Pinteon Extends Collaboration with Lonza for Manufacturing PNT001, a Novel Tau Antibody Targeting Alzheimer’s Disease and Traumatic Brain Injury
- The agreement builds upon a long-term collaboration with the aim to provide drug substance of PNT001 for additional clinical studies beginning in Q4 2021
- Drug substance manufacturing will be carried out in Lonza’s brand new, state-of-the-art facility in Guangzhou and will enable Pinteon to conduct clinical trials in the US with potential future expansion into Europe
Quote from Jennifer Cannon, Senior Vice President, Global Head of Mammalian Biologics, Lonza:
“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, CN site.”
Quote from Martin Jefson, CEO, Pinteon:
“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.”
Newton (MA), USA and Basel, Switzerland, 24 June 2021 – Pinteon Therapeutics, a biotechnology company focused on protecting neuronal health by targeting neurotoxic forms of the tau protein, and Lonza announced today that the companies have expanded their manufacturing agreement to enable future clinical production of Pinteon’s lead candidate, PNT001, which showed promising results in Phase 1 clinical study.
This collaboration extension follows a successful multi-year manufacturing relationship established in Lonza’s Slough (UK) site in 2018, providing drug substance (DS) manufacturing for Phase 1 clinical supply. Starting in Q4 2021, PNT001 cGMP DS will be manufactured in Lonza’s brand new, state-of-the-art cGMP mammalian facility in Guangzhou (CN) and will enable Pinteon to conduct clinical trials in the US with potential future expansion into Europe.
PNT001 is a monoclonal antibody targeting an epitope on a highly neurotoxic conformation of the tau protein called cis-pT231 tau. 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. PNT001 is currently being studied in a Phase 1 trial of patients with acute traumatic brain injury. Pinteon expects to initiate a Phase 1b/Phase 2 study of PNT001 in patients with Alzheimer’s disease by the end of 2021.
Pinteon will leverage Lonza’s global manufacturing network, regulatory competence, extensive expertise in manufacturing monoclonal antibodies, and experience in supporting accelerated manufacturing while laying a foundation for potential commercial manufacturing in the future.