Phase I/II Evaluation of a Cancer Lysate Vaccine and Montanide(R) ISA-51 VG With or Without the IL-15 Super-Agonist N-803 as Adjuvant Therapy for PD-L1 Negative Non-Small Cell Lung Cancer

Background:
Surgery is the primary treatment for non-small cell lung cancer (NSCLC) that is diagnosed in its earlier stages. But the tumors often return. Radiation and chemotherapy can improve survival in some people who have had surgery for NSCLC, but these treatments also cause serious side effects. A new approach, called immunotherapy, may be a better way to stop NSCLC tumors from coming back.
Objective:
To test a new treatment (H1299 lung cancer cell vaccine combined with the drug N-803) in people who received surgery for NSCLC.
Eligibility:
Adults aged 18 years or older with no sign of disease after surgery for NSCLC.
Design:
Participants will be screened. They will have a physical exam with blood tests. They will have tests of their heart and lung function. They will have imaging scans.
Study treatment will be given in 28-day cycles. Participants will visit the clinic on the first day of each cycle. They will receive 2 treatments at each visit:
The study vaccine is given as 2-4 small shots under the skin of the thigh or arm.
N-803 is given as a shot under the skin of the abdomen.
Treatment will continue for 6 cycles. Blood tests and imaging scans will be repeated throughout the study.
Participants will have a blood test 1 month after receiving the 6th vaccine. Some participants may then resume taking N-803; they may also receive 2 more vaccinations at 3 and 6 months after their previous treatment.
Follow-up visits will continue for up to 5 years.

Start Date04 Aug 2026

Sponsor / Collaborator

National Cancer Institute

NCT07574541

/ Not yet recruitingPhase 2IIT

Phase II Trial of a Multitargeted Recombinant Ad5 PSA/MUC-1/Brachyury-based Immunotherapy (TriAdeno) Vaccine With IL-15 Superagonist N-803 in Participants With Clinically Localized Prostate Cancer Undergoing Active Surveillance

Background:
Prostate cancer is the second most common cause of cancer-related death among men in the United States. Early-stage, low-grade prostate cancer is managed with active monitoring. However, 35% of men with this cancer will need treatment within 5 years because of tumor growth. Researchers want to know if a new vaccine that targets 3 anti-cancer proteins (TriAdeno) plus a drug (N-803) approved for bladder cancer can help stop prostate tumors from growing.
Objective:
To test TriAdeno and N-803 in people with early-stage prostate cancer.
Eligibility:
People aged 18 years and older with early-stage low- or medium-risk prostate cancer.
Design:
Participants will be screened. They will have a physical exam with blood tests. They will have a test of their heart function. They will have an imaging scan. They may have a rectal exam.
TriAdeno is injected under the skin of the upper thigh; N-803 is injected under the skin of the abdomen. Participants will be treated in up to four 21-day cycles. They will get both injections on the first day of each cycle.
Participants may opt to complete a memory aid: They may record all of their symptoms for 7 days after each injection. They may also complete a questionnaire about their prostate symptoms.
Blood tests, imaging scans, and other tests will be repeated during the study.
A tissue sample (biopsy) of the tumor will be collected during or after cycle 2; a second biopsy may be taken about 1 year later.
Participants will have follow-up phone calls for 5 years....

Start Date04 Aug 2026

Sponsor / Collaborator

National Cancer Institute

NCT07686380

/ Not yet recruitingPhase 2IIT

Phase II Trial of IL-15 Superagonist With or Without Vaccine in Biochemically Recurrent Prostate Cancer After Previous Stereotactic Body Radiation Therapy

Background:
Biochemically recurrent prostate cancer (BCR) occurs when prostate-specific antigen (PSA) levels in the blood rise after surgery or radiation. BCR affects 30,000 to 50,000 men each year. Researchers want to know if a drug (N-803) alone or combined with a vaccine (ETBX-071) can reduce PSA in BCR prostate cancer after radiation.
Objective:
To test a study drug alone and combined with a vaccine in people with BCR prostate cancer who have been treated with targeted radiation to areas of recurrent prostate cancer in the past.
Eligibility:
People aged 18 years and older with BCR prostate cancer who have previously undergone treatment with stereotactic body radiation therapy (SBRT).
Design:
Participants will be screened. They will have a physical exam with blood tests. They will have tests of their heart and kidney function. They will have 3 different imaging scans of their tumors.
N-803 is injected under the skin of the abdomen. ETBX-071 is injected under the skin of thigh.
Participants will be divided into 2 groups: 1 group will get N-803 alone; 1 group will get both N-803 and ETBX-071.
The drug or drugs will be given on the first day of 21-day treatment cycles. Participants will have 8 treatment cycles.
Participants will have a follow-up visit 3 weeks after their last dose of the study drugs. Blood tests and all 3 imaging scans will be repeated.
Follow-up visits will continue every 4 to 8 weeks for 5 years. These visits will include a positron emission tomography (PET) scan every 6 months.

Start Date04 Aug 2026

Sponsor / Collaborator

National Cancer Institute

100 Clinical Results associated with Nogapendekin alfa inbakicept-pmln

100 Translational Medicine associated with Nogapendekin alfa inbakicept-pmln

100 Patents (Medical) associated with Nogapendekin alfa inbakicept-pmln

399

Literatures (Medical) associated with Nogapendekin alfa inbakicept-pmln

31 Dec 2026·Emerging Microbes & Infections

Neuraminidase-inhibiting antibodies boosted by H1N1pdm infection cross-react differently with H5N1 of clades 2.3.4.4b and 2.3.2.1a

Article

Author: Aziz, Dinah Binte ; Tan, Yee-Joo ; Chan, Yee Teng ; Liew, Kong Yen ; Tambyah, Paul ; Tan, Chee Wah

