Immunotherapy is already a treatment option for bladder cancer, but in many cases, these therapies fail or the cancer comes back. When it returns, the next option is removing the bladder. FDA approval of a novel immunotherapy gives bladder cancer patients an alternative to surgical removal of the organ..

免疫疗法已经是膀胱癌的一种治疗选择，但在许多情况下，这些疗法失败或癌症复发。当它返回时，下一个选择是移除膀胱。FDA批准的一种新型免疫疗法为膀胱癌患者提供了手术切除器官的替代方案。。

The FDA has approved ImmunityBio’s therapy, Anktivo, for the treatment of non-muscle invasive bladder cancer (NMIBC), which is cancer found only on the inner layer of the bladder wall. The regulatory decision announced late Monday covers adults whose disease is unresponsive to Bacillus Calmette-Guérin (BCG), a standard of care immunotherapy for bladder cancer..

FDA已经批准ImmunityBio的疗法Anktivo用于治疗非肌肉浸润性膀胱癌（NMIBC），这是一种仅在膀胱壁内层发现的癌症。周一晚些时候宣布的监管决定涵盖了对卡介苗（BCG）无反应的成年人，卡介苗是治疗膀胱癌的标准免疫疗法。。

BCG is a benign type of bacteria. Delivered to the bladder via a catheter, the bacteria induce an immune response that can clear cancer. But BCG therapy fails in up to 40% of patients. Other immunotherapies used to treat NMIBC include checkpoint inhibitors, drugs that block a protein used by cancer cells to avoid detection by the immune system..

卡介苗是一种良性细菌。通过导管输送到膀胱，细菌诱导免疫反应，可以清除癌症。但卡介苗治疗失败率高达40%。用于治疗NMIBC的其他免疫疗法包括检查点抑制剂，这些药物可以阻断癌细胞使用的蛋白质，以避免被免疫系统检测到。。

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San Diego-based ImmunityBio developed Anktiva to offer patients a multi-pronged immune response to bladder cancer. The therapy, which is administered directly into the bladder by catheter, is a fusion protein that enhances the therapeutic potential of cytokines, signaling proteins that can spark an immune response.

总部位于圣地亚哥的ImmunityBio开发了Anktiva，为患者提供对膀胱癌的多管齐下的免疫反应。这种通过导管直接进入膀胱的疗法是一种融合蛋白，可以增强细胞因子的治疗潜力，细胞因子是一种可以引发免疫反应的信号蛋白。

This biologic drug is specifically engineered to bind to and activate the IL-15 receptor, which plays a role in modulating immune cells..

这种生物药物经过专门设计，可以结合并激活IL-15受体，IL-15受体在调节免疫细胞中起作用。。

Anktiva is intended to increase the activity of two types of cancer-killing immune cells, natural killer cells and CD8 positive T cells. It does so without also activating regulatory T cells that suppress immune responses. The therapy also stimulates memory T cells that lead to a longer duration of immune response.

Anktiva旨在增加两种杀死癌症的免疫细胞（自然杀伤细胞和CD8阳性T细胞）的活性。它这样做的同时也不会激活抑制免疫反应的调节性T细胞。该疗法还刺激记忆T细胞，从而导致更长的免疫反应持续时间。

Compared to native IL-15, ImmunityBio says Anktivo offers greater therapeutic activity over a longer period of time..

ImmunityBio说，与天然IL-15相比，Anktivo在更长的时间内提供了更大的治疗活性。。

“Anktiva enhances natural killer cell recruitment as well as T cell stimulation,” Sam Chang, professor of urology and chief surgical officer of the Vanderbilt Ingram Cancer Center, and a principal investigator for the therapy’s clinical trial, said in a prepared statement. “By doing this and stimulating the innate immune memory response, we get an improved ability to kill tumor cells.”.

范德比尔特英格拉姆癌症中心泌尿学教授兼首席外科主任、该疗法临床试验的主要研究者SamChang在一份准备好的声明中表示：“Anktiva可以增强自然杀伤细胞的募集以及T细胞的刺激。”。“通过这样做并刺激先天免疫记忆反应，我们可以提高杀死肿瘤细胞的能力。”。

Approval of Anktiva covers use of the new ImmunityBio product alongside BCG therapy, which is how it was tested in clinical trials. The pivotal Phase 2/3 study enrolled 77 patients who had BCG-unresponsive, high-risk NMIBC following surgery to remove tumors. The main efficacy goal was measuring complete responses to the therapy at any time as well as the duration of responses..

Anktiva的批准包括将新的ImmunityBio产品与BCG疗法一起使用，这是它在临床试验中的测试方式。关键的2/3期研究纳入了77例BCG无反应的高危NMIBC患者，手术切除肿瘤。主要疗效目标是随时测量对治疗的完全反应以及反应的持续时间。。

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A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS. .

特种药物是一类用于治疗复杂、慢性或罕见疾病的处方药。虽然这种分类最初是为了定义罕见病（也称为“孤儿”疾病）的治疗方法，但在美国影响不到20万人，最近，特种药物已成为治疗癌症，自身免疫性疾病，糖尿病，丙型肝炎和艾滋病毒/艾滋病等慢性和复杂疾病的基石。

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The complete response rate was 62%. In 58% of those with a complete response, the duration of that response was 12 months or longer; 40% of those responders had a duration of response 24 months or longer. ImmunityBio noted that the duration of response is ongoing, so the final median duration of response has yet to be determined.

