CULVER CITY, Calif.--(

加利福尼亚州卡尔弗市--(

BUSINESS WIRE

商业热线

)--ImmunityBio, Inc. (

)--ImmunityBio公司(

NASDAQ: IBRX

纳斯达克：IBRX

), a leading immunotherapy company, today announced the European Medicines Agency (EMA) has accepted for review and begun assessing the marketing authorization application (MAA) for ANKTIVA (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin (BCG) for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.

)一家领先的免疫治疗公司今天宣布，欧洲药品管理局（EMA）已接受审查，并开始评估ANKTIVA（nogapendekin alfa inbakicept pmln）联合卡介苗（BCG）治疗卡介苗无反应性非肌肉浸润性膀胱癌（NMIBC）伴原位癌（CIS）患者的上市许可申请（MAA），无论有无乳头状肿瘤。

The EMA covers 27 countries in the European Union (EU), as well as Iceland, Norway and Liechtenstein..

EMA涵盖欧盟（EU）27个国家，以及冰岛、挪威和列支敦士登。。

“We are encouraged by the speed in which the EMA accepted our marketing authorization application and determined it would begin its assessment of our innovative treatment for this serious condition, just nine months after it was first approved by the FDA for use in the United States,” said Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio.

ImmunityBio创始人、执行主席兼全球首席科学和医学官Patrick Soon Shiong博士表示：“我们对EMA接受我们的上市授权申请的速度感到鼓舞，并决定在FDA首次批准在美国使用后9个月，就开始评估我们针对这种严重疾病的创新治疗方法。”。

“Along with our submission to the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA), this action by the EMA is strong evidence of the momentum for putting ANKTIVA+BCG into the hands of physicians who are treating patients with NMIBC.”.

“随着我们提交给英国药品和保健品管理局（MHRA），EMA的这一行动有力地证明了将ANKTIVA+卡介苗交给治疗NMIBC患者的医生的势头。”。

The EMA submission is based on the ongoing QUILT 3.032 study in which the complete response rate for the 100 evaluable patients in Cohort A as of the July 15, 2024 cut-off was 71%. In these responders, the range of duration of response is 0.03 to 54 months and is ongoing. These prolonged duration of complete response results beyond four years with ANKTIVA and BCG .

EMA的提交是基于正在进行的QUIST 3.032研究，其中截至2024年7月15日，队列A中100名可评估患者的完全缓解率为71%。在这些应答者中，应答持续时间范围为0.03至54个月，并且正在进行中。这些延长的完全缓解持续时间导致ANKTIVA和BCG超过四年。

exceed the benchmark

超越基准

of 18 months for the magnitude of meaningful clinical results suggested by a panel of experts at the International Bladder Cancer Group.

国际膀胱癌组织的一个专家小组提出了18个月的有意义的临床结果。

About ANKTIVA®

关于ANKTIVA®

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。与体内天然的非复合IL-15相比，ANKTIVA具有改善的药代动力学特性，在淋巴组织中的持久性更长，并且增强了抗肿瘤活性。。

ANKTIVA was approved by the FDA in 2024

ANKTIVA于2024年获得FDA批准

for BCG-unresponsive non-muscle invasive bladder cancer CIS with or without papillary tumors. For more information, visit

对于卡介苗无反应的非肌肉浸润性膀胱癌，有或没有乳头状肿瘤。有关更多信息，请访问

Anktiva.com

Anktiva.com 网站

.

.

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 CIS 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CIS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, visit .

这些平台及其相关的候选产品旨在比目前的肿瘤学和传染病护理标准更有效，更容易获得和管理。有关更多信息，请访问。

ImmunityBio.com

免疫生物.com

and connect with us on

并与我们联系

X

十

(Twitter),

（推特），

Facebook

脸书

,

,

LinkedIn

LinkedIn

, and

，以及

Instagram

Instagram

.

.

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 the anticipated timing of the EMA’s review of ImmunityBio’s MAA and ultimate decision regarding whether to approve ANKTIVA for the treatment of patients with BCG-unresponsive NMIBC CIS in the countries under its jurisdiction, additional regulatory submissions and timing thereof, global expansion efforts, clinical trial data and potential results 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, potential future uses and applications of ANKTIVA and use in cancer vaccines and across multiple tumor types, 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》含义内的前瞻性声明，例如关于EMA审查ImmunityBio MAA的预期时间以及是否批准ANKTIVA治疗其管辖国家卡介苗无反应NMIBC CIS患者的最终决定的声明，额外的监管提交和时间安排，全球扩张努力，临床试验数据和从中得出的潜在结果，癌症和传染病治疗药物的开发，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贡献，ANKTIVA的潜在未来用途和应用以及在癌症疫苗和多种肿瘤中的应用类型，以及与现有治疗方案相比，ImmunityBio批准的产品和研究药物等。

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.

本新闻稿中非历史事实陈述的陈述被视为前瞻性陈述，通常通过使用“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”、“是”、“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.

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，而是基于ImmunityBio管理层目前的信念。

www.sec.gov

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.

。ImmunityBio提醒您不要过度依赖任何前瞻性声明，这些声明仅在本协议签署之日起生效。ImmunityBio不承担更新本新闻稿中任何前瞻性声明或其他信息的任何义务，除非法律要求。

Indication and Important Safety Information

指示和重要安全信息

INDICATION AND USAGE:

适应症和用法：

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.

ANKTIVA是一种白细胞介素-15（IL-15）受体激动剂，用卡介苗（BCG）指示，用于治疗卡介苗无反应性非肌层浸润性膀胱癌（NMIBC）伴原位癌（CIS）伴或不伴乳头状肿瘤的成年患者。

WARNINGS AND PRECAUTIONS:

警告和注意事项：

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 patient with CIS do not have a complete response to treatment after a second induction course of ANKTIVA with BCG, reconsider cystectomy..

延迟膀胱切除术转移性膀胱癌的风险。延迟膀胱切除术可能导致肌肉浸润性或转移性膀胱癌的发展，这可能是致命的。如果CIS患者在第二次卡介苗诱导ANKTIVA后对治疗没有完全反应，请重新考虑膀胱切除术。。

DOSAGE AND ADMINISTRATION:

剂量和给药：

For lntravesical Use Only. Do not administer by subcutaneous or intravenous routes. Instill intravesically only after dilution. Total time from vial puncture to the completion of the intravesical instillation should not exceed 2 hours.

仅供膀胱内使用。不要通过皮下或静脉途径给药。仅在稀释后膀胱内滴注。从小瓶穿刺到完成膀胱内滴注的总时间不应超过2小时。

USE IN SPECIFIC POPULATIONS:

在特定人群中使用：

Pregnancy: May cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.

怀孕：可能会对胎儿造成伤害。建议女性注意对胎儿的潜在风险的生殖潜力，并使用有效的避孕措施。

ADVERSE REACTIONS:

不良反应：

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。

For more information about ANKTIVA, please see the Full Prescribing Information at

有关ANKTIVA的更多信息，请参阅完整的处方信息

www.anktiva.com

www.anktiva.com

.

.

You are encouraged to report negative side effects of prescription drugs to FDA.

鼓励您向FDA报告处方药的负面副作用。

Visit

访问

www.FDA.gov/medwatch

政府/医疗观察

or call 1-800-332-1088. You may also contact lmmunityBio at 1-877-ANKTIVA (1-877-265-8482).

或致电1-800-332-1088。您也可以通过1-877-ANKTIVA（1-877-265-8482）联系lmmunityBio。