CD137 Antibodies Clinical Trials Companies Approval Insight

Release Date: 24-Apr-2023

Cytotoxic T lymphocytes are an essential component of the body’s immunity against cancer, and agents that can stimulate the activation and proliferation of T cells form an ideal therapeutic strategy for the treatment of cancer. The CD137 molecule found on the surface of the T cells is a receptor that has perfect downstream implications in respect to the body’s fight against cancer, and has thus emerged as an impeccable target in the cancer therapeutics domain. For its role in the resulting activation of the cytotoxic T lymphocytes, many therapeutic strategies are now being developed to engage the CD137 and stimulate T cell proliferation and the production of T cell cytokines.


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CD137 was first identified in the late 1980s on activated cells, and further studies were carried out to elaborate on its functions. It was found that though a positive feedback cycle the interaction of the CD137 with its ligand led to the production of more T cells and T cell cytokines that were fruitful for enhancing the immune response towards cancer cells. Since then, the development of anti-CD137 agonist antibodies took up pace and many antibodies with the potential to stimulate the receptor were developed for research purposes. Subsequently, pharmaceutical companies also delved into this research and development process and certain candidates are now in different phases of development of clinical evaluation, with some candidates now in phase II clinical evaluation.


As in the case of other immunotherapies, monoclonal antibodies formed the first drug candidates to enter the pipeline for CD137 drugs pipelines. Roche, Bicycle Therapeutics and Eutilex are among some companies that have CD137 targeted agonistic monoclonal antibodies under clinical evaluation. The initial results from these clinical trials have shined light on the promising future of these candidates because of their potential in generating the required response against the cancer cells.


The success of monoclonal antibodies in the global pharmaceutical industry encouraged drug developers to experiment with the idea of multispecific antibodies as a result of which, many bispecific antibodies entered the development pipelines. The same has been observed in the clinical pipelines of CD137 antibodies wherein, bispecific antibodies targeting CD137 along with another protein target are now being evaluated in clinical trials. In this respect, Yuhan Corp. was one of the first companies to develop drug candidates that targeted the CD137.


Another interesting market player to mention here is Pieris Pharmaceuticals, who ventured into the CD137-targeting drugs domain with its bispecific fusion protein candidates PRS-343 and PRS-344, which consist of CD137-targeting Anticalin proteins genetically fused to each arm of monoclonal antibodies targeting the HER2 and PD-L1 respectively. Anticalin proteins make up a promising new generation of therapeutic agents that are being explored for their associated benefits over antibodies. They can be delivered through non-injectable routes and can penetrate deeper, allowing a more intense therapeutic effect. Both PRS-343 and PRS-344 are being evaluated in phase I/II clinical trials in solid tumors by Pieris.


Adding on this is Sichuan Baili Pharmaceutical and its US-based subsidiary SystImmune with their proprietary tetraspecific antibody candidates to treat hematological and solid cancers. The companies’ candidates have been designed to engage the CD3, CD137 and PD-L1 proteins with three of their arms, with the fourth arm binding to a cancer-specific antigen. One of these namely GNC-038 has entered into phase II clinical trials for the treatment of leukemia and lymphoma, and based on data from trials so far, holds potential to become the first-in-class tetraspecific antibody to gain approval from a regulatory body. GNC-038 was also the first tetraspecific antibody to enter clinical trials for evaluation in humans.


The research and development segment for CD137-targeted drugs looks highly promising considering the abundance of key players of the global pharmaceutical industry engaged in the development of antibodies and other novel strategies to stimulate the CD137 and launch a full-blown attack on cancer cells. It is believed that over 60 candidates are now in different phases of preclinical and clinical trials, and many of these have now entered phase II. Moreover, the first CD137-targeting drug is anticipated to gain approval within the next 5-7 years, which will give an additional boost to its rapidly expanding drugs pipeline.


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