Tetraspecific Antibody Emfizatamab Anticipated Approval

Release Date: 23-Mar-2023

In recent years, multispecific antibodies have caused waves in the drug research and development domain for having properties that surpass that of monoclonal antibodies. Tetraspecific antibodies have become the newest kind of multispecific antibody to enter the developmental pipelines and results from preclinical and clinical trials have not been disappointing and point towards the raging potential they possess. Currently less than 10 candidates are being evaluated in clinical trials at present while more than 15 candidates are further expected to enter the trials by 2028.

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Sichuan Baili Pharmaceutical, along with its US-based subsidiary Systimmune, is currently pioneering the development of tetraspecific antibodies having three candidates in their pipeline. These candidates are now progressing towards phase II and therefore offer hope for becoming the first tetraspecific antibodies to get approved by the regulatory authorities. GNC-038 is the candidate farthest in clinical trials and is being evaluated in different subsets of patients with lymphoma such as secondary central nervous system lymphoma and diffuse large B-cell lymphoma.

Other candidates from Sichuan Baili Pharmaceutical and Systimmune are GNC-039 and GNC-035. All these candidates were developed using the companies’ proprietary GNC platform, which allows the development of novel tetraspecific antibodies. The platform is also designed to educate and empower the anti-cancer effects of the candidates developed. GNC-038 is the flag bearer of the concept of the GNC platform and holds a lot of potential as does the platform itself for developing novel tetraspecific antibodies for targeting novel combinations of proteins for cancer cell eradication.

As observed, the market for tetraspecific antibodies is still in infancy. The development of antibodies is mainly still dominated by monospecific and bispecific antibodies because of the clinical and commercial successes of the antibodies of these classes already on the market. The development of these antibody classes was boosted by the approval and the blockbuster status of many of these. Therefore, it is anticipated that the approval of the first tetraspecific antibody will provide a similar boost to the research and development activities aimed at developing tetraspecific antibody in the future, which makes it important to speed up the development and entry of candidates in preclinical trials currently into clinical trials to make this happen. 

GNC-038 has made the most progress in clinical trials since it was first approved for clinical evaluation by China’s National Medical Products Administration in 2019. The drug is being evaluated in China as a part of five clinical trials, the last of which is estimated to conclude in 205. Therefore, it is anticipated that GNC-038, which also goes by the name Emfizatamab, will get approved by 2030 at least by the China’s drug regulatory authority. The other tetraspecific candidates developed by Sichuan Baili Pharmaceutical and Systimmune will follow this hopefully. The company’s innovative platform technology has played an essential role  in enabling this, which highlights the importance of proprietary technologies in the development of tetraspecific and other novel drugs candidates. 

As has been seen in the past with other drug classes, the development of drugs of a novel class was significantly boosted by the approval of the first candidate in the class, which enables the entry of more of those drugs in the global market. The same trend is expected to follow with tetraspecific antibodies, as the first-in-class tetraspecific antibody is anticipated to get approved by 2030. Though Emfizatamab has no designation from the US FDA or the EU EMA, its exceptional properties are anticipated to help it gain approvals for entering clinical trials in the region to allow testing on a wider group of ethnicities, and results from these will help it gain approval in the next few years. 

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