Search API

Anktiva® (N-803) IL-15 Superagonist Vaccine BioShield Platform Availability, Clinical Trials, Dosage, Side Effects

ImmunityBio, Inc.'s BioShield platform, powered by Anktiva®, represents a paradigm shift in cancer care. Anktiva® (N-803) (nogapendekin alfa inbakicept-pmln) is a first-in-class interleukin-15 agonist IgG1 fusion complex consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. The fusion complex of Anktiva mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 through dendritic cells and driving the activation and proliferation of NK cells, resulting in the generation of memory killer T cells that retain immune memory against these tumor clones. The proliferation of the trifecta of these immune-killing cells and the activation of trained immune memory result in immunogenic cell death, inducing a state of equilibrium that leads to durable, complete responses. Anktiva has improved pharmacokinetic properties, longer persistence in lymphoid tissues, and enhanced anti-tumor activity compared to native, non-complexed IL-15 in vivo. 

The Company's Cancer Moonshot program, QUILT clinical trials, was launched in January 2016. Anktiva is the backbone of ImmunityBio's Quantum Oncotherapeutics immunotherapy-based vaccine approach for treating multiple tumor types. Anktiva's triangle offense against cancer includes natural killer cells, T cells, and memory T cells. "We hypothesized that activation and proliferation of natural killer cells through IL-15 stimulation could rescue T cells after checkpoint failure, regardless of tumor type or location. As with non-muscle invasive bladder cancer, we believe that ANKTIVA enhanced the NK and T cell activity critical for targeting and killing cancer cells, which have entered the phase of tumor evasion and resistance," said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio, in a press release in April 2024. The Company is applying its science and platforms to treat cancers, including the development of potential cancer vaccines, immunotherapies, and cell therapies that significantly reduce or eliminate the need for standard high-dose chemotherapy.

On April 22, 2024, ImmunityBio announced that the U.S. Food and Drug Administration (FDA) had approved BLA 761336, Anktiva plus BCG, for treating patients with BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. The U.S. FDA has approved Merck's TICE BCG and ImmunityBio's recombinant Bacillus Calmette-Guérin (BCG) vaccine for this therapy. The BCG vaccine is an approved combination therapy for treating adults with NMIBC carcinoma in situ, either alone or in combination with Ta/T1 papillary disease. On February 27, 2025, ImmunityBio announced that the FDA had granted Regenerative Medicine Advanced Therapy (RMAT) designation for Anktiva and CAR-NK (PD-L1 t-haNK) for the reversal of Lymphopenia in Patients Receiving Standard-of-Care Chemotherapy/Radiotherapy and in multiply relapsed, locally Advanced, or Metastatic Pancreatic Cancer.

On June 2, 2025, the FDA authorized expanded access to ANKTIVA to treat lymphopenia, a life-threatening immune deficiency induced by chemotherapy, radiotherapy, and immunotherapy, resulting in depletion of natural killer (NK) and CD4+ CD8+ T cells (lymphocytes). Expanded Access includes all patients with solid tumors who have failed first-line treatment on chemotherapy, radiotherapy, or immunotherapy and exhibit low Absolute Lymphocyte Counts (ALC <1,000/μL)

On July 4, 2025, the UK's Medicines and Healthcare products Regulatory Agency approved nogapendekin alfa inbakicept (Anktiva) for adults with BCG-unresponsive non-muscle-invasive bladder cancer, where the disease remains confined to the inner lining of the bladder and may include tumors. The approval was granted to Serum Life Science Europe GmbH. As of December 12, 2025, Anktiva has a Conditional Marketing Authorization by the European Union.

ImmunityBio is a vertically integrated biotechnology company based in Culver City, CA. It is developing next-generation therapies and vaccines that bolster the natural immune system to defeat cancers and infections. The Company's pipeline is based on broad immunotherapy and cell therapy platforms designed to attack cancer and infectious pathogens by orchestrating the innate and adaptive branches of the immune system. ImmunityBio's clinical pipeline comprises 27 clinical trials, 18 of which are in Phase 2 or 3 development.

Anktiva Plus BCG Therapy Bladder Cancer Indication

On December 16, 2025, ImmunityBio, Inc. announced treatment with ANKTIVA® plus BCG demonstrates efficacy at 12 and 36 months, including disease-free survival, disease-specific survival, long-term progression-free survival, and high cystectomy avoidance in patients with BCG-unresponsive high-grade papillary-only NMIBC. Published in The Journal of Urology's January 2026 print edition, the research findings also show tolerable safety consistent with BCG treatment alone, with 3% grade 3 and no grade 4 or 5 treatment-related adverse events.

On April 27, 2025, ImmunityBio presented updated clinical data highlighting the durability and impact of Anktiva in combination with BCG. The results demonstrated the most extended complete response duration and the highest cystectomy-avoidance rate among therapies studied in BCG-unresponsive NMIBC, including CIS with or without papillary disease and papillary-only disease without CIS. Sam S. Chang, M.D., Professor of Urology and Chief Surgical Officer of the Vanderbilt Ingram Cancer Center stated, "Our latest findings, including an 82% cystectomy avoidance rate, provide additional evidence that Anktiva can restore BCG activity and promote durable complete responses and, most importantly, help patients preserve their bladder for a prolonged duration from surgery in both CIS, as well as papillary without CIS disease."

