Articles from ImmunityBio, Inc.

ImmunityBio, Inc. (NASDAQIBRX) today announced it has entered into a collaboration and supply agreement with BeiGene, Ltd. (to be changed to BeOne Medicines, Ltd.), a global oncology company, to conduct a confirmatory randomized Phase 3 clinical trial (ResQ201A-NSCLC), combining BeiGene's tislelizumab, a PD-1 checkpoint inhibitor (CPI), and ImmunityBio's ANKTIVA (nogapendekin alfa inbakicept-pmln). The Phase 3 ResQ201A-NSCLC study (NCT06745908) aims to confirm the efficacy and safety of combination ANKTIVA plus CPI therapy previously demonstrated in the trial QUILT 3.055 and provide evidence of the potential for these two immunotherapeutic agents to improve overall survival in patients with advanced or metastatic NSCLC who have acquired resistance to immune CPI therapy.

ImmunityBio, Inc. (NASDAQIBRX), a leading immunotherapy company, today announced the European Medicines Agency (EMA) has accepted for review and begun assessing the marketing authorization application (MAA) for ANKTIVA (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin (BCG) for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. The EMA covers 27 countries in the European Union (EU), as well as Iceland, Norway and Liechtenstein.

ImmunityBio, Inc. (NASDAQIBRX), a leading immunotherapy company, today announced significant progress in its ongoing discussions with the U.S. Food and Drug Administration (FDA) regarding three areas of its clinical development pipeline in non-muscle invasive bladder cancer (NMIBC) and non-small cell lung cancer (NSCLC).

ImmunityBio, Inc. (NASDAQIBRX) today announced the completion of the submissions of its marketing authorization applications (MAA) for ANKTIVA® (nogapendekin alfa inbakicept) plus Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors, to both the European Union (EU) European Medicines Agency (EMA) and the United Kingdom's (UK) Medicines and Healthcare products Regulatory Agency (MHRA).

ImmunityBio, Inc. (NASDAQIBRX), a leading immunotherapy company, today announced the unique, permanent Healthcare Common Procedure Coding System (HCPCS) J-code assigned by the Centers for Medicare & Medicaid Services (CMS) for ANKTIVA® (nogapendekin alfa inbakicept-pmln) became effective January 1, 2025. The U.S. Food and Drug Administration (FDA) approved ANKTIVA with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.

ImmunityBio, Inc. (NASDAQIBRX), a leading immunotherapy company, today announced the pricing of its previously announced underwritten public offering of an aggregate of 33,333,334 shares of its common stock at a price to the public of $3.00 per share. ImmunityBio has granted the underwriters a 30-day option to purchase up to an additional 5,000,000 shares of its common stock at the public offering price, less underwriting discounts and commissions. All of the shares were sold by ImmunityBio. Before deducting the underwriting discount and offering expenses payable by ImmunityBio, ImmunityBio expects to receive gross proceeds of approximately $100.0 million, assuming no exercise of the underwriters’ option to purchase additional shares. The offering is expected to close on or about December 12, 2024 subject to satisfaction of customary closing conditions.

ImmunityBio, Inc. (NASDAQIBRX), a leading immunotherapy company, today announced that it intends to offer and sell, subject to market and other conditions, shares of its common stock in an underwritten public offering. In addition, ImmunityBio expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the offering at the public offering price, less underwriting discounts and commissions. ImmunityBio currently intends to use the net proceeds from this offering to progress its continued commercialization of ANKTIVA® for treatment of BCG-unresponsive non-muscle invasive bladder cancer (“NMIBC”) with carcinoma in situ (“CIS”) with or without papillary tumors, to fund its trials in BCG-naïve NMIBC and non-small cell lung cancer (“NSCLC”), toward further research and development, for working capital needs, and for other general corporate purposes. All of the shares are being offered by ImmunityBio. There can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering.

ImmunityBio, Inc. (NASDAQIBRX), a leading immunotherapy company, today announced compelling new data from its ongoing QUILT 3.032 study. As of November 2024, 100 patients with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer with carcinoma in situ (NMIBC CIS) have been treated with ANKTIVA® (nogapendekin alfa inbakicept-pmln) in combination with BCG, achieving a 71% complete response (CR) rate. In these responders, the range of durable response extended to 54 months. This data update will be submitted to the European Medicines Agency (EMA) in a Marketing Authorization Application (MAA) for ANKTIVA in the European Union (EU), which is anticipated during Q4 2024.

ImmunityBio, Inc. (NASDAQIBRX) today announced its financial results for the third-quarter ended September 30, 2024.

