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ImmunityBio is pursuing the development of an hAd5 COVID-19 vaccine using S-Fusion and N-ETSD—our novel construct of COVID-19 spike (S) and nucleocapsid (N) proteins. This vaccine candidate generated CD4+ and CD8+ T cell-mediated immunity and neutralizing antibodies in animal models, and inhibition of viral replication in nasal and lung passages in a non-human primate challenge study. On October 13, 2020, the FDA authorized the Phase I, open-label, dose-finding study to examine the safety, reactogenicity, and immunogenicity of the low-dose (5×1010 VP) and intermediate-dose (1×1011 VP) in healthy volunteers. In early 2021, we received FDA authorization to study sublingual and oral formulations with a chosen subcutaneous dose
ImmunityBio announces durable virus control of SHIV without anti-retroviral therapy #ART by activating #NK and memory T cells with #N803, an #IL15 superagonist. First demonstration of durable control of viremia without antiviral therapy in 9 of 13 SHIV-infected monkeys receiving combination therapy with N-803 and broadly neutralizing antibodies; Study results presented at the Conference on Retroviruses and Opportunistic Infections #CROI #infectiousdisease #SHIV
ImmunityBio has received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) 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 non-muscle invasive bladder carcinoma in situ (CIS). #immunotherapy
