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CULVER CITY, Calif.--( BUSINESS WIRE )--ImmunityBio, Inc. ( NASDAQ: IBRX ), a leading immunity therapy company, today announced the Medicines and Healthcare products Regulatory Agency (MHRA) has validated and accepted the marketing authorization application for ANKTIVA. The MHRA will now begin 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. MHRA regulates medicines, medical devices and blood components for transfusion in the UK. “MHRA’s acceptance of our marketing authorization application for the UK comes less than three weeks after the European Medicines Agency accepted for review our MAA for the 30 countries covering the European Union, and just 10 months after FDA approval in the United States,” said Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. “We are determined to reach as many patients as possible with ANKTIVA and BCG and are encouraged by the momentum of our efforts.” About 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. 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. 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. ANKTIVA was approved by the FDA in 2024 for BCG-unresponsive non-muscle invasive bladder cancer CIS with or without papillary tumors. For more information, visit ImmunityBio.com (Founder’s Vision) and Anktiva.com. About 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. 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. 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 the anticipated timing of the MHRA’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 territory 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. 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 the MHRA regulatory review process, potential actions required in connection with the same, and whether or not the MHRA will ultimately approve ImmunityBio’s MAA that has been accepted for review, (ii) risks and uncertainties regarding commercial launch execution, success and timing, (iii) risks and uncertainties related to the regulatory submission, filing and review process and the timing thereof, (iv) the ability of ImmunityBio to fund its ongoing and anticipated clinical trials, (v) whether clinical trials will result in registrational pathways, (vi) whether clinical trial data will be accepted by regulatory agencies, (vii) 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, (viii) potential delays in product availability and regulatory approvals, (ix) ImmunityBio’s ability to retain and hire key