Immunotherapy innovator ImmunityBio, Inc. (NASDAQIBRX), announced today that the first patients have been dosed in an initial trial studying the potential of the company’s CAR-NK cell therapy targeting CD-19 in the treatment of non-Hodgkin’s lymphoma (NHL). In the QUILT 106 trial, CD19-targeted high-affinity natural killer (t-haNK) cells are being tested initially as a single agent, and after demonstrating safety, then in combination with standard NHL treatment rituximab, in participants with selected CD19+ and CD20+ relapsed/refractory B-cell NHL. The phase 1, open label clinical study is designed to enroll up to 10 participants and is being conducted in Johannesburg, Pretoria, and Bloemfontein, South Africa.

Immunotherapy innovator ImmunityBio, Inc. (NASDAQIBRX), announced today that company executives will be participating in the Jefferies London Healthcare Conference, which is taking place November 19-21 at the Waldorf Hilton London.

Immunotherapy innovator ImmunityBio, Inc. (NASDAQIBRX), today announced positive results from its QUILT 3.055 trial demonstrating long-term extended survival of 14 months to as much as five years for patients with advanced non-small cell lung cancer (NSCLC) being treated with checkpoint inhibitors (CPI). An oral presentation of the data was presented by John Wrangle, M.D., MPH, Associate Professor, Medical University of South Carolina, at the World Congress on Lung Cancer in San Diego on Sunday, September 8 in the session titled “Novel Immunotherapy Strategies and Combinations.”

ImmunityBio, Inc. (NASDAQIBRX), today announced significant progress in market access, making ANKTIVA® (nogapendekin alfa inbakicept-pmln) widely available to patients through both commercial and government insurance programs. The company also announced plans to expand its bladder cancer program globally, notably in the European Union and India.

Immunotherapy company ImmunityBio, Inc. (NASDAQIBRX), today announced the opening of a clinical trial to study ANKTIVA® (nogapendekin alfa inbakicept-pmln) together with the investigational AdHER2DC vaccine (autologous dendritic cells transduced with HER2 expressing adenovirus), in individuals with HER2-expressing endometrial cancer. It marks the latest trial involving ANKTIVA, the company’s IL-15 superagonist immune enhancer, to evaluate ANKTIVA as an agent to replace the short-term activity of checkpoint inhibitor immunotherapies with long-term effectiveness. ANKTIVA was recently approved by the FDA for BCG-unresponsive non-muscle invasive bladder cancer CIS with or without papillary tumors.

ImmunityBio, Inc. (NASDAQIBRX) today announced the initial treatment of multiple patients in the United States to receive therapy with ANKTIVA® (nogapendekin alfa inbakicept-pmln), ImmunityBio’s recently approved immunotherapy for Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ. ANKTIVA was approved by the U.S. Food and Drug Administration (FDA) on April 22, 2024 for the treatment of patients with BCG-unresponsive NMIBC CIS with or without papillary tumors.

ImmunityBio, Inc. (NASDAQIBRX) announced today that its 2024 Annual Meeting of Stockholders will be held on Tuesday, June 11, 2024 at 9:30 a.m. Pacific Time. The Annual Meeting will be held in a virtual-only format and there will not be a physical location for the Annual Meeting. Stockholders of record at the close of business on April 17, 2024 are entitled to vote at and participate in the Annual Meeting.

ImmunityBio, Inc. (NASDAQIBRX) today announced the publication of three podcasts with UroToday highlighting the company’s recent FDA approval of ANKTIVA® (N-803, or nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) for non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS) and advances in bladder cancer research.

ImmunityBio, Inc. (NASDAQIBRX) announced today that the drug substance (DS) has been completed and successfully qualified for “fill finish” (filling vials and finishing packaging), sufficient for 170,000 doses of 400mcg ANKTIVA (nogapendekin alfa inbakicept-pmln). Coupled with the recent announcement of a partnership with the Serum Institute of India (SII) for BCG availability, this provides the Company with a significant initial supply of ANKTIVA for commercial and clinical trial use in advance of the full operation of the Company’s own drug substance and fill-finish manufacturing plants in California and New York.

ImmunityBio, Inc. (NASDAQIBRX), has signed an exclusive global arrangement with the Serum Institute of India, the world’s largest manufacturer of vaccines by number of doses produced, to supply ImmunityBio with Bacillus Calmette-Guerin (BCG). The agreement covers the manufacturing of standard BCG (sBCG) that is currently approved for use outside the U.S., as well as a next-generation recombinant BCG (iBCG) undergoing testing, intended for use in combination with ImmunityBio’s ANKTIVA (nogapendekin alfa inbakicept-pmln) for currently approved and potential future indications, subject to regulatory approvals.

The Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio, Inc. (NASDAQIBRX), a next-generation immunotherapy company, will discuss the implications of the recent FDA approval of ANKTIVA® (nogapendekin alfa inbakicept-pmln) for use in combination with bacillus Calmette-Guerin (BCG) for non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors at the American Urological Association Annual Meeting (AUA 2024) this week in San Antonio, Texas.

