AC Immune and WuXi Biologics have announced a partnership to advance the development of an investigational antibody treatment that targets the protein TAR binding DNA protein 43 (TDP-43) for treating certain central nervous system (CNS) conditions, including amyotrophic lateral sclerosis (ALS).
Having identified and developed the anti-TDP-43 antibody, AC Immune now is looking to use the advanced technological resources of WuXi, with the goal of bringing the antibody to clinical trial.
“We are pleased to enable AC Immune to turn promising candidates into tangible treatments to fulfill the unmet medical needs in the field of CNS disorder,” Chris Chen, PhD, CEO of WuXi, said in a press release.
“This strategic partnership reflects the extensive trust and recognition of WuXi Biologics from AC Immune. Through our leading technology platforms, we look forward to empowering AC Immune to accelerate novel biologics development and benefiting patients worldwide,” Chen said.
The TDP-43 protein typically is involved in the production of other proteins through the regulation of messenger RNA (mRNA), the intermediary product between DNA and protein, in the cell nucleus. When the gene providing instructions for making TDP-43 is mutated, the resulting protein has an abnormal shape that makes it more prone to accumulate in the cytoplasm and clump together.
TDP-43 protein clumps have been observed in the motor neurons of patients with CNS diseases such as ALS, age-related dementia, limbic-predominant age-related TDP-43 encephalopathy, and frontotemporal lobar degeneration.
These pathological findings led researchers at AC Immune to develop an antibody that can directly target TDP-43, potentially breaking up the aggregates and restoring normal function.
To do so, AC Immune made use of its SupraAntigen platform, a technological system that generates highly specific antibodies against a particular substance.
Earlier this year, AC Immune shared preclinical data at the Advances in Alzheimer’s and Parkinson’s Therapies (AAT-AD/PD) Focus Meeting, showing that the anti-TDP-43 antibody mitigated brain damage associated with TDP-43 in a mouse model.
These and other studies enabled AC Immune to launch further preclinical studies, aimed at supporting an investigational new drug application for the U.S. Food and Drug Administration, necessary to begin clinical trials in people.
The partnership with WuXi will advance this initiative. In particular, WuXi has the technology to test the strength of the interaction between TDP-43 and the antibody, and to ensure the antibody prevents TDP-43 from becoming toxic. WuXi also has facilities that would allow for a significant increase in anti-TDP-43 antibody manufacturing.
“This strategic partnership highlights the benefits of a synergy between the WuXi Biologics’ integrated platforms and AC Immune’s leading drug discovery and development platforms for neurodegenerative diseases, to rapidly move candidates from discovery through clinical development and accelerate the time-to-market,” said Andrea Pfeifer, CEO of AC Immune.
“Particular expertise is required in the field of monoclonal antibody development, working with a global leader like WuXi Biologics allows us to work together up to commercialization. This also reflects AC Immune’s growth, where previously monoclonal antibodies were licensed out from discovery phase,” she said.
Per the terms of the agreement, AC Immune will retain the intellectual property rights to the anti-TDP-43 antibody, but will gain access to the WuXi facilities and proprietary technologies.
This type of strategic partnership is not new for either company. WuXi specializes in the advancement of investigational biologic treatments, and is currently working on a total of 286 integrated projects at various stages of development worldwide.
Meanwhile, AC Immune, which specializes in treatment discovery, has developed 12 potential therapeutic and diagnostic products, and is currently collaborating with Genentech, Janssen Pharmaceuticals, and Eli Lilly and Company on other projects.
“The agreement with WuXi Biologics is a further demonstration of how we partner productively with major industry players to enhance the drug development process and bring our groundbreaking treatments to patients,” said Pfeifer.
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