Antibodies against neuraminidase (NA) are an independent correlate of protection and the antigenic relatedness between H1N1pdm and H5N1 NAs suggests that seasonal influenza infection may provide cross-reactive immunity. In this study, recent H1N1pdm infection elicited modest NA-inhibiting (NAI) antibody responses against contemporary A/Victoria/4897/2022 (H1N1pdm) but strong responses against older A/California/7/2009 (H1N1pdm). Convalescent sera exhibited significantly higher cross-reactive NAI against clade 2.3.4.4b H5N1 (A/Texas/37/2024) than non-flu A patients, whereas H3N2 infection did not elicit such cross-reactivity. NAI titres were comparable between N1-California and N1-Texas but lower against N1-Victoria, indicating greater antigenic similarity between N1-California and N1-Texas. This was supported by stronger inhibition of N1-Texas by N1-California sheep antiserum compared with N1-Victoria sheep antiserum. Surprisingly, H1N1pdm-infected patients exhibited very low NAI against clade 2.3.2.1a H5N1 (N1-Bangladesh; GMT of 171 vs GMT 1159 for N1-Texas). Mouse antisera demonstrated reduced reciprocal inhibition between N1-Texas and N1-Bangladesh, consistent with their antigenic divergence. When four residues in N1-Bangladesh were substituted with their corresponding residues in N1-Texas, N1-Bangladesh antiserum showed reduced NAI, while N1-Texas antisera showed increased inhibition compared with wild-type N1-Bangladesh. This suggests that these amino acid differences are partially responsible for their antigenic divergence. Importantly, longitudinal analysis revealed that boosted cross-reactive NAI responses waned by day 90 post-infection, highlighting their limited durability. Together, these findings demonstrate that seasonal H1N1pdm infection can transiently boost cross-reactive NAI antibodies against clade 2.3.4.4b H5N1, but antigenic divergence in clade 2.3.2.1a limits cross-reactivity. As such, the impact of pre-existing antibody during an H5N1 outbreak is dependent on the infecting clade.

01 Aug 2026·UROLOGIC CLINICS OF NORTH AMERICA

Emerging Intravesical Therapies for Non–Muscle-Invasive Bladder Cancer

Review

Author: Isali, Ilaha ; Bukavina, Laura ; Wang, Betty ; Calaway, Adam

Non-Muscle-Invasive Bladder Cancer poses significant therapeutic challenges due to high recurrence and progression rates. While intravesical Bacillus Calmette-Guérin (BCG) has long been the standard, limitations in efficacy, global shortages, and patient-specific contraindications to radical cystectomy have fueled the development of novel bladder-sparing therapies. Recent advances include UGN-102 for low-grade/intermediate-risk disease and multiple FDA-approved agents-nadofaragene firadenovec, TAR-200, and nogapendekin alfa inbakicept-for BCG-unresponsive disease. Ongoing trials of TAR-210, cretostimogene, and other combination regimens promise to further expand options. Comparative studies and real-world evidence will be critical to define optimal sequencing, benchmark outcomes against radical cystectomy, and address quality-of-life considerations.

01 Jun 2026·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

Advances in intravesical therapy for non-muscle-invasive bladder cancer

Review

Author: Tang, Yanfeng ; Zeng, Hao ; Zhu, Qiyu ; Xu, Chenhao ; Chen, Junru ; Wang, Ling ; Liu, Haoyang

Non-muscle-invasive bladder cancer (NMIBC) accounts for roughly 75% of newly diagnosed bladder cancer and associates with high risk of recurrence and progression. Intravesical therapy remains the cornerstone of NMIBC management following transurethral resection of bladder tumor (TURBT). For low-risk NMIBC, immediate single instillation of chemotherapy after TURBT effectively reduces recurrence. Intermediate-risk patients could benefit from either intravesical chemotherapy or Bacillus Calmette-Guérin (BCG) instillation, with emerging therapies such as UGN-102 chemoablation showing promise. For high/very high-risk NMIBC, full-dose, 3-year BCG instillation remains the standard of care, However, global BCG shortages and treatment failures have prompted the need for alternative strategies. Optimization of BCG regimens, such as two induction courses, may preserve efficacy while improving feasibility. Moreover, alternative agents such as sequential gemcitabine and docetaxel instillation have demonstrated favorable outcomes in both BCG-naïve and BCG-unresponsive patients. For those with BCG failure, a number of novel therapies are under active investigation. Gene therapy (nadofaragene firadenovec), oncolytic viral therapy (CG0070), interleukin-15 superagonist (Nogapendekin alfa-inbakicept), and innovative drug delivery systems (TAR-200) have shown encouraging clinical potential in this population. This review provides an overview of current intravesical treatment strategies for NMIBC across different risk groups and highlights promising new approaches aimed at overcoming the limitations of BCG therapy.

215

News (Medical) associated with Nogapendekin alfa inbakicept-pmln

31 Jul 2026

·www.biospace.com

ImmunityBio Receives United Arab Emirates (UAE) Marketing Authorization for ANKTIVA® Across BCG-Unresponsive Non-Muscle Invasive Bladder Cancer for CIS and Papillary Disease and Metastatic Non-Small Cell Lung Cancer