On July 2, 2024, Taylor and Francis Online published a Plain Language Review. It reported that N-803 plus BCG eliminated NMIBC in all nine BCG-naïve participants in NCT02138734 (Phase 1/2 study) and NCT03022825 (Phase 2/3 study), and the effects were long-lasting. Participants remained NMIBC-free for 8.3 to 9.2 years. On November 19, 2024, ImmunityBio announced that 100 patients with BCG-unresponsive NMIBC and CIS have been treated with ANKTIVA in combination with BCG, achieving a 71% complete response (CR) rate. In these responders, the range of durable responses extended to Companynths.

The Company stated that while BCG vaccination is an effective treatment for many patients, it doesn't work for an estimated 40% of NMIBC cases. Patients with intermediate or high-risk NMIBC typically receive a treatment of transurethral resection of the bladder tumor (TURBT) followed by BCG intravesical instillation. However, cancer will recur in 30% to 40% of patients with NMIBC despite adequate treatment with BCG. Moreover, even among those in whom a complete response is achieved with BCG, up to 50% see their cancer return. The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by influencing the development, maintenance, and function of critical immune cells—namely, natural killer (NK) cells and CD8+ killer T cells—that target and kill cancer cells. 

Bladder cancer was the 9th most commonly diagnosed cancer in 2022. In the U.S., the American Cancer Society estimates there will be 83,190 new cases and 16,840 deaths from bladder cancer in 2024.

Anktiva Plus BCG Vaccine Mechanism of Action

Anktiva's mechanism of action involves the direct, specific stimulation of CD8+ T cells and Natural Killer (NK) cells through beta-gamma T-cell receptor binding, thereby generating memory T cells while avoiding stimulation of T-regulatory cells (Tregs). N-803 is designed to have improved pharmacokinetic properties, longer persistence in lymphoid tissues, and enhanced anti-tumor activity compared to native, non-complexed IL-15 in vivo. The IL-15 superagonist N-803 acts synergistically with Bacille CaCalmette-Guérin (BCG). As a result, n-803 has improved pharmacokinetic properties, longer persistence in lymphoid tissues, and enhanced anti-tumor activity compared to native, non-complexed IL-15 in vivo.

The superagonist N-803 has been studied in over 700 patients across multiple Phase 1 and 2 clinical trials for liquid and solid tumors. In addition to the NMIBC study, it is currently being investigated in trials for pancreatic cancer, non-small cell lung cancer (NSCLC), non-Hodgkin lymphoma, and HIV. On November 10, 2022, the journal NEJM Evidence published its conclusion from a phase 2/3 study: In patients with BCG-unresponsive bladder carcinoma in situ and papillary NMIBC treated with BCG and the novel agent NAI, CRs were achieved with the persistence of effect, cystectomy avoidance, and 100% bladder cancer–specific survival at 24 months. Given the observed strong efficacy and favorable adverse event (AE) profile, as well as the mode of administration, N-803 represents a significant advance in treatment options compared to existing therapies for BCG-unresponsive CIS and Papillary NMIBC, as these researchers wrote in 2022. On December 27, 2022, an editorial from urological cancer experts from Memorial Sloan Kettering Cancer Center stated: "The efficacy and minimal toxicity of this combination represents a major advance for the care of patients with BCG-unresponsive NMIBC, and the authors should be congratulated. In addition, this promising combination offers a potential alternative to cystectomy and may allow us to move beyond single-arm studies toward randomized phase 3 trials against other novel therapies."

In February 2024, the Company announced that the journal Urology Practice had published findings from the Patient-Reported Outcomes (PROs) of participants in the phase 2/3 QUILT 3.032 study. These PROs support the positive interim results from the study published in NEJM Evidence, in which 71% of patients in cohort A with CIS, with or without Ta/T1 disease, achieved a complete response. The finding of relative stability in global health and physical function during the study is similar to that reported by others for BCG monotherapy. This suggests that the novel combination is as tolerable as treatment with BCG alone.

Anktiva Plus BCG Vaccine Dosage

For dosage induction, 400 mcg of Anktiva is administered intravesically with BCG vaccine once weekly for 6 weeks. A second induction course may be administered if the complete response is not achieved at month 3. For maintenance, 400 mcg of Antiva is administered intravesically with BCG once a week for three weeks at months 4, 7, 10, 13, and 19. Additional maintenance instillations with BCG may be required for patients with an ongoing complete response at month 25 and later.

