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Published Date : April 2019

Nanobodies have emerged as one of the best technologies in the fields of therapeutic and diagnostic research.  This technology came to the forefront with the development of antigen binding fragments which has its origins in the heavy chain antibodies of the Camelid. In sharp contrast to the antibodies found in human, the molecular structure of nanobodies does not have any light chains.  In this backdrop, nanobodies molecule consisting single domain only were developed whose functional and structural properties were similar to heavy chain antibodies.  In comparison to conventional antibodies, these molecules rendered several advantages like picomolar to nano affinities, and administration through multiple routes.

In the global market of nanobodies, it is anticipated that Europe will hold a dominant position by virtue of the first mover advantage. At present Europe is the only market to make nanobodies commercially available. In this regard, mention could be made to Caplacizumab developed by Ablynx and approved in the European Union that is used in the treatment of acquired Thrombotic Thrombocytopenic Purpura (TTP). Eminent companies like Merck and Co. in collaboration with Ablynx are working on the development of multi specific nanobodies by heavily investing I/O R&D pipeline. Keytruda® has been approved in for advanced melanoma (first line) and metastatic NSCLC where more than 160 clinical trials have been conducted for more than 30 different kinds of tumor.

Ablynx has already filed for a biologic license agreement for the same product to U.S FDA in 2018 and expects to get it approved from the FDA by 2019. Hence, there is a high possibility that the North American market will take giant strides in growth.

In the Asia Pacific, Japan may emerge as the hotbed as several products like Caplacizumab, Vobarilizumab, and ALX- 0171 has successfully gone through the initial phase of clinical development.

However, it has to be kept in mind, more than two-third products are in a very early phase of development and they will have to go through various phases of clinical trial. If these products fail to clear the clinical trials or gets delayed approval from regulatory bodies in the market it may prove to be a vital restraint in the contemporary market.

Novartis is the first company to have its antibody anti-IL-17 approved by the European Union and the US for the treatment of psoriasis. Antibodies like ALX0171 for the treatment of Respiratory Syncytial Virus in infants and ALX 0061 Anti IL-6R Nanobody for the treatment of Autoimmune disorder, and ALX 0761 (IL-17A/F) for the treatment of psoriasis are undergoing the second phase of clinical trials.

Conclusion

Nanobodies that are already in the pipeline or in advanced clinical trial phases are intended to treat cancer, diseases like amyloidosis, viral infection or toxin envenoming. No doubt, they are versatile molecules having properties that can be used in therapeutic and diagnostic applications, and on research tools. The way has been paved where inexhaustible potentials of nanobodies can be utilized to position them as pharmaceuticals for use in daily clinical practice.   

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