Nogapendekin alfa inbakicept-pmln

Methods developed and validated to establish the “World Bank of NK Cells” from healthy donors and cancer patients Single apheresis yields up to 5 billion (5×10 9 ) highly pure activated memory cytokine-enhanced NK cells (M-ceNK), providing up to 8-10 doses of M-ceNK product per patient Manufacturing and cryo-banking process established with finished dosage form of M-ceNK cells available within 12 days from apheresis M-ceNK cells successfully cryopreserved with demonstration of retained cytotoxicity against multiple tumor cell lines Methods now established in readiness for manufacturing in AI-driven automated robotic systems (NANT Leonardo) Combination of M-ceNK with ANKTIVA® successfully completed in Phase 1 safety study (QUILT 3.076) CULVER CITY, Calif.--(BUSINESS WIRE)--ImmunityBio (NASDAQ: IBRX), a commercial-stage immunotherapy company, today announced the successful completion of manufacturing engineering programs, NK2022 and NK2023, establishing a safe, reproducible, and scalable leukapheresis-to-manufacturing pathway for its autologous memory cytokine-enhanced natural killer (M-ceNK) cell therapy platform. In addition, a Phase I program (QUILT-3.076; NCT04898543) combining M-ceNK with ANKTIVA ® (nogapendekin alfa inbakicept-pmln) was completed in patients with relapsed or refractory tumors demonstrating safety following infusion of the M-ceNK drug product. Collectively, these programs enrolled 74 subjects, including both healthy donors and patients with cancer, and generated the foundational process development and robotic automation datasets required to support first-in-human clinical translation. Manufacturing Validation The NK2022 (Cancer and Healthy Volunteers) and NK2023 (Healthy Volunteers) programs (N=64) evaluated the safety of large-volume, non-mobilized leukapheresis and the reproducibility of downstream NK cell enrichment and cytokine-driven memory programming across two distinct donor populations. Across both programs, 64 subjects successfully completed apheresis collection across healthy and cancer subjects without procedure-related serious adverse events (SAEs). Collected cells were stored and used for process development and validation. Among the 64 completed apheresis subjects, 10 cancer subjects received their collected cells following ImmunityBio’s NK cell enrichment process. A total of 23 doses were administered to patients demonstrating successful repeat dosing and cryo-banking of M-ceNK cells. No SAEs were reported in the 10 cancer subjects during their treatment cycles. Post-collection immune profiling demonstrated preserved NK cell activity and phenotype in healthy donors and in cancer patients, including those with prior exposure to systemic therapy. Critically, NK cells derived from cancer patients demonstrated cytotoxic activity equivalent to that of healthy donor-derived NK cells against NK-resistant cell lines representing multiple histologies, including breast, Merkel cell, ovarian, chordoma, medulloblastoma, glioblastoma, adenocarcinoma, and lymphoma. “These data demonstrate that potent NK cell therapy can be manufactured at scale and administered safely, potentially offering a reliable autologous source of potent NK cells,” said Patrick Soon-Shiong, MD, Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. “The ability to generate up to 5 billion highly pure NK cells from a single apheresis collection, yielding up to 8-10 therapeutic doses within 12 days, opens the possibility of creating the ‘World Bank of Natural Killer Cells’, with NK cells able to be universally donated to any patient without HLA matching.” QUILT-3.076 Safety Phase I Trial of M-ceNK Cells Manufacturing feasibility data from NK2022 and NK2023 directly enabled ImmunityBio’s Phase 1 dose-escalation trial (QUILT-3.076; NCT04898543) evaluating autologous M-ceNK cells in combination with nogapendekin alfa inbakicept-pmln (ANKTIVA ® ) in patients with relapsed or refractory solid tumors. 10 patients were enrolled in the treatment cohort and received weekly intravenous M-ceNK infusions (0.25 to 0.75×10 9 cells per dose, up to 10 doses) combined with subcutaneous ANKTIVA ® administered every two weeks. Patient infusions to date: N=10. All infusion performed in an outpatient setting Cancer types (2 nd line & greater): Breast (N=4), Colon (N=1), Duodenum (N=1), Renal (N=1), Pancreatic (N=1), Rectal (N=1), Osteosarcoma (N=1) Range of M-ceNK infusions (2 to 5 bags infused) with NAI subcutaneously Safety: Zero (0%) TRAE Grade 4 or 5. Zero (0%) cytokine storm The combination of autologous M-ceNK cells with ANKTIVA ® is mechanistically designed to leverage the IL-15 superagonist activity of ANKTIVA ® to sustain in vivo M-ceNK proliferation and persistence following adoptive transfer. M-ceNK Antitumor Activity in Neuroendocrine Tumors: NCI-Led Preclinical and In Vivo Efficacy Data Additional translational evidence supporting the M-ceNK platform was presented by K Fousek et al., National Cancer Institute (NCI) at the AACR IO Annual Meeting, 2026 . The AACR IO 2026 presentation reported the first in vivo efficacy data for the M-ceNK platform. In two SCLC xenograft models, M-ceNK cells combined with ANKTIVA produced statistically significant tumor volume reductions (p<0.01 and p<0.001, respectively), with confirmed in vivo persistence of functional M-ceNK cells. M-ceNK treatment also significantly increased MHC-Class I expression on residual tumor cells (p<0.0001), suggesting a potential dual mechanism: direct NK cell mediated tumor killing followed by conversion of residual tumors to a state potentially responsive to immune checkpoint inhibitors. SCLC is an aggressive neuroendocrine carcinoma with limited treatment options. Tissue microarray analysis demonstrated that 62% of