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 Date08 Dec 2025

Sponsor / Collaborator

National Cancer Institute

NCT07049432

/ Not yet recruitingPhase 1IIT

A Phase I Study of N-803 Maintenance Therapy Following CD19 Directed CAR T-cell Therapy in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphomas (CARMEN-803 Trial)

The purpose of this clinical trial is to learn whether the study drug N-803 is safe and tolerable in patients with B-cell non-Hodgkin lymphoma who have undergone CAR T-cell therapy.

Start Date01 Dec 2025

Sponsor / Collaborator

University of Utah

[+1]

NCT07217496

/ Not yet recruitingPhase 1IIT

Phase Ib Trial Combining N-803 and Pembrolizumab With Shorter Duration of Enfortumab Vedotin in Treatment-Naïve Patients With Metastatic Urothelial Carcinoma

This phase Ib trial will investigate the effect of N-803 in combination with pembrolizumab and enfortumab vedotin in treating participants with urothelial cancer that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic).

Start Date30 Nov 2025

Sponsor / Collaborator

The University of California, San Francisco

[+1]

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

Literatures (Medical) associated with Nogapendekin alfa inbakicept-pmln

15 Oct 2025·CLINICAL CANCER RESEARCH

FDA Approval Summary: Nogapendekin Alfa Inbakicept-pmln with BCG for BCG-Unresponsive Carcinoma In Situ

Article

Author: Pierce, William F. ; Dellibovi-Ragheb, Teegan A. ; Heiss, Brian L. ; Tang, Shenghui ; Chiu, Haw-Jyh ; Rahman, Nam Atiqur ; Koh, Eun Hee ; Joeng, Hee-Koung ; Suzman, Daniel L. ; Kluetz, Paul G. ; Pazdur, Richard ; Wang, Min ; Chang, Elaine ; Amiri-Kordestani, Laleh ; Leighton, John K. ; Ricks, Tiffany K. ; Lee, Christal ; Wang, Lingshan ; Fiero, Mallorie H. ; Hamed, Salaheldin S.

Abstract:

On April 22, 2024, the U.S. FDA granted regular approval to nogapendekin alfa inbakicept-pmln (N-803) with Bacillus Calmette-Guerin (BCG) for the treatment of adult patients with BCG-unresponsive non–muscle-invasive bladder cancer with carcinoma in situ, with or without papillary tumors. Substantial evidence of effectiveness for this application was obtained from cohort A of the single-arm, multicenter QUILT-3.032 trial. Patients received N-803 400 μg administered intravesically with TICE BCG once a week for 6 weeks as induction therapy, a second induction course if complete response (CR) was not achieved at month 3, and maintenance N-803 with BCG weekly for 3 weeks at months 4, 7, 10, 13, and 19 (for a total of 15 maintenance doses). The major efficacy outcome measures were CR at any time [as defined by negative results for cystoscopy [with transurethral resection of bladder tumor (TURBT)/biopsies as applicable] per local investigator assessment and urine cytology] and duration of response. The CR rate in the 77-patient efficacy population, per FDA review, was 62% [95% confidence interval (CI), 51%–73%]. Of the 48 patients with a CR, 28 (58%; 95% CI, 26%–55%) and 19 (40%; 95% CI, 16%–36%) maintained a response for ≥12 months and ≥24 months, respectively. The most common adverse reactions were increased creatinine, dysuria, hematuria, urinary frequency, urinary urgency, and urinary tract infection. This article summarizes the data and FDA thought process supporting the approval of N-803 with BCG.

19 Aug 2025·PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA

Therapeutic CD8⁺ T cell tissue retention and immunomodulation during ART interruption fail to prevent SIV rebound.

Article

Author: Viox, Elise G ; Samer, Sadia ; Deleage, Claire ; Kuri-Cervantes, Leticia ; Betts, Michael R ; Paiardini, Mirko ; Safrit, Jeffrey T ; Pampena, M Betina ; Davenport, Miles P ; Regan, James ; Docken, Steffen ; Bar, Katharine J ; Wu, Vincent H ; Keele, Brandon F ; Nguyen, Kevin

