ImmunityBio has received authorisation from the United States Food and Drug Administration (FDA) for Expanded Access to its Cancer BioShield™ platform.

ImmunityBio 已获得美国食品药品监督管理局 (FDA) 的扩大使用授权，用于其 Cancer BioShield™ 平台。

The Cancer BioShield platform is an integrated immunotherapy strategy aimed at restoring immune function by reversing lymphopenia. At its centre is ANKTIVA®, approved for use in non–muscle-invasive bladder cancer. This IL-15 superagonist activates and expands NK cells and CD4+/CD8+ T cells, helping to re-establish the immune system's capacity to fight cancer..

Cancer BioShield平台是一个综合免疫治疗策略，旨在通过逆转淋巴细胞减少来恢复免疫功能。其核心是ANKTIVA®，已被批准用于非肌层浸润性膀胱癌。这种IL-15超级激动剂激活并扩增NK细胞和CD4+/CD8+ T细胞，有助于重建免疫系统对抗癌症的能力。

This platform, led by ANKTIVA® (nogapendekin alfa inbakicept-pmln), is now available for adult patients with refractory or relapsed solid tumours experiencing lymphopenia after standard first-line treatments such as chemotherapy, radiation, or immunotherapy.

该平台由ANKTIVA®（nogapendekin alfa inbakicept-pmln）主导，现在可用于在接受化疗、放疗或免疫疗法等标准一线治疗后出现淋巴细胞减少的难治性或复发性实体瘤成年患者。

Lymphopenia is a condition marked by the depletion of crucial immune cells, including natural killer (NK) cells and CD8+ and CD4+ T cells. It often arises as a side effect of cancer treatment and leaves patients vulnerable to infections and reduced immune response, which can accelerate cancer progression and lead to early mortality.

淋巴细胞减少症是一种以关键免疫细胞（包括自然杀伤细胞（NK细胞）和CD8+、CD4+ T细胞）耗竭为特征的疾病。它常常作为癌症治疗的副作用出现，使患者容易受到感染且免疫反应减弱，这可能加速癌症进展并导致早期死亡。

Despite its significance, there have been no approved therapies specifically aimed at reversing lymphopenia until now..

尽管它具有重要意义，但迄今为止尚无特别针对逆转淋巴细胞减少症的获批疗法。

While treatments like EPOGEN® and NEUPOGEN® have long addressed chemotherapy-induced anaemia and neutropenia, no similar option existed for lymphopenia. ANKTIVA, an interleukin-15 (IL-15) agonist, becomes the first therapy approved to restore lymphocyte levels. It promotes the activation and proliferation of NK and T cells without stimulating regulatory T cells (Tregs), which can suppress immune function..

虽然像EPOGEN®和NEUPOGEN®这样的治疗手段长期以来一直用于解决化疗引起的贫血和中性粒细胞减少症，但针对淋巴细胞减少症却一直没有类似的治疗选择。ANKTIVA是一种白细胞介素-15（IL-15）激动剂，成为首个获批用于恢复淋巴细胞水平的疗法。它能够促进自然杀伤（NK）细胞和T细胞的活化与增殖，同时不会刺激可能抑制免疫功能的调节性T细胞（Tregs）。

In addition, ImmunityBio was granted Regenerative Medicine Advanced Therapy (RMAT) designation in early 2025 for ANKTIVA and CAR-NK (PD-L1 t-haNK), recognising their potential to meet serious unmet medical needs in cancer care.

此外，ImmunityBio于2025年初获得ANKTIVA和CAR-NK（PD-L1 t-haNK）的再生医学先进疗法（RMAT）认定，认可了它们在癌症治疗中满足严重未满足医疗需求的潜力。