Gilead Teams Up With Kiniksa, Submits BLA for CAR T Therapy


2019-12-13 10:00:01 YAHOO!FINANCE


Gilead Sciences, Inc.’s GILD Kite and Kiniksa Pharmaceuticals, Ltd. KNSA have entered a clinical collaboration to conduct a phase II, multicenter study on pipeline candidate mavrilimumab in combination with Yescarta. We note that Gilead’s Yescarta was the first CAR T cell therapy to be approved by the FDA for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, and high-grade B-cell lymphoma and DLBCL arising from follicular lymphoma. Mavrilimumab is an investigational, fully human monoclonal antibody that targets granulocyte macrophage colony-stimulating factor receptor alpha (GM-CSFRα). The combination study will be sponsored by Kite and conducted in patients with relapsed or refractory large B-cell lymphoma. The objective of the study is to determine the effect of mavrilimumab on the safety of Yescarta. Concurrently, Kite announced that it has submitted a Biologics License Application (BLA) to the FDA for the investigational CAR T cell therapy, KTE-X19, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). The BLA was based on data from the phase II ZUMA-2 study, which demonstrated an overall response rate of 93%, including 67% with complete response, as assessed by an Independent Radiologic Review Committee following a single infusion of KTE-X19. We remind investors that KTE-X19 has been granted Breakthrough Therapy designation by the FDA and Priority Medicines (PRIME) by the European Medicines Agency (EMA) for relapsed or refractory MCL. Kite plans to submit a Marketing Authorization Application for KTE-X19 in the European Union in early 2020. A potential approval will boost Gilead’s portfolio even though the competition is stiff in the CAR T therapy space from the likes of Novartis’ NVS Kymriah. Gilead’s stock has gained 8.4% in the year so far compared with the industry's growth of 6.3%. The massive decline in sales of the HCV franchise has propelled the company to focus on its HIV franchise, Yescarta and other newer avenues. The rapid adoption of Biktarvy maintains momentum in the HIV space amid stiff competition from the likes of GlaxoSmithKline GSK. Gilead’s intent to foray into the inflammation market to diversify the revenue base is encouraging as well.     Gilead currently carries a Zacks Rank #3 (Hold). (Strong Buy) stocks here.
吉利德科学(Gilead Sciences), Inc .的 GILD Kite 和 Kiniksa Pharmaceuticals , Ltd . KNSA 已进入临床合作阶段,与 Yescasta 联合开展管线候选 mavrilimumab 的 II 期多中心研究。 我们注意到吉利德(Gilead)的 Yescarta 是 FDA 批准的第一个 CAR T 细胞疗法,用于治疗成人复发或难治性大 B 细胞淋巴瘤,经过两个或两个以上的系统治疗,包括弥漫性大 B 细胞淋巴瘤( DLBCL )未另有规定,原发性纵隔大 B 细胞淋巴瘤,以及由滤泡性淋巴瘤引起的高级 B 细胞淋巴瘤和 DLBCL 。 Mavrilimumab 是一种以粒细胞巨噬细胞集落刺激因子受体 alpha ( GM-CSFRα)为靶标的全人单克隆抗体。联合研究将由 Kite 赞助,并在复发或难治性大 B 细胞淋巴瘤患者中进行。 研究的目的是确定马夫利木单抗对耶斯卡塔安全的影响。 同时, Kite 宣布,它已向 FDA 提交了一份 Biologics License Application ( BLA ),用于研究 CAR T 细胞疗法 KTE-X19,用于治疗成人复发或难治性地幔细胞淋巴瘤( MCL )。 BLA 是根据第二阶段 ZUMA-2研究的数据得出的,该研究显示总体的反应率为93%,包括67%的完全反应,这是一个独立的放射审查委员会在一次注射 KTE-X19后评估的。 我们提醒投资者, KTE-X19已被欧洲药品管理局( EMA )授予复发或难治性 MCL 的 FDA 和优先药物( PRIME )的突破性治疗指定。 Kite 计划于2020年初在欧盟提交 KTE-X19上市许可申请。 尽管诺华(Novartis)( Novartis )的 NVS Kymriah 等公司在 CAR T 治疗领域的竞争十分激烈,但潜在的批准将提振吉利德(Gilead)的产品组合。 吉利德(Gilead)的股价今年迄今已上涨8.4%,而该行业的涨幅为6.3%。 HCV 特许经营权的销售大幅下降,促使该公司专注于其艾滋病毒特许经营权、 Yescarta 和其他新的途径。在葛兰素史克( GlaxoSmithKline 葛兰素史克(GSK))等公司的激烈竞争中, Bitarvy 的迅速采用保持了 HIV 领域的势头。吉利德(Gilead)进军炎症市场以实现收入基础多元化的意图也令人鼓舞。 吉利德(Gilead)目前拥有 Zacks 排名第3(保持)。这里的股票。