A primary obstacle for HIV elimination is the long-term viral reservoir in lymphoid tissues (LT) that can cause rebound viremia if therapy is stopped. Cytotoxic CD8⁺ T cells are critical for control of HIV and Simian immunodeficiency virus (SIV) viremia; however, CD8⁺ T cells that migrate to LT are primarily noncytotoxic, calling into question whether these cells could reduce the viral reservoir on antiretroviral therapy (ART) or control viral replication when therapy is halted. To determine whether CD8⁺ T cells can inhibit viral replication when retained in LT, we inhibited lymphocyte egress from LTs in ART-treated SIV-infected rhesus macaques (RMs) during analytic treatment interruption (ATI) using the S1PR modulator FTY720 alone or in combination with anti-PD1 antibody (αPD1) and the IL-15 receptor superagonist N-803 to increase cytolytic function. FTY720 retained migrating CD4⁺ and CD8⁺ T cells in LT, whereas cytotoxic CD8⁺ T cells remained in the vasculature. After ATI and viral rebound, activated SIV-specific CD8⁺ T cells increased in frequency in LT of FTY720-treated RMs but failed to become cytotoxic or control plasma viremia compared to controls, even when combined with αPD1 and N-803. These findings indicate that LT-localized CD8⁺ T cells alone may be insufficient to delay or prevent plasma viral rebound during ATI.

08 Jul 2025·JCI Insight

Impact of the IL-15 superagonist N-803 on lymphatic reservoirs of HIV

Article

Author: Miller, Jeffrey S ; Wieking, Garritt ; Schacker, Timothy W ; Beilman, Gregory J ; Reichel, Jarrett ; Safrit, Jeffrey T ; Baker, Jason V ; Deeks, Steven G ; Khoruts, Alexander ; Klatt, Nichole R ; Vaughn, Byron P ; Soon-Shiong, Patrick ; Chipman, Jeffrey G ; Anderson, Jodi ; Batres, Rodolfo ; Davis, Zachary B ; Cromarty, Ross ; Escandón, Kevin ; Eilkhani, Elnaz ; Hinderlie, Peter ; Eaton, Anne ; Basting, Christopher M ; Rhein, Joshua

BACKGROUNDNK cell function is impaired in people with HIV (PWH), hindering their potential to reduce the lymphoid tissue (LT) reservoir. The IL-15 superagonist N-803 has been shown to enhance NK and T cell function and thus may reduce viral reservoirs.METHODSTo determine the impact of N-803 on LTs, we conducted a clinical trial where 10 PWH on effective antiretroviral therapy (ART) were given 3 subcutaneous 6 mcg/kg doses of N-803. We obtained PBMCs and lymph node (LN) and gut biopsies at baseline and after the last N-803 dose.RESULTSWe found a nonstatistically significant approximately 0.50 median log reduction in the frequency of viral RNA+ (vRNA+) and vDNA+ cells/g in the 6 participants with baseline and posttreatment LN biopsies. In the ileum, we observed reductions of vRNA+ cells in 8/10 participants and vDNA+ cells in all participants. We also found significant inverse correlations between NK cell proliferation and the frequency of vRNA+ cells and between NKG2A expression on NK cells and the frequency of vRNA+ cells.CONCLUSIONOur findings suggest N-803 may reduce the HIV reservoir in LTs of PWH on ART, an effect likely mediated by enhanced NK cell function. Controlled studies assessing the impact of NK cell therapy on HIV LTs are needed.TRIAL REGISTRATIONClinicalTrials.gov NCT04808908.FUNDINGNIH grants 5UM1AI126611, UL1TR002494, R01 AI147912, R35 CA283892, and UM1AI164561.

147

News (Medical) associated with Nogapendekin alfa inbakicept-pmln

13 Nov 2025

·www.businesswire.com

New Survey Reveals Non-Muscle Invasive Bladder Cancer Patients Seek More Care Conversations

