therapy company Voyager Therapeutics to develop and commercialize vectorized antibodies to combat tau in patients with Alzheimer disease (AD) and similar dementias.1
The collaboration between the major players in the space will seek to develop adeno-associated viral (AAV) vectors by combining AbbVie’s clinical resources and Voyager’s gene therapy platform. The partnership is intended to address the current limitations faced by biologic therapies, due to the current infusions’ inability to completely reach the targets in the brain.
Tau, which is altered and accumulates during neurodegenerative processes, resulting in damage to brain function and neuronal cell loss, would be the main target for these AAV vectors. The plan, according to the companies, is to use Voyager’s delivery system to deliver these vectors, which in turn would produce anti-tau antibodies in the brain.
“Voyager’s vectorized antibody platform presents an innovative approach to addressing challenges in treating neurological disorders associated with the administration of biologic therapies,” Jim Sullivan, PhD, vice president, pharmaceutical discovery, AbbVie, said in a statement. “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.”
Matt Osborne, MBA, vice president of investor relations and corporate, Voyager, told MD Mag, NeurologyLive’s sister publication, that the role of gene therapies in tau pathology, while in early development, has shown incredible promise. “Right now, some of these antibodies in development penetrate tissues in the brain at a very low level and require weekly or bi-weekly infusions. With gene therapy, we are attempting to deliver higher amounts of antibodies to the brain, and with a one-time treatment,” he said.
According to the collaboration agreement, Voyager will be responsible for the initial research and preclinical development of targeted vectorized antibodies, which AbbVie will select for clinical development. Then, AbbVie will have an option to license the programs for the respective antibodies and lead the follow-up clinical research and commercialization. Voyager will conduct and cover the costs of research and phase I studies and will hold an option to share costs of development for higher royalties.
A successful therapy for AD is going require a combination approach, like what is done in cancer, according to Howard Fillit, MD, founding executive director and chief scientific officer, Alzheimer’s Drug Discovery Foundation, due to the multi-faceted nature of the disease. “You have inflammation, epigenetic changes, neuronal energy failure, mitochondrial dysfunction, hypoxia and ischemia from microvascular disease, protein chaperone misfolding and failure,” he told MD Mag.
Osborne continued that the therapies developed could also be utilized to improve current regimens, saying that the ultimate goal is to reach greater levels of anti-tau antibodies in a single treatment that what current weekly or bi-weekly infusions can achieve. While it is still early to accurately predict the timeline to phase I trials, Osborne said the companies are hopeful to test the therapies in humans within a couple years.
Voyager will receive an upfront cash payment of $69 million, in addition to up to $155 million in potential payments for preclinical and phase I options. Overall, the collaboration could result in $895 million in development and regulatory milestones per vectorized tau antibody compound for Voyager, as well as tiered royalties on global net sales.
This is the second collaboration of its kind for AbbVie in the past 4 months, as the company announced a partnership with Alector in October 2017 to develop therapies to treat AD.2 That partnership is also focusing on a novel class of treatments, this time in immuno-neurology, an area that is rapidly evolving due to the increasing suspicion about the role immune deficiencies within the central nervous system (CNS) play in neurodegeneration progression.
Alector, similarly to Voyager, poses an innovative platform in its respective field which targets multiple pathologies associated with neurodegeneration. Arnon Rosenthal, PhD, chief executive officer, Alector, said in a statement at the time that "we seek to advance the field of immuno-neurology as a new therapeutic modality for dementia and neurodegeneration. We anticipate that immuno-neurology therapies will have as much of an impact on brain disorders as immuno-oncology is having on cancer."
Under those terms, Alector will conduct the exploratory research, discovery of therapies, and development for the lead programs until the conclusion of the proof-of-concept studies. At that point, AbbVie will take the lead. The profits will be shared equally, but Alector will receive $205 million upfront, coupled with a future equity investment of up to $20 million.
1. Abbvie and Voyager Therapeutics announce global strategic collaboration to develop potential new treatments for Alzheimer’s disease and other tau-related neurodegenerative diseases [press release]. AbbVie Investor Relations and Corporate Communications. Chicago, Illinois. news.abbvie.com/news/abbvie-and-voyager-therapeutics-announce-global-strategic-collaboration-to-develop-potential-new-treatments-for-alzheimers-disease-and-other-tau-related-neurodegenerative-diseases.htm. Accessed February 22, 2018.
2. Alector and AbbVie announce collaboration to advance a novel class of immune therapies for patients with
disease [press release]. AbbVie Investor Relations and Corporate Communications. Chicago, Illinois. news.abbvie.com/alert-topics/neurology/alector-and-abbvie-announce-collaboration-to-advance-novel-class-immune-therapies-for-patients-with-alzheimers-disease.htm. Accessed February 22, 2018.