neuroendocrine tumors lack MHC-Class I expression, rendering them resistant to T cell-based immunotherapies but vulnerable to NK cell mediated killing, identifying a substantial patient population with unmet therapeutic need. Low MHC class I surface expression limits T cell-mediated and immune checkpoint blockade (ICB)-dependent tumor killing, a contributing mechanism of ICB resistance, while simultaneously creating susceptibility to NK cell-mediated cytotoxicity via the missing-self recognition mechanism. M-ceNK cells generated from healthy donor peripheral blood mononuclear cells expressed high levels of activating receptors, low levels of inhibitory receptors, and produced elevated interferon-gamma (IFN-γ) and granzyme B upon stimulation, consistent with an enhanced cytotoxic effector phenotype. In standardized cytotoxicity assays, M-ceNK cells demonstrated potent killing activity against the majority of tumor cell lines evaluated, with the greatest cytotoxic activity observed against neuroendocrine tumor models, including five SCLC lines, four pulmonary carcinoid lines, and a large cell neuroendocrine carcinoma line, supporting the potential breadth of clinical applicability across neuroendocrine malignancies. 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. A key component in the Company’s BioShield platform, ANKTIVA is a first-in-class IL-15 agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA ® mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by 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 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, 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. All statements in this press release that are not historical facts are forward-looking statements, including, without limitation, statements regarding: the potential clinical utility, safety, and therapeutic benefit of memory cytokine-enhanced natural killer (M-ceNK) cell therapies; the potential of ImmunityBio’s NK cell manufacturing and cryopreservation processes to enable scalable, reproducible, and rapid production of NK cell therapies; the ability to generate multiple therapeutic doses from a single leukapheresis collection; the potential to establish a “world bank” of NK cells or otherwise enable broad patient access to NK cell therapies; the readiness and potential advantages of automated or AI-driven robotic manufacturing systems; the expected development pathway, clinical evaluation, and future studies of the M-ceNK platform; the potential clinical benefits of combining M-ceNK cells with ANKTIVA® (nogapendekin alfa inbakicept-pmln); the potential mechanisms of action of M-ceNK cells and ANKTIVA®, including NK cell activation, proliferation, and persistence; the potential applicability of the platform across multiple tumor types; the significance of preclinical or early clinical findings; and ImmunityBio’s plans to advance clinical development, present additional data, pursue regulatory discussions, and explore future regulatory approvals. Forward-looking statements are based on current expectations, estimates, projections, and assumptions of management and involve known and unknown risks, uncertainties, and other factors that may cause actual results, performance, or achievements to differ materially from those expressed or implied by these forward-looking statements. Such risks and uncertainties include, but are not limited to: uncertainties regarding the translation of preclinical findings or early clinical observations into meaningful clinical outcomes; risks related to the development, manufacture, and scale-up of cell therapy products; the possibility that manufacturing processes may not perform as expected at larger scale or in commercial settings; the ability to successfully automate or implement AI-driven manufacturing systems; the ability to establish or maintain reliable supply, cryopreservation, and distribution capabilities for cellular therapies; risks associated with clinical trial design, enrollment, conduct, and outcomes; the possibility that additional data may not confirm initial safety or activity observations; the risk that regulatory authorities may require additional studies, data, or manufacturing validation; uncertainties regarding regulatory review, approvals, timelines, and inspections of the relevant manufacturing facilities; ImmunityBio’s ability to successfully advance clinical programs and obtain regulatory approvals in the United States or other jurisdictions; competition from other therapeutic approaches; changes in regulatory requirements or standards; and ImmunityBio’s ability to obtain sufficient funding and resources to support its development programs and manufacturing efforts. 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: 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

Study fully enrolled ahead of schedule, with 366 of 366 BCG-naïve NMIBC patients randomized to receive BCG alone or ANKTIVA plus BCG Interim analysis requested by the FDA demonstrated a statistically significant improvement in duration of complete response with ANKTIVA plus BCG, with no significant safety signals observed Company anticipates submitting a biologics license application (BLA) to the U.S. FDA by Q4 2026 Expanded access program (EAP) of recombinant BCG is ongoing, with 580 patients currently enrolled throughout the U.S. CULVER CITY, Calif.