U.S. FDA Review Anktiva Plus BCG Vaccine

The U.S. FDA approved Anktiva on April 22, 2024. On October 23, 2023, ImmunityBio announced that it had resubmitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Anktiva. Recent study results support the BLA, including the pivotal Phase II/III, open-label, single-arm, multicenter QUILT-3.032 clinical study published in NEJM Evidence in November 2022. Anktiva has received both FDA Breakthrough Therapy and Fast Track designations for treating BCG-unresponsive NMIBC CIS and a Fast Track designation for BCG-unresponsive NMIBC papillary and BCG-naïve NMIBC CIS.

Anktiva Plus BCG Papillary Disease Indication

In Company 2025, the Company submitted a supplemental Biologics License Application (sBLA) for the use of Anktiva® plus Bacillus Calmette-Guérin (BCG) in BCG-unresponsive NMIBC for the indication of papillary disease. The data submitted to the FDA included efficacy results demonstrating durable complete remissions in patients with BCG-unresponsive NMIBC papillary disease. In 88% and 82% of subjects, the probability of avoiding surgical removal of the bladder was achieved for 2 and 3 years following Anktiva plus BCG, respectively. The mortality and morbidity associated with a radical total cystectomy are high, and this long-term bladder-sparing therapy has the potential to provide a significant benefit and quality of life to patients suffering from BCG-unresponsive papillary disease. In a pivotal study published in NEJM Evidence, BCG plus Anktiva resulted in disease-free survival (DFS) rates of 55%, 51%, and 48% at 12, 18, and 24 months, respectively, in participants with papillary non-muscle-invasive bladder cancer (NMIBC). In addition, patients receiving the novel treatment achieved a 93% avoidance of cystectomy (surgical removal of the bladder) with a median follow-up of 20.7 months.

Anktiva Long COVID Indication

ImmunityBio announced on August 19, 2025, the opening of a new Phase 2 clinical study to assess the BioShield™ platform in 40 individuals in California, anchored by ANKTIVA®, in patients with long COVID. This condition comprises a broad range of symptoms. The new study, COVID-4.019-Long, aims to evaluate the safety of ANKTIVA when administered subcutaneously in participants with long COVID. The secondary objective is to assess the effect of ANKTIVA on absolute lymphocyte count. Exploratory objectives include evaluation of ANKTIVA's ability to improve post-COVID natural killer cell and CD8+ T cell counts, and assessment of the immunological function of NK cells and CD8+ T cells. The safety and tolerability of ANKTIVA for long COVID is also being assessed in a separate Phase 2 study conducted at the University of California, San Francisco. ImmunityBio supports both studies.

Anktiva Plus BCG Vaccine Availability

As of August 20, 2025, Anktiva plus BCG Vaccine is approved in the UK and the United States and is available at various clinical sites and cancer centers in the U.S. On August 11, 2025, the Company announced that the Michael E. DeBakey Department of Veterans Affairs (VA) Medical Center had recently become the first VA hospital in the Houston, Texas, region and one of the first in the U.S. to provide treatment with ANKTIVA® to a veteran with bladder cancer. On May 27, 2025, ImmunityBio announced that a multi-party collaboration will introduce the Cancer BioShield platform to Saudi Arabia and the broader Middle East. 

In September 2024, ImmunityBio announced that more than 100 million medical lives are covered by medical reimbursement policies that include ANKTIVA reimbursement eligibility. In May 2024, it was added to the National Comprehensive Cancer Network guidelines. On June 20, 2024, ImmunityBio, Inc. announced the initial treatment of multiple patients in the U.S. with ANKTIVA. According to an X post by @DrPatSoonShiong, the initial 1,000 doses of ANKTIVA were shipped on Company2024. The Company previously announced that the ANKTIVA Drug Substance had been completed and released, accompanied by two-year storage stability data sufficient for 170,000 doses.

Anktiva Availability Europe

ImmunityBio confirmed on January 27, 2025, that the filing process for regulatory approval of Anktiva for the Treatment of Patients with BCG-unresponsive non-muscle-invasive bladder cancer (carcinoma in situ) in the European Union (EU) has commenced. The filing will include 30 countries, including 27 in the EU and three in the European Economic Area.

Anktiva Access to BCG Vaccines

In the second quarter of 2025, the Serum Institute of India will become an alternative source of BCG vaccines, including TUBERVAC. On May 2, 2024, ImmunityBio, Inc. announced an exclusive arrangement with the Serum Institute of India (SII) to supply the Company with BCG vaccines. The agreement encompasses the manufacturing of standard BCG (sBCG), which is currently approved for use outside the United States, as well as a next-generation recombinant BCG (iBCG) that is undergoing clinical trials. BCG has been modified with two genetic modifications to enhance immunogenicity and safety, resulting in iBCG. It is intended for use with Anktiva for currently approved and potential future indications, pending regulatory approval. The companies plan to accelerate the ongoing Phase 2 clinical trials of iBCG in Europe, which have demonstrated safety advantages over sBCG and enhanced immunogenicity in driving both CD8+ and CD4 T cells. ImmunityBio plans to submit this protocol to the U.S. Food and Drug Administration (FDA) and global regulatory bodies in mid-2024.