Insights show patients with non-muscle invasive bladder cancer want to explore new treatment options, yet fewer than one in five say their doctors discuss all available procedures/treatments at most or every visit Nearly three in four patients said they would choose intravesical chemotherapy only as a last resort, rather than earlier in their treatment journey Over 80% believe immunotherapy has fewer side effects than chemotherapy, and 72% of immunotherapy recipients are satisfied with the duration of positive treatment effects* As bladder cancer rates continue to rise in the United States, ensuring access to innovative therapies that can improve long-term outcomes has become increasingly critical CULVER CITY, Calif.--(BUSINESS WIRE)--A new U.S. survey conducted by The Harris Poll on behalf of ImmunityBio, Inc. (NASDAQ: IBRX) reveals that many people living with non-muscle invasive bladder cancer (NMIBC) feel left out of critical treatment conversations. Fewer than one in five patients surveyed (18%) report their healthcare providers (HCPs) discuss all available treatment options during most or every visit. More than four in five (84%) believe immunotherapy has fewer side effects than chemotherapy, with 72% of those who received immunotherapy expressing satisfaction with the duration of positive treatment effects. The findings highlight a pressing need for more open dialogue and greater awareness of innovative therapies in treating NMIBC. Nearly three in four patients said they would choose intravesical chemotherapy only as a last resort, rather than earlier in their treatment journey, and 72% of immunotherapy recipients are satisfied with the duration of positive treatment effects. Bladder cancer is a serious public health concern, ranking as the seventh-most common cancer overall and the third most frequently diagnosed cancer in men.1 Bladder cancer is also on the rise in the United States.1 The American Cancer Society projects that more than 84,000 patients will be diagnosed in 2025.2 Approximately 70% of these patients will have NMIBC, which is cancer that has grown only on the lining of the bladder and not into the muscle layer underneath, and is the most common form of bladder cancer.3 Patient and HCP Relationships: A Notable Disconnect Only 18% of NMIBC patients say they have frequent discussions with their HCPs about all available procedures/treatment options for NMIBC during most or every visit, yet most patients (92%) say they rely on information from HCPs to guide treatment decisions, with few saying they rely on other sources outside of conversations with their HCPs, such as patient advocacy groups (6%). Nearly two in three patients who have not had a full cystectomy (64%) remain unsure which treatments are still effective for their type or stage of NMIBC. Patients Are Looking for Alternatives to Chemotherapy Nearly six in 10 NMIBC patients (58%) say their HCPs discussed/provided information on chemotherapy before their first (initial) round of procedure(s) and/or treatment(s), even though nearly three out of four (72%) would prefer this option only as a last resort rather than earlier in their treatment. More than four in five (81%) are interested in trying new/different treatments, and the majority of patients who have not had a full cystectomy (89%) say they would try anything to avoid removal of their bladder (cystectomy). Almost all patients (97%) report that it is important that a treatment works quickly to stop or slow disease progression, and a similar proportion (94%) indicate it is important that a treatment have long-lasting duration of positive effects. Nine in 10 (90%) would be willing to receive a treatment more frequently if it had longer lasting effects than other therapeutic options. Immunotherapy Offers Renewed Hope The vast majority of patients (89%) regard using a treatment that enhances their body's immune system to fight cancer (i.e., immunotherapy) as cutting-edge. More than four in five (84%) believe this treatment modality has fewer side effects than chemotherapy. Among those who received immunotherapy1, 72% express satisfaction with the duration of positive treatment effects, such as cystectomy avoidance and disease-free survival, while two out of three are satisfied with the speed at which it stops or slows disease progression. “This survey highlights the urgent need for patients and providers to engage in deeper, more collaborative conversations about all treatment choices for non-muscle invasive bladder cancer,” said Richard Adcock, President and CEO of ImmunityBio. “Immunotherapy is empowering the body’s own defenses to fight bladder cancer, offering real hope for patients who have run out of options. At ImmunityBio, we’re committed to advancing science that transforms these insights into life-changing care.” About the Survey The research was conducted online in the United States by The Harris Poll on behalf of ImmunityBio among 200 US adults 18+ who were diagnosed with non-muscle invasive bladder cancer. The survey was conducted 9/3-10/1/2025. Raw data were not weighted and are therefore only representative of the individuals who completed the survey. Respondents for this survey were selected from among those who have agreed to participate in Harris Poll surveys. The sampling precision of Harris online polls is measured by using a Bayesian credible interval. For this study, the sample data is accurate to within ± 6.9 percentage points using a 95% confidence