The UAE authorization further expands ANKTIVA’s global regulatory footprint to 34 countries. The BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) authorization is the first worldwide to span the full spectrum of BCG-unresponsive disease: carcinoma in situ (CIS) with or without papillary tumors, and papillary disease alone without CIS. The Emirates Drug Establishment (EDE) of the United Arab Emirates (UAE) granted Marketing Authorization for two ANKTIVA presentations, the broadest approval to date for ANKTIVA including papillary disease and CIS in non-muscle invasive bladder cancer and non-small cell lung cancer in patients who failed checkpoint inhibitors and chemotherapy. Each approval covers a distinct indication: ANKTIVA 0.4 mg/0.4 mL (solution for intravesical instillation) in combination with Bacillus Calmette-Guérin (BCG) for BCG-unresponsive NMIBC, and ANKTIVA 1.2 mg/0.6 mL (solution for subcutaneous injection) in combination with immune checkpoint inhibitors for metastatic non-small cell lung cancer (NSCLC). NMIBC evidence (QUILT-3.032): in the CIS cohort (N=100), ANKTIVA plus BCG produced a complete response rate of 71% (95% CI: 61,80), with duration of complete response extending beyond 54 months; in the papillary-only cohort (N=80), 12-month disease-free survival rate was 58.2% (95% CI: 46.6, 68.2), with a cystectomy free rate at 36-months of 83%. In the NSCLC indication, ANKTIVA plus a checkpoint inhibitor is authorized for adult patients with metastatic disease that progressed on or after standard of care including checkpoint failure. NSCLC evidence (QUILT-3.055): in checkpoint-refractory advanced NSCLC (N=79), median overall survival was 14.6 months (95% CI: 12.0, 19.5), with subjects of mean on-treatment ALC ≥ 1,000 achieving of median OS of 16.2 months (95% CI: 13.8, 22.0). CULVER CITY, Calif.--(BUSINESS WIRE)--ImmunityBio, Inc. ( NASDAQ: IBRX ), a vertically integrated commercial-stage biotechnology company, today announced that the Emirates Drug Establishment (EDE) of the United Arab Emirates (UAE) has granted Marketing Authorization for ANKTIVA ® (nogapendekin alfa inbakicept) across two indications. The authorization covers ANKTIVA 0.4 mg in combination with BCG for the treatment of adult patients with BCG-unresponsive NMIBC, and ANKTIVA 1.2 mg in combination with immune checkpoint inhibitors for the treatment of adult patients with metastatic NSCLC. With this action, the UAE becomes the fifth regulatory jurisdiction to authorize ANKTIVA, expanding its global footprint to 34 countries. The UAE has taken the lead in the broadest approval of ANKTIVA to date. The NMIBC authorization is the first anywhere in the world to span carcinoma in situ (CIS) and papillary disease, including patients with papillary-only tumors in the absence of CIS. World’s First Approval Spanning the Full Spectrum of BCG-Unresponsive Disease in NMIBC Per the approved UAE Summary of Product Characteristics, ANKTIVA is indicated with BCG for the treatment of adult patients with BCG-unresponsive NMIBC with carcinoma in situ (CIS) with or without papillary tumors and BCG-unresponsive NMIBC with papillary tumors. Eligible patients therefore include those with CIS alone, CIS accompanied by papillary tumors, and papillary disease alone without CIS. BCG-unresponsive NMIBC carries a high risk of progression and, historically, radical cystectomy has been the standard option for patients who fail BCG. An approval that spans CIS and papillary disease addresses a defined unmet need across the disease spectrum by offering an alternative immunotherapy option. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); “For patients with BCG-unresponsive bladder cancer, the choice has too often been between losing the bladder and running out of options. This approval by the Emirates Drug Establishment is the first in the world to reach across the entire spectrum of non-muscle invasive bladder cancer from carcinoma in situ with or without papillary tumors, and, for the first time, papillary disease alone. Since the National Cancer Institute ranked IL-15 as the number one priority cytokine for cancer immunotherapy in 2007 , we have worked to translate that biology into an immunotherapy that activates the trifecta of natural killer cells, CD8+ killer T cells, and memory T cells to deliver durable responses. That same immunological backbone now extends to lung cancer, where ANKTIVA, by stimulating NK cells which target tumor cells that have lost MHC-I T cell receptors, can restore the immune response in patients whose disease has progressed on checkpoint therapy . This approval in lung cancer patients who failed checkpoint inhibitors supports the evidence that the MHC-I receptor is lost in patients who progressed on checkpoint inhibitors,” said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Medical and Scientific Officer of ImmunityBio. Authorization in Checkpoint-Refractory Metastatic Non-Small Cell Lung Cancer Per the approved UAE Summary of Product Characteristics, ANKTIVA is indicated in combination with immune checkpoint inhibitors for the treatment of adult patients with metastatic NSCLC with disease progression on or after standard of care (immune checkpoint inhibitors alone or in combination with chemotherapy). Patients with actionable genomic alterations should have disease progression on approved therapy for those alterations, before receiving ANKTIVA in combination with immune checkpoint inhibitors. In this indication, ANKTIVA is administered as a fixed 1 mg subcutaneous dose once every 21 days for the duration of checkpoint inhibitor therapy. Checkpoint inhibitor resistance represents a defined unmet need in metastatic NSCLC, with limited options and poor survival after progression. By activating the natural killer and memory T cells that checkpoint inhibitors alone do not reach, ANKTIVA is designed to restore anti-tumor immunity in this setting. Clinical Evidence Supporting the Approvals NMIBC Indication: The NMIBC authorization is supported by QUILT-3.032, the multicenter registrational trial of ANKTIVA plus