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.
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.
ImmunityBio's Phase 1 study results for Anktiva (N-803), published in Nature Medicine, demonstrate the drug's ability to stimulate latent HIV replication in CD4+ cells and activate immune response. The study involved 16 participants, with no serious adverse events reported. Nearly 38 million people live with HIV globally, highlighting the need for alternative therapeutics as current treatments can be costly. Ongoing Phase 1 and 2 trials aim to validate Anktiva’s efficacy in eliminating HIV reservoirs in patients.
ImmunityBio, Inc. (NASDAQ: IBRX) reported promising interim results from its QUILT 88 trial, focusing on the Nant Cancer Vaccine for advanced pancreatic cancer. The median overall survival (OS) for patients who received the therapy exceeded historical data, reaching 6.3 months (N=30) after two prior therapies and 5.8 months (N=63) for those with even more advanced disease. Serious adverse events were infrequent, with no treatment-related deaths. The company plans to engage with the FDA to discuss the path forward for approval of combination therapies for pancreatic cancer.
ImmunityBio has entered into a definitive agreement to acquire a leasehold interest in a 409,000 square foot cGMP manufacturing facility in Dunkirk, New York, from Athenex (NASDAQ: ATNX). This facility will enable the production of one billion doses of RNA and adjuvant vaccines, significantly enhancing ImmunityBio's manufacturing capabilities. The investment aims to expedite the company's development and commercialization of immunotherapy and vaccine products, with production expected to commence in Q4 2022. The acquisition bolsters ImmunityBio's global manufacturing capacity.
ImmunityBio has been granted a U.S. patent for a novel NK cell therapy that combines genetically modified NK-92 cells with CD16 receptors to enhance monoclonal antibody efficacy against cancer. This patent, extending protection to 2036, addresses cancer relapse by boosting the patient’s natural immune response. The NK-92 cells offer higher cytotoxicity against tumors and are included in over 450 research studies. ImmunityBio’s comprehensive intellectual property portfolio includes more than 1,100 patents across various biotherapeutic domains, bolstering its market position.
Amyris and ImmunityBio have finalized their joint venture to commercialize a next-generation COVID-19 vaccine. This collaboration aims to leverage their combined strengths in vaccine technology and manufacturing capabilities. They plan to begin human trials and seek regulatory approval to deliver the vaccine by 2022, targeting underserved areas affected by vaccine accessibility challenges. The partnership aims to provide robust immunity against COVID-19 variants and adapt to future viruses. Further updates on trial outcomes will be provided as they become available.
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