Welcome to our dedicated page for Immunitybio news (Ticker: IBRX), a resource for investors and traders seeking the latest updates and insights on Immunitybio stock.
ImmunityBio, Inc. (NASDAQ: IBRX) generates frequent news as a commercial-stage biotechnology company centered on IL‑15–based immunotherapies and cell therapies. Its updates often highlight clinical data, regulatory milestones, and commercial performance for ANKTIVA, an IL‑15 receptor agonist fusion complex that the company describes as a key component of its BioShield platform.
News coverage commonly focuses on bladder cancer and non‑small cell lung cancer (NSCLC). For non‑muscle invasive bladder cancer, ImmunityBio reports results from the QUILT‑3.032 trial of ANKTIVA plus BCG in BCG‑unresponsive disease, including data on disease‑specific survival, progression‑free survival, and cystectomy avoidance. For NSCLC, press releases describe findings from QUILT‑2.023 and QUILT‑3.055, where ANKTIVA combined with checkpoint inhibitors has been associated with immune restoration, measured by absolute lymphocyte count, and linked to survival outcomes in checkpoint‑experienced patients.
Regulatory developments are another major news theme. Recent announcements include a conditional marketing authorization recommendation from the European Medicines Agency for ANKTIVA plus BCG in BCG‑unresponsive NMIBC CIS, as well as Saudi Food and Drug Authority approvals for ANKTIVA plus BCG in NMIBC CIS and for ANKTIVA in combination with checkpoint inhibitors in metastatic NSCLC, including the first approval for subcutaneous administration. These items illustrate how ImmunityBio’s news flow tracks the global expansion of ANKTIVA‑based regimens.
Investors and observers can also expect news on financial results and product revenue, particularly net product revenue and unit growth for ANKTIVA, along with cash position and capital‑raising activities disclosed in earnings releases and related Form 8‑K filings. Additional stories cover early data in glioblastoma using ANKTIVA plus NK cell therapy and the Optune Gio device, initiatives in non‑Hodgkin lymphoma and other cancers, and participation in forums such as the U.S.–Saudi Biotech Alliance Summit.
By following ImmunityBio’s news page, readers can track clinical trial progress, new approvals, and commercial trends that shape the outlook for IBRX and its IL‑15–based immunotherapy programs.
CytRx Corporation highlights the early efficacy of its licensed drug aldoxorubicin in ImmunityBio's Phase 2 trial for advanced pancreatic cancer. The trial shows that 90% of evaluable patients exceeded historical survival rates, with 87% of those with extremely advanced disease also surpassing these rates. Mature data is expected in Q1 2022, and ImmunityBio is expanding enrollment due to positive early results. CytRx has potential milestone payments of up to $343 million from ImmunityBio for aldoxorubicin.
ImmunityBio has completed enrollment of 50 participants in Cohort C of its QUILT 88 trial, focusing on advanced metastatic pancreatic cancer. The early results show that 90% of evaluable patients surpassed the two-month historical survival rate with standard chemotherapy. Among the most advanced patients, 87% exceeded these rates. The company plans to increase enrollment due to the positive early data and aims to discuss approval pathways with the FDA in 2022.
ImmunityBio, a clinical-stage immunotherapy company, has announced the initiation of the Lung Cancer Master Protocol (Lung-MAP) trial, to evaluate its IL-15 receptor superagonist complex, N-803 (Anktiva), combined with Merck's pembrolizumab (Keytruda) for patients with non-small cell lung cancer (NSCLC) who have failed previous treatments. The study will target 478 patients and will be conducted at over 700 sites in the U.S. This landmark study aims to enhance treatment options for NSCLC patients without targetable mutations, providing a potential chemotherapy-free alternative with fewer side effects.
ImmunityBio (NASDAQ: IBRX) reported promising results from its ongoing QUILT 3.032 bladder cancer trial, revealing that 72% of 81 patients achieved a complete response to the combination of intravesical BCG and N-803 (Anktiva). The median duration of this response was 19.9 months, with 85% of patients avoiding cystectomy as of May 2021. Moreover, there were no reported treatment-related serious adverse events. The data was presented on September 10 at the American Urological Association’s Annual Meeting, highlighting the drug's potential to redefine treatment for BCG-unresponsive patients.
ImmunityBio (NASDAQ: IBRX) has appointed Helen Luu as its first Chief Commercial Officer and Sigrid Schreiner as Senior Vice President of Global Market Access. Luu, previously CEO of Cell BT, brings extensive experience in urology and oncology commercialization, while Schreiner has over 25 years in market access. These appointments are strategically aimed at enhancing ImmunityBio's commercialization efforts as it advances its Phase 2 and 3 clinical trials in bladder and lung cancer. The company aims to leverage their expertise to drive growth and market penetration.
ImmunityBio, Inc. (NASDAQ: IBRX) announced that Dr. Karim Chamie from UCLA will present Phase 2/3 clinical results of IL-15 Superagonist N-803 combined with BCG for BCG-unresponsive bladder cancer at the American Urological Association's Annual Meeting on Sept. 10. Cohort A of the QUILT 3.032 trial now includes 81 subjects with a median follow-up exceeding 20 months. The trial has received Fast Track and Breakthrough Therapy Designations from the FDA, indicating significant potential for treating non-muscle invasive bladder cancer.
CytRx Corporation highlights the positive results from the Phase 2/3 trial of arimoclomol, an investigational treatment for Niemann-Pick disease type C. The study showed a significant treatment effect with a 65% relative reduction in disease progression over 12 months. Notably, in patients aged 4 and above, arimoclomol demonstrated an 82% reduction. The treatment was well-tolerated, with fewer serious adverse events compared to placebo. Orphazyme is awaiting a regulatory decision in Europe by Q4 2021 and is assessing the path forward in the U.S.
ImmunityBio has been granted a patent (U.S. Patent 11,071,774) for its NANT Cancer Vaccine, enhancing its proprietary immunotherapy approach. This candidate aims to stimulate the immune system against cancers using natural killer and T-cell therapies and has been in clinical testing since 2017. The NANT Cancer Vaccine has been studied in over 100 patients across various cancers, with a Phase 2 trial (QUILT 88) focused on metastatic pancreatic cancer. The patent recognition reaffirms the innovative treatment strategy aimed at reducing chemotherapy toxicity while providing long-term immunity.
ImmunityBio (NASDAQ: IBRX) received authorization from the South Africa Health Products Regulatory Authority to initiate the Sisonke T-Cell Universal Boost trial, set to begin in Q3 2021. This Phase 1/2/3 study will assess the efficacy of the hAd5 Spike + Nucleocapsid vaccine as a booster for healthcare workers already vaccinated with an S-only vaccine. Preliminary Phase 1 results indicate a 10-fold increase in T cell response. The trial will also explore combined vaccination routes, highlighting an urgent need for a boost to protect against emerging COVID-19 variants.
ImmunityBio (NASDAQ: IBRX) and NantOmics announced a new pipeline for identifying neoepitopes and neoepitope-reactive T cells in cancer patients. This methodology aims to personalize immunotherapy by predicting mutated peptide sequences that trigger immune responses. Collaborative efforts with leading institutions have shown promise in previous trials, hinting at improved cancer treatment outcomes. ImmunityBio's approach integrates bioinformatics for neoepitope discovery, potentially enhancing vaccine and cell transfer therapies.