personnel, (x) ImmunityBio’s ability to obtain additional financing to fund its operations and complete the development and commercialization of its various product candidates, (xi) potential product shortages or manufacturing disruptions that may impact the availability and timing of product, (xii) ImmunityBio’s ability to successfully commercialize its approved product and product candidates, (xiii) ImmunityBio’s ability to scale its manufacturing and commercial supply operations for its approved product and future approved products, and (xiv) 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 19, 2024 and the Company’s Form 10-Q filed with the SEC on November 12, 2024, 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. Indication and Important Safety Information INDICATION AND USAGE: ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guerin (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 patient 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 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. USE IN SPECIFIC POPULATIONS: Pregnancy: May cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception. ADVERSE REACTIONS: 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. For more information about ANKTIVA, please see the Full Prescribing Information at www.anktiva.com . You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.FDA.gov/medwatch or call 1-800-332-1088. You may also contact lmmunityBio at 1-877-ANKTIVA (1-877-265-8482).

近期，强生宣布已向FDA提交TAR-200的新药申请，用于对卡介苗治疗无反应的高风险非肌层浸润性膀胱癌伴原位癌（可伴或不伴乳头状肿瘤）患者。 此前，强生在膀胱癌领域还有一个更大的突破，其泛FGFR抑制剂厄达替尼（Erdafitinib）正式获NMPA批准，用于治疗携带易感型FGFR3基因变异，且既往接受至少一线含抗PD-1或抗PD-L1期间或之后出现疾病进展的手术不可切除的局部晚期或转移性尿路上皮癌（UC）成人患者。 长期深耕男性泌尿肿瘤的强生，在前列腺癌领域凭借阿比特龙和阿帕他胺两款重磅产品牢牢占据了前列腺癌市场领先地位。如今，又强势入局膀胱癌领域，有意巩固其泌尿肿瘤霸主地位的野心昭然。 1 新颖的药物形式 TAR-200最初由Taris Biomedical公司开发，强生于2019年底收购了这家公司。该公司致力于开发用于治疗包括膀胱癌在内的泌尿系统疾病的新型药物递送技术，自主研发了TARIS系统。TARIS系统是一种基于硅酮的药物输送装置，可使用微创方法植入体内并从膀胱中取出。这个系统可以将药物直接释放到膀胱肿瘤，评估针对膀胱癌和其他类型癌症患者的新型局部治疗方法。膀胱癌基因容易激活突变，异常基因型的长期积累会导致恶性表型的出现。TARIS系统以一种量身定制的方法提供联合治疗，可以治疗多种膀胱癌类型。 TAR-200是第一个也是唯一个针对膀胱癌的膀胱内药物释放系统，可以通过一根5厘米长的硅胶管，利用其渗透性将化疗药吉西他滨持续、可控地释放到膀胱中，与传统的2小时膀胱灌注时间相比，它可以实现连续几周到几个月向膀胱输送药物。吉西他滨是膀胱癌化疗的首选药物。 图片来源：EtudeImpromptu ImpromptuThoughts 作为一种新的膀胱内递送系统，TAR-200能够使肿瘤持续暴露于药物中，并且对比其他化疗或其他药物，TAR-200使肿瘤暴露于药物的总时间更长。同时，TAR-200通过局部给药产生的疗效强大，与标准吉西他滨膀胱内灌注相比，TAR-200的给药剂量明显较低，还不易发生常规化疗导致的患者全身性药物暴露，能够大幅降低毒副作用。此外，比较方便的是，TAR-200易于安装，安装过程仅需3～5分钟，无需麻醉即可完成。 这一创新膀胱内药物释放系统的提交，得到了来自2b期SunRISe-1注册研究的数据支持，已在2024 ESMO年会上作为临时口头报告呈现。TAR-200单药治疗显示出83.5%的完全缓解率（CR），并且CR具有高度耐久性，无需重新诱导治疗——在中位随访9个月时，82%的反应者维持了反应。