--(BUSINESS WIRE)--ImmunityBio ( NASDAQ: IBRX ), a commercial-stage immunotherapy company, today announced completion of enrollment in its Phase 2 clinical trial evaluating ANKTIVA ® (nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) versus BCG alone in patients with BCG-naïve non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS), with or without papillary tumors. The QUILT 2.005 trial (NCT02138734), which completed enrollment ahead of schedule, includes 366 patients randomized to receive either BCG alone, the current standard-of-care for NMIBC CIS, or ANKTIVA in combination with BCG. An interim analysis requested by the U.S. Food and Drug Administration (FDA) demonstrated that treatment with ANKTIVA plus BCG resulted in a statistically significant improvement in the duration of complete response compared with BCG alone, with no significant safety concerns reported. The interim analysis demonstrated that at six months, 85% of patients receiving ANKTIVA plus BCG maintained a complete response, compared with 57% of patients treated with BCG alone. At nine months, 84% of subjects in the ANKTIVA plus BCG arm maintained a complete response, compared with 52% of patients in the BCG-alone arm. Despite the limited sample size of the interim analysis, the difference in duration of complete response at nine months reached statistical significance (p=0.0455). 1 “The interim results from this randomized study are encouraging and suggest that ANKTIVA plus BCG may improve the durability of response in patients with BCG-naïve NMIBC,” said Dr. Christopher Pieczonka, Corporate Director of Clinical Research at U.S. Urology Partners and Global Principal Investigator of the trial. “Given the historical limitations of BCG alone, continued evaluation of this combination has the potential to inform future treatment strategies and potentially change the current standard-of-care recommendations for NMIBC. Importantly, no new or worsening safety signals have been observed to date, which is encouraging when considered alongside prior studies evaluating BCG in combination with checkpoint inhibitors in this disease setting.” Additional study results are expected to be available in the fourth quarter of 2026. Based on these data, ImmunityBio anticipates submitting a biologics license application (BLA) to the FDA by Q4 2026. “We are encouraged by these interim results and await the final unblinding of the completed trial,” said Patrick Soon-Shiong, Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio. “If approved, ANKTIVA plus BCG could offer a new treatment option earlier in the disease course for patients with NMIBC CIS, building on the therapy’s existing approval in the BCG-unresponsive setting.” In parallel, ImmunityBio continues to address the ongoing shortage of TICE ® BCG through its Expanded Access Program (EAP) for recombinant BCG (NCT06810141), which is progressing and supporting patient access. The Company has requested consultation with the FDA regarding the potential approval of recombinant BCG as an alternative supply source in anticipation of continued clinical need, including for patients with BCG-naïve disease. 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. A key component in the Company’s BioShield platform, ANKTIVA is a first-in-class IL-15 agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA ® mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by 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. 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 . References: Reddy S, et al. QUILT-2.005: A comparison of intravesical Bacillus Calmette-Guérin (BCG) in combination with the IL-15 superagonist N-803 versus BCG alone in patients with BCG-naïve NMIBC. Presented at AUA Annual Meeting 2024; May 3–6, 2024; San Antonio, TX. 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, 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 clinical development, therapeutic potential, safety, efficacy, and regulatory pathway of ANKTIVA; the anticipated clinical benefits of ANKTIVA plus BCG in patients with BCG-naïve non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS); the potential for ANKTIVA plus BCG to improve durability of complete response compared to BCG alone; the timing, availability, and results of additional data from the QUILT 2.005 trial; the Company’s anticipated submission of a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) by the fourth quarter of 2026; the potential for FDA approval of ANKTIVA in the BCG-naïve setting; the potential for ANKTIVA plus BCG to change the standard of care for NMIBC; the progress and potential regulatory outcome of the Company’s Expanded Access Program for recombinant BCG; the potential approval of recombinant BCG as an alternative supply source; and the broader capabilities and expected benefits of the Company’s Cancer BioShield™ platform. These forward-looking statements are based on current expectations, estimates, forecasts, and projections, as well as the beliefs and assumptions of management, and are subject to significant risks and uncertainties. Actual results may differ materially from those expressed or implied by such forward-looking statements due to a variety of factors, including, but not limited to: risks related to clinical trial design, enrollment, timing, interim analyses, and final data outcomes; the possibility that interim results may not be predictive of final trial results; regulatory risks, including the timing and outcome of interactions with the FDA and other regulatory authorities, and the risk that a BLA may not be submitted when anticipated or, if submitted, may not be approved or may require additional data or studies; risks related to safety signals or adverse events that may arise during continued evaluation; the Company’s ability to manufacture sufficient quantities of ANKTIVA and recombinant BCG to support clinical development and potential commercialization; risks associated with product supply, including ongoing BCG shortages; competitive developments; changes in standard-of-care treatment; market acceptance; reimbursement; and intellectual property protection. 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