ImmunityBio Receives Conditional Marketing Authorization Recommendation from the European Medicines Agency for ANKTIVA® with BCG for Non-Muscle Invasive Bladder Cancer Carcinoma in Situ—A First in Europe
ImmunityBio (
NASDAQ: IBRX), a leading immunotherapy company, announced today that the European Medicines Agency has recommended granting a conditional marketing authorization in the EU for ANKTIVA® (nogapendekin alfa inbakicept) in combination with Bacillus Calmette-Guérin (BCG) for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ. This recommendation will help facilitate early access to medicines that address conditions where the remaining treatment option is surgery to remove the bladder.
NIAID-Sponsored Study Shows N-803 Combined with Neutralizing Antibodies Could Lead to Sustained HIV Viral Control After Discontinuation of Antiretroviral Therapy
ImmunityBio (
NASDAQ: IBRX), a clinical-stage immunotherapy company, today announced the recent publication of preclinical data in the online issue of Science, First Release indicating that combination therapy with N-803, an IL-15 superagonist, and broadly neutralizing antibodies may potentially enable the immune system to manage human immunodeficiency virus (HIV) without the need for antiretroviral treatment.
N-803 Combined with Natural Killer Cells Showed Potential to Reduce HIV Viral Load in HIV Positive Subjects; Part of HIV Cure Study
ImmunityBio (
NASDAQ: IBRX), a clinical-stage immunotherapy company, today announced data from a Phase 1 pilot study showed N-803 combined with natural killer cells could have the potential to reduce viral load in people living with HIV.
ImmunityBio Announces Full Accrual of First Two Phases of Cancer Vaccine Trial in Participants with Lynch Syndrome and Initiation of Randomized Controlled Phase of the Trial
ImmunityBio (
NASDAQ: IBRX), a clinical-stage immunotherapy company, today announced that enrollment and initial follow-up has been completed for the safety portions of a clinical trial that is studying ImmunityBio’s investigational cancer vaccine of a tri-valent combination of antigens delivered by a second-generation Adenovirus vector (Tri-Ad5 CEA/MUC1/brachyury) together with its IL-15 superagonist N-803 for participants with Lynch syndrome. The study, sponsored by the National Cancer Institute, part of the National Institutes of Health, will include up to 186 participants when fully enrolled and is now open to the randomized controlled portion of the trial.
NEJM Evidence Publishes Results for ImmunityBio’s QUILT 3.032 Registrational Trial of IL-15 Superagonist N-803 Plus BCG in Patients with Bladder Cancer
NEJM Evidence has published results from the QUILT 3.032 trial studying N-803 plus BCG in adults with NMIBC CIS with or without Ta/T1 papillary disease. These positive data form the basis of ImmunityBio’s BLA for BCG-unresponsive NMIBC CIS, which the FDA accepted for review in July 2022.
ImmunityBio Announces FDA Acceptance of Biologics License Application for N-803 in BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer Carcinoma In Situ
The FDA accepted for review a Biologics License Application (BLA) from ImmunityBio, Inc. (
NASDAQ: IBRX), for its antibody cytokine fusion protein as a treatment for patients with BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ (CIS) with or without Ta or T1 disease. ImmunityBio, a leading clinical-stage immunotherapy company, filed the BLA based on positive results from a series of studies of the investigational treatment, including the ongoing QUILT 3.032 trial. The Prescription Drug User Fee Act (PDUFA) target action date is May 23, 2023.
