3P Bio to manufacture SpyBiotech vaccine

Under the agreement, Navarra-based CDMO 3P Biopharmaceuticals will produce cGMP lots for Phase I testing of SpyBiotech’s (Oxford) vaccine candidate against the human Cytomegalie virus (CMV) starting next year. SpyBiotech, which has developed a technology platform that allows to "glue" antigens stochiometrically to virus-like particles (VLPs), selected 3P Biopharmaceuticals in June 2019 to manufacture a cGMP batch of their VLP carrier with the goal of completing production in 2021. This carrier will be used to initially display antigens from CMV, but can be used for a huge number of different pathogens. A US partner, for instance, uses SpyBiotech’s platform to couple SARS-CoV-2 antigens to ferritin VLPs. Thus, the vaccine platform can be used to target many infectious agents, but also cancer or chronic diseases.

The SpyCatcher/SpyTag is a platform technology that allows antigens to be displayed onto virus-like particles (VLPs) with a covalent, irreversible bond in a highly stable and effective way with specific orientation/epitope presentation and high density. The platform allows to split a protein from Streptococcus pyogenes into two parts: the SpyTag peptide that can be bound to antigens and its partner protein SpyCatcher that binds to the VLP. The two pieces of the original SpyTag/SpyCatcher protein then bind back together in a spontaneous conjugation forming an unbreakable covalent bond. This innovation can be used for an exceptionally broad range of applications in vaccine development and has established proof of concept data in viral, bacterial, parasitic diseases as well as chronic diseases and cancer.

3P Biopharmaceuticals has led process development and now will produce the first batches for clinical testing. Dámaso Molero, CEO of 3P Pharmaceuticals, said: “It is amazing being part of a project, which presents an opportunity to develop treatments for a broad range of diseases. We are helping to support manufacturing which we believe will open the door for pioneering vaccines which could offer hope for improving the lives of many people. That is extremely exciting.”

Genevieve Labbe, Senior Scientist and GMP Project Manager for SpyBiotech commented: “It’s critical to have a trusted partner in place for cell line and cGMP production. SpyBiotech is looking forward to advancing this product and we are delighted to be working with 3P Biopharmaceuticals, a leading CDMO.”

The partnership is a validation of 3P Biopharmaceuticals’ ability not only to develop and produce biologicals and cell therapy’s GMP compliantly but also find process for highly innovative novel drug formats.  Starting 13 years ago at CIMA Navarra, 3P Biopharmaceuticals has expanded its GMP and FDA-inspected production capacities and staff to over 250 experts and has grown up to one of the most trusted CDMOs in Europe.