The commercial success of monoclonal antibodies in major pharmaceutical markets sparked the development of multispecific antibodies.
The commercial success of monoclonal antibodies in major pharmaceutical markets sparked the development of multispecific antibodies. Bispecific antibodies were the first type of multispecific antibodies to be developed and commercialized. They had the capacity to attach to two receptors at once which made it easier to limit tumor growth through improved immune function by simultaneously agonizing or antagonizing numerous biochemical pathways resulting in an additive or synergistic pharmacological effect. Tri and tetra specific antibodies came into picture following more developmental activities and the market success of bispecific antibodies. Even though neither has been approved yet, they are thought to be even better as compared to monoclonal and bispecific antibodies. Tetra specific antibodies are especially thought to be more efficient and effective than the other three because of the specificity of its receptor arms.
With the advancements in biotechnology, especially after the development of bioinformatics, several novel molecules have now been introduced whose production was historically not considered to be feasible because of the limitations in technology and expertise of researchers. However with improvements in bioinformatics, more particularly after the introduction of computers in the process of designing new molecules, tetra specific antibodies were developed and are now being tested in clinical trials. In certain clinical studies, these antibodies have demonstrated superior inhibitory effects in the case of cancer which demonstrates their possibility in revolutionizing cancer treatment in the future.
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Having four arms developed to bind to four different antigens, tetra specific antibodies are highly specific which theoretically make them even better than the currently commercialized mono specific and bispecific antibodies. Currently, there are no tetra-specific antibody has gained approval from any drug regulatory body but there are some which are under development and are being experimented with, majorly for cancer. All these are in preclinical stage or in early phases of clinical trials. FL518 is one such example of a tetra specific antibody developed by Creative Biolabs. Instead of being an antibody with four arms for antigen recognition, FL518 was instead produced by the fusion of two bispecific antibodies. Therefore, it is a four-in-one IgG form, which is able to simultaneously recognize 4 target antigens without changing the high affinity of its parental antibodies. CRTB6 is another tetra specific antibody, also developed by Creative Biolabs, which is able to simultaneously bind to one EGFR, one HER2, one HER3 and one VEGF.
Currently there are very few clinical trials that have been registered in the clinical trials database which are testing the effects of experimental tetra specific antibodies and China is leading all these trials. All of them are being trialed against both solid tumors and cancers of the blood and are in their phase I or phase I/II of trials. Some of the prominent pharma companies working on the development of tetra specific antibodies are AstraZeneca and Sanofi. However the number of clinical stage biotechnology companies working on these novel antibodies is quite more, including Innate Pharma, Numab and SystImmune among others. Some companies have also developed platforms to aid the production of tetra specific antibodies. For instance, Biomunex, a Paris-based pharma company, has a unique bispecific antibody platform called BiXAb®, whose application can also be expanded for the development for tetra specific antibodies.
Currently, very little is known about this novel class of antibodies. It is still a relatively new pharmacological class, but researchers from all over the world are beginning to pay attention to it. There are now a few research projects underway, so in the upcoming years, we might hear more about these antibodies. Since they are constructed to bind with specific antigen molecules, they are a type of targeted immunotherapy, which has long been favored by physicians and patients as the last resort after the failure of other conventional therapies. Tetra specific antibodies have many advantages over monospecific and bispecific antibodies, including being the most effective and having low non-target interactions hence generating fewer side effects, which is likely to positively affect its use in the treatment of cancer once it is approved. Since there are currently no approved tetra specific antibodies, the approval of the first one will undoubtedly spur additional research in the field, revolutionize the tetra specific antibodies R&D segment, and at the same time, enjoy the commercial benefits that come with its introduction to the market, including market exclusivity and patent protection.
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Neeraj Chawla
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