3P Biopharmaceuticals, a leading CDMO specialized in the process development and GMP manufacturing of biologics, has signed a collaboration agreement with the Dutch biotech company Xenikos B. V. (Xenikos) that will cover the global manufacturing of Xenikos’ proprietary lead product candidate T-Guard®.
3P and Xenikos started their collaboration in 2015 and now, according to this new agreement, 3P is responsible for the process transfer and scale-up, cGMP production for clinical trials and process validation.
T-Guard is a novel therapeutic approach designed to help reset the immune system in patients who have a severe immune disease or have developed post-transplantation rejection. T-Guard consists of a unique combination of two toxin-conjugated monoclonal antibodies that has been shown in preclinical and early clinical testing to safely and swiftly restore a patient’s immune system.
“We are very pleased to continue working with Xenikos on this project and to create a strong long-term partnership with them,” said Dámaso Molero, General Manager at 3P Biopharmaceuticals. “This collaboration proves the experience and know-how of 3P’s services for recombinant protein production in both mammalian and microbial expression systems. 3P, as a global manufacturing partner, has proven expertise in commercial production as well as in process validation and process characterization.”
“The successful process development and the smooth technology transfer of T-Guard’s GMP manufacturing turned out to be a real team effort. In this process, we have come to know 3P as an appreciated, flexible and reliable service partner that delivers on its promises,” said Ypke van
Oosterhout, PhD, Chief Executive Officer of Xenikos. “We look forward to continuing our collaboration and having the tremendous expertise of 3P on our side as we move our lead candidate into Phase 3 clinical development.”
Xenikos develops innovative new immunotherapies based on conjugated antibodies. This novel therapeutic approach helps reset the immune system in patients who have a severe immune disease or have developed post-transplantation rejection. For its flagship product, T-Guard®, Xenikos expects to file an Investigational New Drug (IND) application with the U.S. Food & Drug Administration (FDA) during 2019 to begin Phase 3 testing for the second-line treatment of steroid-resistant acute graft-versus-host disease (SR-aGVHD) in patients following hematopoietic stem cell transplantation. For more information, please visit www.xenikos.com.
About 3P Biopharmaceuticals
3P Biopharmaceuticals is a leading CDMO specialized in the process development and GMP manufacturing of biologics and cell therapy products. 3P offers its customers solutions at all stages of biologics development: all through the initial process as well as analytics development, preclinical and clinical phases to commercial prodcution. Its extensive experience, flexibility and adaptation as well as innovative technology and qualified team have made 3P an example for the international market.
3P has the support of an important group of investors: Cinfa Group. Cinfa Group is a holding of companies that handle different business lines in the world of health, with more than 50 years of experience and expertise in the biotech and pharma market. It’s flagship company, Laboratorios Cinfa, is a successful manufacturer that ranks first in terms of generics´ retail in Spanish pharmacies.