ANKTIVA® and CAR-NK Regenerative Medicine Advanced Therapy Designation

The U.S. FDA's Regenerative Medicine Advanced Therapy designation in February 2025 follows clinical data showing correlations between Absolute Lymphocyte Count (ALC) and significant overall survival in QUILT trials across multiple tumor types, including third-line or more advanced metastatic pancreatic cancer, checkpoint-relapsed non-small cell lung cancer (NSCLC), and supportive data from healthy volunteers. The reversal of lymphopenia by ImmunityBio's IL-15 superagonist is consistent with the mechanism of action of ANKTIVA, which demonstrates the proliferation and activation of NK cells, CD4+ T cells, CD8+ T cells, and memory T cells, without upregulation of suppressive T regulatory cells, as approved in the ANCompanyabel. The Company intends to submit an FDA BLA for the indication of reversing lymphopenia in patients receiving standard-of-care chemotherapy and/or radiation, as well as for the treatment of locally advanced or metastatic pancreatic cancer, which includes the first-in-class CAR-NK (PD-L1 t-haNK).

On August 13, 2025, ImmunityBio announced early findings from its QUILT-106 Phase I trial, showing highly promising complete responses in the first two patients treated to date with late-stage Waldenstrom macroglobulinemia, using its CD19 CAR-NK natural killer cell therapy.

Anktiva Plus Checkpoint Inhibitor Therapy Non-Small Cell Lung Cancer Indication

Non-small cell lung cancer (NSCLC) accounts for about 80% to 85% of all lung cancer diagnoses (230,000). The development of checkpoint inhibitors in NSCLC has been revolutionary, doubling the median overall survival in some settings; however, patient responses may be short-lived, with late responses and/or progression after achieving an initial response.

On September 9, 2024, the phase 2b study of ANKTIVA in combination with the checkpoint inhibitors KEYTRUDA or OPDIVO in multiple tumor types, including NSCLC who failed CPI, showed long-term overall survival of 57% (49/86) and 34% (29/86) at 12 and 18 months, respectively, exceeding the current standard of care. Based on the results of the QUILT 3.055 study and other trials involving ANKTIVA with checkpoint inhibitors, ImmunityBio is opening Phase 3 trials of ANKTIVA plus KEYTRUDA or OPDIVO in 1st and 2nd-line NSCLC.

On April 25, 2024, ImmunityBio announced positive overall survival results in the QUILT 3.055 study of 2nd- and 3rd-line Non-small cell lung cancer (NSCLC) patients who progressed after checkpoint inhibitor therapy (pembrolizumab, nivolumab, or atezolizumab) and standard-of-care chemotherapy. The study's results 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.

Anktiva Endometrial Cancer Indication

ImmunityBio, Inc. announced on August 6, 2024, the opening of the QUILT 502 clinical trial to study ANKTIVA® together with the investigational AdHER2DC vaccine (autologous dendritic cells transduced with HER2-expressing adenovirus) in individuals with HER2-expressing endometrial cancer. This trial will evaluate ANKTIVA as a replacement for the short-term activity of checkpoint inhibitor immunotherapies, with long-term effectiveness. The Phase1/2 interventional study will enroll 60 participants with HER2-positive endometrial cancer, who will also receive pembrolizumab and lenvatinib, two FDA-approved drugs for endometrial cancer. The study is expected to be completed in 2026.

Ankylosing Spondylitis Indication

ImmunityBio partnered with the NCI in February 2024 to study the use of ANKTIVA in cases of Lynch syndrome. This genetic condition is linked with a significantly increased incidence of cancers, particularly colon cancer. 

Cancer BioShield™ Platform Lymphopenia Indication

On June 2, 2025, ImmunityBio announced that the U.S. FDA had granted Expanded Access authorization for the use of its Cancer BioShield™ platform, anchored by ANKTIVA®, to treat lymphopenia in adult patients with refractory or relapsed solid tumors independent of tumor type who have progressed after first-line standard-of-care treatment, chemotherapy, radiation, or immunotherapy.

BCG Naïve Trial Global Expansion

ImmunityBio continues to add U.S. sites to the BCG-naïve trial (QUILT-2.005) and to enroll patients in the study; the Company has received regulatory approval to begin patient enrollment in QUILT-2.005 in India. The Company plans to submit an application to the South African regulatory authorities in Q3 2024 to initiate the QUILT-2.005 trial in that country.

Anktiva Plus BCG Therapy Side Effects

Anktiva's most common adverse reactions (occurring in≥15% of patients) include laboratory test abnormalities, such as increased creatinine, dysuria, hematuria, urinary frequency, micturition urgency, urinary tract infection, increased potassium, musculoskeletal pain, chills, and pyrexia. Pregnancy: May cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.

Tri-Ad5 Vaccine Combination With N-803

On April 25, 2023, ImmunityBio, Inc. announced the opening of a phase 2b clinical trial to study its investigational Tri-Ad5 vaccine combination (Adenovirus 5 CEA/MUC1/brachyury) together with its IL-15 superagonist N-803 for people with a hereditary condition known as Lynch syndrome to prevent colorectal and other cancers in study participants.