level. This credible interval will be wider among subsets of the surveyed population of interest. All sample surveys and polls, whether or not they use probability sampling, are subject to other multiple sources of error which are most often not possible to quantify or estimate, including, but not limited to coverage error, error associated with nonresponse, error associated with question wording and response options, and post-survey weighting and adjustments. References Bladder Cancer Advocacy Network. Bladder Cancer Cases Expected to Rise in 2025, ACS Reports. January 21, 2025. Available at https://bcan.org/bladder-cancer-cases-expected-to-rise-in-2025-acs-reports/ American Cancer Society. Key Statistics for Bladder Cancer. Last revised January 22, 2025. Available at https://www.cancer.org/cancer/types/bladder-cancer/about/key-statistics.html Leyderman, M., Chandrasekar, T., Grivas, P. et al. Metastasis development in non-muscle-invasive bladder cancer. Nat Rev Urol 22, 375–386 (2025). https://doi.org/10.1038/s41585-024-00963-y About ImmunityBio ImmunityBio is a vertically-integrated commercial stage biotechnology company developing next-generation therapies that bolster the natural immune system to defeat cancers and infectious diseases. The Company’s range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates NK cells, T cells, and memory T cells for a long-duration response. The Company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases. For more information, visit ImmunityBio.com (Founder’s Vision) 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, such as statements regarding survey data from a Harris Poll and potential implications to be drawn therefrom, statements about how patients living with non-muscle invasive bladder cancer view care options, chemotherapy, cystectomy, and immunotherapy and potential implications to be drawn therefrom, the development of therapeutics for cancer and infectious diseases, potential benefits to patients, potential treatment outcomes for patients, the described mechanism of action and results and contributions therefrom, the application of the Company’s science and platforms to treat cancers or develop cancer vaccines, immunotherapies and cell therapies that has the potential to change the paradigm in cancer care, and ImmunityBio’s approved product and investigational agents as compared to existing treatment options, among others. Statements in this press release that are not statements of historical fact are considered forward-looking statements, which are usually identified by the use of words such as “anticipates,” “believes,” “continues,” “goal,” “could,” “estimates,” “scheduled,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “indicate,” “projects,” “is,” “seeks,” “should,” “will,” “strategy,” and variations of such words or similar expressions. Statements of past performance, efforts, or results of our preclinical and clinical trials, about which inferences or assumptions may be made, can also be forward-looking statements and are not indicative of future performance or results. 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. Such information may be limited or incomplete, and ImmunityBio’s statements should not be read to indicate that it has conducted a thorough inquiry into, or review of, all potentially available relevant information. Such statements reflect the current views of ImmunityBio with respect to future events and are subject to known and unknown risks, including business, regulatory, economic and competitive risks, uncertainties, contingencies and assumptions about ImmunityBio, including, without limitation, (i) risks and uncertainties regarding participation and enrollment and potential results from the clinical trial described herein, (ii) whether clinical trials will result in registrational pathways, (iii) whether clinical trial data will be accepted by regulatory agencies, (iv) the ability of ImmunityBio to fund its ongoing and anticipated clinical trials, (v) the ability of ImmunityBio to continue its planned preclinical and clinical development of its development programs through itself and/or its investigators, and the timing and success of any such continued preclinical and clinical development, patient enrollment and planned regulatory submissions, (vi) potential delays in product availability and regulatory approvals, (vii) ImmunityBio’s ability to retain and hire key personnel, (viii) ImmunityBio’s ability to obtain additional financing to fund its operations and complete the development and commercialization of its various product candidates, (ix) potential product shortages or manufacturing disruptions that may impact the availability and timing of product, (x) ImmunityBio’s ability to successfully commercialize its approved product and product candidates, (xi) ImmunityBio’s ability to scale its manufacturing and commercial supply operations for its approved product and future approved products, and (xii) ImmunityBio’s ability to obtain, maintain, protect, and enforce patent protection and other proprietary rights for its product candidates and technologies. 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 March 3, 2025, and the Company’s Form 10-Q filed with the SEC on November 5, 2025 and in subsequent filings made by ImmunityBio with the SEC, which are available on the SEC’s website at www.sec.gov. 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. *Patient sample size n=<50