BCG in BCG-unresponsive NMIBC (ClinicalTrials.gov NCT03022825 ). CIS with or without Papillary Disease (QUILT-3.032, Cohort A): In the CIS cohort (N=100), ANKTIVA plus BCG produced a complete response rate of 71% (95% CI: 61, 80) as shown in table below. Table 2. Efficacy Results in QUILT-3.032: NMIBC CIS (Cohort A) ClinicalTrials.gov NCT03022825 Endpoint ANKTIVA with BCG (n=100) Complete response rate (95% CI) 71% (61, 80) Median duration of complete response (DoR), months (95% CI) (n=71) 26.6 (13.0, 49.9) Range in monthsᵃ 0.0, 54+ months CR rate of responders at 12 and 24 months % (n) with CR at 12 months 66% (47/71) % (n) with CR at 24 months 42% (30/71) + Denotes ongoing response. ᵃ Based on 71 patients that achieved a complete response at any time; reflects period from the time complete response was achieved. Papillary Disease Alone (QUILT-3.032, Cohort B): In the papillary-only cohort (papillary disease without CIS; N=80), the 12-month disease-free survival rate was 58.2% (95% CI: 46.6, 68.2), with a median disease-free survival of 25.3 months, and 83.1% of patients avoided cystectomy at 36 months as shown in the table below. Table 3. Efficacy Results in QUILT-3.032: Papillary NMIBC (Cohort B) ClinicalTrials.gov NCT03022825 Endpoint ANKTIVA with BCG (n=80) Disease-Free Survival (DFS) Rate at 12 Months (95% CI)¹ 58.2% (46.6, 68.2) Median Disease-Free Survival (DFS), months (95% CI)¹ 25.3 (9.8, 33.5) Cystectomy-Free Rate² Median Time to Cystectomy (months) Not Reached Rate at Month 12 (95% CI) 92.2% (83.4, 96.4) Rate at Month 18 (95% CI) 87.9% (78.0, 93.5) Rate at Month 24 (95% CI) 87.9% (78.0, 93.5) Rate at Month 36 (95% CI) 83.1% (70.8, 90.5) ¹ DFS defined as time from initial study drug administration until recurrence of high-grade Ta (excluding low-grade Ta) or any grade T1, persistent CIS ≥6 months, new CIS, disease progression, cystectomy, change in therapy indicative of more advanced disease, or death (any cause), whichever occurred first. Patients who didn’t have any evidence of disease at end of study were censored at last known date the patient was disease-free. DFS rate was estimated and DFS was analyzed using Kaplan-Meier analysis method. ² Time to cystectomy defined as time from initial study drug administration to cystectomy using Kaplan-Meier analysis method. Patients who did not have documented cystectomy during the study were censored at the last date of follow up visits. Cystectomy-free rates were estimated using Kaplan Meier analysis method. In the QUILT-3.032 program, most treatment-related adverse events were Grade 1 or 2; Grade 3 treatment-related adverse events occurred in 1% of patients, and no Grade 4 or Grade 5 treatment-related events were reported. NSCLC Indication: The NSCLC authorization is supported by QUILT-3.055 (ClinicalTrials.gov NCT03228667 ), a Phase 2 study of ANKTIVA in combination with a checkpoint inhibitor in patients with advanced NSCLC whose disease had progressed on prior checkpoint inhibitor therapy (N=79). Median overall survival was 14.6 months (95% CI: 12.0, 19.5). Among the 77% of patients who achieved an absolute lymphocyte count of at least 1,000 cells/µL, median overall survival was 16.2 months (95% CI: 13.8, 22.0). The table below summarizes these findings. OS Results in QUILT-3.055 – Safety Population ClinicalTrials.gov NCT03228667 (Phase 2, checkpoint-refractory advanced NSCLC) ANKTIVA plus CPI All NSCLC (N=79) Mean On-Treatment ALC < 1000/µL (N=18) Mean On-Treatment ALC ≥ 1000/µL (N=61) Log-rank P-value Hazard Ratio (95% CI) Number of deaths 58 (73%) 14 (78%) 44 (72%) 0.0369 0.52 (0.28, 0.97) Median OSᵃ (months) 14.6 11.8 16.2 95% CI for the Median OS 12.0, 19.5 6.9, 14.1 13.8, 22.0 Overall survival (OS) rateᵇ at: Month 12 61.4% (49.5, 71.4) 44.1% (20.0, 65.9) 66.1% (52.6, 76.6) - - Month 24 29.8% (19.8, 40.4) 12.6% (2.1, 33.0) 34.6% (22.7, 46.8) - - ALC, absolute lymphocyte count; CI, confidence interval; CPI, checkpoint inhibitor; NSCLC, non-small cell lung cancer; OS, overall survival. ᵃ OS defined as time from date of first study drug administration to date of death from any cause. Participants who were alive at end of follow-up were censored at the last known date the participant was alive. ᵇ OS rates estimated using Kaplan-Meier analysis method. In QUILT-3.055, the most common NAI-related adverse drug reactions were injection site reaction (86%), chills (46%), fatigue (32%), pyrexia (28%), nausea (16%), injection site erythema and injection site pruritus (15% each), injection site pain (14%), influenza like illness (13%), decreased appetite (10%). Regulatory Details The EDE issued Marketing Authorization approval for both presentations with first registration in July 2026 and validity through July 2031. ANKTIVA 0.4 mg (solution for intravesical instillation), indicated for BCG-unresponsive NMIBC, is registered under No. 78609-45860-260486. ANKTIVA 1.2 mg (solution for subcutaneous injection), indicated for metastatic NSCLC, is registered under No. 78609-1572-260487. ImmunityBio, Inc. is the Marketing Authorization Holder, with Modern Pharmaceutical Company serving as the local agent in the United Arab Emirates. The UAE is the fifth regulatory jurisdiction to authorize ANKTIVA, following the United States, the United Kingdom, the Kingdom of Saudi Arabia, and the European Union, and expands the global footprint of ANKTIVA to more than 30 countries. “With this authorization, the global regulatory footprint for ANKTIVA now includes 34 countries. Securing approvals across two distinct indications, bladder cancer and lung cancer, on the strength of the same data packages we submitted to the FDA, positions us to broaden access across the Gulf region through our partnership with Modern Pharmaceutical Company, in markets where the need for new treatment options is significant,” said Richard Adcock, President and Chief Executive Officer of ImmunityBio. Sources Chamie K, et al. IL-15 Superagonist NAI (N-803) plus BCG for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer. NEJM Evidence . 