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IL-15 plays a vital role in the immune system by affecting natural killer cells and T cells, and N-803 is a new IL-15 hyper agonist complex, made up of IL-15 mutants (IL-15N72D) and IL-15 subjects α/IgG1 Fc fusion proteins.
N-803 has better pharmacodynamic properties, longer presence in lymphatic tissue, and stronger anti-tumor activity than natural, non-composite IL-15 in the human body.
previously awarded N-803 fast-track qualification based on Phase I clinical study data, and in 2019, based on Phase II clinical studies, the FDA awarded N-803 breakthrough therapy.
bladder cancer is one of the world's most common malignancies, with about 212,536 deaths from bladder cancer in 2020 and about 573,278 new confirmed cases.
In the United States, bladder cancer is the fourth most commonly diagnosed malignant solid tumor in men, with about 75-85% of all newly diagnosed cases of bladder cancer being non-myocardial indaching bladder cancer (NMIBC) patients.
nearly 30 years, the immunotherapy has been the standard treatment for NMIBC, however, the recurrence and progress rate of the disease is very high.
patients with relapses, 30 percent progressed and eventually died within 15 years, and another 50 percent undercurred bladder removal to control the condition.
Soon-Shiong, chairman and chief executive officer of ImmunityBio, said NMIBC's high rate of progress and recurrence made it one of the most overburdened cancers to treat.
's initial treatment results are encouraging and provide evidence that N-803 is another new treatment option for NMIBC patients following a highly invasive genomic bladder excision, and we plan to submit a biological product license application for N-803 after meeting with the FDA in 2021.
content Source: Medical Rubik's Cube Info