Bladder Cancer Patient Treatment Costs

The annual projected cost of bladder cancer treatment is over $2 billion. The cost profile varies substantially across the different stages of the disease. The average price per patient ranged from $19,521 (stage 0a) to $169,533 (metastatic disease).

Anktiva plus BCG Vaccine Price

In 2024, Anktiva will be priced at $35,800 per dose. On January 1, 2025, the Healthcare Common Procedure Coding System J-code assigned by the Centers for Medicare & Medicaid Services for ANKTIVA® became effective. Healthcare providers may now use the permanent J-code, J9028 (Injection, nogapendekin alfa inbakicept-pmln, for intravesical use, one microgram) when submitting claims for ANKTIVA.

Anktiva Plus BCG Vaccine Payment Options

The ImmunityBio CARE™ program is designed to help patients access ImmunityBio's innovative treatment. Since its launch in May 2024, ANKTIVA has become accessible to patients through commercial and government insurance programs, including the VA, DoD, and Medicare. In April 2025, the Company also announced that it had submitted an EAP to the FDA to make ANKTIVA available for the treatment of lymphopenia. Lymphopenia is characterized by the loss of natural killer cells and T cells, which are essential for fighting cancer. 

ImmunityBio Investments

In January 2024, the Company announced an aggregate capital raise of $850 million in 2023, comprising $320 million from institutional investors and $530 million from the Founder, Dr. Patrick Soon-Shiong. In April 2024, the Company confirmed a $100 million non-dilutive cash infusion following Anktiva's FDA approval, bringing its cash on hand to approximately $240 million for the launch of Anktiva in NMIBC. On ApCompany2025, the Company announced a securities purchase agreement with an investor.

ImmunityBio Revenues

In the second quarter of 2025, ImmunityBio reported $26.4 million in revenue, representing a 60% increase from $16.5 million in the first quarter of 2025. This growth reflects continued commercial traction of ANKTIVA + BCG in BCG-unresponsive non-muscle invasive bladder cancer with CIS with or without Papillary tumors. ImmunityBio announced on April 15 that the Company earned net product revenue of approximately $16.5 million during the three months ended March 31, 2025, representing a 129% increase over the $7.2 million in net revenue earned during the fourth quarter of 2024.

Anktiva News

August 11, 2025 - Dr. Patrick Soon-Shiong, Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio, commented in a press release, "Drs. Jones' and Taylor's leadership and commitment to innovation are exactly what's needed to expand access to transformative treatments like ANKTIVA across the VA system. This milestone at DeBakey underscores the real-world impact of our mission."

July 25, 2025 - The 1H 2025 sales of $42.9 million represent a 246% increase in unit volume during the first two quarters of 2025 since the J-code approval versus the last two quarters of 2024. 

May 27, 2025 - His Excellency Khalid A. AlFalih, Minister of Investment, Saudi Arabia, commented: "This partnership reflects the Kingdom's commitment to positioning itself as a global hub in the biotechnology sector in advanced therapeutics. Through this collaboration, we will localize cutting-edge technologies, build biomanufacturing capabilities, and enhance our national biotechnology infrastructure and human capabilities in alignment with the objectives of the National Biotech Strategy."

April 8, 2025 - The Company entered into a securities purchase agreement for a potential investment of up to $90 million. 

February 27, 2025 - "The Founder applied for RMAT designation for ANKTIVA combined with NK cells in the initial 2017 IND. With the clinical results of the QUILT trials across multiple tumor types from 2017 to 2024, validating the hypothesis that high-dose chemotherapy and radiation induce lymphopenia and can be reversed by ANKTIVA together with off-the-shelf CAR-NK cells, resulting in prolongation of overall survival, and enabling ImmunityBio to reapply for RMAT in 2025," said Dr. Patrick Soon-Shiong, Founder, Executive Chairman, and Global Chief Scientific & Medical Officer of ImmunityBio, in a press release.

February 6, 2025 - Patrick Soon-Shiong, MD, shares key updates in the development of Anktiva.

November 12, 2024 - "The response from the urologists and clinical practices about the utility of ANKTIVA in NMIBC CIS has been gratifying. ImmunityBio's clinical trial in BCG naïve NMIBC is enrolling well, and clinical sites have been expanded from the U.S. to multiple global locations. In the urology space, initial clinical trials of ANKTIVA are being designed for high-risk prostate cancer," said Dr. Patrick Soon-Shiong, Executive Chairman and Global Chief Scientific & Medical Officer of ImmunityBio.

September 9, 2024 - Patrick Soon-Shiong, M.D., Executive Chairman, Founder, and Global Chief Scientific and Medical Officer at ImmunityBio, commented, "Based on this study, the ResQ studies have been activated as randomized Phase 3 trials in both 1st- and 2nd-line NSCLC by combining ANKTIVA with pembrolizumab or nivolumab versus standard of care. The current results presented at the World  Congress on Lung Cancer confirm that by activating the body's natural immune system and proliferating natural killer cells, killer T cells, and memory T cells, this IL-15 superagonist boosts, or rescues, the checkpoint inhibitor, likely by reactivating MHC1 expression on the tumor. We are excited about the potential of converting an MHC-ve cold tumor to an MHC+ve hot tumor and evolving the field of immunotherapy beyond T cells."