2023;2(1). (CIS cohort complete response rate.) QUILT-3.032 updated analyses, including the papillary-only (Ta/T1) cohort and extended duration-of-response follow-up, as presented at AUA 2025 and disclosed by ImmunityBio, Inc. QUILT-3.055 Phase 2 overall survival results in checkpoint-refractory advanced NSCLC, as disclosed by ImmunityBio, Inc. (ClinicalTrials.gov NCT03228667). ClinicalTrials.gov Identifiers NCT03022825 (QUILT-3.032) and NCT03228667 (QUILT-3.055). Emirates Drug Establishment, Product Marketing Authorization Approval certificates and approved Summaries of Product Characteristics, Registration Nos. 78609-45860-260486 (NMIBC) and 78609-1572-260487 (NSCLC), first registration 24 July 2026. Immunotherapy Agent Workshop, July 12, 2007 NCI, Cancer Immune Evasion Through Loss of MHC Class I Antigen Presentation. Karthik Dhatchinamoorthy, et. al. About ANKTIVA® (nogapendekin alfa inbakicept-pmln) The interleukin-15 (IL-15) cytokine plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells, NK and CD8+ killer T cells, that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response. ANKTIVA is a first-in-class IL-15 receptor 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. This fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 independent of dendritic cells and driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones. About ImmunityBio, Inc. ImmunityBio, Inc. is a biotechnology company focused on innovating, developing, and commercializing next-generation immunotherapies designed to activate the patient’s immune system and deliver durable protection against cancer and infectious diseases. Our approach harnesses both the adaptive and innate immune systems with the goal of restoring immune function and generating lasting immunological memory in patients. At the core of our strategy is the Cancer BioShield ™ platform, which is designed to stimulate critical lymphocytes, including natural killer (NK) cells, cytotoxic T cells, and memory T cells via our proprietary IL-15 receptor superagonist, ANKTIVA® (nogapendekin alfa inbakicept). Our Cancer BioShield platform is anchored by this antibody-cytokine fusion protein and is complemented by a portfolio that includes adenovirus-vectored vaccines, allogeneic (off-the-shelf) and autologous NK-cell therapies, and additional immunomodulators intended to promote immunogenic cell death and support durable immune responses while potentially reducing reliance on high-dose chemo-radiation therapy. For more information, visit ImmunityBio.com and connect with us on X (Twitter), Facebook , LinkedIn , and Instagram . About U.S. Indication U.S. Indication and Important Safety Information: The following U.S. Prescribing Information applies only to ANKTIVA ® as approved in the United States for the treatment of adults with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS), with or without papillary tumors, in combination with BCG. ANKTIVA has not been approved in the United States for the treatment of metastatic non-small cell lung cancer (NSCLC). U.S. IMPORTANT SAFETY INFORMATION INDICATION AND USAGE: ANKTIVA ® is an interleukin-15 (IL-15) receptor agonist indicated 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. WARNINGS AND PRECAUTIONS: Risk of Metastatic Bladder Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the development of muscle-invasive or metastatic bladder cancer, which can be lethal. If patients with CIS do not have a complete response to treatment after a second induction course of ANKTIVA ® with BCG, reconsider cystectomy. DOSAGE AND ADMINISTRATION: For Intravesical Use Only. Do not administer by subcutaneous or intravenous routes. Please see the complete Indication and Important Safety Information and Prescribing Information for ANKTIVA ® at Anktiva.com . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company’s clinical development programs, commercial success of its products and product candidates, manufacturing capabilities, continued collaboration with third parties, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such statements include, but are not limited to, statements regarding the commercial availability and uptake of ANKTIVA in the United Arab Emirates, the scope and interpretation of the Marketing Authorizations granted by the Emirates Drug Establishment for the NMIBC and NSCLC indications, the number of jurisdictions and countries in which ANKTIVA is authorized, the timing and outcome of pending and future regulatory submissions in the United States and other jurisdictions, including for papillary disease and for lung cancer, and the clinical benefit, durability of response, overall survival benefit, and safety pro ANKTIVA in combination with BCG and in combination with immune checkpoint inhibitors Additional risks related to international commercialization include: our reliance on our regional partner in the UAE and their ability to successfully launch and distribute ANKTIVA; the timing and outcome of pricing and reimbursement decisions by UAE health authorities; continued global BCG supply shortages that could limit combination therapy availability; manufacturing and supply chain complexities for international distribution; regulatory actions in any of the 34 countries where ANKTIVA is authorized that could affect labeling or market access; and competition from existing or new therapies in the UAE and broader Gulf region. Forward-looking statements are neither forecasts, promises nor guarantees, and are based on the current beliefs of ImmunityBio’s management as well as assumptions made by and information currently available to ImmunityBio. Actual results may differ materially. For a discussion of factors that could cause actual results to differ, please refer to ImmunityBio’s filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. ImmunityBio does not undertake any obligation to update forward-looking statements. Contacts ImmunityBio Contacts: Investors Hemanth Ramaprakash, PhD, MBA ImmunityBio, Inc. +1 858-746-9289 Hemanth.Ramaprakash@ImmunityBio.com Media Sarah Singleton ImmunityBio, Inc. +1 415-290-8045 Sarah.Singleton@ImmunityBio.com

