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 plans for an underwritten public offering of its common stock. The company will grant underwriters a 30-day option to purchase up to an additional 15% of offered shares. Proceeds will fund ANKTIVA® commercialization for BCG-unresponsive non-muscle invasive bladder cancer treatment, trials in BCG-naïve NMIBC and non-small cell lung cancer, R&D activities, working capital needs, and general corporate purposes. Jefferies and Piper Sandler are acting as joint book-running managers, while BTIG and H.C. Wainwright & Co. serve as co-lead managers.
ImmunityBio (NASDAQ: IBRX) and nCartes have entered a collaboration agreement to automate and streamline clinical trial data fulfillment processes. The partnership aims to replace manual data entry into Electronic Data Capture (EDC) systems with direct digital information transfer from electronic medical record (EMR) systems. This automation initiative is designed to make the process faster, more cost-effective, and reduce potential errors in data entry. The collaboration seeks to improve data quality and reduce the time required for source data verification, potentially accelerating the timeline for bringing therapies to market.
ImmunityBio (NASDAQ: IBRX) has announced new data from its QUILT 3.032 study, where 100 patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC CIS) were treated with ANKTIVA in combination with BCG. The treatment achieved a 71% complete response rate, with durable responses extending up to 54 months. The company plans to submit this updated data to the European Medicines Agency (EMA) in Q4 2024 as part of a Marketing Authorization Application. The results align with previous findings published in the New England Journal of Medicine and demonstrate ANKTIVA's potential in treating patients with treatment options.
ImmunityBio (NASDAQ: IBRX) reported Q3 2024 financial results, highlighting $6.0 million in net product revenue from ANKTIVA®, significantly up from $1.0 million in the previous quarter. The company secured coverage for over 200 million medical lives and received a J-code effective January 2025. ANKTIVA's shelf life was extended to three years with 125,000 doses available. The company submitted MAA applications in the UK and plans EU submission in Q4 2024. Financial results showed cash position of $130.4 million, with a net loss of $85.7 million compared to $95.6 million in Q3 2023. R&D expenses increased to $50.4 million, while SG&A expenses rose to $35.9 million.
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.