CULVER CITY, Calif.--(BUSINESS WIRE)--ImmunityBio, Inc. (NASDAQ: IBRX) today announced the initial treatment of multiple patients in the United States to receive therapy with ANKTIVA® (nogapendekin alfa inbakicept-pmln), ImmunityBio’s recently approved immunotherapy for Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ.

加利福尼亚州卡尔弗市（商业新闻短讯）--ImmunityBio，Inc.（纳斯达克：IBRX）今天宣布对美国多名患者进行初步治疗，接受ANKTIVA®（nogapendekin alfa inbakicept pmln）治疗，这是ImmunityBio最近批准的用于卡介苗（BCG）无反应性非肌肉浸润性膀胱癌（NMIBC）原位癌的免疫疗法。

ANKTIVA was approved by the U.S. Food and Drug Administration (FDA) on April 22, 2024 for the treatment of patients with BCG-unresponsive NMIBC CIS with or without papillary tumors..

ANKTIVA于2024年4月22日获得美国食品和药物管理局（FDA）的批准，用于治疗卡介苗无反应性NMIBC-CIS伴或不伴乳头状肿瘤的患者。。

The intravesical therapy employs a combination of ANKTIVA, an IL-15 agonist in combination with BCG. The combination is the first FDA-approved immunotherapy in NMIBC that functions by activating the body’s NK and killer T-cell immune system to attack tumor cells, while simultaneously activating memory T cells, leading to a prolonged duration of complete response exceeding 47 months for some patients..

膀胱内治疗采用ANKTIVA（一种IL-15激动剂）与BCG的组合。该组合是FDA批准的第一种NMIBC免疫疗法，其功能是激活人体的NK和杀伤性T细胞免疫系统来攻击肿瘤细胞，同时激活记忆T细胞，导致某些患者的完全缓解持续时间延长超过47个月。。

“We are grateful to be able to offer this first-in-class immunotherapy to qualified bladder cancer patients less than two months after the therapeutic was approved by the FDA,” said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio. “The interest in this next era of immunotherapy beyond checkpoint inhibitors—the era of cytokines—from urologists treating NMIBC patients has been strong and we look forward to offering more patients an alternative to bladder removal.”.

ImmunityBio执行主席兼全球首席科学和医学官Patrick Soon Shiong医学博士说：“我们很高兴能够在FDA批准治疗后不到两个月内向合格的膀胱癌患者提供这种一流的免疫治疗。人们对下一个免疫治疗时代的兴趣超越了检查点抑制剂，泌尿科医生治疗NMIBC患者的细胞因子时代一直很浓厚，我们期待着为更多患者提供膀胱切除的替代方案。”。

The first patients to receive commercial doses are located throughout the U.S. and several are being treated by community urologists, as the therapy does not require any special handling or equipment that would limit its use to specialty medical centers.

第一批接受商业剂量治疗的患者遍布美国各地，其中一些患者正在接受社区泌尿科医生的治疗，因为该疗法不需要任何特殊处理或设备，从而限制其在专业医疗中心的使用。

“In addition to its unique mechanism of action, ANKTIVA can be readily administered by urologists in their own offices and clinics enabling more patients to receive it in familiar settings from their own providers,” said Richard Adcock, President and CEO of ImmunityBio. “We look forward to ANKTIVA reaching more and more eligible NMIBC patients and for our science to deliver even more therapies from our pipeline.”.

ImmunityBio总裁兼首席执行官理查德·阿德科克（Richard Adcock）表示：“除了其独特的作用机制外，ANKTIVA还可以由泌尿科医生在自己的办公室和诊所轻松管理，使更多患者能够在熟悉的环境中从自己的提供者那里获得它。我们期待ANKTIVA能够惠及越来越多符合条件的NMIBC患者，并期待我们的科学能够从我们的管道中提供更多的治疗。”。

ANKTIVA received Breakthrough Therapy Designation and approval from the FDA based on the safety and efficacy outcome of complete responses (CR) and duration of complete response (DOR) in BCG-unresponsive NMIBC CIS. The 77 evaluable patients in this single-arm, multicenter trial received ANKTIVA with BCG maintenance therapy for up to 37 months.