Clinical ResultImmunotherapyDrug ApprovalPhase 2

31 Jul 2026

·www.biospace.com

ACTG to Make Three Presentations on HIV Cure and Aging with HIV at AIDS 2026

CHAPEL HILL, N.C., July 29, 2026 (GLOBE NEWSWIRE) -- ACTG, a global clinical trials network focused on HIV and other infectious diseases, announced today that it will make three presentations at AIDS 2026 , which is being held July 26 – 31, 2026 in Rio de Janeiro, Brazil. ACTG’s oral and poster presentations will highlight two key focus areas for the network’s research: HIV cure and aging with HIV. “ACTG is committed to research that meaningfully impacts people living with HIV,” said ACTG Chair Joseph J. Eron, M.D., University of North Carolina. “We are excited to make these three presentations at AIDS 2026, an international conference that brings together scientists, providers, and advocates from around the globe to tackle the challenges that remain around treating, preventing, and curing HIV. ACTG has been a leader in HIV research for nearly four decades, and we are proud to share data that continue to advance our understanding of how to improve the experiences of people living with HIV.” HIV Cure Research ACTG will make two presentations from its HIV cure study A5386, an open-label, phase 1 trial evaluating whether N-803 (a clinical-stage biologic) can control HIV alone or together with combination broadly neutralizing antibodies (also called bNAbs, they are antibodies that neutralize different variants of HIV) after participants stop taking antiretroviral therapy (ART) during an analytic treatment interruption (ATI). When taking ART, people living with HIV have latent HIV reservoirs – groups of immune cells that contain HIV but do not produce new copies of the virus. When people stop taking ART, the virus in the latent cells reactivates and infects new CD4 cells, thereby increasing the amount of HIV in a person’s body. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); IL-15 Superagonist N-803, With or Without bNAbs, Induces Reduction and Transcriptional Activation of the Intact HIV Reservoir is an oral presentation taking place on Wednesday, July 29 from 10:30 - 11:30 Brasilia Time (BT) in session room 103 ( Rachel Scheck, et al.) TCF-1 ⁺ CD8 ⁺ T-cells Link Immune Modulation to Post-Intervention Control in ACTG A5386 will be part of the poster presentations made on Wednesday, July 29 from 12:00 - 1:00 pm BT in the poster exhibit hall ( Itzayana Miller, et al.) These presentations report that N-803, with and without bNAbs, was able to significantly reduce the HIV reservoir, providing evidence that approaches using N-803 or other similar interventions can meaningfully modulate the reservoir. The presentations also suggest that immune fitness among study participants, coupled with this kind of treatment, may determine who is best able to control HIV without medication. Researchers found that among both groups of participants (those receiving N-803 alone and those receiving it in combination with bNAbs), the HIV reservoir declined by roughly 37 percent after five doses of N-803, and there were signs of increased viral transcription that are consistent with latency reversal. To date, four participants have remained off ART for at least the duration of the ATI (24 weeks), and their ATI remains ongoing. Researchers further identified that N-803 reshaped the immune landscape in ways associated with HIV control, shifting CD8⁺ T cells toward a more stem-like, less exhausted state among the entire cohort. “In spite of huge advances in the treatment of HIV, we remain unable to cure it, which means that people living with HIV have to rely on taking ART for their entire lives,” said oral presenter Rachel Scheck, M.D., Weill Cornell Medicine. “Identifying a cure that would contribute to the end of HIV is a high priority for ACTG; these studies provide us with important insights into the HIV reservoir and T cell states.” Poster presenter Itzayana Miller, Ph.D. student, Weill Cornell Medicine, added: “We now look forward to determining who is most likely to benefit from N-803 and how different treatment courses, alone or in combination with other interventions, can be optimized to support durable HIV control without ART.” Research into Aging with HIV ACTG will also present a poster based on findings from a subset of HAILO (A5322), a long-term observational study of older adults living with HIV that addressed issues related to aging and inflammation. The poster, Inhibiting Glycan Degradation Attenuates HIV-Induced Inflammaging and Cognitive Impairment will be part of the presentations made on Wednesday, July 29, from 12:00 - 1:00 pm BT in the poster exhibit hall ( Leila B. Giron, et al.). The study found that the breakdown of glycans (complex sugars found throughout the body) may contribute to chronic inflammation, accelerated aging, and cognitive decline in people living with HIV. This breakdown process involves the loss of galactose and sialic acid, two sugars known for their anti-inflammatory properties, and may be more severe in women than in men. In experiments involving mice, treatments that prevented the removal of these protective sugars (namely, sialidase inhibitors, a class of drugs often used to treat influenza) reduced inflammation, slowed age-related biological changes (such as aging-associated epigenetic changes), and protected against memory impairment. “People living with HIV can develop problems with memory and thinking even when standard treatment keeps the virus under control,” said presenting author Leila B. Giron, M.Sc., Ph.D., Northwestern University. “It is important that we understand why this happens because these changes can reduce quality of life and may worsen with age. The findings we’re presenting at AIDS 2026 suggest that these sugar molecules could help identify people at risk, and that protecting them may offer a new approach for treating brain and aging-related complications linked to long-term viral infection.” These data were also recently published in Cell : “ Inhibiting glycan degradation prevents HIV-induced inflammaging and cognitive impairment. ” A5386 is led by Timothy Wilkin, M.D., M.P.H., University of California San Diego (study chair) and Marina Caskey, M.D., The Rockefeller University and Richard Brad Jones, Ph.D., Weill Cornell Medicine (study vice chairs). N-803 is provided by ImmunityBio and the bNAbs are provided by Gilead Sciences. A5322 is led by Frank Palella, M.D., Northwestern University and Katherine Tassiopoulos D.Sc., M.P.H., Harvard School of Public Health (study co-chairs) and Susan Koletar, M.D. (study vice chair). ACTG is led by Dr. Eron and Rajesh T. Gandhi, M.D., Massachusetts General Hospital and Harvard Medical School (ACTG Vice Chair). It is sponsored by the National Institutes of Health’s (NIH) National Institute of Mental Health and National Institute of Allergy and Infectious Diseases (NIAID, which also funds ACTG) under award numbers UM1 AI068636, UM1 AI107716, and UM1 AI068634. About ACTG ACTG is the world’s largest and longest running clinical trials network focused on HIV and other infectious diseases and the people living with them. It is funded by NIAID and collaborating NIH Institutes. Founded in 1987, ACTG conducts research and implementation science studies to improve the management of HIV and its comorbidities; develop a cure for HIV; and discover treatments for tuberculosis, hepatitis B, and emerging infectious diseases. It comprises thousands of dedicated researchers, staff, and community members who are pursuing research into novel treatments and cures for infectious diseases at 65 locations across four continents, with the ultimate goal of advancing science that meaningfully impacts the lives of the people we serve. Disclaimer: This content is solely the responsibility of ACTG and does not necessarily represent the official views of the NIH. Media Contact: Jenna Conley, ACTG jenna@conleycommunications.net