September 8, 2024 - John Wrangle, M.D., MPH, Associate Professor, Medical University of South Carolina, presented an oral presentation of the data at the World Congress on Lung Cancer in San Diego in the session titled "Novel Immunotherapy Strategies and Combinations."

August 12, 2024 - "We are encouraged by the keen interest that physicians are showing in ANKTIVA as a treatment option for their patients with non-muscle invasive bladder cancer with carcinoma in situ (CIS), as well as by our conversations with payers as we see them adding our approved product into their policies," said Richard Adcock, President and CEO of ImmunityBio.

June 20, 2024 - Richard Adcock, President and CEO of ImmunityBio, stated, "We look forward to ANKTIVA reaching an increasing number of eligible NMIBC patients and for our science to deliver even more therapies from our pipeline."

May 2, 2024 - "We are pleased to partner with the Serum Institute of India so that the power of its large-scale, world-class GMP manufacturing capacity can be used to address the issue of BCG shortage, which affects thousands of bladder cancer patients annually," said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio. 

April 25, 2024 - The Company announced positive overall survival results of ANKTIVA combined with checkpoint inhibitors in NSCLC from the completed QUILT 3.055 trial. 

April 22, 2024 - "The FDA's approval of ANKTIVA marks our launch of a next-generation immunotherapy beyond checkpoint inhibitors," said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio.

February 5, 2024 - "Many current therapies for bladder cancer slow disease progression but can cause debilitating side effects," commented Principal Investigator Karim Chamie, M.D., Associate Professor of Urology at UCLA, in a press release. "The QUILT 3.032 Quality of Life study data suggest that many patients not only have a durable response but also report no decline in physical function, which is very important for these patients."

January 2, 2024 - "This transaction raises significant capital for the Company to support important growth plans, yet with limited equity dilution and with a cap on total payments tied to the initial investment," said Richard Adcock, Chief Executive Officer and President of ImmunityBio.

October 26, 2023 - "We are pleased that the FDA has accepted ImmunityBio's resubmission of the BLA as a complete response, following our productive interactions leading up to the resubmission," said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio.

February 16, 2023—ImmunityBio, Inc. announced that it had executed financing expected to result in gross proceeds at closing of approximately $50 million before deducting any offering-related expenses, subject to customary closing conditions. The warrants could result in additional gross proceeds of up to $60 million if fully exercised.

November 10, 2022 -  NEJM Evidence has published results from the QUILT 3.032 phase 2/3 clinical trial studying N-803 plus BCG in adults with NMIBC CIS with or without Ta/T1 papillary disease.

July 28, 2022 - The U.S. FDA accepted a BLA from ImmunityBio, Inc. for review.

February 2022 - Data presented at the ASCO Genitourinary Cancers Symposium showed a complete response in 59 of 83 patients, with a 1% complete response rate (95% CI: 0.6, 1.8) and a median duration of complete response of 24.1 months. In patients who responded to the investigational therapy, the probability of avoiding bladder cancer and cystectomy progression at 24 months exceeded 90%. In addition, the combination of Anktiva and BCG had a well-tolerated profile, with 0% treatment-related severe adverse events (SAEs), 0% immune-related adverse events (irAEs), and 100% bladder cancer-specific overall survival at 24 months.

January 2019 - ScienceDirect published a Brief Correspondence: Prognostic Implications of the U.S. FDA-defined BCG-unresponsive Disease.

N-803 plus BCG Vaccine Clinical Trials

As of August 12, 2024, ImmunityBio continues to add U.S. sites to the BCG-naïve trial (QUILT-2.005) and to enroll patients in the study. The Company has received regulatory approval to begin patient enrollment in QUILT-2.005 in India, and the necessary medicines have been successfully imported into the country for use in the trial. A Companyally, the Company plans to submit an application to the South African regulatory authorities in Q3 2024 to initiate the QUILT-2.005 trial in that country.

N-803 is currently being evaluated in adult patients in two clinical trials for non-muscle-invasive bladder cancer (NMIBC). QUILT-2.005 is investigating the use of N-803 in combination with BCG for patients with BCG-naïve non-muscle-invasive bladder cancer (NMIBC); QUILT-3.032 is studying N-803 in combination with BCG in patients with BCG-unresponsive NMIBC, CIS, and Papillary Disease. QUILT 3.032 Registrational Trial of IL-15 Superagonist N-803 Plus BCG in Patients with Bladder Cancer - results presentation.