ImmunityBio, Inc. (NASDAQIBRX), an immunotherapy company, today announced positive overall survival results in the QUILT 3.055 study of 2nd- and 3rd-line NSCLC patients who progressed after checkpoint inhibitor therapy (pembrolizumab, nivolumab, or atezolizumab) and standard-of-care chemotherapy to be discussed during the upcoming conference call. The results continue to reinforce ImmunityBio’s belief in the unique mechanism of action of ANKTIVA (N-803, or nogapendekin alfa inbakicept-pmln) and its potential efficacy as a next-generation immunotherapy across multiple solid and liquid tumor types.

ImmunityBio, Inc. (NASDAQIBRX), an immunotherapy company, today announced that the U.S. Food and Drug Administration (FDA) has approved ANKTIVA (N-803, or nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.

ImmunityBio, Inc. (NASDAQIBRX), a clinical-stage immunotherapy company, today announced that findings from Patient-Reported Outcomes (PROs) of participants in the phase 2/3 QUILT 3.032 study of N-803 plus BCG in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) were published by the peer-reviewed journal Urology Practice. These PROs support the positive interim results from the study published in NEJM Evidence, wherein 71% of patients in cohort A with CIS with or without Ta/T1 disease achieved a complete response.

ImmunityBio, Inc. (NASDAQIBRX), a clinical-stage immunotherapy company (“ImmunityBio” or the “Company”), today announced an up to $320 million royalty financing and equity investment in the Company by Oberland Capital, with $210 million of gross proceeds received at closing on December 29, 2023. The additional capital provides significant financial resources for the Company to accelerate its commercialization efforts in anticipation of a potential regulatory approval, as well as to expand its pipeline within the broader urological cancer space. The proceeds will also be used to fund ongoing business operations and clinical trials expanding N-803 (Anktiva®) indications into multiple solid tumors.

ImmunityBio, Inc. (NASDAQIBRX), a clinical-stage immunotherapy company, announced today that the company will be participating in the 35th Annual Piper Sandler Healthcare Conference, which is taking place in New York City, November 28-30, 2023.

ImmunityBio, Inc. (NASDAQIBRX), a clinical-stage immunotherapy company, today announced new data showing that the company’s Memory Cytokine-Enriched Natural Killer cells (M-ceNK) may provide benefit to patients with small cell lung cancer and patients with other types of neuroendocrine tumors. Findings from the study titled “Characterization of the anti-tumor activity of memory cytokine enriched NK cells (M-ceNK) against tumors with neuroendocrine features” were presented by Kristen Fousek, Ph.D., Research Fellow with the Center for Immuno-Oncology of the National Institutes of Health’s National Cancer Institute (NCI) in a poster session (Abstract #358) at the annual meeting of the Society for Immunotherapy of Cancer (SITC) in San Diego, November 4, 2023.

ImmunityBio, Inc. (NASDAQIBRX), a clinical-stage immunotherapy company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review ImmunityBio’s resubmission of its Biologics License Application (BLA) for N-803, a first-in-class IL-15 superagonist, plus Bacillus Calmette-Guérin (BCG) for the treatment of BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ (CIS) with or without Ta or T1 disease, and considered it as a complete response to the FDA’s May 9, 2023 complete response letter. The FDA has set a user fee goal date (PDUFA date) of April 23, 2024.

ImmunityBio, Inc. (NASDAQIBRX), a clinical-stage immunotherapy company, today announced it has completed the resubmission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for N-803 (Anktiva®), a first-in-class IL-15 superagonist, plus Bacillus Calmette-Guérin (BCG) for the treatment of BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ (CIS) with or without Ta or T1 disease.

ImmunityBio, Inc. (NASDAQIBRX), a clinical-stage immunotherapy company, today announced that it has executed financing transactions resulting in approximately $200 million of proceeds to the Company through a financing including an exchange into equity of current debt and a new convertible debt instrument from Nant Capital, LLC, an entity affiliated with Dr. Patrick Soon-Shiong, the Company’s Founder, Executive Chairman and Global Chief Scientific and Medical Officer. With this new financing from Dr. Soon-Shiong, including the extension of the maturity date of current debt, ImmunityBio believes that it is well-positioned to fund its ongoing business operations and pre-commercialization efforts as it continues to drive toward a potential regulatory approval of N-803 plus BCG for BCG-unresponsive non-muscle invasive bladder cancer.

ImmunityBio, Inc. (NASDAQIBRX), a clinical-stage immunotherapy company, today announced that it has named Enrique Diloné, Ph.D., to the newly created role of Chief Technology Officer. With more than three decades of pharmaceutical manufacturing expertise, Dr. Diloné will assume responsibility for all global manufacturing functions as the company prepares for potential FDA approval of a key bladder cancer drug. He will report directly to President and CEO Richard Adcock.

