Tetraspecific Antibodies Clinical Trials Therapeutic Development Insight

Release Date: 04-Oct-2023

The advent of tetraspecific antibodies as the successor of monospecific and bispecific antibodies was another one of the greatest milestones achieved in the market segment of antibodies. Though tetraspecific antibodies are majorly in clinical development, they have demonstrated treatment outcomes comparable to monospecific and bispecific antibodies, but with an enhanced specificity and less adverse events, giving them an edge. With a number of factors favoring their research and development, tetraspecific antibodies are anticipated to lead the next generation of antibodies in the coming years. 


Sichuan Baili Pharmaceutical and its US based subsidiary SystImmune are credited for pioneering the development and clinical evaluation of tetraspecific antibodies. The companies’ tetraspecific antibody candidate GNC-038 was the first to enter clinical trials. The candidate simultaneously targets CD3, CD19, 41BB and PD-L1, and is in phase II clinical trials for the treatment of lymphoma and leukemia. The companies are also clinically evaluating two more candidates, GNC-035 and GNC-039, in ROR1+ malignancies and EGFRvIII+ malignancies respectively. Both these candidates are in phase I clinical trial and target four antigens simultaneously similar to GNC-038.


The development of GNC-038, GNC-035 and GNC-039 was made possible through the use of the company’s proprietary Guidance and Navigation Control (GNC) technology. All molecules developed on this platform, represented by GNC-038, are tetraspecific T-cell engagers that bind to both cancer cells and immune cells, thereby boosting the ability of immune cells to eliminate cancer cells.


SystImmune’s continuous innovation was highlighted in a poster presentation at the American Association of Cancer Research (AACR) Annual Meeting in 2023. The GNC molecules were presented as a set of multi-specific and multi-modal immune cell engagers capable of driving the regression of malignancies that present specific antigens, overcoming immune escape based on TCRs, and reversing T cell immune suppression in tumor microenvironments.


In addition to Sichuan Baili Pharmaceutical and SystImmune, Innate Pharma is also emerging as a significant player in the market of tetraspecific antibodies, supported by its proprietary ANKETandreg; (Antibody-based NK cell Engager Therapeutics) platform, which allows for the creation of next-generation, multi-specific NK cell engagers for the treatment of certain forms of cancer. IPH6501, a preclinical candidate from Innate, is a first-in-class CD20-targeting tetraspecific ANKET molecule that interacts with NKp46, CD16, IL-2R, and CD20.


In vitro results presented at the EHA 2023 Congress in June indicated that IPH6501 could increase NK cell proliferation and strong NK cell cytoxicity towards CD20+ target cells. Furthermore, IPH6501 was proven to be more efficient than a T cell engager targeting CD20 in ex vivo experiments with relapsed/refractory B-cell non-Hodgkin lymphoma (R/R B-NHL) patient samples.


Aside from this, some tetraspecific options are allegedly being developed for research studies. FL518 and CRTB6, for example, are tetravalent antibodies that suppressed EGFR, HER2, HER3, and VEGF signaling while also disrupting HER-MET interaction via an unanticipated mechanism. They, however, did not advance to preclinical and human trials, and their present development status is unknown.


At present, all these candidates are being developed for the treatment of different cancers; nonetheless, they may also find use in other indications like microbial infections, inflammatory and autoimmune diseases, similar to monospecific and bispecific antibodies. The emergence of this new class of antibodies is anticipated to give an inevitable competition to existing antibodies. It is also believed that positive results from ongoing clinical trials with tetraspecific antibodies will help grab attention of prominent pharmaceutical companies globally, which will ignite the research and development of more of these new generation multispecific antibodies.  


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