Open-Label, Phase 1 Clinical Trial of Neoadjuvant Nogapendekin Alfa Inbakicept, Sotevtamab, and Zabadinostat in Combination With Gemcitabine and Nab-Paclitaxel for Participants With Borderline Resectable or Locally Advanced Pancreatic Cancer

This is an open-label, phase 1 clinical trial to evaluate the safety and preliminary efficacy of neoadjuvant chemoimmunotherapy (NAI, sotevtamab, and zabadinostat in combination with gemcitabine and nab-paclitaxel) followed by resection and adjuvant immunotherapy for participants with borderline resectable or locally advanced pancreatic ductal adenocarcinoma (PDAC). Eligible participants will undergo endoscopic ultrasound (EUS)-guided biopsies of the primary pancreatic tumor within 7 days of enrollment and prior to study day 1. EUS-guided biopsies will be used for histopathological examination to give clinical diagnostic information (as SoC) and will be stored in an ethically approved tissue bank.

Start Date01 Jun 2026

Sponsor / Collaborator

ImmunityBio, Inc.

NCT07524257

/ Not yet recruitingPhase 3

Phase 3, Randomized, Open-Label Study of Nogapendekin Alfa Inbakicept in Combination With Standard of Care Versus Standard of Care as First-Line Treatment for Patients With Advanced or Metastatic Non-Small Cell Lung Cancer

This is a randomized, open-label, phase 3 study evaluating nogapendekin alfa inbakicept (NAI) plus chemoimmunotherapy containing pembrolizumab and platinum-based chemotherapy versus chemoimmunotherapy alone as first-line treatment in patients with stage IV squamous or nonsquamous non-small cell lung cancer (NSCLC) without actionable genomic alterations. Primary endpoint is progression-free survival by RECIST v1.1 based on blinded independent central review.

Start Date29 May 2026

Sponsor / Collaborator

ImmunityBio, Inc.

NCT07551544

/ Not yet recruitingPhase 3

Open Label Randomized Phase 3 Clinical Trial Of ANKTIVA In Combination With Intravesical BCG Versus BCG Monotherapy In Participants With BCG-Naïve/BCG-Exposed High-Grade Non-Muscle Invasive Papillary Bladder Cancer

This is an open-label, randomized, phase 3 study of intravesical BCG plus ANKTIVA (experimental arm) versus BCG alone (control arm) in participants who have histologically confirmed, BCG-naïve/BCG-exposed high-grade Ta/T1 papillary disease. The purpose of this study is to evaluate the contribution of effect of neoadjuvant ANKTIVA plus BCG experimental therapy in papillary NMIBC.

Start Date15 May 2026

Sponsor / Collaborator

ImmunityBio, Inc.

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

393

Literatures (Medical) associated with Nogapendekin alfa inbakicept-pmln

31 Dec 2026·JOURNAL OF MEDICAL ECONOMICS

Budget impact model of nadofaragene firadenovec for the treatment of high-risk non-muscle-invasive bladder cancer that is unresponsive to Bacillus Calmette-Guérin immunotherapy

Article

Author: Ye, Dongni ; Yang, Min ; Chai, Xinglei ; Moradi, Ashton ; Zhao, Angela ; Lotan, Yair

AIMS:

To estimate the budget impact of adopting nadofaragene firadenovec for the treatment of adults with high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ with or without papillary tumors (CIS ± Ta/T1) from a US third-party payer's perspective.

METHODS:

A budget impact model was developed to compare total healthcare costs under two scenarios: (1) with nadofaragene firadenovec included in the treatment mix, and (2) without it. The model simulated a hypothetical US health plan covering one million members over a 3-year time horizon. Costs assessed included drug acquisition and administration, surveillance and disease management, cystectomy, and treatment-related adverse events (AEs). Base-case inputs were informed by trial data, published literature, and real-world evidence. Scenario analyses explored alternative population definitions, epidemiology and clinical inputs; one-way sensitivity analyses tested parameter uncertainty.

RESULTS:

In the base-case, the estimated per-member-per-month (PMPM) budget impact of adopting nadofaragene firadenovec ranged from $0.0010 in Year 1 to $0.0084 in Year 3. Increased drug and administration costs were partially offset by cost savings from reduced disease progression, fewer cystectomies, and lower AE rates. Scenario analyses demonstrated that even examining a broader population including papillary disease-only patients, the budget impact remained modest ($0.0064-$0.0548 PMPM from Years 1-3). Sensitivity analyses confirmed that results were most influenced by uptake rate, drug cost, and target population size.

