SEATTLE, Jan. 05, 2024 (GLOBE NEWSWIRE) -- Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on changing the possible for patients through engineered cells, today announced the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application to initiate a study of SC262 in patients with relapsed or refractory B-cell malignancies, initially in patients who have received prior CD19-directed CAR T therapy.

2024年1月5日，西雅图（环球通讯社）--专注于通过工程细胞改变患者可能性的萨那生物技术公司（NASDAQ:Sana）今天宣布，美国食品和药物管理局（FDA）已批准该公司的研究性新药（IND）申请，以启动对复发或难治性B细胞恶性肿瘤患者SC262的研究，最初在接受过CD19指导的CAR T治疗的患者中。

Engineered CAR T cell therapies for B-cell malignancies use binders to target proteins expressed on the surface of B cells. One such protein, CD19, has been the target of all approved autologous CAR T therapies for B-cell lymphoma and B-cell acute lymphoblastic leukemia to date. Unfortunately, incomplete responses or relapses occur in approximately 60% of CD19 CAR T-treated patients.

用于B细胞恶性肿瘤的工程化CAR T细胞疗法使用结合剂靶向B细胞表面表达的蛋白质。迄今为止，一种这样的蛋白质CD19一直是所有批准的用于B细胞淋巴瘤和B细胞急性淋巴细胞白血病的自体CAR T疗法的靶标。不幸的是，大约60%的CD19 CAR T治疗患者发生不完全反应或复发。

CD22, which is also a B-cell surface protein, has emerged as an alternative to address failure to achieve durable complete responses with CD19-directed CAR T therapy. SC262 expresses the same CAR, including the same CD22 binder, used in CD22-directed CAR T therapies tested in multiple academic clinical trials.

CD22也是一种B细胞表面蛋白，已成为解决CD19定向CAR T治疗无法实现持久完全反应的替代方案。SC262表达相同的CAR，包括相同的CD22粘合剂，用于在多个学术临床试验中测试的CD22指导的CAR T疗法。

To date, these trials have shown durable complete responses in a substantial number of patients in the relapse setting following treatment with a CD19-directed CAR T therapy. “Patients who have failed a CD19-directed CAR T therapy represent a significant unmet need, and this population is growing as more patients receive these therapies,” said Doug Williams, PhD, Sana’s President of Research and Development.

迄今为止，这些试验已经显示，在CD19指导的CAR T治疗后，大量复发患者的持久完全反应。Sana研发总裁道格·威廉姆斯（DougWilliams）博士说：“CD19导向的CAR T治疗失败的患者代表了一个严重的未满足需求，随着越来越多的患者接受这些治疗，这一人群正在增长。”。

“SC262 represents an important potential option for these patients and is the next step in building Sana’s hypoimmune CAR T therapy platform. Over the past twelve months, Sana has received three IND regulatory clearances, as we.

“SC262代表了这些患者的一个重要潜在选择，是建立Sana低免疫CAR T治疗平台的下一步。在过去的十二个月里，Sana已经获得了三项IND监管许可，正如我们一样。