- Source : Press Release
- Date : 2021-06-24
- Event type : Phase 1
- Companies : Lonza Group Ltd.
Pinteon Extends Collaboration with Lonza for Manufacturing PNT001, a Novel Tau Antibody Targeting Alzheimer's Disease and Traumatic Brain Injury
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.
Lonza is the preferred global partner to the pharmaceutical, biotech and nutrition markets. We work to prevent illness and enable a healthier world by supporting our customers to deliver new and innovative medicines that help treat a wide range of diseases. We achieve this by combining technological insight with world-class manufacturing, scientific expertise and process excellence. These enable our customers to commercialize their discoveries and innovations in the healthcare sector.
Founded in 1897 in the Swiss Alps, today Lonza operates across five continents. With approximately 14,000 full-time employees, we are built from high-performing teams and of individual talent who make a meaningful difference to our own business, as well as to the communities in which we operate. The company generated sales of CHF 4.5 billion in 2020 with a CORE EBITDA of CHF 1.4 billion. Find out more at www.lonza.com.
Follow @Lonza on LinkedIn
Follow @LonzaGroup on Twitter
About Pinteon Therapeutics
Pinteon Therapeutics is advancing clinical studies of a novel antibody that aims to interrupt the spread of toxic tau and protect and preserve brain function in patients with neurodegenerative disease, with a focus on Alzheimer’s disease and traumatic brain injury. Pinteon's lead asset, PNT001, is the only antibody in development that targets cis-pT231 tau, a neurotoxic epitope that has been identified in multiple preclinical studies as a potent driver of neurodegenerative disease. Pinteon is led by an experienced management team with strong track records in CNS drug discovery and development and is funded by Morningside Ventures. For more information, visit pinteon.com.
Lonza Contact Details
Head of External Communications
Lonza Group Ltd
Tel 41 61 316 2283
Dr. Martina Ribar Hestericová
Trade Media Lead
Lonza Group Ltd
Tel 41 61 316 8982
Lonza Group Ltd
Tel 41 61 316 8540
Pinteon Therapeutics Contact Details
Ten Bridge Communications
Tel 1 678-662-9166
Additional Information and Disclaimer
Lonza Group Ltd has its headquarters in Basel, Switzerland, and is listed on the SIX Swiss Exchange. It has a secondary listing on the Singapore Exchange Securities Trading Limited ("SGX-ST"). Lonza Group Ltd is not subject to the SGX-ST's continuing listing requirements but remains subject to Rules 217 and 751 of the SGX-ST Listing Manual.
Certain matters discussed in this news release may constitute forward-looking statements. These statements are based on current expectations and estimates of Lonza Group Ltd, although Lonza Group Ltd can give no assurance that these expectations and estimates will be achieved. Investors are cautioned that all forward-looking statements involve risks and uncertainty and are qualified in their entirety. The actual results may differ materially in the future from the forward-looking statements included in this news release due to various factors. Furthermore, except as otherwise required by law, Lonza Group Ltd disclaims any intention or obligation to update the statements contained in this news release.