Genetic Engineering & Biotechnology News

MAY15 2017

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Genetic Engineering & Biotechnology News | GENengnews.com | MAY 15, 2017 | 31 Corporate Capabilities transgenic mouse models. The OmniAb plat- form is based on groundbreaking work in gene editing to overcome this problem. As reported in Science in 2009, a sequence-spe- cific Zn-finger exonuclease was used to inac- tivate the endogenous Ig loci in rat embryos, enabling creation of OmniRat, the first rat model for human antibody discovery 1-4 . For many target indications and antigens, murine models are encumbered by existing intel- lectual property (IP) and on-going litigation presents a considerable risk. In contrast, the OmniAb platform is protected by numerous patents and offers partners freedom to oper- ate across all potential targets and indications worldwide. With the OmniAb platform, it is possible to generate diverse therapeutic hu- man antibodies in both rat and mouse, with- out concern of infringement. OmniAb Models Maximize Probability of Success (POS) The OmniAb platform encompasses three different transgenic animal models for human antibody discovery: • OmniRat 2.0, launched in 2017, harbors a complete set of human V H genes and both light chains for replicating a full range of human mono-specific antibodies • OmniMouse, developed as a complement to the OmniRat, expands the universe of possibly antibodies that can be elicited by a given antigen • OmniFlic, like OmniRat, bears a complete human V H locus, but has a fixed light chain type (kappa) to facilitate engineering and production of bi-specific antibodies All three OmniAb animal models are patent protected and enable generation of fully human antibodies with high affinity, specificity, expression, solubility and stabil- ity. Because each individual animal mounts a different antibody response following immu- nization with a target antigen, the availabil- ity of both rat and mouse OmniAb models is a key platform advantage. Immunizing both OmniRat and OmniMouse ensures drug dis- coverers more 'shots on goal' and the great- est probability of success. The OmniAb platform has been extensively characterized and validated 1-4 . Rodent anti- body expression is inactivated and antibody generation includes all transgenic human V H and V K and V L genes. B-cell development, an- tibody production, and affinity maturation occur normally. Immunization produces a diverse antibody repertoire of human Ig's, in- cluding high-titer, high-affinity (subnanomo- lar) antibodies with broad epitope coverage, and complementarity-determining regions (CDR) diversity and length similar to that seen in a human immune response. Partnering for Success Ligand provides access to all OmniAb animal platforms under flexible licensing terms suitable for small biotech as well as large pharmaceutical companies. The focus of every deal is on maximizing program suc- cess. Options include unlimited or single- target licenses with annual access fee, clinical milestone payments and royalties or unlim- ited access without milestones or royalties. So far about 30 companies have licensed the OmniAb platform, including Genentech, Roche, Pfizer, Merck KGaA, Amgen, Cel- gene and Janssen. The latter recently filed an IND for an antibody discovered using the OmniAb technology, which represents the fourth OmniAb antibody entering clinical development. Recognizing that smaller biotechs and start-ups may prefer to outsource animal care and antibody generation, Ligand has also partnered with Charles River Laborato- ries and Taconic and several CROs to ensure the widest possible access to the OmniAb platform, and ultimately to maximize ad- vances in drug development. n References 1. Geurts AM, Cost GJ, Freyvert Y, et al 2009. Science 325(5939):433 2. Menoret S, Iscache A-L, Tesson, L, et al 2010. Eur J Immunol 40:2932 3. Osborn MJ, Ma B, Avis S, et al 2013. J Immunol 190:1481 4. Bruggemann M, Osborn, MJ, Ma B, et al. 2015. Arch Immunol Ther Exp 63:101 Advertorial Naturally Optimized Human Antibodies ® OmniAb, the industry's only multi-species, genetically engineered platform for the generation of diverse mono- and bi-specific fully human antibodies. Contact us at OmniAb@ligand.com. OMNIAB, OMNIRAT, OMNIMOUSE, OMNIRAT, OMNIFLIC, the mouse design, and NATURALLY OPTIMIZED HUMAN ANTIBODIES are trademarks of OMT, Inc., registered in the United States and elsewhere

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