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Fully Human Domain Antibody Therapeutics: the Best of Both Worlds

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Fully Human Domain Antibody Therapeutics: the Best of Both Worlds Drug Discovery Fully Human Domain Antibody Therapeutics: The Best of Both Worlds By combining the therapeutic benefits of small molecule drugs with those of fully human antibodies, Domain Antibodies are expected to have strong therapeutic and commercial potential. By Robert Connelly at Domantis Robert Connelly is Chief Executive Officer of Domantis. He has over 22 years’ commercial experience of the life science sector, including that gained in the fields of diagnostics, drug discovery technologies and antibody therapeutics. Prior to joining Domantis, he was CEO of Veritas Pharmaceuticals (Los Angeles, USA), an in vivo imaging start-up company. He spent over five years with IGEN International, latterly as Senior Vice President and General Manager, Life Sciences, where he took part in the company’s IPO and financing rounds, raising $130 million. The first 11 years of his career were spent at Abbott Laboratories in sales, marketing and management positions. Domain Antibodies (dAbs) are the smallest functional variable regions of either the heavy (VH) or light (VL) binding units of antibodies. At Domantis, we are chains of human antibodies. Domantis scientists applying our proprietary know-how in dAbs to deliver have used the variable domains sequences of human human therapies that address large, unmet medical antibodies to create a series of large and highly needs in areas such as inflammation, cancer and functional libraries of fully human dAbs, with each autoimmune diseases. Three and a half years after library comprising at least 1010 different dAbs. The opening our laboratories, we have a dozen proprietary dAbs selected from these libraries are both specific therapeutic programmes underway, and an additional for their biological target and are well folded and eight therapeutic programmes with partners. A third of well expressed. these have reached a preclinical stage and several are expected to begin clinical trials in late 2006. They The Domantis dAb libraries are a rich supply of drug include dAb products to address chronic obstructive leads, but before I turn to the therapeutic potential of pulmonary disease, rheumatoid arthritis, lupus, dAbs, I need to underline the fact that they can be asthma, solid tumours and multiple myeloma. made cost-effectively and with relative ease. dAbs express at substantially greater yields than full In this article, I aim to cover some of the unique antibodies or other antibody fragments, like Fabs and characteristics of dAbs, which give them particularly scFvs. And unlike conventional antibodies, dAbs are strong therapeutic and commercial potential. This amenable to a wide range of manufacturing processes potential is derived from the fact that dAbs combine – including bacterial, yeast and mammalian cell many of the advantageous characteristics of traditional expression. Their small size should also allow for small molecule drugs and conventional human higher molar quantities per gram of product, antibodies, thereby offering patients and clinicians ‘the providing a significant increase in potency per best of both worlds’. dose. This combination of expression yield, cheaper manufacturing alternatives and dosing DOMAIN ANTIBODIES flexibility should lead to a significant cost of goods reduction compared with full antibodies Domain Antibodies (dAbs) are less than a tenth of and other antibody fragments. Furthermore, the the size of a full antibody and correspond to the proprietary selection technologies we use ensure that 42 Innovations in Pharmaceutical Technology our dAbs are extremely stable and resistant to harsh Dual Targeting dAbs will create Figure 1: Structure of a human dAb conditions, which circumvents some of the delivery, new market opportunities by The protein backbone of a human VK dAb storage and shelf-life issues associated with full offering novel therapeutic (108 amino acid chain) is represented is antibodies. rationales, better efficacy and beige ribbon as well as the exposed surface. increased patient coverage. We The antigen-specificity is defined by amino acids located in three exposed loops – the The Domantis product engine supports the rapid are currently developing dual complementarity-determining regions or generation of dAb leads, such that a constant supply targeting dAbs against cytokine CDRs (in green for CDR1, pink for CDR2 and of early stage molecules is available to progress into targets for inflammatory diseases blue for CDR3). The figure was built with the Pymol software from DeLano Scientific LLC. preclinical evaluation. The robustness of our and respiratory diseases, tumour technology allows us to take 15 discovery programs antigens present on the