ImmunityBio, Inc. (NASDAQIBRX), a clinical-stage immunotherapy company, today announced that it has executed financing to provide further working capital and support its ongoing business operations. The Company entered into a securities purchase agreement for a registered direct offering with multiple institutional investors, providing for the issuance of common stock of ImmunityBio as well as warrants for the purchase of additional shares of common stock of ImmunityBio that is expected to result in gross proceeds at closing of approximately $40 million before deducting any offering-related expenses, subject to customary closing conditions. If fully exercised, the warrants could result in additional gross proceeds of up to $48 million. In addition, in connection with the current financing, the Company agreed to amend the terms of the existing warrants issued in February 2023 so that the pricing and term of such warrants match the newly issued warrants.

ImmunityBio, Inc. (NASDAQIBRX), a clinical-stage immunotherapy company, today announced findings from a Phase 1 study showing that allogeneic cytokine-induced memory-like (CIML) natural killer (NK) cells used in combination with ImmunityBio’s IL-15 superagonist N-803 may induce tumor regression associated with persistent CIML NK cell expansion in advanced head-and-neck cancer patients. The results indicate the potential for a new treatment approach for the disease in advanced cases that currently have extremely poor prognoses.

ImmunityBio, Inc. (NASDAQIBRX), a clinical-stage immunotherapy company, today announced that Executive Chairman and Global Chief Scientific and Medical Officer Dr. Patrick Soon-Shiong, M.D., will participate in a fireside chat at the Jefferies Global Healthcare Conference on Wednesday, June 7, 2023, at 10:00 am Eastern Time (ET) at the Marriott Marquis, New York.

ImmunityBio, Inc. (NASDAQIBRX), a clinical-stage immunotherapy company, today announced the opening of a clinical trial to study its investigational Tri-Ad5 vaccine combination (Adenovirus 5 CEA/MUC1/brachyury) together with its IL-15 superagonist N-803, an immune-enhancer, for people with a hereditary condition known as Lynch syndrome. This Phase 2b trial (NCT05419011) sponsored by the National Cancer Institute, part of the National Institutes of Health, will study whether Tri-Ad5 in combination with N-803 works to prevent colorectal and other cancers in study participants.

ImmunityBio, Inc. (NASDAQIBRX), a clinical-stage immunotherapy company, today announced that Executive Chairman and Global Chief Scientific and Medical Officer Patrick Soon-Shiong, M.D., has been invited to deliver the 2023 David Packard Award Lecture at the Uniformed Services University of the Health Sciences (USU). The university extended Dr. Soon-Shiong the invitation to give this prestigious guest lecture in recognition of his “scientific accomplishments as a pioneer” in cancer therapies, immunotherapy, and digital technologies to share genomic information.

ImmunityBio, Inc. (NASDAQIBRX), a clinical-stage immunotherapy company, today announced Dr. Karim Chamie, Associate Professor of Urology at UCLA, will be presenting “Quality of life in QUILT 3.032 study: Patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) receiving IL-15R⍺Fc superagonist N-803 plus BCG” at the ASCO Genitourinary Cancers Symposium (ASCO GU) conference in San Francisco, February 16-18. The Food and Drug Administration (FDA) is currently reviewing the Biologics License Application (BLA) for ImmunityBio’s N-803 plus BCG for the treatment of NMIBC CIS with a Prescription Drug User Fee Act (PDUFA) date of May 23, 2023.

ImmunityBio, Inc. (NASDAQIBRX), a clinical-stage immunotherapy company, today announced that it has executed financing to provide further working capital and support its ongoing business operations. The Company entered into a securities purchase agreement for a registered direct offering with multiple institutional investors, providing for the issuance of common stock of ImmunityBio as well as warrants for the purchase of additional shares of common stock of ImmunityBio that is expected to result in gross proceeds at closing of approximately $50 million before deducting any offering-related expenses, subject to customary closing conditions. If fully exercised, the warrants could result in additional gross proceeds of up to $60 million.

ImmunityBio, Inc. (NASDAQIBRX), a clinical-stage immunotherapy company, today announced positive results in its fully-enrolled metastatic pancreatic cancer study in third-line or greater subjects (QUILT 88) showing that the overall survival rate for patients continues to be double compared to historical survival rates after two or more prior lines of therapy. The results were presented at the American Society of Clinical Oncology Gastrointestinal (ASCO GI) conference in San Francisco January 19-21.

ImmunityBio, Inc. (NASDAQIBRX), a clinical-stage immunotherapy company, today announced that it has executed financing to provide further working capital and support its ongoing business operations.

ImmunityBio, Inc. (NASDAQIBRX), a clinical-stage immunotherapy company, announced today that the company will be participating in the 34th Annual Piper Sandler Healthcare Conference, which is taking place in New York City, November 29 - December 1, 2022.

ImmunityBio, Inc. (NASDAQIBRX), a clinical-stage immunotherapy company, announced today that the company will be presenting at the Jefferies London Healthcare Conference, which is taking place in London from November 15-17, 2022.

