Aura Biosciences' Bladder Cancer Candidate Demonstrates Tumor Shrinkage In Patients With High-Grade Disease
Aura Biosciences' Bladder Cancer Candidate Demonstrates Tumor Shrinkage In Patients With High-Grade Disease
The secondary endpoints are to evaluate biological activity and immune-mediated changes in the tumor microenvironment (TME).On Thursday, Aura Biosciences, Inc. (NASDAQ:AURA) revealed early data from an ongoing Phase 1 trial of bel-sar (AU-011) in patients with non-muscle-invasive bladder cancer (NMIBC).
周四，Aura Biosciences, Inc.（纳斯达克:AURA）披露了bel-sar（AU-011）正在进行的非肌层侵袭性膀胱癌（NMIBC）患者的Ⅰ期试验的初期数据。
To date, the trial includes 13 patients, with the primary endpoints of evaluating the safety and feasibility of local administration of bel-sar alone (n=5) and bel-sar with light activation (n=8).
迄今为止，该试验包括了13名患者，主要目标是评估单独使用bel-sar（n=5）和联合光激活的bel-sar（n=8）的局部给药的安全性和可行性。
Also Read: Aura Biosciences Touts Promising Data From Eye Cancer Candidate.
同时阅读：Aura Biosciences宣布眼部癌症候选药物的有前景数据。
The secondary endpoints are to evaluate biological activity and immune-mediated changes in the tumor microenvironment (TME).
次要目标是评估肿瘤微环境（TME）中的生物活性和免疫介导的变化。
In patients receiving bel-sar with light activation (n=8), 4 out of 5 patients with low-grade disease demonstrated a clinically complete response with no tumor cells remaining on histopathological evaluation.
接受联合光激活的bel-sar治疗（n=8）的患者中，5名低级别疾病患者中有4名在组织病理学评估中表现出无肿瘤细胞残留的临床完全缓解。
Two out of 3 patients with high-grade disease demonstrated visual tumor shrinkage observed on cystoscopy.
3名高级别疾病患者中有2名在膀胱镜检查中观察到肿瘤萎缩。
The data in these eight patients receiving bel-sar with light activation showed clinical activity detectable as soon as seven days after a single low dose of bel-sar with light activation.
接受联合光激活的bel-sar治疗的8名患者的数据显示，即使在单剂次低剂量bel-sar联合光激活后的7天内也可以检测到临床活性。
"A potentially differentiating aspect of this novel treatment is the rapid tumor response accompanied by an immune-oncology effect such as a marked CD8+ T-cell infiltration observed in just a matter of days with a single low dose. We believe this could have the potential to translate into a durable response. In parallel with expanding the ongoing Phase 1 trial, we are preparing for a Phase 2 trial to further evaluate bel-sar's clinical activity and durability of response," said Sabine Brookman-May, Senior Vice President, Therapeutic Area Head Urologic Oncology of Aura Biosciences.
Aura Biosciences的泰拉普昂代表Sabine Brookman-May，泰拉普昂领域高级副总裁，泰拉普昂学医生方向，表示：“这种新型治疗的潜在差异性在于迅速的肿瘤反应，伴随着免疫学效应，例如在短短几天内观察到的明显的CD8+T细胞浸润，通过单剂次便可以产生持久的反应。我们相信这有潜力转化为持久的反应。与扩大进行中的Ⅰ期试验同时，我们正在准备进行Ⅱ期试验，以进一步评估bel-sar的临床活性和持续缓解。”
In the safety analysis as of Sept. 9, data cut-off date (n=12), bel-sar was well-tolerated, with less than 10% of patients reporting Grade 1 and no Grade 2 or higher drug-related adverse events reported.
在截止日期为9月9日的安全性分析中（n=12），bel-sar耐受性良好，少于10%的患者报告了1级症状，没有报告2级或更高级别的与药物相关的不良事件。
No serious adverse events have been reported.
没有报告任何严重的不良事件。
Price Action: AURA stock traded 18.85% higher at $12.23 during after-hours trading on Thursday.
股价走势：周四盘后交易中，AURA股票以12.23美元的价格上涨了18.85%。
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Photo: Shutterstock
Photo: shutterstock