ImmunotherapyBreakthrough TherapyClinical StudyClinical Result

22 Oct 2025

·www.globenewswire.com

Calidi Biotherapeutics Announces Establishment of Scientific Advisory Board to Support Development of CLD-401 and Advance its RedTail Platform for the Systemic Delivery of Targeted Genetic Medicine

SAN DIEGO, Oct. 22, 2025 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics, Inc. (NYSE American: CLDI) (“Calidi” or the “Company”), a clinical-stage biotechnology company pioneering the development of systemically delivered, targeted genetic medicines, today announced the formation of its Scientific Advisory Board (SAB) comprised of leading industry and academic researchers in with deep expertise in drug development. The SAB will work with Calidi to further develop its RedTail platform and advance CLD-401 into the clinic. RedTail is Calidi’s groundbreaking approach to genetic medicines that utilizes an enveloped form of vaccinia virus genetically engineered to overexpress CD55 and avoid immune clearance, allowing for systemic delivery and targeting of genetic medicine payload(s) to sites of disease. CLD-401, the first lead from the RedTail platform, is designed to home to metastatic sites after systemic administration, replicate only in tumors cells, induce an immune priming event at the tumor site, and express high levels of IL-15 superagonist in the tumor microenvironment, a potent cytokine that induces NK and T-cell responses to the tumor. “We are excited to have such an internationally esteemed group of advisors working with the company,” said Eric Poma, Ph.D., CEO of Calidi. “We believe their insight and experience will help guide the efficient development of CLD-401 into the clinic and advance what the utility of the RedTail platform in oncology and beyond.” Founding members of Calidi’s new Scientific Advisory Board are: Mace L. Rothenberg, MD, FACP, is a physician-executive with more than 30 years of experience in drug development, translational research, and risk-benefit assessment. Mace Rothenberg, MD is President and Executive Director of the Museum of Medicine and Biomedical Discovery. His nearly 40-year career has spanned government, academia, industry, and the not-for-profit sector. Prior to his current role, Dr. Rothenberg was Chief Medical Officer of Pfizer from 2019 to 2021, during which time the company developed and received Emergency Use Authorization for Comirnity®, its Covid-19 vaccine. Prior to that role, Mace was Chief Development Officer/Head of Clinical Development & Medical Affairs for Pfizer Oncology. Over the course of 10 years in that role, his organization developed and obtained regulatory approval for 11 new cancer medicines. Prior to joining Pfizer, Dr. Rothenberg was Professor of Medicine at the University of Texas Health Science Center at San Antonio (1991-1998) and Vanderbilt University (1998-2008). Dr. Rothenberg began his career as Special Assistant to the Director, Division of Cancer Treatment at the National Cancer Institute in Bethesda, Maryland (1988-1991). Dr. Rothenberg received his BA magna cum laude from the University of Pennsylvania, his MD from New York University, his post-graduate training in Internal Medicine at Vanderbilt, and his medical oncology training at the National Cancer Institute. He is a Fellow of the American College of Physicians, the American Society of Clinical Oncology, and the New York Academy of Medicine. Mace serves as a director of Tango Therapeutics, Surrozen, and Aulos Biosciences. He is chairman of the board of Chiara Biosciences. He also serves on the board of several non-profit organizations including the Pancreatic Cancer Action Network (PanCAN), NashBio, and the Councils of Advisors for the Vanderbilt-Ingram Cancer Center and Vanderbilt University School of Medicine Basic Sciences. Dmitriy Zamarin MD, PhD, is a medical oncologist and Section Head of Gynecologic Medical Oncology and Co-Director of the Center of Excellence for Gynecologic Cancer and a world leader in virotherapy for cancer. Dr. Dmitriy Zamarin is a member of the Icahn Genomics Institute and the Precision Immunology Institute at The Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai. Prior to Mount Sinai, Dmitriy spent a decade as a faculty and Translational Research Director in Gynecologic Medical Oncology at the Memorial Sloan Kettering Cancer Center before transitioning to his current role in September of 2023. Dr. Zamarin has served as a principal investigator and a translational chair on multiple institutional and cooperative group clinical trials exploring novel immunotherapy combinations in gynecologic cancers and other solid tumors and serves as the translational research co-chair on the NRG Oncology Cervical Cancer committee. In the laboratory, his research uses mouse models to explore the mechanisms of tumor-immune system interactions and to develop novel therapeutics, with particular focus on oncolytic viruses, vaccines, and targeted therapies. For his work Dr. Zamarin has received awards and funding from multiple organizations including Damon Runyon Foundation, Ovarian Cancer Research Alliance, Department of Defense, and R01 grants from the National Cancer Institute. John Wrangle, MD, MPH, is a thoracic oncologist and scientist and an expert in translation immunotherapy with extensive experience around IL-15-based treatment in metastatic cancer Dr. John M. Wrangle is Associate Professor of Hematology/Oncology at the Medical University of South Carolina (MUSC) and holds the