SAN DIEGO--(BUSINESS WIRE)--Artiva Biotherapeutics, Inc., a clinical stage company whose mission is to deliver highly effective, off-the-shelf, allogeneic natural killer (NK) cell-based therapies, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Artiva’s lead program AlloNK® (also known as AB-101) for the treatment of lupus nephritis (LN) in combination with rituximab or obinutuzumab.

圣地亚哥--（商业新闻短讯）--Artiva Biotherapeutics，Inc.，一家临床阶段公司，其使命是提供高效，现成的同种异体自然杀伤（NK）细胞疗法，今天宣布，美国食品和药物管理局（FDA）已授予Artiva治疗狼疮性肾炎（LN）的领先项目AlloNK®（也称为AB-101）快速通道指定与利妥昔单抗或obinutuzumab联合使用。

Artiva previously received FDA clearance of an Investigational New Drug (IND) application for AlloNK in combination with rituximab in LN, marking the first IND clearance of an allogeneic, off-the-shelf NK cell therapy in autoimmune disease. AlloNK is a non-genetically modified, allogeneic, cryopreserved NK cell therapy candidate that enhances the activity of B-cell-targeting monoclonal antibodies to drive B-cell depletion..

Artiva之前接受了FDA批准的AlloNK联合利妥昔单抗治疗LN的研究性新药（IND）申请，标志着同种异体现成NK细胞治疗自身免疫性疾病的首次IND清除。AlloNK是一种非基因修饰的同种异体冷冻保存的NK细胞治疗候选药物，可增强B细胞靶向单克隆抗体的活性，从而驱动B细胞耗竭。。

“The FDA Fast Track designation gives us an opportunity to accelerate our efforts to bring our AlloNK cell therapy to autoimmunity patients,” said Fred Aslan, M.D., Chief Executive Officer of Artiva. “We are encouraged by clinical data from our Phase 1/2 multicenter clinical trial in non-Hodgkin lymphoma, where we observed that AlloNK in combination with rituximab can drive deep B-cell depletion in patients with late-line B-cell cancers.

Artiva首席执行官医学博士弗雷德·阿斯兰（FredAslan）说：“FDA的快速通道指定为我们提供了一个机会，可以加速我们的努力，将AlloNK细胞疗法应用于自身免疫患者。”。“我们对非霍奇金淋巴瘤1/2期多中心临床试验的临床数据感到鼓舞，我们观察到AlloNK联合利妥昔单抗可以驱动晚期B细胞癌患者的深度B细胞耗竭。

Our therapy has a mechanism very similar to the B-cell targeted autologous CAR-T therapies, but with the benefits of being an off-the-shelf therapy with a better safety profile, and that we believe will not be subject to the secondary malignancy risk associated with genetically engineered cell therapies.”.

我们的疗法具有与B细胞靶向自体CAR-T疗法非常相似的机制，但具有作为具有更好安全性的现成疗法的益处，并且我们相信不会受到与基因工程相关的继发性恶性肿瘤风险细胞疗法“。

AlloNK is being investigated in a multi-center, open-label clinical trial to assess the safety and clinical activity of AlloNK in combination with anti-CD20 antibodies in patients with LN who have relapsed or did not respond to previous standard of care treatment approaches (ClinicalTrials.gov Identifier: NCT06265220).

AlloNK正在一项多中心，开放标签的临床试验中进行研究，以评估AlloNK联合抗CD20抗体治疗复发或对先前标准治疗方法无反应的LN患者的安全性和临床活性（ClinicalTrials.gov标识符：NCT06265220）。

In addition, safety and activity have been established for AlloNK in combination with rituximab in a Phase 1/2 multicenter clinical trial in patients with relapsed or refractory B-cell-non-Hodgkin lymphoma (B-NHL) (ClinicalTrials.gov Identifier: NCT04673617)..

此外，在复发或难治性B细胞非霍奇金淋巴瘤（B-NHL）患者的1/2期多中心临床试验中，已确定AlloNK联合利妥昔单抗的安全性和活性（ClinicalTrials.gov标识符：NCT04673617）。。

About AlloNK®

关于AlloNK®

AlloNK® (also known as AB-101) is an allogeneic NK cell therapy candidate designed to enhance the antibody-dependent cellular cytotoxicity (ADCC) effect of monoclonal antibodies or NK cell engagers. AlloNK is a cryopreserved, off-the-shelf therapy with the potential to be administered in the community setting.