ImmunityBio, Inc. (NASDAQIBRX), a leading clinical-stage immunotherapy company, today announced new positive data from the company’s pivotal Phase 2/3 trial for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (QUILT 3032) and Phase 2 trial in advanced pancreatic cancer (QUILT 88). The results, which were presented during the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, demonstrate the strong and diverse growth of ImmunityBio’s immunotherapy platform that includes an IL-15 superagonist (N-803), adenovirus vaccine platform, and engineered off-the-shelf natural killer (NK) cell therapy. Together with the company’s self-amplifying RNA and yeast platforms, and Toll receptor activators, along with clinical progress across a range of highly challenging cancer types and commercial-scale manufacturing capabilities, ImmunityBio believes that it is well positioned to change the paradigm of care in cancer and infectious disease.

ImmunityBio, Inc. (NASDAQIBRX), a clinical-stage immunotherapy company, today announced it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for N-803, a first-in-class IL-15 superagonist, plus Bacillus Calmette-Guérin (BCG) for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS) with or without Ta or T1 disease. The BLA is supported by the results of ImmunityBio’s studies in bladder cancer including the pivotal QUILT 3032 study (NCT03022825), where 71% of patients who had failed on previous therapies showed an over 50% increase in both response and median duration compared to the FDA-approved alternatives Valrubicin and Pembrolizumab, a systemic checkpoint inhibitor therapy for this indication.1

ImmunityBio, Inc. (NASDAQIBRX), a clinical-stage immunotherapy company, announced today its abstracts were accepted for presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting, June 3-7, in Chicago.

ImmunityBio, Inc. (NASDAQIBRX), a clinical-stage immunotherapy company, announced today that the first participants have been enrolled in a study that is part of an 800-site master protocol trial for non-small cell lung cancer (NSCLC). The Lung Cancer Master Protocol trial (Lung-MAP) includes a study of Anktiva™ (N-803) plus Keytruda (pembrolizumab) versus investigator choice of standard-of-care chemotherapy in patients with non-small cell lung cancer (NSCLC) whose cancer has progressed after prior checkpoint-inhibitor-containing regimens. The study, which opened in March and currently includes nearly 200 sites across the U.S., will involve 478 patients when fully enrolled.

ImmunityBio, Inc. (NASDAQIBRX), a clinical-stage immunotherapy company, today announced that it has achieved a major milestone with over 80 subjects in the QUILT-3.032 study completing at least 12 months of follow-up as of January 14, 2022. All data for QUILT-3.032, which is studying VesAnktiva™ plus BCG in subjects with BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ (NMIBC CIS), have been locked and analyzed. The results continue to demonstrate a clinically meaningful benefit that is sustained. The BLA has been compiled and, following final quality review, is expected to be submitted to the U.S. Food and Drug Administration (FDA) this month. The FDA granted Fast Track Designation to the pivotal trial based on Phase I data. In December 2019, the FDA granted ImmunityBio Breakthrough Therapy Designation (BTD) based on interim Phase 2 data indicating the primary endpoint of the trial was already met.

ImmunityBio, Inc. (NASDAQIBRX), a clinical-stage immunotherapy company (“ImmunityBio”), today announced the successful completion of its acquisition of the leasehold interest in an ISO Class 5 pharmaceutical manufacturing space in western New York from global pharmaceutical company Athenex, Inc. NASDAQ: ATNXNASDAQATNX)

ImmunityBio, Inc. (NASDAQIBRX), a clinical-stage immunotherapy company, today announced positive data from the company’s late-stage bladder cancer trial (QUILT-3.032). The data showed sustained complete response rates in patients with BCG-unresponsive non-muscle invasive carcinoma in situ (NMIBC CIS) bladder cancer (Cohort A) and with papillary disease (Cohort B). Of the 83 patients with BCG-unresponsive NMIBC CIS, 59 (71%) had a complete response with a median duration of response of 24.1 months—exceeding historical complete response rates of 41% and 18% for FDA-approved therapies pembrolizumab and valrubicin, respectively. In the papillary disease arm of the study (Cohort B), 57% of patients are disease free at 12 months and 53% at 18 months.

ImmunityBio, Inc. (NASDAQIBRX), a clinical-stage immunotherapy company, today announced promising study results that demonstrate the activation of CD4+ and CD8+ T cells and natural killer (NK) cells in people living with HIV by ImmunityBio’s IL-15 superagonist Anktiva (N-803). Anktiva stimulates latent HIV replication (the “kick”) in CD4 memory cells allowing the previously hidden infected cells to be revealed and eliminated (the “kill”) by CD8 and NK cells. This mechanism is key for killing cells that harbor latent virus, thereby reducing viral reservoirs in antiretroviral (ART)-suppressed HIV patients and ultimately ridding the body of the virus and the threat of re-activation. These positive clinical findings support ImmunityBio’s “Kick-and-Kill” strategy to cure HIV.