same from receipt of target to preclinical development in 18 tumour cells for improved months or less, with 35 bench scientists. Remarkably, targeting and growth/angiogenic we have had no attrition to date, and have succeeded factors for solid tumours. Our in all 10 in vivo efficacy models performed. We lead dual targeting dAb product are almost spoilt for choice in terms of the number has now reached the preclinical of drug leads we can take forward and the range of stage and a separate dual targeting diseases they might address. Hence, our plan is dAb product has been successfully to out-license several of our preclinical leads in the delivered to Abbott Laboratories next 12 months, whilst we take several dAbs for their further preclinical and into the clinic. Our proprietary and partner dAb clinical development. therapeutics will offer many unique product advantages to doctors and patients, some of which I TAILORED SERUM will outline below. HALF-LIFE DUAL TARGETING DOMAIN ANTIBODIES Domain Antibodies can be engineered to allow precise control Many human illnesses are multifactorial, involving a over both their biophysical number of targets, so the creation of potent, dual properties and in vivo half-life to create the optimal action dAbs should lead to better therapies for a broad safety and efficacy product profile. In December 2004, range of disorders. Conventional antibodies bind Domantis launched its AlbudAb technology, which strongly to a single therapeutic target. Although extends the serum half-life of a therapeutic molecule by attempts have been made to produce antibodies that several orders of magnitude, from a matter of minutes to can bind multiple targets, most have been hampered several days. by manufacturing and purification issues. Domantis has successfully created Dual Targeting antibody molecules that are fully human, bind two separate targets and can be manufactured using industry standard manufacturing processes in dimer, Fab-like or IgG formats. Natural antibodies have two different variable regions called VH and VL that come together to bind a single target. At Domantis, we have shown that the VH and VL regions of natural antibodies can be replaced with pairs of fully human dAbs to create potent molecules that bind two different therapeutic targets. AlbudAbs are fully human dAbs that bind to serum through preclinical PK studies and efficacy studies albumin. They can be genetically or chemically that show enhanced efficacy of proteins formatted in conjugated to therapeutic molecules – such as proteins, this way. peptides and small molecules – that would normally have short half-lives in humans. Once injected, the DIVERSE DELIVERY OPTIONS AlbudAb-drug conjugate binds to serum albumin in the bloodstream. Serum albumin has a half-life in dAbs are uniquely suited to delivery by injection or humans of three weeks, so drugs with half-lives of (unlike conventional antibodies) non-injectable routes minutes can be converted into AlbudAb-drug such as pulmonary or oral administration. These options conjugates with half-lives of several days. AlbudAbs are possible because dAbs are very soluble, stable when represent a powerful and broadly applicable approach freeze-dried or mixed with a range of excipients, resistant to improving the efficacy of short-lived therapeutic to proteolysis in the colon and suitable for encapsulation. drugs, which we expect to rival the industry gold After reconstitution, dAbs remain highly soluble, with standards – such as PEGylation, Fc fusion and albumin no loss of functional binding activity. The small size of fusion technologies. Furthermore, they are small and dAbs should also allow a sufficient dose to be easy to manufacture in microbial expression systems, delivered by the pulmonary route to treat topically such as bacteria or yeast. AlbudAb formats for diseases of the lung (such as asthma) and by oral customising the serum half-life of dAbs and other delivery to treat disorders of the gastro-intestinal tract proteins have already been successfully validated (such as inflammatory bowel disease). These delivery options should translate into better patient compliance, Figure 2: Formatting human domain antibodies (dAbs) increased potency and fewer side effects compared with A human dAb (11-15 kDa) is either an isolated antibody VH conventional antibodies. domain (in blue) or an isolated VL domain (in pink). These domains confer the antigen specificity to the two chains (H and L chains) which are normally associated as pairs in conventional BROAD THERAPEUTIC RELEVANCE human immunoglobulins (150-180 kDa). To increase the serum persistence of dAbs, a 20-60 kDa molecule of polyethylene glycol Domain Antibodies can address those targets suited to (PEG) (in gray – not to scale) is attached at a specific site within the antigen-specific dAb (in blue). Alternatively, the
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