这个数据目前看起来是所有HR-NMIBC在研产品里面单药CR率最高的。 2 竞争进入白热化 膀胱癌作为全球高发的恶性肿瘤之一，分为非肌层浸润性膀胱癌（NMIBC，占70%）和肌层浸润性膀胱癌（MIBC，占30%）两大类。非肌层浸润性膀胱癌包括膀胱的原位癌、非浸润性乳头状癌，以及侵犯上皮下结缔的膀胱癌，肌层浸润性膀胱癌是指侵犯浅肌层以上的膀胱癌。 NMIBC是早期阶段膀胱癌，肿瘤的浸润深度尚未超过尿路壁的浅表层。同时，NMIBC也是最常见的膀胱癌类型，约占膀胱肿瘤新发病例的75%。根据弗若斯特沙利文分析，中国NMIBC市场规模在2015-2019年的复合年增长率为14.4%，中国NMIBC市场将继续保持增长，预计于2024年达到26亿元，2030年预计达到88亿元。 NMIBC的标准治疗方式是经尿道膀胱肿瘤切除术（TURBT），微创手术之后临床指南推荐化疗灌注和卡介苗（BCG）膀胱灌注作为辅助治疗，但仍有部分患者对BCG治疗无反应，约50%的患者在5年内发生肿瘤复发。传统上针对复发患者是采用根治性膀胱切除术，但该项手术会使患者失去正常的储尿和排尿功能，严重影响患者的生活质量。因此，对于化疗和BCG无应答NMIBC患者而言，二线治疗的新药研发十分关键。 截至目前，全球仅批准三款可用于NMIBC患者的二线疗法，分别是默沙东的K药、Ferring Pharmaceuticals的Adstiladrin和去年4月份刚获得FDA批准的ImmunityBio的Anktiva。不过从其获批适应症上来看，K药以及Adstiladrin仅限于原位癌（CIS），其在NMIBC中占比仅有10%，意味着目前现有获批的二线疗法覆盖的患者群体始终有限。 2024年，可以说是NMIBC治疗领域加速突破的一年。 4月，Anktiva作为ImmunityBio推出的首个基于IL-15的免疫疗法治疗NMIBC，获得了FDA的批准。 8月，UroGen Pharma宣布其丝裂霉素灌注疗法UGN-102已向FDA提交了NDA，用以治疗低级别中等风险非肌层浸润性膀胱癌（LG-IR-NMIBC）患者。试验中，首次使用UGN-102的患者在三个月后，接近80%的人实现了肿瘤完全消失，且12个月后82.3%的患者依然维持无瘤状态。 12月，Protara Therapeutics宣布，其试验性细胞疗法在六个月内对18名对携带高风险原位癌的NMIBC患者的CR率高达72%，在这项积极数据的推动下，公司股价从3.54美元飙升至6.76美元，暴涨119%。 同样在12月份，CG Oncology公布了其溶瘤病毒疗法Cretostimogene用于治疗对BCG无应答的高风险NMIBC患者的3期BOND-003试验的主要结果。接受Cretostimogene（CG0070）单药治疗后，近75%的患者在任何时间点达成完全缓解（CR），已计划在2025年下半年向FDA提交上市申请。值得一提的是，2019年，乐普生物获得Cretostimogene（CG0070）中国内地、香港和澳门的开发和商业化权益，目前正在国内开展单药治疗NMIBC临床试验。 而国内进展最快的，则是亚虹医药的全球首个进入关键性3期临床试验的NMIBC口服可逆性MetAP2抑制剂APL-1202。在该药物二线NMIBC适应症折戟后，目前正在开展APL-1202另外两项临床试验，分别为APL-1202单药治疗未经治疗的中、危NMIBC的3期临床试验（一线NMIBC适应症）以及APL-1202口服联合PD-1替雷利珠单抗作为MIBC新辅助治疗的2期临床试验。 在接二连三的突破性进展之下，NMIBC领域的竞争将愈发激烈。因此对于强生而言，从NMIBC到MIBC深入布局膀胱癌全程化诊疗是其必由之路，目前也初见成效。 以TAR-200为例，除了此次提交NDA的单药治疗NMIBC适应症外，强生还设计了一系列研究探索TAR-200单药或联合Cetrelimab（PD-1单抗）治疗NMIBC和MIBC的安全性和有效性，这些研究大都已进行到2/3期，展示出优秀的临床应用前景。 此外，强生还有意将厄达替尼拓展到NMIBC领域。厄达替尼虽然在NMIBC患者中显示出了疗效，但全身给药的副作用很大。利用TARIS系统强生如法炮制以膀胱内药物输送系统将厄达替尼在较长时间内、以非常低的剂量持续局部释放到膀胱（TAR-210），完美解决了全身毒性的问题。 根据在2024年美国泌尿外科协会年会上报告的一项1期研究的结果显示：TAR-210对具有FGFR基因突变的高风险和中风险非肌层浸润性膀胱癌（NMIBC）患者显示出非常积极的临床活性。在队列1中，90%的患者在12个月时无复发，中位随访时间为8.9个月；在队列3中，31名患者的反应可评估，CR率90%。 参考来源 1.https://www.onclive.com/view/fda-approval-sought-for-tar-200-in-bcg-unresponsive-high-risk-nmibc-with-cis. 2.https://www.investor.jnj.com/news/news-details/2025/New-Drug-Application-initiated-with-U.S.-FDA-for-TAR-200-the-first-and-only-intravesical-drug-releasing-system-for-patients-with-BCG-unresponsive-high-risk-non-muscle-invasive-bladder-cancer/default.aspx. 友情推荐：医药行业深度技术内容，点击“博药”查看详情~ 声明：本内容仅用作医药行业信息传播，为作者独立观点，不代表药智网立场。如需转载，请务必注明文章作者和来源。对本文有异议或投诉，请联系maxuelian@yaozh.com。 责任编辑 | 史蒂文 合作、投稿、转载开白 | 马老师 18323856316（同微信）  阅读原文，是受欢迎的文章哦