ImmunityBio, Inc. (NASDAQIBRX), a clinical-stage immunotherapy company, today announced interim results (N=63) in its metastatic pancreatic cancer trial (QUILT 88) showing that the overall survival rate for patients doubled compared to historical survival rate of three months after two prior lines of therapy (Manax ASCO GI 2019). The data of the Phase 2 trial studying a combination immunotherapy (Nant Cancer Vaccine) also show treatment-related serious adverse events were uncommon (8%) and no treatment-related deaths were reported. Based on these findings, ImmunityBio plans to meet with the FDA in 2022 to discuss the path for the approval of combination therapies for pancreatic cancer.

ImmunityBio, Inc. (NASDAQIBRX), a clinical-stage immunotherapy company (“ImmunityBio”), today announced that it has entered into a definitive agreement to acquire a leasehold interest in 409,000 square feet of ISO Class 5 pharmaceutical manufacturing space in western New York (the “Dunkirk Facility”), and certain related assets, from global pharmaceutical company Athenex, Inc. NASDAQ: ATNXNASDAQATNX)

ImmunityBio, Inc. (NASDAQIBRX), a clinical-stage immunotherapy company, has been granted a U.S. patent (11,207,350 B2) for a novel natural killer (NK) cell therapy composition and method for treating cancer that combines the company’s genetically modified NK-92 cells with CD16 receptors to enhance binding and activity of monoclonal antibodies. The combination of these engineered NK-92 cells with current monoclonal antibody therapies has the potential to augment the overall cytotoxic effects of monoclonal antibody treatment alone and help to address relapse by bolstering the patient’s own natural immune system response.

ImmunityBio, Inc. (NASDAQIBRX), a clinical-stage immunotherapy company, has successfully raised an aggregate $470 million of equity and debt financing in 2021, with $300 million in new debt financing from NantCapital, LLC. With this new financing from ImmunityBio’s founder, Executive Chairman and Global Chief Scientific and Medical Officer, Dr. Patrick Soon-Shiong, on December 17, 2021, the company is now well positioned to pursue its late-stage clinical portfolio, expand large-scale GMP manufacturing capacity, and advance recruitment of a commercial organization in the urology market.

ImmunityBio, Inc. (NASDAQIBRX), a clinical-stage immunotherapy company, today announced the expansion of the company’s cancer and infectious disease vaccine programs to include self-amplifying self-adjuvating RNA (SASA-RNA), recombinant protein vaccine candidates, and potent adjuvant formulations that enhance the quality, durability and breadth of immune responses to infectious diseases and cancer. When combined with the company’s hAd5 T-cell-based vaccine candidate, the company believes this “mix-and-match” approach will enable a new generation of COVID-19 vaccines that could potentially confer long-term immune memory to overcome the threat of current and future variants of the SARS-CoV-2 virus.

ImmunityBio, Inc. (NASDAQIBRX), a clinical-stage immunotherapy company, today announced that Founder, Executive Chairman and Global Chief Scientific and Medical Officer Dr. Patrick Soon-Shiong, M.D., will deliver a company presentation at the 2021 Jefferies London Healthcare Conference, which is being held November 16-18, 2021. Dr. Soon-Shiong will present updates on ImmunityBio’s infectious disease and oncology programs. Management will be available during the conference for virtual one-on-one meetings.

ImmunityBio, Inc. (NASDAQIBRX), a clinical-stage immunotherapy company, today announced that Papillary disease (Cohort B), the second indication of its QUILT 3.032 Phase 2/3 study of intravesical BCG plus Anktiva in patients with BCG-unresponsive high-grade NMIBC (NCT03022825), also met its primary endpoints with disease-free survival of 57% of patients at 12 months. The company has previously reported that the primary endpoint of Cohort A, patients with CIS disease, has been met with a complete response of 72% (58/81).

ImmunityBio, Inc. (NASDAQIBRX), a clinical-stage immunotherapy company, today announced it has fully accrued the initial planned number of participants in Cohort C (third-line or greater) of its Phase 2 trial studying a combination immunotherapy (Nant Cancer Vaccine) in advanced metastatic pancreatic cancer. The majority of participants in the study to date remain on therapy and 90% (43/48) of the evaluable patients have exceeded the approximately two-month historical survival rate. Of the 48 evaluable patients, 23 (48%) had extremely advanced disease upon enrollment (i.e. had progressed after three to six prior lines of therapy) and, of these patients, 20 out of 23 (87%) have exceeded historical survival rates. On the strength of this early data and significant unmet medical need, the company has submitted an amendment to increase enrollment in Cohort C.

