VIENNA, Austria and STRASBOURG, France, February 27, 2018 /PRNewswire/ --
Hookipa Biotech AG, a clinical stage biotech company aiming to develop best-in-class active immunization therapies for infectious diseases and oncology, and ABL Europe SAS, an ABL Inc. company providing dedicated viral vector GMP contract manufacturing (CMO) services for oncolytic, vaccine and gene therapy projects in all stages of clinical development through to commercial launch, have entered in a manufacturing collaboration. Under the agreement, ABL will perform process transfer, scale-up and GMP manufacturing of attenuated replicating viral vectors based on Hookipa's proprietary arenavirus heterologous TheraT® platform.
"The team in Strasbourg is delighted to have been selected by Hookipa to support the manufacturing of innovative viral vectors and we are excited to support the rapid development of high potent immunotherapy candidates in Hookipa's pipeline," commented Patrick Mahieux, Ph.D., General Manager of ABL Europe. "Hookipa's data so far for the TheraT® approach is compelling as vindicated by their recent oversubscribed Series C financing round. The ABL and Hookipa teams have already established a strong relationship and it is our pleasure as we both look forward to developing this further."
Under the manufacturing collaboration, Hookipa will utilize the recently expanded GMP viral vector facilities and capacities of ABL Europe's new state-of-the-art single use bioreactor suite able to support both adherent and suspension cell culture capabilities at a 200 L and 500 L SUB scale. In addition to the supply of drug substance, ABL will manufacture aseptic drug product for Hookipa in-house at the Strasbourg facility, able to accommodate batch sizes in the region of 10,000 vials.
About Hookipa Biotech
Hookipa Biotech is a clinical stage company developing next-generation immunotherapies for infectious diseases and cancer using novel proprietary arenavirus vector platforms.
Hookipa´s Vaxwave® technology presents a completely new replication-defective viral vector platform designed to overcome the limitations of current technologies. Vaxwave® is based on lymphocytic choriomeningitis virus (LCMV). In this vector the gene encoding the LCMV envelope protein, normally responsible for virus entry into target cells, has been deleted and replaced with an antigen of interest. The resulting vectors infect dendritic cells and stimulate very potent and long-lasting immune response, however they cannot replicate and are therefore non-pathogenic and inherently safe.
Hookipa's TheraT® platform is based on an attenuated replicating arenavirus and is capable of eliciting the most potent T cell responses - a crucial step in treating patients with aggressive cancers. Significant pre-clinical data demonstrates that TheraT® is a powerful modality capable of turning "cold tumors hot" which should result in an additional layer of efficacy in the fight against solid tumors. Specifically, TheraT® has proven to be safe in animals as well as capable of eliciting uniquely potent antigen-specific CD8+ cytotoxic T cell responses and strong tumor control in mice. The first clinical trial with HB-201 targeting human papilloma virus-induced head and neck cancer is currently being prepared. This immuno-oncology technology is further being leveraged to target tumor self-antigens or shared neoantigens.
ABL Europe, a subsidiary of ABL, Inc. under the corporate ownership of Institut Mérieux, offers clinical and commercial scale GMP manufacturing of viral vectors for supply of gene therapy, oncolytic and vaccine products for use in all stages of product development globally. From its state-of-the-art GMP facility located in Strasbourg, France, ABL Europe's aseptic processing capabilities for drug substance and drug product, includes stirred single use bioreactors (SUB) < 500 L, adherent capacity in roller bottles or cell stacks < 90 m2, and automated filling using a rigid isolator < 10,000 vials per batch. ABL Europe has recently completed a significant facility expansion of the manufacturing capacity available to its growing client base, currently supporting projects in phase 1/2 development in addition to providing process validation and product supply for phase 3 / pivotal efficacy studies.