ImmunityBio, Inc. - IBRX STOCK NEWS

ImmunityBio announced positive results from its Phase 2/3 trial of Anktiva (N-803) combined with BCG for treating BCG-unresponsive non-muscle invasive bladder cancer. Both cohorts met primary endpoints: 57% disease-free survival after 12 months in cohort B (papillary disease) and a 72% complete response rate in cohort A (carcinoma in situ). Importantly, the therapy had no severe adverse events. A key patent for Anktiva use in bladder cancer has been granted, extending coverage until 2035.

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.