The smaller size of ESBATech’s proprietary single-chain antibody fragment therapeutics addresses and overcomes many of the challenges associated with whole antibodies when treating diseases of the eye.
Unlike monoclonal antibodies that contain the Fc part of the antibody that triggers immune responses, antibody fragments consist of only the naturally occurring antigen-binding pocket of the monoclonal antibody. This can be advantageous for disease indications such as age-related macular degeneration (AMD) and uveitis, where no immune response is required. For this reason, endogenous proteins make excellent targets for these novel biologics.
“While antibody fragments are an appealing new therapy class, limitations such as poor production yields due to low stability, immunogenicity due to their high proclivity to aggregate, and a short half-life in the blood stream have hindered their success in preclinical and clinical trials,” says Frost & Sullivan Research Analyst Misty Hughes. “In response, ESBATech developed its cutting-edge, repeatable-antigen independent screening platform, Immuna®, for selecting and optimizing highly-stable, single-chain antibody fragments (scFv) without any phage display.”
ESBATech’s successful screening and characterization of all 1.5 million naturally occurring antibody fragment frameworks resulted in highly-stable, single-chain antibody fragments. These drug-like fragments are ideal for pioneering therapeutic interventions that require high drug affinity and specificity, but do not require an immune effector response. ESBA105, the company’s lead product candidate, is a recombinant humanized scFv non-aggregating antibody fragment being evaluated in treating a number of indications including ocular disease.
ESBA105 is directed against human TNF? – a cytokine that has been identified as the cause of many inflammatory conditions including uveitis, a group of inflammatory diseases affecting the uvea. To date, the only class of drugs approved to treat uveitis is corticosteroids, which are often associated with serious side effects such as cataract and glaucoma hypertension, and in many instances must be dosed up to 16 times a day.
However, topical corticosteroids only show limited intraocular penetration, and in severe disease cases they frequently require periocular injections or even systemic immunosuppressive therapy. In contrast, in preclinical in vivo testing, high concentrations of ESBA105 were achieved in all segments of the eye when administered topically through eye drops. As anterior uveitis accounts for up to 90 percent of all cases of uveitis, FDA approval of ESBA105 – which, pending favorable clinical studies the company anticipates could come as soon as 2012 – will undoubtedly offer those with this disease a much needed and much more convenient treatment.
“The ability of ESBATech’s innovative antibody fragments to improve clinical effects as compared to typical monoclonal antibody therapies, offers the company limitless possibilities in advancing and improving treatment options for not only ocular diseases, but numerous disease targets,” notes Hughes. “The company’s antibody fragment’s unique capacity to topically and locally deliver high drug concentrations to targeted sites, coupled with strikingly low systemic load and the resulting lowered risk of drug interactions, puts it at the forefront of innovation ushering in a new era in medicine.”
In recognition of these innovations in biotechnology, Frost & Sullivan is pleased to present ESBATech with the 2009 Technology Innovation of the Year Award in the ophthalmic pharmaceuticals market. Each year, this award is presented to a company that has demonstrated technological superiority within its industry. The award acknowledges the ability of the company to successfully develop and introduce new technology, formulate a well-designed product family, and make significant product performance contributions to the industry.
Frost & Sullivan’s Best Practices Awards recognize companies in a variety of regional and global markets for demonstrating outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service, and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analysis, and extensive secondary research in order to identify best practices in the industry.
ESBATech is a clinical-stage biotechnology company concentrating its research in developing and commercializing fully human single-chain antibody fragments and formulation technologies to safely and non-invasively deliver biologic therapeutics. The company was the first to non-invasively deliver an ophthalmic biologic drug via eye drops elucidating a depot effect in the eye’s vitreous. ESBATech’s lead antibody fragment, ESBA105, is in clinical trials for several indications including uveitis, an inflammatory condition responsible for an estimated 10 to 15 percent of all cases of blindness in the Unites States. The company recently completed a phase I clinical study of ESBA105, and is now in preparation for phase II trials.
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