The expanded manufacturing agreement between Pinteon and Lonza enables future clinical production of PNT001, a novel anti-Tau therapeutic antibody that targets Alzheimer’s disease and traumatic brain injury.
Pinteon Therapeutics, a biotechnology company, and Lonza announced on June 24, 2021 that they have extended their manufacturing agreement to allow future clinical production of Pinteon’s lead candidate, PNT001, which has shown promising results in a clinical study of phase I.
This expansion follows the multi-year manufacturing relationship between companies established at the Lonza’s Slough, UK site in 2018, which were to provide drug substance manufacturing (DS) for clinical supply phase I Beginning in Q4 2021, the Good Manufacturing Practices (CGMP) PNT001 DS will be manufactured at Lonza’s new CGMP mammal plant in Guangzhou, China, which will enable Pinteon to conduct clinical trials in the United States. with potential future expansion in 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 highly 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 said in a press release.
PNT001 is currently being investigated in a Phase I trial for the treatment of acute traumatic brain injury. Pinteon plans to launch a Phase Ib / Phase II study in patients with Alzheimer’s disease by the end of 2021.
âWe look forward to building on a strong relationship with Pinteon to help advance their innovative tau antibody therapy into commercialization. This collaboration demonstrates our flexibility and commitment to providing high quality manufacturing to meet the clinical needs of our global customers while leveraging our cGMP manufacturing expertise at our Guangzhou, [China] site, âJennifer Cannon, senior vice president, global head of Mammalian Biologics, Lonza, said in the press release.
âWe have been working with Lonza since 2017 and appreciate their flexibility to meet our needs. This agreement is exciting because it ensures sufficient clinical supply as we seek to rapidly advance PNT001, a novel tau antibody that uniquely targets a toxic epitope known to drive neurodegenerative disease, âsaid Martin Jefson, CEO of Pinteon, in the press release.