ImmunityBio announced that the FDA has granted Breakthrough Therapy designation for its interleukin-15 agonist complex, N-803, in combination with Bacillus Calmette-Guerin (BCG), for the treatment of patients with BCG-unresponsive nonmuscle-invasive bladder carcinoma in situ.
ImmunityBio announced that the FDA has granted Breakthrough Therapy designation for its interleukin-15 (IL-15) agonist complex, N-803, in combination with Bacillus Calmette-Guerin (BCG), for the treatment of patients with BCG-unresponsive nonmuscle-invasive bladder carcinoma in situ.
The cytokine IL-15 plays a crucial role in the immune system by affecting the development, maintenance, and function of the natural killer and T cells. N-803 is a novel IL-15 superagonist complex consisting of an IL-15 mutant (IL-15N72D) bound to an IL-15 receptor α/IgG1 Fc fusion protein. N-803 has improved pharmacokinetic properties, longer persistence in lymphoid tissues, and enhanced anti-tumor activity compared to native, non-complexed IL-15 in vivo.
N-803 is currently being evaluated for adult patients in two clinical NMIBC trials. QUILT 2.005 is investigating use of N-803 in combination with BCG for patients with BCG-naïve NMIBC; QUILT 3.032 is studying N-803 in combination with BCG in patients with BCG-unresponsive NMIBC.
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June 26th 2024“The MAT2A-Trop2 ADC combination targets 2 distinct, yet complementary nodes in patients with MTAP-deleted urothelial cancer and has first-in-class potential to improve clinical outcomes for bladder cancer patients with poor prognosis associated with MTAP-deletion," says Darrin M. Beaupre, MD, PhD.