完全缓解率为62%。在58%完全缓解的患者中，该缓解的持续时间为12个月或更长时间；这些应答者中有40%的应答持续时间为24个月或更长。ImmunityBio指出，反应持续时间正在进行中，因此最终的中位反应持续时间尚未确定。

The most common adverse reactions reported in the study included higher blood levels of creatinine, which is a waste product from the breakdown of muscle; pain during urination; blood in the urine; a strong urge to urinate; and urinary tract infection..

研究报告中最常见的不良反应包括血肌酐水平升高，这是肌肉分解产生的废物；排尿时疼痛；尿液中的血液；强烈的小便冲动；和尿路感染。。

Last May, ImmunityBio disclosed that the FDA turned down the application for Anktiva, citing problems at the therapy’s third-party manufacturer. No additional clinical data were requested. After ImmunityBio addressed the issues identified by the FDA, the agency accepted the company’s resubmitted application last October..

去年5月，ImmunityBio透露，FDA拒绝了Anktiva的申请，理由是该疗法的第三方制造商存在问题。没有要求额外的临床数据。在ImmunityBio解决了FDA确定的问题后，该机构于去年10月接受了该公司重新提交的申请。。

Biotech companies have pursued different ways of leveraging components of the body to fight bladder cancer. In 2022, privately held Ferring Pharmaceuticals won FDA approval for Adstiladrin, a gene therapy that uses the protein-making machinery of bladder cells to make therapeutic protein that has anti-tumor effects..

生物技术公司一直在寻求不同的方法来利用身体的成分来对抗膀胱癌。2022年，私人控股的费林制药公司（Ferring Pharmaceuticals）获得了FDA对Adstiladrin的批准，Adstiladrin是一种基因疗法，它利用膀胱细胞的蛋白质制造机制来制造具有抗肿瘤作用的治疗性蛋白质。。

Other companies are trying to provide bladder cancer patients with additional treatment options. CG Oncology raised $380 million from its IPO to finance clinical development of cretostimogene, an oncolytic virus for NMIBC. Genetic medicines company enGene, which became public last fall via a merger deal, develops therapies with proprietary technology that enables localized delivery of gene cargos to mucosal tissues and organs.

其他公司正试图为膀胱癌患者提供额外的治疗选择。CG Oncology从IPO中筹集了3.8亿美元，用于资助cretostimogene（一种NMIBC的溶瘤病毒）的临床开发。基因药物公司enGene于去年秋天通过一项合并协议上市，该公司利用专有技术开发治疗方法，使基因货物能够局部输送到粘膜组织和器官。

Lead program EG-70, which delivers three gene cargos to generate an immune reaction close to tumors, is currently in Phase 1/2 testing in NMIBC that’s unresponsive to BCG therapy..

主要项目EG-70提供三种基因货物以产生接近肿瘤的免疫反应，目前正在NMIBC进行对BCG治疗无反应的1/2期测试。。

Anktiva was initially developed by Altor BioScience, which ImmunityBio acquired in 2017. ImmunityBio reported a $265.5 million cash position at the end of 2023. In January, the company secured up to $320 million in financing from Oberland Capital. The deal gives Oberland the right to royalty payments on net sales of ImmunityBio’s products.

Anktiva最初由Altor BioScience开发，ImmunityBio于2017年收购。ImmunityBio报告称，截至2023年底，其现金头寸为2.655亿美元。1月份，该公司从Oberland Capital获得了高达3.2亿美元的融资。该协议使奥伯兰有权获得ImmunityBio产品净销售额的特许权使用费。

The firm also made an equity investment in ImmunityBio and has the option to buy more of the company’s stock in the future..

该公司还对ImmunityBio进行了股权投资，并有权在未来购买更多该公司的股票。。

ImmunityBio said it would apply proceeds from the financing toward commercialization of Anktiva and for ongoing clinical development of the therapy in other types of solid tumors. In addition to a Phase 2 test enrolling NMIBC patients who had not previously received BCG therapy, mid-stage clinical trials for Anktiva are underway or planned in lung cancer, colorectal cancer, ovarian cancer, acute myeloid leukemia, and glioblastoma..

ImmunityBio表示，它将把融资所得用于Anktiva的商业化，并用于其他类型实体瘤治疗的持续临床开发。除了招募以前未接受卡介苗治疗的NMIBC患者进行的2期试验外，正在或计划在肺癌，结直肠癌，卵巢癌，急性髓细胞白血病和胶质母细胞瘤中进行Anktiva的中期临床试验。。

ImmunityBio has not yet disclosed a price for Anktiva, which it expects will launch in mid-May.

ImmunityBio尚未透露Anktiva的价格，预计Anktiva将于5月中旬推出。

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Anktiva

Anktiva

bladder cancer

膀胱癌

cancer immunotherapy

癌症免疫疗法

Clinical Trials

临床试验

FDA

FDA

ImmunityBio

ImmunityBio

San Diego

圣地亚哥

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