ImmunityBio, Inc. (NASDAQIBRX), a clinical-stage immunotherapy company, today announced the Lung Cancer Master Protocol (Lung-MAP) public-private partnership—which includes the National Cancer Institute (NCI), the National Clinical Trials Network (NCTN) Cooperative Groups (SWOG, ECOG-ACRIN, Alliance, and NRG), Friends of Cancer Research, and the Foundation for the National Institutes of Health (FNIH)—will study the company’s IL-15 receptor superagonist complex, N-803 (Anktiva), in the Lung-MAP trial. Anktiva will be given in combination with Merck’s pembrolizumab (Keytruda) to participants with non-small cell lung cancer who have failed previous treatments. The combination therapy will be offered as a treatment to patients with tumors that do not have mutations targetable with a drug, which is the case for the majority of NSCLC patients.

ImmunityBio, Inc. (NASDAQIBRX), a clinical-stage immunotherapy company, today announced updated data from an ongoing bladder cancer trial showing sustained complete response rates in patients with BCG-unresponsive non-muscle invasive carcinoma in situ (CIS) bladder cancer (Cohort A). Of the 81 patients in the QUILT 3.032 study, 58 patients (72%) had a complete response (CR) at any time (three or six months) to intravesical BCG plus N-803 (Anktiva) with median duration of CR of 19.9 months.

ImmunityBio, Inc. (NASDAQIBRX), a clinical-stage immunotherapy company, today announced two key executive appointments that bring industry-leading market growth and access experience to the company. Helen Luu will serve as the company’s first Chief Commercial Officer, joining ImmunityBio from her position as CEO of CAR-T developer Cell BT. The company also named Sigrid Schreiner as Senior Vice President of Global Market Access. She joins the company from Stemline Therapeutics (now Menarini Group), a global commercial-stage oncology therapeutics company.

ImmunityBio, Inc. (NASDAQIBRX), a clinical-stage immunotherapy company, today announced Karim Chamie, M.D., Associate Professor of Urology, UCLA Department of Urology, will be presenting the Phase 2/3 clinical results of IL-15 Superagonist N-803 with BCG in BCG-unresponsive bladder cancer at the American Urological Association’s Annual Meeting on Sept. 10th.

ImmunityBio, Inc. (NASDAQIBRX), a clinical-stage immunotherapy company, appointed Patrick Soon-Shiong, M.D., to the newly created role of Global Chief Scientific and Medical Officer, effective as of August 11, 2021. In this additional role, Dr. Soon-Shiong will oversee the company’s global research and development programs and pipeline investments in support of its ambitious growth plans, which include bringing advanced technology to a broad global marketplace.

ImmunityBio, Inc., a publicly traded immunotherapy company, announced today that it has been granted a patent by the U.S. Patent and Trademark Office for its proprietary NANT Cancer Vaccine (U.S. Patent 11,071,774). This novel investigational treatment for cancer is designed to bolster a patient’s own immune response to cancerous cells, augment that response with additional natural killer and T-cell therapies to overcome the cancer’s resistance, and induce long-term T-cell memory to induce remission across multiple tumor types.

ImmunityBio, Inc., (NASDAQIBRX), a publicly traded immunotherapy company, today announced authorization from the South Africa Health Products Regulatory Authority (SAHPRA) to proceed with the South Africa Sisonke T-Cell Universal Boost trial. The Phase 1/2/3 study, which will begin in Q3 2021, is designed to evaluate hAd5 Spike + Nucleocapsid (S+N) as a boost for South African healthcare workers previously vaccinated with an S-only vaccine.

ImmunityBio, Inc. (NASDAQIBRX), a publicly traded immunotherapy company , and privately-held NantOmics today announced publication of a stepwise approach or “pipeline” for identification and validation of neoepitope and neoepitope-reactive T cells from individual patients. The identification of neoepitopes—short peptide sequences that are mutated in tumors and are capable of generating an immune response—provides critical support in the successful development of next-generation immunotherapies delivered by ImmunityBio’s Adeno- and yeast-based platforms. The pipeline is described in “Identification and validation of expressed HLA-binding breast cancer neoepitopes for potential use in individualized cancer therapy,” which recently published in the Journal for Immunotherapy of Cancer.

ImmunityBio, Inc. (NASDAQIBRX), a clinical-stage immunotherapy company, today announced it has received FDA authorization to conduct a Phase 1b/2 open-label study to evaluate the safety and preliminary efficacy of its superagonist Anktiva (N-803, an IL-15 superagonist) and PD-L1 targeted high-affinity natural killer (t-haNK) cells in combination with standard chemo and Trodelvy (sacituzumab govitecan-hziy), in subjects with advanced triple-negative breast cancer (TNBC). The study may provide data indicating whether this combination can increase the effectiveness of Trodelvy in patients who have failed to respond to other treatments.