ANKTIVA根据BCG无反应NMIBC-CIS完全缓解（CR）和完全缓解持续时间（DOR）的安全性和有效性结果，获得了FDA的突破性治疗指定和批准。在这项单臂多中心试验中，77名可评估患者接受了ANKTIVA联合卡介苗维持治疗长达37个月。

The tumor status was assessed with cystoscopy and urine cytology and will continue for up to five years after each patient began their participation in the trial..

通过膀胱镜检查和尿细胞学检查评估肿瘤状态，并在每位患者开始参与试验后持续长达五年。。

The CR rate for the 77 evaluable patients was 62% with the upper end of the confidence interval being 73%. The duration of complete response as of the November 2023 cut-off was more than 47 months and is ongoing to date. These prolonged duration of complete response results beyond 24 months with ANKTIVA and BCG exceed the benchmark for the magnitude of meaningful clinical results suggested by a panel of experts at the International Bladder Cancer Group..

。截至2023年11月的截止日期，完全响应的持续时间超过47个月，目前仍在进行中。ANKTIVA和BCG在24个月以上的这些延长的完全缓解结果超过了国际膀胱癌小组专家建议的有意义的临床结果的基准。。

In May, ImmunityBio announced it had drug substance sufficient for 170,000 doses of ANKTIVA for commercial and clinical trial use.

5月，ImmunityBio宣布其原料药足以满足170000剂ANKTIVA的商业和临床试验使用。

ImmunityBio CARE™

ImmunityBio CARE™

The ImmunityBio CARE™ program is designed to help patients access ImmunityBio’s innovative treatment for NMIBC CIS. The program offers services and resources for benefits investigation, prior authorization support and tracking, coding and billing assistance, claim denial guidance and payer specific appeal assistance.

ImmunityBio CARE™计划旨在帮助患者获得ImmunityBio针对NMIBC CI的创新治疗。该计划为福利调查、事先授权支持和跟踪、编码和计费帮助、索赔拒绝指导和特定于付款人的上诉帮助提供服务和资源。

More information for patients and healthcare professionals is available on Anktiva.com..

有关患者和医疗保健专业人员的更多信息，请访问Anktiva.com。。

How ANKTIVA Works

ANKTIVA的工作原理

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..

细胞因子白细胞介素-15（IL-15）通过影响参与杀死癌细胞的关键免疫细胞NK和CD8+杀伤性T细胞的发育，维持和功能，在免疫系统中起着至关重要的作用。通过激活NK细胞，ANKTIVA克服了对T细胞具有抗性的克隆的肿瘤逃逸阶段，并恢复了记忆T细胞的活性，从而延长了完全反应的持续时间。。

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 drives the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones.

ANKTIVA是一流的IL-15激动剂IgG1融合复合物，由与IL-15受体α融合的IL-15突变体（IL-15N72D）组成，其与NK上的IL-15受体高亲和力结合，CD4+和CD8+T细胞。ANKTIVA的这种融合复合物模拟膜结合的IL-15受体α的天然生物学特性，通过树突状细胞递送IL-15，并通过产生记忆杀伤T细胞来驱动NK细胞的活化和增殖，所述记忆杀伤T细胞保留了针对这些肿瘤克隆的免疫记忆。

The proliferation of the trifecta of these immune killing cells and the activation of trained immune memory results in immunogenic cell death, inducing a state of equilibrium with durable complete responses. ANKTIVA has improved pharmacokinetic properties, longer persistence in lymphoid tissues, and enhanced anti-tumor activity compared to native, non-complexed IL-15 in-vivo..