08 Jul 2026

·allsci.com

UroGen’s UGN-501 oncolytic virus gains FDA clearance for non-muscle invasive bladder cancer trial

UroGen Pharma (Nasdaq: URGN) announced on July 8, 2026 that the US FDA cleared its Investigational New Drug application for UGN-501, an oncolytic virus designed for intravesical delivery in patients with non-muscle invasive bladder cancer (NMIBC). The UGN-501 FDA clearance enables the company to initiate a Phase 1 clinical trial, with patient enrollment expected to begin in Q4 2026. NMIBC is among the most prevalent urological malignancies, and its management is complicated by high recurrence rates even after standard treatment. The disease spans a spectrum of risk — from low-grade papillary tumors to carcinoma in situ (CIS) — and despite an expanding roster of approved therapies, a meaningful proportion of patients continue to experience recurrence or progression. Cystectomy, the definitive surgical option, carries substantial morbidity, and bladder-sparing alternatives remain an active area of development. The approved landscape has expanded considerably in recent years. Merck’s BCG live (Tice BCG) remains the first-line standard of care for intermediate- and high-risk disease following transurethral resection of bladder tumor. For patients whose disease does not respond to BCG, options now include Merck & Co.’s pembrolizumab (Keytruda) administered intravenously, Ferring Pharmaceuticals’ nadofaragene firadenovec-vncg (Adstiladrin) — a non-replicating adenoviral gene therapy delivering interferon-alpha 2b — ImmunityBio’s nogapendekin alfa inbakicept-pmln (Anktiva) combined with BCG, and most recently Janssen Biotech’s gemcitabine intravesical system (Inlexzo), approved in September 2025. UroGen itself received approval in June 2025 for mitomycin intravesical solution (Zusduri), a sustained-release hydrogel formulation targeting recurrent low-grade intermediate-risk NMIBC. Against this backdrop, UGN-501 represents UroGen’s push into a mechanistically distinct space: replication-competent oncolytic virus therapy for bladder cancer, a modality not yet represented among approved NMIBC treatments. UGN-501 (ICVB-1042) is an engineered oncolytic adenovirus that exploits aberrant E2F transcription factor activity — a hallmark of tumor cells — to drive selective viral replication within cancer cells. Normal urothelial tissue, which maintains regulated E2F activity, is designed to be spared. Viral replication within tumor cells leads to direct cell lysis, and the resulting immunogenic cell death is intended to trigger a secondary anti-tumor immune response. This dual mechanism — direct cytotoxicity combined with local immune activation — is the defining rationale for the program. Nonclinical data cited by UroGen demonstrated cytotoxic activity across a broad panel of bladder cancer cell lines representing multiple disease stages and grades, though the company has not publicly disclosed the specific parameters or comparative benchmarks from those studies. The planned Phase 1 clinical trial will assess the safety, tolerability, and feasibility of intravesical UGN-501 administration in NMIBC patients, with no public listing available for the study at present. The oncolytic virus field in bladder cancer has no currently approved representative, making UGN-501 an early mover in this specific modality for NMIBC. Within NMIBC specifically, the closest mechanistic neighbor is nadofaragene firadenovec, which uses a non-replicating adenoviral vector to deliver a therapeutic gene locally. UGN-501 is designed to actively replicate within tumor cells, amplifying its cytotoxic effect in situ, whereas nadofaragene firadenovec functions as a one-time gene delivery vehicle without viral replication. Complete response rates in the BCG-unresponsive CIS setting for currently approved agents range from roughly 40% to 62% at six months, with durability remaining a challenge across the class. An oncolytic approach that generates durable local immune memory, if validated clinically, could offer a meaningful complement or alternative to existing options. UGN-501 is UroGen’s third clinical-stage asset and its first in the oncolytic virus modality. The company’s two approved products — Zusduri and its upper tract urothelial cancer therapy — both rely on the proprietary RTGel reverse-thermal hydrogel platform for sustained local drug delivery. UGN-501 does not use RTGel; it represents a distinct biological approach within the same disease focus. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Privacy Terms About Us Copyright © 2026. AllSci Corp. All rights reserved.

INDPhase 1Drug ApprovalGene TherapyClinical Study

100 Deals associated with Nogapendekin alfa inbakicept-pmln

External Link

KEGG	Wiki	ATC	Drug Bank
D12888	-	-	-

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
metastatic non-small cell lung cancer	Saudi Arabia	ImmunityBio, Inc.	21 Apr 2026
Carcinoma in Situ	European Union	ImmunityBio, Inc.	16 Feb 2026
Carcinoma in Situ	Iceland	ImmunityBio, Inc.	16 Feb 2026
Carcinoma in Situ	Liechtenstein	ImmunityBio, Inc.	16 Feb 2026
Carcinoma in Situ	Norway	ImmunityBio, Inc.	16 Feb 2026
Non-Muscle Invasive Bladder Urothelial Carcinoma	Saudi Arabia	ImmunityBio, Inc.	14 Jan 2026
Lymphopenia	United States	ImmunityBio, Inc.	02 Jun 2025
Non-Muscle Invasive Bladder Neoplasms	United States	Altor BioScience Corp.	22 Apr 2024

