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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.
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ImmunityBio has announced the initiation of a Phase 2b clinical trial for its investigational Tri-Ad5 cancer vaccine, which combines three vaccines with the IL-15 superagonist N-803. This trial aims to assess the effectiveness of this combination in preventing colorectal and other cancers in individuals with Lynch syndrome, a hereditary condition increasing cancer risks. The study will enroll 186 participants across 14 U.S. centers, marking a significant advancement in Lynch syndrome research. Lynch syndrome, which affects about 1 in 300 people, can lead to multiple cancers at a younger age. The Tri-Ad5 vaccines target specific cancer-associated proteins and are designed to enhance immune response.
ImmunityBio, Inc. (NASDAQ: IBRX) announces that Executive Chairman Patrick Soon-Shiong, M.D., will deliver the 2023 David Packard Award Lecture at the Uniformed Services University in Bethesda, MD, on April 25. This lecture recognizes his pioneering contributions to cancer therapies and immunotherapy, specifically discussing the activation of natural killer and T cells for cancer treatment. Dr. Soon-Shiong's illustrious career includes significant achievements in immunology and over 500 patents. He founded American Pharmaceutical Partners and developed Abraxane, a groundbreaking chemotherapy drug. The lecture is part of an annual event honoring David Packard, a key figure in U.S. defense and education. ImmunityBio focuses on developing advanced immunotherapies for cancer and infectious diseases.
ImmunityBio, Inc. (NASDAQ: IBRX) announced that Dr. Karim Chamie from UCLA will present findings from the QUILT 3.032 study at the ASCO GU conference in San Francisco from February 16-18. This study assesses the quality of life for patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) receiving N-803 combined with BCG. Results showed improved physical function among responders and highlighted a favorable risk/benefit ratio. The FDA is reviewing the Biologics License Application for N-803, with a PDUFA date set for May 23, 2023.
ImmunityBio, Inc. (NASDAQ: IBRX) has announced a registered direct offering to institutional investors, aiming to raise approximately $50 million in gross proceeds. The financing involves the issuance of common stock and warrants for additional shares, potentially generating up to $60 million if the warrants are fully exercised. This funding is intended to bolster working capital and support ongoing operations. Jefferies LLC acts as the exclusive placement agent for the offering. ImmunityBio is focused on developing innovative immunotherapies targeting cancers and infectious diseases, with its lead candidate N-803 currently under FDA review for bladder cancer.
ImmunityBio, identified by NASDAQ: IBRX, announced positive outcomes from its Phase 2 study on metastatic pancreatic cancer, QUILT 88. The study involved 83 patients and showed a median overall survival (OS) of 5.8 months, significantly higher than historical rates of 2-3 months. In the third-line cohort, the median OS reached 6.3 months. Notably, 61% of patients demonstrated disease control. The company held discussions with the FDA regarding registration pathways for pancreatic cancer and NMIBC. A randomized trial is in place for second-line patients, with 25 enrolled to date.
ImmunityBio has secured approximately $50 million in equity financing and $50 million in debt financing from Nant Capital, LLC. The financing also includes a conversion of $56.6 million in debt from NantWorks LLC into equity at a price of $5.67 per share. Furthermore, up to $60 million may be raised through warrants over two years. The funds will be utilized for pre-commercialization, clinical development, and general corporate purposes.
LadRx Corporation (OTCQB: LADX) provides a quarterly update for Q3 2022, highlighting its biopharmaceutical advancements, particularly in cancer therapeutics. The company focuses on its LADR technology, enabling targeted chemotherapeutic delivery. Key developments include the next-gen LADR drug candidates LADR7-10 and the progress of Aldoxorubicin, now in clinical trials under Immunity Bio (NASDAQ: IBRX). Financially, LadRx aims to extend its cash runway into mid-2023 while seeking additional funding amidst challenging market conditions.
ImmunityBio, Inc. (NASDAQ: IBRX) announced its participation in the 34th Annual Piper Sandler Healthcare Conference in location value="LU/us.ny.nyc"New York City from November 29 - December 1, 2022. The presentation is scheduled for November 29 at 2:30 - 2:55 pm EST, featuring a fireside chat with Director and Senior Research Analyst, Joseph Catanzaro, Ph.D. A webcast will be available for those interested. ImmunityBio focuses on developing next-generation immunotherapies and vaccines, currently conducting 27 clinical trials across various cancer and infectious disease indications.