LIMITATIONS:

Key limitations include reliance on projected market shares for nadofaragene firadenovec, omission of recently approved treatments (nogapendekin alfa inbakicept-pmln and TAR-200) due to the lack of publicly available market share data, and assumptions to derive clinical outcomes for certain treatments due to lack of reported data.

CONCLUSIONS:

Despite its higher acquisition cost, the inclusion of nadofaragene firadenovec resulted in a minimal budget impact as bladder-sparing option for patients with BCG-unresponsive NMIBC with CIS ± Ta/T1.

01 May 2026·Biomaterials advances

A novel ROS switcher potentiates the type-I photodynamic effect of sodium zinc chlorophyllin against Pseudomonas aeruginosa in diabetic wounds

Article

Author: Yuan, Cai ; Wang, Guodong ; Chen, Hongjie ; Huang, Mingdong ; Wu, Lusheng

Skin wound infections present a serious threat to human health, with bacterial infections in diabetic wounds being particularly challenging due to impaired healing. Gram-negative bacteria are common pathogens in diabetic wound infections and often exhibit high resistance to conventional treatments, necessitating prolonged and costly therapies. Photodynamic antibacterial therapy (PACT) is regarded as a non-invasive and effective approach, with minimal risk of inducing resistance. Sodium zinc chlorophyllin (ZnChl), a water-soluble metalloporphyrin photosensitizer, offers multiple advantages such as low cost, high safety, and the ability to promote wound healing. However, its bactericidal efficacy against Gram-negative bacteria is limited under the hypoxic conditions typically found in diabetic wounds. Herein, we report a strategy to develop an efficient chlorophyll-based photosensitizer operating via an oxygen-independent Type I mechanism by combining ZnChl with inorganic salts (NaI, KBr, or KI). This approach significantly improved antibacterial performance, particularly with NaI or KI. Upon 630 nm light irradiation, low concentrations of KI (5 mM) markedly enhanced the bactericidal effect of ZnChl (50 μM), reducing the survival of three Gram-negative bacterial strains by 3 logs (99.9%). Interestingly, we further discovered that KI acts as a "reactive oxygen species (ROS) converter," shifting the photodynamic mechanism of ZnChl from a mixed Type I/Type II mode to a dominant Type I mechanism, generating highly reactive hydroxyl radicals (OH). Moreover, the ZnChl-KI combination demonstrated significant therapeutic efficacy in treating Pseudomonas aeruginosa-infected diabetic wounds without inducing apparent toxicity in rats. This work provides a foundation for developing efficient and economical Type I photosensitizers for the treatment of bacterial infections in diabetic wounds.

01 Mar 2026·Molecular therapy. Oncology

Efficiently targeting neuroblastoma with the combination of anti-ROR1 CAR NK cells and N-803 in vitro and in vivo in NB xenografts

Author: Cripe, Timothy P. ; Cairo, Mitchell S. ; Liao, Yanling ; Ayello, Janet ; Riddell, Stanley ; Chu, Yaya ; Tian, Meijuan ; Ozkaynak, Mehmet F. ; Ayala-Cuesta, Jessica ; Klose, Kayleigh ; Luo, Wen ; Lee, Dean A. ; Nayyar, Gaurav ; Foley, Keira ; Behbehani, Gregory K. ; Mendelowitz, Alyssa S.

[This corrects the article DOI: 10.1016/j.omton.2024.200820.].

