Research & Development (R&D)

ReiThera has 20 years experience conducting successful preclinical studies in different inbred and outbred mouse strains, as well as in coordinating immunogenicity and efficacy studies in other relevant animal models (rats, rabbits, bovine, non-human primates) where the in vivo phase is outsourced. The Immunology team has strong laboratory expertise in the analysis of both humoral and cellular immunity directed at the encoded antigens and the viral vector itself that led to publications in high impact journals, patents’ inventorship and clinical development.

Given this track record, ReiThera is well equipped to directly run immunogenicity and efficacy studies in mice and coordinate studies outsourced to CROs when relevant and/or specific animal models are requested. The company has direct access to an animal facility for rodent species including in vivo imaging instrumentation. The immunology lab is equipped with two cytofluorimeters (8 and 13-colors), a FACS sorter, and state-of-the-art readers enabling implementation of multicolor ELISpot with a colorimetric or fluorescent readout for accurate measurement of antigen-specific T cells and antibody-secreting B cells (ASC). The R&D team has experience in the administration of viral vectors via systemic and mucosal routes in animal models, and in the development of cell-based or soluble (serum or body fluid) immunoassays with optical density, luminescence or fluorescence read outs for quantification of antibody responses (total and neutralizing). Established SOPs for organ and tissue processing and isolation of relevant immune cell populations are also available.

Our proven expertise in the design and sponsoring of GLP Toxicology and biodistribution studies of viral vector-based vaccine candidates have been instrumental in the successful progression of programs to clinical testing.

ReiThera can support studies of immune responses in human samples from observational and clinical studies, using validated protocols.

ReiThera has developed tools and procedures based on high-throughput sequencing for the generation of human monoclonal antibodies for virtually any native antigen involved in human diseases, for therapeutic and/or diagnostic applications.

ReiThera’s technology has been successfully applied to the generation of human anti-infectious and immunomodulatory antibodies capable of binding their targets in their native conformation. By massive parallel screening of molecular repertoires with activated human lymphocytes we generated large collections of human mAbs against different immune checkpoints: LAG-3, PD-L1, PD-1, TIM3, BTLA, TIGIT, OX40, 4-1BB, CD27 and ICOS. Our mAbs were shown to have comparable or better binding affinity and biological activity than the clinically validated anti-PD-1 mAb nivolumab.

The repertoires generated in this work represent a convenient source of agonistic or antagonistic antibodies against the ‘Checkpoint Immunome’ for preclinical screening and clinical implementation of optimized treatments.

The aim of the Technology Development is to unlock the potential of the viral vector gene delivery platforms for any medical need.

The team is skilled in creating new and innovative cloning strategies for a number of viral vector systems, including adenoviruses (replication incompetent, replication competent and high capacity helper-dependent HD adenoviruses), Adeno-Associated Viruses (AAV), Modified Vaccinia Ankara (MVA), RhabdovirusesLentiviruses and Retroviruses, in order to improve vector technology.

Vector engineering and optimization of gene delivery represent the major objectives of this unit. The Unit works closely with the Process Development team and the Immunology Unit by supporting not only vector construction but also its characterization in vitro and in vivo and the definition of new strategies to improve the production process

ReiThera’s Clinical Trial Department (CTD) is a flexible and responsive Team accustomed to developing a regulatory strategy plan early in the vaccine development, and to interact collaboratively with regulatory authorities. Phase I Clinical Trial sponsorship has evolved together with the current ICH-GCP guidelines, under which the ReiThera’s CTD takes care of the IMP lifecycle management, preclinical and CMC Regulatory documentation, Early Phase Clinical Trial application and Clinical Trial management.