In February 2024 - The ongoing phase 2/3 open-label multicenter registrational study QUILT 3.032 (NCT03022825) is evaluating the safety and efficacy of the investigational interleukin-15 superagonist N-803 (also known as Anktiva® and nogapendekin alfa in Aricept, NAI) in combination with standard therapy for NMIBC, bacillus CaCalmette-GuérinBCG), in patients who failed or in whom cancer returned after BCG monotherapy, and thus were diagnosed as BCG-unresponsive. Durability, cystectomy avoidance, progression-free survival, disease-specific survival (DSS), and overall survival are secondary endpoints for cohort A. Cohort C was discontinued per the study design due to a low response rate with N-803 monotherapy.

In 2022, an open-label, multicenter Phase 3 study (QUILT 3.032) of intravesical BCG plus N-803 in patients with BCG-unresponsive high-grade non-muscle-invasive bladder cancer (NMIBC), including those with carcinoma in situ (CIS) and Papillary disease, was reported (NCT03022825). Results: Cohort A (CIS) Efficacy: Fully enrolled n = 81 with a 20.9-month median follow-up. CR rate 72% (95% CI: 60.5%, 81.1%) with a median duration for 3-month responders of 24.1 months and a 60% probability of maintaining this CR for ≥ 18 months (95% CI: 43.1%, 73.5%). The 12-month cystectomy-free rate is 89% (95% CI: 80.1%, 94.6%), with a 100% cancer-specific survival rate at 24 months. Cohort B (Papillary) Efficacy: To date, 73 patients have enrolled with a median follow-up of 17.3 months. The primary endpoint was met, with a disease-free rate of 57% (95% CI: 43.7%, 68.5%) at 12 months and 53% (95% CI: 38.8%, 64.8%) at 18 months. The 12-month cystectomy-free rate is 95% (95% CI: 84.7%, 98.3%), with a 98% cancer-specific survival rate at 24 months. Combined Efficacy: In the combined group (n = 154) of BCG-unresponsive NMIBC, with a 19.3 months median follow-up, the 12-month cystectomy-free rate was 92% (95% CI: 85.5%, 95.3%), and the 24 months OS is 94% (95% CI: 86.9%, 97.1%) with 99.5% cancer-specific overall survival. Combined Safety: There were 0% treatment-related SAEs and 0% immune-related SAEs, with 4/ 154 (3%) ≥ TR Grade 3 AEs. 0% treatment-related deaths have occurred as of the Sept 2021 analysis date.

DUKORAL® Cholera Vaccine Clinical Trials, Dosage, Indication, Side Effects

Valneva SE's DUKORAL® is an oral, inactivated vaccine for preventing diarrhea caused by Vibrio cholerae and/or heat-labile toxin-producing enterotoxigenic Escherichia coli (ETEC). Since the 1980s, either killed or live oral cholera vaccines (OCVs) have been developed, and efficacy and effectiveness studies have been conducted. DUKORAL contains four different inactivated strains (types) of V. cholerae serotype O1 and part of a toxin from one of these strains as active ingredients, according to the European Medicines Agency (EMA). Dukoral is a vaccine administered orally to protect individuals against cholera. DUKORAL suspension and effervescent granules for oral suspension. DUKORAL's ATC code: J07AE01, J07AE02, J07AE51.

The World Health Organization (WHO) has prequalified the DUKORAL vaccine. It is authorized in Europe, Australia, Canada, Ireland, Mayotte, New Zealand, Switzerland, Thailand, and the United Kingdom to protect people against cholera and Enterotoxigenic Escherichia coli (ETEC). The EMA (EMEA/H/C/000476) states that Dukoral is used in individuals aged 2 years who will be visiting areas with a high risk of cholera. The WHO announced on February 12, 2024, that global demand for OCVs (74 million) has exceeded supply (38 million). Valneva announced on November 7, 2024, that DUKORAL sales in the third quarter of 2024 increased by 85% year-over-year, as marketing investments resumed following a successful regulatory inspection of the Company's new manufacturing site in Sweden.

France-based Valneva SE's strategy is rooted in its vision of contributing to a world where no one dies or suffers from a vaccine-preventable disease. Dukoral initially produced the SBL vaccine. 

DUKORAL Cholera Vaccine Indication

The U.S. CDC recommends vaccination for people traveling to or living in areas of active cholera transmission. In addition, active immunization against disease caused by Vibrio cholerae serogroup O1 is recommended for adults and children (2 years and older) who will be visiting endemic/epidemic areas. But cholera vaccines are not 100% effective. Check the CDC's Travel Health Notices to identify areas with active cholera transmission.

DUKORAL Cholera Vaccine Dosage

DUKORAL is administered orally with a buffer solution that requires 150 ml of clean water for adults. The standard primary course for adults and children over six years old consists of two doses; children under six years old should receive three doses. Doses are to be administered at intervals of at least one week but less than six weeks apart. The primary immunization course should be restarted if more than six weeks have elapsed since the last dose. Immunization should be completed at least one week before potential exposure to Vibrio cholerae O1.

