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The extended manufacturing agreement between Pinteon and Lonza enables future clinical production of PNT001, a novel Tau antibody therapeutic that targets Alzheimer's disease and traumatic brain injury.
Pinteon Therapeutics, a biotechnology company, and Lonza announced on June 24, 2021 that they have expanded their manufacturing agreement to enable future clinical production of Pinteon's lead candidate, PNT001, which has shown promising results in a Phase I clinical study.
This extension follows the multi-year manufacturing relationship between the companies established in Lonza's Slough, UK, site in 2018, which was to provide drug substance (DS) manufacturing for Phase I clinical supply. Starting in the fourth quarter of 2021, PNT001 current good manufacturing practice (CGMP) DS will be manufactured in Lonza's new CGMP mammalian facility in Guangzhou, China, which will enable Pinteon to conduct clinical trials in the United States with potential future expansion into Europe.
PNT001 is a monoclonal antibody that targets cis-pT231 tau, an epitope on a highly neurotoxic conformation of the tau protein. This conformation of tau is acutely neurotoxic and also contributes to the initiation and spread of tau pathology in neurodegenerative tauopathies, such as traumatic brain injury, chronic traumatic encephalopathy, Alzheimer's disease, and progressive supranuclear palsy, the companies stated in a press release.
PNT001 is currently being studied in a Phase I trial for treating acute traumatic brain injury. Pinteon expects to initiate a Phase Ib/Phase II study in patients with Alzheimer's disease by the end of 2021.
"We look forward to building upon a strong relationship with Pinteon to help advance their innovative tau antibody therapy towards commercialization. This collaboration highlights our flexibility and commitment to providing high-quality manufacturing to serve the clinical needs of our global customers while also leveraging our cGMP manufacturing expertise at our Guangzhou, [China] site," said Jennifer Cannon, senior vice-president, global head of Mammalian Biologics, Lonza, in the press release.
"We have been working with Lonza since 2017 and appreciate their flexibility in responding to our needs. This agreement is exciting because it ensures sufficient clinical supply as we look to rapidly advance PNT001, a novel tau antibody that uniquely targets a toxic epitope known to drive neurodegenerative disease," said Martin Jefson, CEO, Pinteon, in the press release.