200

News (Medical) associated with Nogapendekin alfa inbakicept-pmln

05 May 2026

·www.biospace.com

ImmunityBio to Present New Comparative Data, Scientific Advances in Non-Muscle Invasive Bladder Cancer CIS and an Update on BCG Naïve Registrational Trial at American Urological Association Annual Meeting

Cross-trial analyses comparing ANKTIVA + BCG with nadofaragene firadenovec-vncg and TAR-200 provide important context, particularly in the absence of head-to-head data, highlighting its efficacy, durability, and safety in patients with CIS ± papillary disease and informing treatment selection and sequencing within current paradigms Exploration of intravesical recombinant BCG (rBCG) in BCG-naïve patients points to continued innovation and potential expansion into earlier lines of care Updates on company’s efforts to expand BCG access and on the status of randomized controlled BCG Naïve registrational trial CULVER CITY, Calif.--(BUSINESS WIRE)--ImmunityBio, Inc. ( NASDAQ: IBRX ), a commercial-stage immunotherapy company, today announced it will present new treatment comparison results evaluating ANKTIVA ® (nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) versus nadofaragene firadenovec-vncg and TAR-200 in patients with non-muscle invasive bladder cancer carcinoma in situ (NMIBC CIS), with or without papillary disease, at the American Urological Association Annual Meeting (AUA 2026) in Washington, DC, May 15-18. An additional oral presentation will include new insights into research of intravesical recombinant BCG (rBCG) in BCG-naïve patients. These analyses are clinically relevant for urologists managing an increasingly complex NMIBC treatment landscape, particularly among patients with BCG-unresponsive disease. In the context of limited direct comparative data, cross-trial analyses may provide important context to inform treatment selection and sequencing. By evaluating ANKTIVA + BCG relative to other available options, these data may help characterize comparative efficacy and durability of response within current treatment paradigms. Dr. Soon-Shiong will be presenting on “The Role of IL15 in the Urological Setting” where he will discuss the mechanisms driving T cell and NK cell activation, examine current clinical evidence, and outline emerging combination approaches in bladder and prostate cancer. “At AUA 2026, we are advancing the conversation around bladder cancer treatment with new comparative analyses that help contextualize the clinical value of ANKTIVA plus BCG in BCG-unresponsive NMIBC CIS with or without papillary disease,” said Dr. Patrick Soon-Shiong, Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio. “These findings, along with emerging insights into recombinant BCG, reflect our commitment to expanding treatment options and addressing critical challenges such as BCG supply constraints. We also continue to prioritize research advancing next-generation immunotherapies for patients with urological cancers, including bladder and prostate cancers, and look forward to sharing this research at the upcoming AUA Annual Meeting.” Oral Presentations The phase 1/2 ResQ133A-NMIBC trial: A study of intravesical recombinant Mycobacterium Bacillus Calmette Guérin (rBCG) in BCG naïve participants with non-muscle invasive bladder cancer Meeks J. Oral Podium Presentation: Clinical Trials in Progress: Bladder Cancer, Sunday, May 17, 9:16 am – 9:24 am EDT , The Square, Learning Lab, Hall B, Walter E. Washington Convention Center Indirect Treatment Comparison of Nogapendekin Alfa Inbakicept-pmln plus Bacillus Calmette–Guérin (NAI+BCG) and Nadofaragene Firadenovec-vncg in patients with BCG-unresponsive Non-Muscle Invasive Bladder Cancer CIS ± Papillary (NMIBC) Edwards B. Oral Podium Presentation PD25-15. Session PD25: Bladder Cancer: Non-invasive V, Monday, May 18, 8:52 am - 9:00 am EDT , Room 206, Walter E. Washington Convention Center Poster Presentation An Indirect Treatment Comparison (ITC) of Nogapendekin Alfa Inbakicept-pmln plus Bacillus Calmette–Guérin (NAI+BCG) and TAR-200 in patients with BCG-unresponsive, Non-Muscle Invasive Bladder Cancer CIS ± Papillary (NMIBC) Flanders S. Poster IP50-12. Session IP50: Bladder Cancer: Non-invasive IV, Sunday, May 17, 7:00 am – 9:00 am EDT , Room 146A, Walter E. Washington Convention Center ImmunityBio Product Theater Presentation Dr. Soon-Shiong will provide an update on the company’s efforts to expand BCG access and advance research in the BCG naïve setting, and will discuss the role of IL-15 in urological oncology, including mechanisms driving T cell and natural killer (NK) cell activation, current clinical evidence, and emerging combination approaches in bladder and prostate cancer. The Role of IL15 in the Urological Setting Dr. Patrick Soon-Shiong, ImmunityBio Product Theater, Saturday, May 16, 1:30 pm EDT , Product Theater booth 2701, Walter E. Washington Convention Center About ANKTIVA ® (nogapendekin alfa inbakicept-pmln) The cytokine interleukin-15 (IL-15) 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 superagonist 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 dendritic cell membrane-bound IL-15 receptor alpha 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 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 . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the potential efficacy, safety, and durability of ANKTIVA ® (nogapendekin alfa inbakicept-pmln) in combination with BCG; the interpretation of indirect treatment comparisons; the development of intravesical recombinant BCG; and the potential to address unmet needs in non-muscle invasive bladder cancer. These statements are based on current expectations and are subject to risk and uncertainties that could cause actual results to differ materially, including risks related to the limitations of cross-trial comparisons; clinical development and regulatory approval; the timing and results of clinical trials; the ability to demonstrate safety and efficacy; regulatory decisions; manufacturing and supply constraints, including BCG availability; competition; and market acceptance. More details about these and other risks that may impact ImmunityBio’s business are described under the heading “Risk Factors” in the Company’s Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on February 23, 2026 and in subsequent filings made by ImmunityBio with the SEC, which are available on the SEC’s website at ImmunityBio cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date hereof. ImmunityBio does not undertake any duty to update any forward-looking statement or other information in this press release, except to the extent required by law. Contacts ImmunityBio Contacts: I nvestors 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