ImmunityBio, Inc. (NASDAQIBRX), a clinical-stage immunotherapy company, today announced its HIV clinical pipeline with an HIV cure study using Anktiva™ (N-803), which is now enrolling participants in the U.S. The trial will study whether Anktiva can control HIV alone or together with combination broadly neutralizing antibodies (bNABs) after participants stop their antiretroviral therapy (ART) and they are carefully monitored. The study is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) and conducted by the AIDS Clinical Trials Group (ACTG), the largest global HIV research network.

ImmunityBio, Inc. (NASDAQIBRX), a clinical-stage immunotherapy company, today announced two South African studies to examine the potential for using its hAd5 T-cell-based COVID-19 vaccine candidate to provide extended protection for subjects with prior COVID-19 vaccinations or infections. One trial will study the use of ImmunityBio’s hAd5 candidate as a “Universal Boost” for healthcare workers previously vaccinated with a currently available spike-only antibody-based vaccine. The other will study the safety and effectiveness of the vaccine candidate intranasally in previously infected subjects.

ImmunityBio, Inc. (NASDAQIBRX), a clinical-stage immunotherapy company, today announced that Founder and Executive Chairman Dr. Patrick Soon-Shiong will deliver a company presentation at the 2021 Jefferies Virtual Healthcare Conference, which is being held June 1-4, 2021. Dr. Soon-Shiong will present updates on ImmunityBio’s infectious disease and oncology programs. Management will be available during the conference for virtual one-on-one meetings.

ImmunityBio, Inc. (NASDAQIBRX), a clinical-stage immunotherapy company, today announced an upcoming poster presentation highlighting its chemotherapy free regimen of interleukin-15 (IL-15) superagonist Anktiva® (also called N-803) in combination with checkpoint therapy in patients who had relapsed from checkpoint inhibitors, at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place virtually this year from June 4 through June 8, 2021.

ImmunityBio, Inc. (NASDAQIBRX), a clinical-stage immunotherapy company, today announced it has received FDA authorization to conduct a Phase 1 study to evaluate the safety and preliminary efficacy of its m-ceNK™ platform combined with its IL-15 superagonist Anktiva (N-803) in subjects with locally advanced or metastatic solid tumors. These NK cells retrieved from the patient and enriched with cytokines have the ability to recognize and kill cancer targets with increased production of interferon-g (IFN-γ), a cytokine demonstrating high activity.

ImmunityBio, Inc. (NASDAQIBRX), a clinical-stage immunotherapy company, today announced the launch of the preclinical development of its liquid tumor pipeline with the publication of results from its Phase 1 study evaluating Anktiva™ (N-803), its IL-15 superagonist, in combination with Rituxan® (rituximab), an anti-CD20 monoclonal antibody therapy, in patients with indolent non-Hodgkin lymphoma (iNHL), who had relapsed or were refractory after two lines of therapy.

ImmunityBio, Inc. (NASDAQIBRX), a clinical-stage immunotherapy company, today announced that the U.S. Military HIV Research Program (MHRP) at the Walter Reed Army Institute of Research has launched a Phase 2 clinical trial in Thailand to evaluate ImmunityBio’s interleukin-15 (IL-15) superagonist Anktiva® (also called N-803) administered in combination with antiretroviral therapy (ART) during acute HIV infection as an experimental therapy to target and inhibit early establishment of HIV ‘reservoirs’ in infected individuals. Researchers will compare levels of HIV RNA and DNA in lymph node samples pre- and post-treatment and evaluate the therapy’s effects on CD8+ T and natural killer (NK) immune cells. The study is being conducted at the Thai Red Cross AIDS Research Centre in Bangkok.

ImmunityBio, Inc. (NASDAQIBRX), a clinical-stage immunotherapy company, today announced it has administered its proprietary Natural Killer cells to more than 100 patients. The cells were administered as part of combination therapies in trials across multiple indications, including pancreatic, triple-negative breast, and Merkel Cell Carcinoma cancers. The 100th patient to receive ImmunityBio’s NK cells is participating in the company’s QUILT 88 trial for pancreatic cancer (NCT04390399).

ImmunityBio, Inc. (NASDAQIBRX), a clinical-stage immunotherapy company, today reported initial data indicating that a single subcutaneous injection of the company’s COVID-19 vaccine candidate in healthy Phase 1 clinical study participants stimulates the generation of T cells that are reactive to the spike (S) and nucleocapsid (N) protein antigens delivered by the vaccine. Just 14-16 days after the single dose, the mean level of T cells generated in response to the hAd5 S+N T cell vaccine were ten times higher for N specific T cells. By day 21, both S and N T cell responses achieved levels ten times higher as compared to pre-vaccination levels. These preliminary findings were published in a preprint server medRxiv (link) titled, “Single Prime hAd5 Spike (S) + Nucleocapsid (N) Dual Antigen Vaccination of Healthy Volunteers Induces a Ten-Fold Increase in Mean S and N T Cell Responses Equivalent to T Cell Responses from Patients Previously Infected with SARS-CoV-2”.