With revolutionization in the medicinal sector and more of inclination towards personalized therapy, the medical world is also witnessing the emergence of advanced analogues of monoclonal antibodies called as Bispecific monoclonal antibodies. As the name signifies the molecules possess “dual specificity”.
The licensing of the first monoclonal antibody for clinical use dates back to 1986, since then almost 70 therapeutic monoclonal antibodies (MAbs) have been approved throughout the world along with several antibody-related products (e.g., Fc-fusion proteins) making MAbs and related products a dominant component of the biopharmaceutical market, generating revenues of several billion dollars. The approach and specificity of these molecules is no doubt gaining the interest of numerous scientists, pharma, biotechnological companies, research laboratories as well as academic institutions adding to everyday improvement in the biological, physical, chemical and bio-chemical aspects of its action and functioning making the segment more interesting.
With coming of the new technology and more of research in this segment around 50 different formats of bispecific antibody production have been discovered and patented by big pharma ventures. Production of CrossMabs, Diabodies, Nano bodies, Bispecific T-cell engager antibodies (BiTEs), dual-variable-domain immunoglobulin (DVD-Ig™) are some of the most employed and significant techniques. These molecules two distinct binding specificities also have shown great potential for a wide range of clinical applications which includes targeting agents for in vitro and in vivo immunodiagnosis, therapy and for improving immunoassays.
They have proven themselves as promising molecules for targeting cytotoxic effector cells, delivering radionuclides, toxins or cytotoxic drugs to specific targets, particularly tumor cells. Much more stills needs to be unravelled making this sector a huge matter of interest.
The applications of these molecules are as wide as the approaches of their development. They are being developed to tackle the plethora of diseases ranging from different cancers (Prostate, Breast, Colon, Squamous cell carcinomas) to non-oncological segment including various chronic inflammatory diseases such as Rheumatoid arthritis etc. Their multifactorial approach to deal with a disease is making them for acceptable as a player of future health market as most of the disease are multifactorial and require treatment with a combination of drugs. Development of single molecule with all the desirable approaches is no doubt a great driving factor when seen from patient compliance view.
Moreover, it has been observed that a single molecule can heal more than one disease and nothing more can than this factor make a pharmaceutical venture to invest in Research and Development of this wonder molecule. As developing and patenting a single agent for multiple diseases is for sure a matter of huge profit for them. Following years of research and development (R&D), the first trifunctional antibody Catumaxomab (Removab®) was approved in 2009. Another BsAb Blinatumomab (Blincyto) marketed by Amgen entered the market in December 2014 and several more AMG-110, ABT-122, SAR156597 etc. are in clinical trials.
The pipeline of bispecific antibodies seems to be extremely rich with more than 100 proposed drugs in trials with most of them being in their Preclinical trials. Most of these drugs are propagated to enter the market in the coming 5 to 6 years, occupying a huge segment of health market. The phase is stipulated to swirl the medical world as this will for sure lead to more investments in this direction. The major challenges associated are the monetary restrictions for both the manufacturers as well as the consumers. Everything novel in medical sector comes with a huge price tag and this was proved by extensively costly therapy of Blinatumomab, which costed $178,000 per two-cycles making it unachievable for the common patients. Other associated challenges include stringent regulatory guidelines, conduction of clinical trials and long duration of research associated.
This report extensively covers the major events from the infancy to the present status of the Bispecific antibodies. It gives a purposeful outlook of the bright future of this wonder molecule which is sure to establish its niche in the coming years; as the abnormalities it is proposed to deal with along with the ways to mitigate them is proportionately too high to be ignored.
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