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BOSTON - Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotech company with a market capitalization of $375 million, has announced positive outcomes from a Phase 1 trial evaluating its investigational drug bel-sar (AU-011) for the treatment of non-muscle invasive bladder cancer (NMIBC). The trial results were presented at the 40th Annual European Association of Urology (EAU) Congress in Madrid, Spain. According to InvestingPro data, the company maintains a strong financial health score, with a current ratio of 12.47x indicating robust short-term liquidity.
The study assessed the safety and feasibility of bel-sar in NMIBC patients through a "window of opportunity" trial, which involved 15 participants. The primary endpoints were the safety and feasibility of local administration of bel-sar, with secondary endpoints focusing on tumor necrosis, shrinkage, and immune responses within the tumor microenvironment (TME). With a beta of 0.3, the stock shows relatively low correlation with market movements, making it an interesting consideration for portfolio diversification. InvestingPro subscribers can access additional insights about the company’s financial stability and growth prospects.
Patients receiving bel-sar with light activation showed promising signs of clinical activity, including complete responses in the target lesion and visual tumor shrinkage. Specifically, in the intermediate-risk NMIBC group, 4 out of 5 patients achieved a clinical complete response, and 3 out of 5 showed necrosis. Among high-risk patients, 1 out of 5 had a complete response, and 3 out of 5 exhibited tumor shrinkage upon cystoscopy.
The drug was well-tolerated, with less than 10% of patients experiencing Grade 1 drug-related adverse events and no higher-grade adverse events reported. The immune profiling conducted post-treatment revealed significant infiltration of cytotoxic effector cells and the formation of tertiary lymphoid structures, suggesting the activation of both innate and adaptive immune responses.
Dr. Seth Lerner, who presented the data, highlighted bel-sar’s potential to shift the front-line treatment approach for NMIBC, citing its favorable safety profile and non-requirement for general anesthesia. Aura’s Senior Vice President, Sabine Brookman-May, MD, FEBU, echoed the sentiment, expressing optimism for the novel mechanism of action’s ability to generate long-lasting responses.
The completed Phase 1 trial was conducted over a 56-day period, with patients receiving treatment 7 to 12 days before the standard transurethral resection of bladder tumor (TURBT) procedure. The trial’s findings are based on the histopathological evaluation of tissue samples and visual assessments of tumor shrinkage.
Aura Biosciences is hosting a virtual urologic oncology investor event today to discuss the trial data and outline future development plans for bel-sar, including the Phase 1b/2 trial.
This report is based on a press release statement from Aura Biosciences, Inc.
In other recent news, Aura Biosciences announced plans to present additional data from its Phase 1 trial of bel-sar, a treatment for non-muscle invasive bladder cancer, at the 40th Annual European Association of Urology Congress. This presentation will include insights into the safety and efficacy of bel-sar, a virus-like drug conjugate, in treating patients with this condition. H.C. Wainwright maintained its Buy rating and $22 price target for Aura Biosciences, reflecting confidence in the potential of bel-sar as a significant treatment option. The firm projects a launch in 2030 with estimated sales of $82 million for that year. Aura Biosciences will also host a virtual urologic oncology investor event to discuss the Phase 1b/2 trial expansion and future development strategies for bladder cancer treatments. The event will feature key opinion leaders and include a live Q&A session. The company aims to provide updates on its bladder cancer program during this event. The presentations and investor event will be available via webcast on the Aura Biosciences website.
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