SmartState Burtschy Family Distinguished Endowed Chair in Lung Cancer Research. He is a thoracic medical oncologist focused on developing novel immunotherapy and gene-based strategies for non–small cell lung cancer and other thoracic malignancies. Dr. Wrangle completed his internship and residency in Internal Medicine at Emory University, followed by fellowship training in Hematology and Medical Oncology at Johns Hopkins University. He is board certified in Internal Medicine and Medical Oncology. In his clinical-translational work, Dr. Wrangle led the Phase 2 trial combining PD-1 checkpoint blockade with the IL-15 superagonist ALT-803 (now known as N-803), demonstrating tumor responses in patients with non–small cell lung cancer (Lancet Oncology, Wrangle et al. 2018). Dr. Wrangle also leads efforts to translate lab discoveries into clinical trials, with recent support from the Department of Defense Lung Cancer Research Program to pursue gene-therapy–inspired cancer strategies. He is deeply committed to reducing disparities in lung cancer care in underserved populations in South Carolina, aiming to bring cutting-edge therapies to patients outside major academic centers. David T. Curiel, MD, PhD is a world leader in cancer immunotherapy and cancer virotherapy. Dr. David T. Curiel is a tenured Professor in the Cancer Biology Division of the Department of Radiation Oncology at Washington University School of Medicine in St. Louis. Dr. Curiel earned his MD from Emory University in 1982 and subsequently completed his internship and residency in internal medicine at Emory. Dr. Curiel’s research has centered on engineering viral vectors for gene therapy, virotherapy, and vaccine development, with an emphasis on improving tumor targeting, immune evasion, and durable therapeutic effects. His oncolytic virus efforts include translation toward clinical trials in glioblastoma, among other cancers. During the COVID-19 pandemic, Dr. Curiel collaborated in developing a nasal vaccine delivered via adenovirus that elicits mucosal and systemic immunity; this vaccine has been licensed for development and has achieved regulatory authorizations in India. He has been recognized with innovation awards for this work. In recognition of his contributions to viral vector–based therapeutics and translation, Dr. Curiel was elected a Fellow of the National Academy of Inventors. He is also a co-founder of biotech companies (e.g. DNAtrix, Precision Virologics) focused on translating gene- and virus-based therapies to the clinic. About Calidi Calidi Biotherapeutics (NYSE American: CLDI) is a clinical-stage company pioneering the development of targeted therapies with the potential to deliver genetic medicines to distal sites of disease. The company's proprietary Redtail platform features an engineered enveloped oncolytic virus designed for systemic delivery and targeting of metastatic sites. This advanced enveloped technology is intended to shield the virus from immune clearance, allowing virotherapy to effectively reach tumor sites, induce tumor lysis, and deliver potent genetic medicine(s) to metastatic locations. CLD-401, the lead candidate from the Redtail platform, currently in IND-enabling studies, targets non-small cell lung cancer, head and neck cancer, and other tumor types with high unmet medical need. Calidi Biotherapeutics is headquartered in San Diego, California. For more information, please visit www.calidibio.com or view Calidi’s Corporate Presentation here. Forward-Looking Statements This press release may contain forward-looking statements for purposes of the “safe harbor” provisions under the United States Private Securities Litigation Reform Act of 1995. Terms such as “anticipates,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predicts,” “project,” “should,” “towards,” “would” as well as similar terms, are forward-looking in nature, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements include, but are not limited to, statements concerning key milestones, including certain pre-clinical data, planned clinical trials, and statements relating to the safety and efficacy of Calidi’s therapeutic candidates in development. Any forward-looking statements contained in this discussion are based on Calidi’s current expectations and beliefs concerning future developments and their potential effects and are subject to multiple risks and uncertainties that could cause actual results to differ materially and adversely from those set forth or implied in such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that Calidi is not able to raise sufficient capital to support its current and anticipated clinical trials, the risk that early results of clinical trials do not necessarily predict final results and that one or more of the clinical outcomes may materially change following more comprehensive review of the data, and as more patient data becomes available, the risk that Calidi may not receive FDA approval for some or all of its therapeutic candidates. Other risks and uncertainties are set forth in the section entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in the Company’s annual report filed with the SEC on Form 10-K on March 31, 2025, as may be amended or supplemented by other reports we file with the SEC from time to time. We disclaim any obligation to update any forward-looking statement to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events. For Investors: Dave Gentry, CEORedChip Companies, Inc.1-407-644-4256CLDI@redchip.com