这些免疫杀伤细胞的三联体的增殖和训练的免疫记忆的激活导致免疫原性细胞死亡，诱导具有持久完全反应的平衡状态。。。

Selected Safety Information for ANKTIVA

ANKTIVA的选定安全信息

The most common (≥15%) adverse reactions, including laboratory test abnormalities, are increased creatinine, dysuria, hematuria, urinary frequency, micturition urgency, urinary tract infection, increased potassium, musculoskeletal pain, chills, and pyrexia.

最常见的（≥15%）不良反应，包括实验室检查异常，是肌酐升高，排尿困难，血尿，尿频，排尿急迫，尿路感染，钾升高，肌肉骨骼疼痛，寒战和发热。

About ImmunityBio

关于ImmunityBio

ImmunityBio is a vertically-integrated biotechnology company developing next-generation therapies and vaccines 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.

ImmunityBio是一家垂直整合的生物技术公司，开发下一代疗法和疫苗，增强自然免疫系统，战胜癌症和传染病。该公司的一系列免疫治疗和细胞治疗平台，单独或共同推动和维持免疫反应，目标是创造持久和安全的疾病防护。

Designated an FDA Breakthrough Therapy, ANKTIVA® is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer that activates natural killer 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.

ANKTIVA®被指定为FDA突破性疗法，是FDA批准的第一种用于非肌肉浸润性膀胱癌的免疫疗法，可激活自然杀伤细胞，T细胞和记忆T细胞以产生长期反应。该公司正在将其科学和平台应用于治疗癌症，包括开发潜在的癌症疫苗，以及开发我们认为可以大大减少或消除对标准高剂量化疗需求的免疫疗法和细胞疗法。

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, please visit: www.immunitybio.com

有关更多信息，请访问：www.immunitybio.com

Forward Looking Statements

前瞻性声明

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements regarding commercial launch activities and timing, product demand, patient treatment, data and results from clinical trials and potential implications therefrom, product availability and supply, potential regulatory pathways and approval requests and submissions, the regulatory review process and timing thereof, market and prevalence data, potential benefits to patients, potential treatment outcomes for patients, the described mechanism of action and results and contributions therefrom, information regarding ongoing pre-clinical studies and clinical trials, potential future uses and applications of ANKTIVA and use in cancer vaccines and across multiple tumor types, ImmunityBio’s financial condition, and ImmunityBio’s approved product and investigational agents as compared to existing treatment options, among others.

本新闻稿包含1995年《私人证券诉讼改革法案》意义下的前瞻性声明，例如有关商业启动活动和时间安排、产品需求、患者治疗、临床试验数据和结果及其潜在影响、产品可用性和供应、潜在监管途径和批准请求和提交、监管审查过程及其时间安排、市场和流行率数据、对患者的潜在益处、患者的潜在治疗结果、所描述的作用机制和结果及其贡献、有关正在进行的临床前研究和临床试验的信息、ANKTIVA的潜在未来用途和应用以及在癌症疫苗和多种肿瘤类型中的用途、ImmunityBio的财务状况以及ImmunityBio批准的产品和研究与现有治疗方案相比，药物等。

Statements in this presentation 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,” “seeks,” “should,” “will,” “strategy,” and variations of such words or similar expressions.

本演示文稿中不属于历史事实陈述的陈述被视为前瞻性陈述，通常通过使用诸如“预期”、“相信”、“继续”、“目标”、“可能”、“估计”、“预定”、“预期”、“打算”、“可能”、“计划”、“潜力”、“预测”、“指示”、“项目”、“寻求”、“应该”、“将”、“战略”等词语以及这些词语或类似表达的变化来识别。

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 wel.

关于我们临床前和临床试验的过去表现，努力或结果的陈述，可以做出推论或假设，也可以是前瞻性的陈述，并不表示未来的表现或结果。前瞻性声明既不是预测、承诺也不是保证，它也是基于ImmunityBio管理层目前的信念。

ANKTIVA Prescribing Information. ImmunityBio Inc.; 2024

ANKTIVA处方信息。。；2024