ImmunityBio, Inc. - IBRX STOCK NEWS

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.

ImmunityBio (NASDAQ: IBRX) has received FDA authorization for a Phase 1b/2 study to assess the safety and efficacy of Anktiva (N-803) and PD-L1 t-haNK cells combined with Trodelvy in advanced triple-negative breast cancer (TNBC) patients. This study aims to evaluate if the combination can enhance Trodelvy's effectiveness in patients who haven't responded to previous treatments. The global incidence of breast cancer was 2.3 million last year, with TNBC being particularly aggressive and accounting for 10-15% of cases. The trial seeks to offer new hope to this patient group.