VaccinePhase 2Executive ChangeImmunotherapy

10 Sep 2025

·www.fiercepharma.com

J&J's 'practice-changing' bladder cancer therapy Inlexzo lands FDA nod

With an 82% complete response rate seen in trials, Johnson & Johnson has touted high market hopes for the med. The FDA has signed off on Johnson & Johnson’s highly anticipated bladder cancer drug Inlexzo, marking an advance in the ability to care for patients who otherwise face bladder removal and limited treatment options.Inlexzo, previously called TAR-200, can now treat patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.The drug-releasing system combo allows for extended release of the chemotherapy gemcitabine directly to patients' bladders through an intravesical system that can be placed in minutes in an outpatient setting, with no general anesthesia needed, J&J said in a Sept. 9 release.Before the approval, the typical treatment route for NMIBC patients who don’t respond to standard-of-care BCG therapy was a radical cystectomy to remove the entire bladder. It's a life-altering and risky procedure that's not appropriate for many patients. J&J’s offering, meanwhile, provides a “potentially practice-changing” treatment, the company said.“We are proud of the science that has brought us to this historic moment,” John Reed, M.D., Ph.D., head of R&D at J&J Innovative Medicine, said in a statement. “As the only major healthcare company that hosts both pharmaceuticals and medical devices, we leveraged the speed and scale of Johnson & Johnson to accelerate innovation and deliver this important therapy to patients.”J&J picked up the asset from Taris Biomedical in 2019 with hopes to “give patients with bladder cancer a renewed sense of hope and belief,” Jennifer Taubert, J&J's head of Innovative Medicine, commented. “In an area that has seen little progress for more than 40 years, Inlexzo delivers a first-of-its-kind breakthrough innovation with a bright future ahead.” In a phase 2b study, 82% of Inlexzo-treated patients experienced a complete response without the need for reinduction, with 51% maintaining the response for at least one year. The complete response rate is the highest recorded among currently available therapies, Mark Wildgust, Ph.D., vice president of oncology global medical affairs for J&J Innovative Medicine, said in an interview with Fierce Pharma earlier this year.With its high complete response rate and its convenience factor, J&J believes Inlexzo will set itself apart from other bladder cancer offerings such as Merck’s Keytruda, Ferring Pharmaceuticals’ gene therapy Adstiladrin and ImmunityBio’s immunotherapy Anktiva, which is used alongside the BCG vaccine. The company has high hopes for the drug’s market potential.“In all the research that we have done, I have absolutely no reason to believe that they will use anything else but us once they fail BCG,” the president of J&J’s solid tumor business, Biljana Naumovic, told Fierce Pharma in April. She acknowledged, however, that the drug won’t reach that level of market dominance right away. J&J has already set up a patient support program and a Care Navigator offering educational resources at no cost to patients. Inlexzo is being further studied across patients with MIBC and those with NMIBC in four ongoing clinical trials.

