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.
ImmunityBio (NASDAQ: IBRX) has initiated dosing in its Phase 1 clinical trial of CAR-NK cell therapy for treating relapsed B-cell Non-Hodgkin Lymphoma. The QUILT 106 trial, testing CD19-targeted high-affinity natural killer cells, represents the first NK cell-based therapy study in Africa. The trial will enroll up to 10 participants across three South African cities. Initially testing the therapy as a single agent, the study will later combine it with rituximab after safety confirmation. Full enrollment is expected in Q1 2025, with topline data anticipated in H2 2025. This trial mirrors the company's U.S.-based QUILT 3.092 study.
ImmunityBio (NASDAQ: IBRX), an immunotherapy innovator, has announced its participation in the Jefferies London Healthcare Conference. The event is scheduled for November 19-21, 2024 at the Waldorf Hilton London. Company executives will engage in a fireside chat on Tuesday, November 19, 2024, at 2:30 PM GT.
Investors and interested parties can access a replay of the recorded presentation through the Events and Presentations section of ImmunityBio's website at https://ir.immunitybio.com/. The replay will be available for 90 days following the conference.
ImmunityBio (NASDAQ: IBRX) presented positive long-term overall survival data for non-small cell lung cancer (NSCLC) patients at the World Conference on Lung Cancer. The Phase 2 QUILT 3.055 trial showed extended survival of 14 months to five years for advanced NSCLC patients treated with ANKTIVA in combination with checkpoint inhibitors like KEYTRUDA or OPDIVO. Key findings include:
- 57% overall survival at 12 months
- 34% overall survival at 18 months
- Survival independent of PDL1 tumor status and line of therapy
- Efficacy in patients who progressed on previous checkpoint inhibitor treatments
Based on these results, ImmunityBio plans to launch global Phase 3 randomized control ResQ trials of ANKTIVA plus KEYTRUDA or OPDIVO in 1st and 2nd line NSCLC (ResQ301 and ResQ302) versus standard of care.
ImmunityBio (NASDAQ: IBRX) has made significant progress in market access for ANKTIVA®, its FDA-approved treatment for non-muscle invasive bladder cancer with carcinoma in situ (CIS). Within three months of approval, ANKTIVA® is now covered by over a dozen insurance plans, representing more than 100 million lives. The company is expanding its bladder cancer program globally, initiating the filing process with the European Medicines Agency (EMA) for EU approval and launching a BCG naïve trial (QUILT-2.005) in India.
ImmunityBio has also held an FDA meeting regarding ANKTIVA's potential in Non-Small Cell Lung Cancer (NSCLC) following positive overall survival results in a completed trial. The company is preparing additional study information for a potential NSCLC pivotal trial. These developments mark significant steps in expanding ANKTIVA's reach and potential applications in cancer treatment.
ImmunityBio (NASDAQ: IBRX) has announced a new clinical trial, QUILT 502, to study ANKTIVA® in combination with the AdHER2DC vaccine for endometrial cancer. This Phase 1/2 study, sponsored by the National Cancer Institute, will enroll 60 participants with HER2-positive endometrial cancer. The trial combines ANKTIVA, recently FDA-approved for bladder cancer, with the investigational AdHER2DC vaccine and FDA-approved drugs pembrolizumab and lenvatinib.
The study aims to evaluate the safety and efficacy of this combination therapy in controlling endometrial cancer, which affects over 65,000 women annually in the U.S. and has treatment options after second-line therapy. The AdHER2DC vaccine targets the HER2 protein, elevated in 30% of endometrial cancer cases. The trial is expected to be completed in 2026 and represents a potential breakthrough in immunotherapy for gynecological cancers.
ImmunityBio has announced the initial commercial administration of ANKTIVA®, an FDA-approved immunotherapy for Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC). Approved less than two months ago, ANKTIVA activates natural killer cells and T cells to attack resistant tumor cells, showing a prolonged complete response duration exceeding 47 months. Multiple patients across the U.S. have already received the treatment.
The therapy, covered by various healthcare plans, can be administered by urologists in their own offices. This first-in-class cytokine therapy aims to provide an alternative to bladder removal surgeries. The ImmunityBio CARE™ program supports patients with benefits investigation, prior authorization, and claims processing.
ImmunityBio (NASDAQ: IBRX) has announced its 2024 Annual Meeting of Stockholders, scheduled for June 11, 2024, at 9:30 a.m. PT. The meeting will be held virtually with no physical location. Shareholders of record as of April 17, 2024, are eligible to vote and participate.
Chief Executive Officer Richard Adcock will provide a business update following the formal business proceedings. Non-shareholders can join the virtual meeting as guests. A replay will be available within 24 hours on the company's investor relations website and remain accessible for 90 days.
Additional presentations and webcasts on company developments can also be found on the investor relations site, which may contain material information.
ImmunityBio (NASDAQ: IBRX) announced three podcasts with UroToday discussing the FDA approval of ANKTIVA® (N-803) plus BCG for non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS). Dr. Patrick Soon-Shiong and Dr. Ashish Kamat highlighted ANKTIVA’s unique mechanism, which activates NK cells, killer T cells, and memory T cells to fight tumors. They emphasized the collaboration with Serum Institute of India to address BCG shortages. ANKTIVA, an IL-15 receptor agonist, offers a new treatment option for BCG-unresponsive NMIBC patients, promoting durable complete responses by converting MHC-negative tumors to MHC-positive. The podcasts are available on UroToday's website.
ImmunityBio, Inc. (NASDAQ: IBRX) has completed the drug substance manufacturing for ANKTIVA, providing 170,000 doses, with two-year storage stability data. The company's GMP fill-finish facility in New York is on track for completion in 12-18 months, capable of producing a million vials annually. The recent partnership with the Serum Institute of India for BCG availability enhances the company's inventory and capacity.
ImmunityBio, Inc. (NASDAQ: IBRX) has entered into an exclusive global agreement with the Serum Institute of India to supply Bacillus Calmette-Guerin (BCG) for use in combination with ImmunityBio's ANKTIVA.
This collaboration will address the chronic BCG supply shortage issue, providing both standard BCG (sBCG) and next-generation recombinant BCG (iBCG) for approved indications benefiting from ANKTIVA's therapeutic effects.
The agreement aims to enhance immunogenicity and safety compared to standard BCG, improving outcomes for bladder cancer patients globally.
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