AlloNK®（也称为AB-101）是一种同种异体NK细胞治疗候选药物，旨在增强单克隆抗体或NK细胞接受者的抗体依赖性细胞毒性（ADCC）作用。AlloNK是一种冷冻保存的现成疗法，有可能在社区环境中使用。

As a non-genetically modified cell therapy manufactured without the usage of integrating vectors, we believe AlloNK will not be subject to extensive patient follow-up or the potential for secondary malignancy class warnings associated with approved autologous CAR-T therapies. Using the company’s cell therapy manufacturing platform, Artiva can generate thousands of doses of cryopreserved, infusion-ready AlloNK cells from a single umbilical cord blood unit while retaining the high and consistent expression of CD16 and activating NK receptors.

作为一种不使用整合载体制造的非基因修饰细胞疗法，我们相信AlloNK不会受到广泛的患者随访或与批准的自体CAR-T疗法相关的继发性恶性肿瘤类别警告的可能性。使用该公司的细胞疗法制造平台，Artiva可以从单个脐带血单元产生数千剂冷冻保存的，可输注的AlloNK细胞，同时保持CD16的高表达和活化NK受体的一致性。

The FDA has granted Artiva Fast Track designations for the treatment of lupus nephritis with AlloNK in combination with rituximab or obinutuzumab, and for the treatment of relapsed/refractory non-Hodgkin lymphoma of B-cell origin with AlloNK in combination with rituximab..

美国食品和药物管理局（FDA）已授予Artiva快速通道名称，用于AlloNK联合利妥昔单抗或obinutuzumab治疗狼疮性肾炎，以及AlloNK联合利妥昔单抗治疗复发/难治性B细胞来源的非霍奇金淋巴瘤。。

About Fast Track Designation

关于快速通道指定

Fast Track Designation is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fulfill an unmet medical need, enabling drugs to potentially reach patients earlier. Clinical programs with Fast Track designation may benefit from early and frequent communication with the FDA throughout the regulatory review process.

快速通道指定旨在促进药物的开发和加速审查，以治疗严重疾病并满足未满足的医疗需求，从而使药物能够更早到达患者。具有快速通道指定的临床计划可能会受益于在整个监管审查过程中与FDA的早期和频繁沟通。

These clinical programs may also be eligible to apply for Accelerated Approval and Priority Review if relevant criteria are met..

如果符合相关标准，这些临床计划也可能有资格申请加速批准和优先审查。。

About Artiva Biotherapeutics

关于Artiva Biotherapeutics

Artiva is an immunotherapy company with the ability to produce off-the-shelf, allogeneic NK cell therapies at a massive scale. Artiva’s mission is to develop effective, safe, and accessible cell therapies for patients with devastating autoimmune diseases and cancers. Artiva’s lead program, AlloNK®, is an allogenic, non-genetically modified NK cell therapy candidate designed to enhance the antibody-dependent cellular cytotoxicity (ADCC) effect of monoclonal antibodies or NK cell engagers.

Artiva是一家免疫治疗公司，能够大规模生产现成的同种异体NK细胞疗法。Artiva的使命是为患有毁灭性自身免疫性疾病和癌症的患者开发有效，安全且易于获得的细胞疗法。Artiva的领先项目AlloNK®是一种同种异体非基因修饰的NK细胞治疗候选药物，旨在增强单克隆抗体或NK细胞参与者的抗体依赖性细胞毒性（ADCC）作用。

Artiva’s pipeline also includes CAR-NK candidates targeting both solid and hematopoietic cancers. Artiva’s cell therapy manufacturing platform incorporates cell expansion, activation, and engineering technology developed by Artiva’s strategic partner, GC Cell Corporation, a member of the GC family of companies, a leading healthcare company in Korea.

Artiva的渠道还包括针对实体癌和造血癌的CAR-NK候选药物。Artiva的细胞治疗制造平台结合了Artiva的战略合作伙伴GC cell Corporation开发的细胞扩增，激活和工程技术，GC cell Corporation是韩国领先的医疗保健公司GC家族的成员。

Artiva is headquartered in San Diego. For more information, visit www.artivabio.com..

Artiva总部位于圣地亚哥。欲了解更多信息，请访问www.artivabio.com。。