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. reports developments as a commercial-stage biotechnology company focused on immunotherapies designed to activate innate and adaptive immune responses for cancer and infectious disease. Its news centers on ANKTIVA® (nogapendekin alfa inbakicept-pmln), an IL-15 superagonist used with BCG for BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ, with or without papillary tumors.
Recurring updates cover ANKTIVA product revenue and unit demand, global regulatory authorizations and commercial availability, distribution partnerships, and scientific presentations involving bladder cancer, lung cancer, and broader IL-15 oncology programs. Company announcements also address BCG-naïve NMIBC clinical development, FDA promotional-compliance correspondence, and financing arrangements tied to revenue interests and convertible debt.
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.
ImmunityBio's Executive Chairman, Dr. Patrick Soon-Shiong, will discuss the recent FDA approval of ANKTIVA® for use in combination with BCG for non-muscle invasive bladder cancer at the AUA 2024 conference. ANKTIVA's Breakthrough Therapy designation and novel mechanism will be highlighted, offering an alternative therapy to radical surgery for advanced bladder cancer cases. The discussion will focus on transforming cold bladder cancer cells to hot tumors via ANKTIVA's activation of NK and T cells, resulting in durable responses.
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