ImmunotherapyClinical StudyClinical ResultAACRRadiation Therapy

30 Apr 2026

·www.prnewswire.com

IBRX Lawsuit Alleges Chairman Allegedly Overstated Drug Capabilities - ImmunityBio Investors Face Losses Following Chairman Allegedly Overstated Drug Capabilities: SueWallSt

Important Notice Regarding Alleged ANKTIVA Drug Efficacy Misrepresentations NEW YORK, April 30, 2026 /PRNewswire/ -- SueWallSt notifies investors in ImmunityBio, Inc. (NASDAQ: IBRX) that a class action lawsuit has been filed on behalf of shareholders who purchased securities between January 19, 2026 and March 24, 2026. Find out if you qualify to recover losses. You may also contact Joseph E. Levi, Esq. at [email protected] or (888) SueWallSt. IBRX shares lost $1.98 per share, a 21% decline, after an FDA Warning Letter revealed that the Company's promotional claims about its lead drug ANKTIVA were false or misleading. The lead plaintiff deadline is May 26, 2026. How Alleged False Efficacy Claims Inflated IBRX Stock ANKTIVA is approved solely for a specific type of bladder cancer, BCG-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ. Bladder cancer itself represents only 4.2% of estimated new cancer cases in 2025, and the approved indication covers an even smaller subset. The drug was studied in a single-arm trial of 77 patients and achieved a complete response rate of 62%. Of those responders, only 40% maintained that response for 24 months or longer. The lawsuit contends that during the Class Period, promotional communications broadcast to the public grossly overstated what the clinical data actually supported, creating an artificially inflated stock price. Key ANKTIVA Misrepresentation Allegations for Shareholders The Company allegedly promoted ANKTIVA as capable of treating "all cancers" when it is approved only for a narrow subset of bladder cancer ANKTIVA was allegedly represented as a cancer vaccine despite having no vaccine mechanism of action; it is an IL-15 receptor agonist Promotional materials allegedly suggested ANKTIVA could prevent cancer in radiation-exposed patients, a claim unsupported by any known data The drug was allegedly promoted for subcutaneous injection when its approved labeling specifies intravesical use only A cohort studying ANKTIVA as a single agent was stopped early for futility, yet promotional statements allegedly suggested standalone efficacy The Company allegedly removed the podcast from its website after the FDA Warning Letter, suggesting awareness of the violations The FDA Regulatory Factor The FDA's Office of Prescription Drug Promotion determined that both a television advertisement and a podcast featuring the Company's Executive Chairman were false or misleading and misbranded the drug in violation of the Federal Food, Drug, and Cosmetic Act. The agency called the claims "especially concerning from a public health perspective" because they "grossly misrepresent the benefits of Anktiva." The Warning Letter, dated March 13, 2026 and publicized on March 24, 2026, triggered the 21% single-day stock decline. "This case presents important questions about drug efficacy disclosure obligations in the biotechnology sector. When promotional statements go far beyond what clinical trial data support, investors who relied on those statements to purchase shares may suffer real financial harm," stated Joseph E. Levi, Esq. Submit your information to join this case or contact Joseph E. Levi, Esq. at (888) SueWallSt. Applications to serve as lead plaintiff must be filed by May 26, 2026. Frequently Asked Questions About the IBRX Lawsuit Q: What is the IBRX class action lawsuit about? A: A securities class action has been filed against ImmunityBio, Inc. (NASDAQ: IBRX) alleging materially false and misleading statements between January 19, 2026 and March 24, 2026. Shares fell approximately 21% after an FDA Warning Letter revealed the Company's drug promotions were false or misleading, causing significant losses for shareholders. Q: Who is eligible to join the IBRX investor lawsuit? A: Investors who purchased IBRX stock or securities between January 19, 2026 and March 24, 2026 and suffered financial losses may be eligible. Eligibility is based on purchase date and documented losses, not on whether you still hold the shares. Q: How much did IBRX stock drop? A: Shares fell approximately 21%, a decline of $1.98 per share, after the FDA Warning Letter regarding false and misleading ANKTIVA promotions was publicized. Investors who purchased shares during the class period at artificially inflated prices may be entitled to compensation. Q: What do IBRX investors need to do right now? A: Gather brokerage records including purchase dates, share quantities, and prices paid. Contact SueWallSt for a free, no-obligation evaluation at [email protected] or (888) SueWallSt. No immediate action is required to remain eligible as a class member. Q: What if I already sold my IBRX shares, can I still recover losses? A: Yes. Eligibility is based on when you purchased, not whether you still hold them. Investors who bought during the class period and sold at a loss may still participate. Q: What does it cost me to participate? A: Nothing. Securities class actions are handled on a pure contingency basis. No upfront fees, no retainer, no out-of-pocket costs. Q: What if I missed the lead plaintiff deadline? A: The deadline applies only to investors seeking lead plaintiff appointment. Class members who miss it can still participate in any settlement or recovery. CONTACT: SueWallSt Joseph E. Levi, Esq. Ed Korsinsky, Esq. 33 Whitehall Street, 27th Floor New York, NY 10004 [email protected] Tel: (888) SueWallSt Fax: (212) 363-7171 SOURCE SueWallSt.com 21% more press release views with Request a Demo