Each dose of DUKORAL vaccine suspension (3ml) contains a total of 1.25 x 1011 bacteria of the following strains: Vibrio cholerae O1 Inaba, classical biotype (heat inactivated) 31.25 x 109 bacteria, Vibrio cholerae O1 Inaba, El Tor biotype (formalin inactivated) 31.25x 109 bacteria, Vibrio cholerae O1 Ogawa, classical biotype (heat inactivated) 31.25x 109 bacteria, Vibrio cholerae O1 Ogawa, classical biotype (formalin inactivated) 31.25x 109 bacteria—recombinant cholera toxin B subunit (rCTB) 1mg.

DUKORAL Vaccine Production

Valneva's global manufacturing network comprises three in-house operations, covering both internal and external production of clinical and commercial products. Valneva's U.S. FDA-approved manufacturing site in Livingston, located just outside Edinburgh, is currently dedicated to producing drug substances for our viral vaccines. Valneva's manufacturing site in Solna is just outside of Stockholm. The site has a long history of vaccine manufacturing and is affiliated with Sweden's state-owned vaccine institute. Valneva's new manufacturing site in Sweden underwent regulatory evaluation and approval in 2024. Along with Valneva's development center in Vienna (Austria), the Company operates GMP laboratories and facilities for the testing and quality control of Valneva's commercial and clinical-stage vaccines.

DUKORAL Cholera Vaccine Warnings and Precautions

DUKORAL® confers protection specific to Vibrio cholerae serogroup O1. Immunization does not protect against V. cholerae serogroup O139 or other species of Vibrio. Administration of DUKORAL® should be postponed for subjects suffering from acute gastrointestinal or febrile illness. DUKORAL is not recommended for use in children under two years of age. Formaldehyde is used during manufacturing, and trace amounts may be present in the final product. Caution should be taken in subjects with known hypersensitivity to formaldehyde. DUKORAL contains approximately 1.1 g of sodium per dose, which patients should consider when following a controlled sodium diet. The vaccine does not provide complete protection against the disease.

Cholera Outbreaks

Various countries have reported cholera outbreaks in 2025.

DUKORAL Vaccine News

August 12, 2025 - In the first half of 2025, DUKORAL® sales were €17.4 million compared to €14.9 million in the first half of 2024. The supply of doses notably contributed to this 16.4% growth, supporting efforts to combat an outbreak on the French island of Mayotte, for a total of €1.1 million in the first quarter of 2025.

May 7, 2025 - Valneva SE reported that in the first quarter of 2025, DUKORAL sales increased 9.4% to €12.3 million, primarily driven by the supply of doses to the French Department of Mayotte.

December 18, 2024—The WHO reported that Oral Cholera vaccine production reached its highest level in November since 2013. This increase allowed the average stock to rise to 3.5 million doses in November, compared to 600,000 in October 2024.

March 20, 2024 - The Company confirmed that DUKORAL® vaccine sales benefited from the significant recovery in the private travel markets.

September 30, 2022 - Cholera Vaccine: Recommendations of the U.S. CDC Advisory Committee on Immunization Practices.

DUKORAL Clinical Studies

In September 2023, a Research Article focused on cholera vaccine clinical trials: A cross-sectional analysis of clinical trials registries.

Challenge studies in human volunteers provided the first demonstration of efficacy. The challenge study at the University of Maryland enrolled healthy participants aged 19 to 35. Participants receiving either WC-BS (with 5 mg of CTB) or WC were given three doses at 2-week intervals. In addition, Cimetidine was administered three hours before receiving the vaccine, along with the sodium bicarbonate solution mixed with the vaccine. Vaccinated participants and unvaccinated controls were challenged with 2 × 106 El Tor Inaba V. cholerae (strain N16961) four weeks after completion of the third dose of WC (n = 9) and five weeks after completion of WC-BS (n = 11). The vaccine efficacy of WC was found to be 56%, and for WC-BS, 64% (Table 2). Vaccinated participants in both groups who developed cholera had less severe illness than controls and complete protection from severe diarrhea.

The EMA states that the Company presented data from the published literature and the results of three central studies involving nearly 113,000 people to support the use of Dukoral. In all three studies, Dukoral, given in either two or three doses, was compared with a placebo (a dummy vaccine). The studies took place in areas where cholera was found. The primary measure of effectiveness was the 'protective effectiveness' of the vaccine, calculated by comparing the number of people in the studies who developed cholera after receiving Dukoral and a placebo.

The first study involved over 89,000 people in Bangladesh and compared Dukoral with the same vaccine without the toxin and with a placebo. In this study, Dukoral was formulated using the cholera toxin extracted from cholera bacteria, rather than the newer recombinant toxin. The protective effectiveness of Dukoral was 85% over a six-month period. Protection lasted for six months in children and two years in adults. In adults, two doses of the vaccine were as effective as 3.

The other two studies compared Dukoral (containing recombinant cholera toxin) with a placebo in over 22,000 people in Peru. In the first of two doses, Dukoral's protective effectiveness was 85% for the first five months after vaccination. The people in the second study also received a booster dose 10 to 12 months later. The protective effectiveness of Dukoral after the booster dose was 61% during the second year of follow-up.