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. (symbol: IBRX) is a pioneering biotechnology company specializing in immuno-oncology and infectious disease treatments. With a focus on activating both the innate (natural killer cell and macrophage) and adaptive (T cell) immune systems, ImmunityBio is at the forefront of developing innovative molecular and product platforms.
The company's key platforms include the development of antibody-cytokine fusion proteins, DNA, RNA, and recombinant protein vaccines, as well as cell therapies. ImmunityBio is working on several significant product candidates, such as n-803, aldoxorubicin, and a second-generation adenovirus vector. These platforms are designed to activate natural killer (NK) cells, T cells, tumoricidal macrophages, and memory T cells, providing a comprehensive approach to cancer treatment and infectious disease management.
Anktiva, one of ImmunityBio's leading product candidates, is an IL-15 superagonist antibody-cytokine fusion protein, which enhances the body's immune response against cancer cells. The company's pipeline includes treatments targeting bladder, lung, and colorectal cancers, as well as glioblastoma multiforme (GBM).
Headquartered in the United States, ImmunityBio operates across two geographical segments: the United States and Europe, with key revenue generated from European markets. The company is integrated from discovery and development to commercialization, ensuring a seamless transition of its products from the laboratory to the market.
ImmunityBio has achieved several milestones, including the initiation of pivotal clinical trials and strategic partnerships with leading research institutions. These accomplishments underscore the company's commitment to transforming the landscape of immuno-oncology and infectious disease treatment.
Stay informed about ImmunityBio's latest developments, financial performance, and upcoming projects by visiting our news section regularly.
Faraday Future has appointed Yun Han as Chief Accounting Officer and Interim Chief Financial Officer, effective October 25, 2022. Han replaces Becky Roof, who served in the interim role until October 12, 2022. The company expects to receive $10 million this week as part of a $60 million financing agreement, following the successful acquisition of $55 million in financing. The funds will support Faraday Future’s operations and its efforts to bring the FF 91 to market. CEO Dr. Carsten Breitfeld expressed confidence in Han’s experience and the company’s growth potential.
The FDA has accepted ImmunityBio's Biologics License Application (BLA) for N-803, an IL-15 superagonist, targeting BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC). This marks a significant milestone for ImmunityBio as it is their first BLA submission. The application is supported by positive results from the QUILT 3.032 trial, where 71% of patients exhibited a complete response, with a median response duration of 26.6 months. The target action date for FDA review is May 23, 2023.
ImmunityBio has released positive data from pivotal clinical trials for treatments in bladder cancer and advanced pancreatic cancer, presented at the ASCO Annual Meeting. In bladder cancer, 71% of patients achieved a complete response, with a median duration of 26.6 months, and a 91% rate of avoiding cystectomy. In pancreatic cancer, the Nant Vaccine doubled median overall survival to 6.2 months. The company is advancing combination immunotherapy strategies and aims to launch additional trials in earlier treatment settings.
ImmunityBio, Inc. has submitted a Biologics License Application (BLA) to the FDA for N-803, a first-in-class IL-15 superagonist, combined with Bacillus Calmette-Guérin (BCG) for treating BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). The pivotal QUILT 3032 study showed a 71% response rate in previously untreated patients, outperforming existing therapies. If approved, this would introduce the first new immunotherapy for this condition in 23 years, potentially reducing the need for radical cystectomy.
ImmunityBio, Inc. (NASDAQ: IBRX) announced that data from its QUILT 3.032 trial for BCG-unresponsive non-muscle invasive bladder cancer will be presented at the ASCO Annual Meeting, taking place from June 3-7 in Chicago. Principal Investigator Karim Chamie, M.D., will share final clinical results of the pivotal trial involving the IL-15RαFc superagonist N-803 combined with BCG. Additionally, the QUILT 88 trial results showcasing improved survival rates in advanced pancreatic cancer patients will also be presented. ImmunityBio will exhibit at booth 26135.
ImmunityBio (NASDAQ: IBRX) has enrolled the first participants in a significant clinical trial studying its IL-15 superagonist, Anktiva, combined with Keytruda for patients with non-small cell lung cancer (NSCLC) who have not responded to prior checkpoint inhibitors. This trial, part of the Lung Cancer Master Protocol, aims to enroll 478 patients across nearly 200 U.S. sites. With lung cancer being the second most common cancer in the U.S., the results could significantly impact treatment options and patient outcomes, offering a chemotherapy-free alternative.
ImmunityBio (NASDAQ: IBRX) announced significant progress in its QUILT-3.032 clinical trial for treating BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). Over 80 subjects completed at least 12 months of follow-up, with results indicating a 71% complete response rate and a median duration of response of 26.6 months. The company plans to submit its Biologics License Application (BLA) to the FDA this month, following the achievement of Fast Track and Breakthrough Therapy Designations. This positions ImmunityBio as a promising alternative for NMIBC patients.
ImmunityBio, Inc. (NASDAQ: IBRX) announced promising results from a Phase 2 study on cytokine-enriched natural killer (NK) cells for treating acute myeloid leukemia (AML). The study showed that using memory-like NK cells alongside ImmunityBio's IL-15 superagonist, Anktiva™, led to a complete response in 87% of patients after Day 28. The scalable process generates over 20 billion NK cells from a single blood extraction, indicating potential for multiple infusions. These findings support ongoing exploration of m-ceNK cells for liquid and solid tumors.
ImmunityBio, Inc. (NASDAQ: IBRX) has completed its acquisition of a leasehold interest in a pharmaceutical manufacturing facility from Athenex, Inc. (NASDAQ: ATNX) in Dunkirk, New York. This 409,000 square foot facility enhances ImmunityBio's capabilities for large-scale vaccine and immunotherapy production. The site includes clean rooms for manufacturing activities and is expected to significantly expand ImmunityBio's production capacity while reducing capital costs. This strategic move aligns with ImmunityBio's growth plans and aims to accelerate product development.
ImmunityBio, Inc. (NASDAQ: IBRX) announced promising results from its late-stage bladder cancer trial (QUILT-3.032). Of the 83 patients with BCG-unresponsive non-muscle invasive carcinoma in situ (CIS), 71% achieved complete response, with a median response duration of 24.1 months, surpassing FDA-approved therapies like pembrolizumab (41%) and valrubicin (18%). The study showed over 90% cystectomy avoidance and a remarkable safety profile with no severe adverse events. This trial positions ImmunityBio's treatment as a potential new standard of care for bladder cancer patients.
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