VaccinePatent InfringementDrug Approval

21 Apr 2026

·www.biospace.com

ImmunityBio Announces ANKTIVA® Is Now Available in Saudi Arabia for Bladder and Lung Cancer Patients; Market Entry Achieved Within Two Months of MENA Partnership

ANKTIVA approved for patients with certain indications of non-muscle invasive bladder cancer and non-small cell lung cancer Commercial availability achieved within two months of announcing MENA partnership with Biopharma and Cigalah Healthcare First patients to be dosed have been identified and will soon receive initial ANKTIVA treatment CULVER CITY, Calif.--(BUSINESS WIRE)--ImmunityBio, Inc. ( NASDAQ: IBRX ), a commercial-stage immunotherapy company, today announced that ANKTIVA® (nogapendekin alfa inbakicept) is now commercially available in Saudi Arabia. Initial patients have been identified for treatment across both approved bladder and lung cancer indications in the Kingdom: In combination with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS), with or without papillary disease; and In combination with an immune checkpoint inhibitor for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC), as authorized by the Saudi Food and Drug Authority (SFDA) ANKTIVA is being distributed through ImmunityBio’s partnerships with Biopharma and Cigalah Healthcare, leading healthcare distribution companies in the Middle East, with support from the company’s wholly owned subsidiary in Saudi Arabia. “Thanks to our strategic partnership with Biopharma and Cigalah Healthcare, and despite a fluid situation in the region, we have been able to bring this innovative cancer treatment to patients ahead of the deadline we announced in February,” said Richard Adcock, President and CEO of ImmunityBio. “We continue to work with the same level of diligence and commitment to expand access to ANKTIVA for eligible patients across the Middle East and North Africa.” The Middle East and North Africa (MENA) region faces one of the most rapidly growing burdens of cancer globally, including bladder and lung cancers, underscoring the need for additional treatment options. Lung cancer today is among the most common cancers in Saudi Arabia, while the incidence of bladder cancer is elevated in several countries across the region. 1 2 “We are pleased to support the introduction of this immunotherapy to physicians and their patients in Saudi Arabia,” said Tamer Eissa, General Manager, Biopharma. “We look forward to expanding access across the region.” “This milestone represents an important step in expanding access to ANKTIVA for patients in Saudi Arabia,” said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio. “We are encouraged by the growing body of clinical data and experience supporting its use across multiple indications and remain committed to working with physicians to bring this immunotherapy to appropriate patients in need around the globe.” ANKTIVA received U.S. Food and Drug Administration approval in April 2024 in combination with BCG for the treatment of BCG-unresponsive NMIBC CIS, with or without papillary tumors. It has subsequently received regulatory authorizations in multiple regions, including the United Kingdom (MHRA, July 2025), the European Union (European Commission, February 2026), Macau Special Administration Region of China (ISAF, March 2026), and Saudi Arabia (SFDA, January 2026); in addition, the SFDA approved ANKTIVA in combination with a checkpoint inhibitor for the treatment of metastatic non-small cell lung cancer. Saudi Arabia Indication and Usage BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ: ANKTIVA in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with high-risk BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) of carcinoma in situ (CIS) with or without papillary disease. Non-small cell lung cancer (NSCLC): 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). This indication is approved under accelerated approval based on the increase of ALC associated with overall survival in single arm study. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory clinical trials. 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 . About ImmunityBio 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 superagonist. Our Cancer BioShield platform is anchored by this antibody-cytokine fusion protein and is complemented by an investigational 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 Cigalah Healthcare: Based in Jeddah, Cigalah Healthcare is a leading pharmaceutical and healthcare distribution company and sole agent for many multinational pharmaceutical, herbal, health care, and cosmetic companies in Saudi Arabia and some other Gulf countries. Established in 1987, Cigalah Healthcare is the fastest growing health care distributor in Saudi Arabia and the Middle East. About Biopharma Middle East and Africa: Biopharma-MEA is a regional Middle East company, headquartered in Dubai, United Arab Emirates, with offices across the Middle East countries. Since 2007, Biopharma has provided commercialization services for international biopharmaceutical companies throughout the Middle East focusing on rare and serious disease therapies. References: Saudi national lung cancer epidemiology from the Saudi Cancer Registry, 2015–2020 (AlOmar & AlAbdulKader, J Epidemiol Glob Health , 2025). Based on 2018 GLOBOCAN cancer incidence data reported in Cancer incidence and mortality estimates in Arab countries (medRxiv, 2022). Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, without limitation, statements regarding the commercialization and distribution of ANKTIVA in Saudi Arabia and the broader MENA region, the identification and treatment of patients with BCG-unresponsive NMIBC CIS and metastatic non-small cell lung cancer (NSCLC), the expansion of access to ANKTIVA across the Middle East and North Africa, the potential for continued regulatory approvals in additional markets, and the therapeutic potential of ANKTIVA across multiple indications. These statements are based on the Company's current expectations, beliefs, assumptions, and plans and involve significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, among others: risks related to the successful commercialization of ANKTIVA in Saudi Arabia and other markets, including the ability to build and maintain adequate supply chains and distribution networks; the Company's dependence on its partnership with Biopharma and Cigalah Healthcare for distribution in the MENA region; the risk that regional instability or other geopolitical factors could disrupt commercial operations; the Company's ability to achieve and maintain adequate levels of reimbursement for ANKTIVA; the risk that safety or efficacy data from ongoing or future clinical trials may not support continued approval or commercial success; competition from other therapies; manufacturing risks and the ability to maintain adequate supply of product; and the Company's ability to obtain and maintain intellectual property protection for ANKTIVA. More details about these and other risks that may impact ImmunityBio's business are described under the heading "Risk Factors" in the Company's Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on February 23, 2026, and in subsequent filings made by ImmunityBio with the SEC, which are available on the SEC's website at . ImmunityBio cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date hereof. ImmunityBio does not undertake any duty to update any forward-looking statement or other information in this press release, except to the extent required by law. 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

ImmunotherapyDrug ApprovalVaccineClinical StudyRadiation Therapy

100 Deals associated with Nogapendekin alfa inbakicept-pmln

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KEGG	Wiki	ATC	Drug Bank
D12888	-	-	-

R&D Status

Approved

10 top approved records.

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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.