Clinical ResultPhase 2ImmunotherapyVaccineDrug Approval

100 Deals associated with Nogapendekin alfa inbakicept-pmln

External Link

KEGG	Wiki	ATC	Drug Bank
D12888	-	-	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
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
Advanced Lung Non-Small Cell Carcinoma	Phase 3	United States	ImmunityBio, Inc.	18 May 2018
metastatic non-small cell lung cancer	Phase 3	United States	ImmunityBio, Inc.	18 May 2018
Bladder Cancer	Phase 3	United States	ImmunityBio, Inc.	02 Jun 2017
Post Acute COVID 19 Syndrome	Phase 2	United States	ImmunityBio, Inc.	04 Sep 2025
Adenocarcinoma of prostate	Phase 2	-	ImmunityBio, Inc.	15 May 2025
Platinum-Resistant Ovarian Carcinoma	Phase 2	United States	ImmunityBio, Inc.	06 Nov 2024
Recurrent Platinum-Resistant Ovarian Carcinoma	Phase 2	United States	ImmunityBio, Inc.	06 Nov 2024
Glioblastoma Multiforme	Phase 2	United States	ImmunityBio, Inc.	07 Aug 2024
Glioblastoma, IDH-Wildtype	Phase 2	United States	ImmunityBio, Inc.	07 Aug 2024
Head and neck cancer metastatic	Phase 2	United States	ImmunityBio, Inc.	16 Feb 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03493945 (QuEST1, SITC2025)	Phase 1/2	Castration-Resistant Prostatic Cancer	37	BNVax+BA+NAI	mxqeilgstk(bymnprelwm) = ectjcgvikd pulpeqmtxy (ciuvomndqi )	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)	cpxydgrhkb(ymwstzsjcd) = zrgqqqwtug crkyecwisc (rluyrfupfz, 46.6 - 68.2) View more	Positive	03 Nov 2025
NEWS Manual	Not Applicable	Recurrent Glioblastoma	5	Anktiva	knufsclbll(boclktxbaf) = lqquatnoko laajkmtrss (syxyuhgjrp )	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)	idmjllsigd = szfpynquwi keyjvmsfvb (quurhzaywv, sndzctdkyd - nxgzbhxgki) View more	-	08 Jun 2025
				N-803+M7824+BN-Brachyury (All Participants in Phase IIA Dose Expansion and Phase IIB Dose Expansion)	idmjllsigd = mfnvdzedco keyjvmsfvb (quurhzaywv, arynsmfbzb - gjyixgdlet) View more
NCT04390399 (QUILT-88, ASCO2025)	Phase 2	Metastatic Pancreatic Cancer ALC \| CA19-9	84	N-803 and PD-L1 t-haNK chemo-immunotherapy	mghmqhophv(wfbwugdmzj) = Grade 3 or higher TEAEs occurred in 95% of patients and were largely chemotherapy-associated ytqsluvcfn (vrmcmdlzjk )	Positive	30 May 2025
				Low-dose SBRT and low-dose chemotherapy
NCT03022825 (QUILT-3.032, Company_Website \| Literature) Manual	Phase 2/3	Non-Muscle Invasive Bladder Neoplasms	180	ANKTIVA®ANKTIVA® plus BCG (CIS with or without Papillary)	qysyibeini(vrzyikrsdc) = hgkivqmvks rwuxqrtlnp (mkbsnuggii ) View more	Positive	28 Apr 2025
				ANKTIVA® Plus BCG (Papillary without CIS)	uxmxjslmjb(ufbnqmhzyw) = fnrleqdhxf bkvqzkjabl (dtvycatoda ) View more
NCT03381586 (CTgov)	Phase 1	-	20	ALT-803 (Group A)	pstqlebkfc(jkphnhrrna) = dkdgjzgbmz ywvhfvumds (ezhmusktvm, 0.813) View more	-	24 Mar 2025
				ALT-803 (Group B)	pstqlebkfc(jkphnhrrna) = brbghmfnzl ywvhfvumds (ezhmusktvm, 0.095) View more
NCT03563157 (CTgov)	Phase 1/2	Metastatic Colorectal Carcinoma	2	SBRT+Aldoxorubicin Hydrochloride+GI-6301+GI-4000+ETBX-061+Cetuximab+ETBX-051+ETBX-011+5-fluorouracil+ALT-803+ETBX-021+Nab-paclitaxel+Cyclophosphamide+Avelumab+haNK+Leucovorin+GI-6207+Regorafenib+oxaliplatin+Capecitabine (NANT Colorectal Cancer (CRC) Vaccine)	hwfazjpxpi = hjolzuojgf vvhvytbfta (vgwpcnosfq, czijfwedtt - onrdzmscvz) View more	-	11 Dec 2024
				Regorafenib (Regorafenib)	nifulcstog(wzpbgefabw) = rauqgdmcde ydcexvhttb (ytxcxuiumf, olxvrypfmz - rfymdvrbqn) View more
NCT02099539 (CTgov)	Phase 1	Relapse multiple myeloma \| Refractory Multiple Myeloma	19	N-803 (Cohort 1: N-803 - IV 1 ug/kg)	qyxtnymmky = ebmnsashft czzxwfvvlo (wmqeewpwrf, rlgxcbdyco - cljuagkdop) View more	-	26 Sep 2024
				N-803 (Cohort 2: N-803 - IV 3 ug/kg)	qyxtnymmky = wkkdvmgrmn czzxwfvvlo (wmqeewpwrf, hamqtdrnil - hthjvcymdr) View more
NCT03493945 (QuEST1, ESMO2024)	Phase 1/2	Castration-Resistant Prostatic Cancer dMMR \| pMMR	25	BNVax + BA + Anktiva	uoqswkxzkm(atzjyfzloe) = vjsuhiuufx aamerrzzwn (kmcaxynlrw, 39.9 - 83.9) View more	Positive	15 Sep 2024

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