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).
週四，Aura Biosciences, Inc.（納斯達克:AURA）披露了bel-sar（AU-011）正在進行的非肌層侵襲性膀胱癌（NMIBC）患者的Ⅰ期試驗的初期數據。
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).
迄今爲止，該試驗包括了13名患者，主要目標是評估單獨使用bel-sar（n=5）和聯合光激活的bel-sar（n=8）的局部給藥的安全性和可行性。
Also Read: Aura Biosciences Touts Promising Data From Eye Cancer Candidate.
同時閱讀：Aura Biosciences宣佈眼部癌症候選藥物的有前景數據。
The secondary endpoints are to evaluate biological activity and immune-mediated changes in the tumor microenvironment (TME).
次要目標是評估腫瘤微環境（TME）中的生物活性和免疫介導的變化。
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.
接受聯合光激活的bel-sar治療（n=8）的患者中，5名低級別疾病患者中有4名在組織病理學評估中表現出無腫瘤細胞殘留的臨床完全緩解。
Two out of 3 patients with high-grade disease demonstrated visual tumor shrinkage observed on cystoscopy.
3名高級別疾病患者中有2名在膀胱鏡檢查中觀察到腫瘤萎縮。
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.
接受聯合光激活的bel-sar治療的8名患者的數據顯示，即使在單劑次低劑量bel-sar聯合光激活後的7天內也可以檢測到臨床活性。
"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，泰拉普昂領域高級副總裁，泰拉普昂學醫生方向，表示：「這種新型治療的潛在差異性在於迅速的腫瘤反應，伴隨着免疫學效應，例如在短短几天內觀察到的明顯的CD8+T細胞浸潤，通過單劑次便可以產生持久的反應。我們相信這有潛力轉化爲持久的反應。與擴大進行中的Ⅰ期試驗同時，我們正在準備進行Ⅱ期試驗，以進一步評估bel-sar的臨床活性和持續緩解。」
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.
在截止日期爲9月9日的安全性分析中（n=12），bel-sar耐受性良好，少於10%的患者報告了1級症狀，沒有報告2級或更高級別的與藥物相關的不良事件。
No serious adverse events have been reported.
沒有報告任何嚴重的不良事件。
Price Action: AURA stock traded 18.85% higher at $12.23 during after-hours trading on Thursday.
股價走勢：週四盤後交易中，AURA股票以12.23美元的價格上漲了18.85%。
- Pharmacy Retailer CVS Health Backs Away From Annual Forecast, Names New CEO
- 西維斯健康連鎖藥店放棄年度預測，任命新首席執行官
Photo: Shutterstock
Photo: shutterstock