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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
Recurrent Non-Small Cell Lung Cancer	Phase 2	United States	ImmunityBio, Inc.	31 Mar 2026
Adenocarcinoma of prostate	Phase 2	-	ImmunityBio, Inc.	01 Dec 2025
Prostatic Cancer	Phase 2	-	ImmunityBio, Inc.	01 Dec 2025

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06745908 (ResQ201A, ESMO_ELCC2026)	Phase 3	-	462	NAI+tislelizumab+docetaxel	whzpmubfhl(bptcanmrzc) = cshbkormtu lsckjdcqqo (jmtxpcthgf ) View more	Positive	25 Mar 2026
				docetaxel	whzpmubfhl(bptcanmrzc) = hkszvbavpw lsckjdcqqo (jmtxpcthgf ) 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)	ifpqqufqko = bfkdorwzkx iraelzcpya (ccktvuluns, nafsjexubw - huqhkglmwz) View more	-	17 Feb 2026
				ALT-803+Nivolumab (Cohort 2: ALT-803 10 µg/kg + Nivolumab 3 mg/kg)	ifpqqufqko = nbnjqhebng iraelzcpya (ccktvuluns, lbidcjfnvp - mcezzfvpwx) View more
NCT04491955 (Pubmed \| Oncologist)	Phase 1/2	Metastatic Colorectal Carcinoma pMMR	32	CV-301 + N-803 + bintrafusp alfa + PDS01ADC	alzvvkefar(oonpefaczr) = czvdzeskey mxowpwqral (fxismquksu ) View more	Negative	05 Feb 2026
NCT03228667 (QUILT-3.055, Company_Website) Manual	Phase 2	Non-Small Cell Lung Cancer Second line	-	ANKTIVA + CPI (NSCLC)	sndrgcpeku(jbgazxvwhi) = ovklcrsnpe fllcfwgflw (tuvlbfwmow )	Positive	13 Jan 2026
				ANKTIVA + CPI (NSCLC + Responders)	bynozozmhi(ogkwbtqhgu) = eyqdipmlgx famhbhundx (krswhvibtp )
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	duqgkeqjzd(bksfmmcwah): P-Value = 0.0065	Positive	13 Jan 2026
				CPI
NCT03022825 (QUILT-3.032, Pubmed \| J Urol)	Phase 2	-	54	NAI plus BCG (BCG-unresponsive high-grade Ta/T1 papillary nonmuscle-invasive bladder cancer)	tlybrtyugb(elqkfdejnk) = kfurwjofek eksylqvaee (ysacbqkihg, 46.6 - 68.2) View more	Positive	01 Jan 2026
NCT03493945 (QuEST1, SITC2025)	Phase 1/2	Castration-Resistant Prostatic Cancer	37	BNVax+BA+NAI	rcnqqxsncu(orxrixwzsq) = rldycckwts hpybhclljs (bkvdrwxhrv )	Positive	05 Nov 2025
NCT03022825 (QUILT-3.032, Pubmed \| J Urol)	Phase 2	-	54	NAI plus BCG (BCG-unresponsive high-grade Ta/T1 papillary nonmuscle-invasive bladder cancer)	kaqgqxyfmi(kpxscjafth) = tltdaqxjvb mbsqvvlwyf (jbbwpiodov, 46.6 - 68.2) View more	Positive	03 Nov 2025
NEWS Manual	Not Applicable	Recurrent Glioblastoma	5	Anktiva	agqsbwsobo(kkmaqajkyc) = cceqwqwksl vqeoozghgr (yoaeqskdtq )	Positive	29 Aug 2025
NCT03493945 (QuEST1, CTgov)	Phase 1/2	Locally Advanced Malignant Solid Neoplasm \| Advanced Malignant Solid Neoplasm	59	castration+M7824+BN-Brachyury (Phase IIA Dose Expansion (Dose Exp.), Cohort 2, Arm 2.1A)	igucxherlj = wyqeqwgugl hhmztjvggb (tffplfbwpt, syrqjqssle - zqwcsuffjr) View more	-	08 Jun 2025
				N-803+M7824+BN-Brachyury (All Participants in Phase IIA Dose Expansion and Phase IIB Dose Expansion)	igucxherlj = wtkptpkche hhmztjvggb (tffplfbwpt, uykrwanohu - hwrpfgloho) View more

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