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Community Acquired Pneumonia	Phase 3	-	ImmunityBio, Inc.	15 Apr 2026
Respiratory Distress Syndrome, Acute	Phase 3	-	ImmunityBio, Inc.	15 Apr 2026
Sepsis	Phase 3	-	ImmunityBio, Inc.	15 Apr 2026
Shock, Septic	Phase 3	-	ImmunityBio, Inc.	15 Apr 2026
Lung Cancer	Phase 3	United States	ImmunityBio, Inc.	27 Jul 2022
Advanced Lung Non-Small Cell Carcinoma	Phase 3	United States	ImmunityBio, Inc.	18 May 2018
Bladder Cancer	Phase 3	United States	ImmunityBio, Inc.	02 Jun 2017
HPV positive oropharyngeal squamous cell carcinoma	Phase 2	-	ImmunityBio, Inc.	22 Jul 2026
HPV16 positive Oropharyngeal Cancer	Phase 2	-	ImmunityBio, Inc.	22 Jul 2026
Recurrent Glioblastoma	Phase 2	-	ImmunityBio, Inc.	22 Jul 2026

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02782546 (CTgov)	Phase 2	Acute Myeloid Leukemia \| Refractory acute myeloid leukemia	60	G-CSF+ALT-803+Tacrolimus+mycophenolate mofetil+CIML NK cell infusion (Recipient)	fmmhcwczum = efwfwcgxbn zcpmcxmati (qurmfkqnrj, zdnzcrprqh - qrsbmvcucb) View more	-	01 Jun 2026
				Leukapheresis (Donor)	vtwyjydpri(tjnkzppxnv) = uhpxfpfmsx znbhxklglf (icoebyhliy, mbraeeanrj - lzpywsihag) View more
NCT03022825 (QUILT-3.032, ASCO2026)	Phase 3	Non-Muscle Invasive Bladder Neoplasms	173	nogapendekin alfa inbakicept-pmln + BCG (NAI+BCG)	gscpekbdrm(sriqqgmtqi) = iwoodrpoea bkxlksikmf (wqgsslbhbn ) View more	Positive	29 May 2026
				pembrolizumab (PEMBRO)	gscpekbdrm(sriqqgmtqi) = zdtymorerd bkxlksikmf (wqgsslbhbn ) View more
NCT03520686 (QUILT-2.023, ASCO2026)	Phase 3	Non-Small Cell Lung Cancer First line PD-L1 TPS	98	CPI+NAI	jrojdaycsy(alroxahics) = nvveeyqrvd fsowaiqufg (vdpvcybvxk ) View more	Positive	29 May 2026
				CPI	jrojdaycsy(alroxahics) = mgcsrxcvbc fsowaiqufg (vdpvcybvxk ) View more
NCT05419011 (TRIAD5-Plus, Pubmed \| Front Immunol)	Phase 2	Hereditary Nonpolyposis Colorectal Cancer Lynch syndrome	158	Tri-Ad5	owolcroqjw(knjwmoqxoj) = gcpefqdyby hmszvbaaoh (tezvrxeuwx )	Positive	19 May 2026
				Tri-Ad5 + NAI	owolcroqjw(knjwmoqxoj) = xhzrrzvxqo hmszvbaaoh (tezvrxeuwx )
NCT06745908 (ResQ201A, ESMO_ELCC2026)	Phase 3	-	462	NAI+tislelizumab+docetaxel	vxmvfqsdwd(tqbxaaqfet) = eipfrmnwgz jnsoenkzuk (ygfvybxrit ) View more	Positive	25 Mar 2026
				docetaxel	vxmvfqsdwd(tqbxaaqfet) = fnrqxpeizt jnsoenkzuk (ygfvybxrit ) View more
NCT02523469 (CTgov)	Phase 1/2	metastatic non-small cell lung cancer	67	ALT-803+Nivolumab (Cohort 1: ALT-803 6 µg/kg + Nivolumab 3 mg/kg)	ntopybvflk = izuqdnbozs oxdzxsgkzn (vpypxjwmcn, dcokmqotjq - ilaohuyvrz) View more	-	17 Feb 2026
				ALT-803+Nivolumab (Cohort 2: ALT-803 10 µg/kg + Nivolumab 3 mg/kg)	ntopybvflk = ausagoijcr oxdzxsgkzn (vpypxjwmcn, mpsbfcgjpe - encswooiuq) View more
NCT04491955 (Pubmed \| Oncologist)	Phase 1/2	Metastatic Colorectal Carcinoma pMMR	32	CV-301 + N-803 + bintrafusp alfa + PDS01ADC	xotnamlpct(tpeioilwjg) = qmugxutalb rsmuwagoxx (cvzuipytvt ) View more	Negative	05 Feb 2026
NCT03520686 (QUILT-2.023, Company_Website) Manual	Phase 3	metastatic non-small cell lung cancer \| Advanced Lung Non-Small Cell Carcinoma First line	-	ANKTIVA + CPI	vfnrgvtkwt(fdjesrajie): P-Value = 0.0065	Positive	13 Jan 2026
				CPI
NCT03228667 (QUILT-3.055, Company_Website) Manual	Phase 2	Non-Small Cell Lung Cancer Second line	-	ANKTIVA + CPI (NSCLC)	lrcpxwbddj(dcirtcttkc) = rdlytgupzn vntykyjxiu (isgglsmffi )	Positive	13 Jan 2026
				ANKTIVA + CPI (NSCLC + Responders)	xhgutthkmt(hkotpbproq) = guktaoylqc mcjforjxdw (zfhnheszul )
NCT03022825 (QUILT-3.032, Pubmed \| J Urol)	Phase 2	-	54	NAI plus BCG (BCG-unresponsive high-grade Ta/T1 papillary nonmuscle-invasive bladder cancer)	vrkhpjxjzw(zbczuklnxn) = vksxymlsdv nbxfcqewls (uulekfjqot, 46.6 - 68.2) View more	Positive	01 Jan 2026

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Hiro LS Researcher

The AI Search Engine Built to Accelerate Biopharma Decisions

Search across billion-scale life sciences data to uncover signals, validate evidence, and act with confidence.

Ask any biopharma research question→

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, Patsnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Discover Synapse Data Servers

Synapse data is now integrated into the PatSnap LS Model Context Protocol (MCP) service. Customize your LLM agent now using our MCP server!

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis