CD3 Antibodies Clinical Trials Market Size Companies Insight


Kuick Research Report Highlights Ongoing Clinical Developments, Antibodies Sales & Market Trends

Delhi, March 21, 2023 (GLOBE NEWSWIRE) — Antibodies have transformed cancer treatment because of their flexible properties that allow them to be used as both antagonists and agonists. With the introduction of multispecific antibodies, it came to be known that antibodies can be molded as needed to treat different indications. After this, a new artificial class of antibodies known as T cell engagers and bispecific antibodies are currently becoming more and more well-known. They attach to a cancer antigen and the CD3 co-receptor on T cells, helping to drive T cells to kill cancer cells. Blincyto has become recognized as the face and pioneer of bispecific antibodies over time, and it has sparked the creation of T cells engagers with novel mechanism of action. The market is now expanding rapidly because of the entry of a large number of candidates binding to the CD3 protein.

Three of the five antibodies that have been given FDA and EMA approval to date are currently on the market. Since they were developed as first-in-class antibodies with higher efficacy and safety profiles than the therapies used to treat these indications, they were all approved under the FDA’s accelerated approval and the EMA’s conditional marketing approval programmes. The majority of these antibodies binds to the CD3 protein complex and engages T cells. The complex is essential for antigen recognition and T cell activation, and the usage of T cell engagers facilitates and accelerates antigen recognition.


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However, one of them commercialized as Tzield, has been created as a CD3 complex blocker and was granted approval in November 2022. Tzield was created and given the regulatory green light as a medication to treat patients at risk for developing Type 1 diabetes, an autoimmune disease. It attracted attention right away because it was the first medicine to be approved with the ability to alter a disease. This groundbreaking drug was developed and commercialized by Provention Bio until it was acquired by pharmaceutical behemoth Sanofi in March 2023. The expense of treating type-1 diabetes is relatively costly, thus Tzield helps by delaying the onset of the condition and thereby delaying the need for therapy and by adding Tzield to its pipeline, Sanofi aims to make the drug accessible to those who need it.

Apart from cancer and type-1 diabetes, antibodies biding with the CD3 complex are also being investigated for the treatment of a number of unrelated conditions as well such as inflammatory and autoimmune diseases. Tiziana Life Sciences recently announced that it had started a pilot study using its drug Foralumab to treat COVID-19. Its CD3-blocking monoclonal antibody was initially tested for type 1 diabetes, Crohn’s disease, and progressive multiple sclerosis and was discovered to lower inflammatory markers in COVID-19 patients. It strengthened its promise in inflammatory diseases by further dampening the inflammatory T cell response and reducing lung inflammation in COVID-19 patients.

As more novel and superior candidates continue to make their way into clinical trials, the future of CD3 antibodies is promising. For example, BioAtla recently announced FDA clearance of the investigational new drug application for its asset BA3182, an EpCAM × CD3 bispecific T-Cell engager, for the treatment of the majority of common subtypes of adenocarcinoma, such as colon, lung, breast, pancreatic, and prostate. Due to the extensive target distribution of the EpCAM in normal tissues and powerful T cell activation, studies with drugs targeting the EpCAM and CD3 were impeded before this by dose-limiting toxicities. Contrarily, BA3182 has great specificity and affinity when binding to the target proteins, human EpCAM and human CD3, under the typically acidic conditions of the tumor microenvironment, demonstrating its efficacy and safety in the treatment of these malignancies.

Years ago, the CD3 had demonstrated its potential as a therapeutic target for a number of diseases, but the ongoing success of Blincyto has brought it back into the spotlight. Five of the many candidates that have been developed to this point have received regulatory approval. Furthermore, four further candidates are predicted to receive approval in 2023, further securing the future of the CD3 targeting antibodies market. More CD3 engaging and blocking antibodies are likely to enter the clinical pipeline in the next years as a result of targeted antibodies receiving increasing attention in recent years.

CONTACT: Contact: Neeraj Chawla Kuick Research Research Head [email protected]

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