BOSTON - Aura Biosciences, Inc. (NASDAQ: AURA) has announced encouraging preliminary results from an ongoing Phase 1 clinical trial of its drug candidate bel-sar (AU-011) for the treatment of non-muscle invasive bladder cancer (NMIBC). The study, which involves 13 patients, is primarily focused on assessing the safety and feasibility of administering bel-sar both with and without light activation.
According to the data released by Aura Biosciences, 4 out of 5 patients with low-grade NMIBC showed a complete clinical response after receiving bel-sar with light activation. This response was characterized by the absence of tumor cells in subsequent histopathological evaluations. Additionally, 2 out of 3 patients with high-grade NMIBC exhibited visual shrinkage of the tumor, as observed through cystoscopy.
The safety profile of bel-sar proved favorable, with less than 10% of patients experiencing Grade 1 drug-related adverse events and no higher-grade adverse events reported. The trial also aims to evaluate the biological activity of bel-sar and its effects on the tumor microenvironment, with early signs showing immune system engagement in the form of T-cell infiltration.
The study's treatment involves administering bel-sar 7 to 12 days before the standard transurethral resection of bladder tumors, with patients then monitored over a 56-day period. The trial's first part, involving five patients receiving a single dose of bel-sar without light activation, is complete. The ongoing second part includes 10 patients, with eight confirmed to have tumors at the time of treatment.
Sabine Brookman-May, MD, Senior Vice President at Aura Biosciences, expressed optimism about the potential of bel-sar to transform cancer treatment due to its rapid tumor response and immune oncology effects. Neal Shore, MD, of the Carolina Urologic Research Center, also highlighted the potential of bel-sar to be a first-in-class immune ablative treatment for early-stage bladder cancer.
The company is preparing for a Phase 2 trial to further evaluate the clinical activity and response durability of bel-sar. Aura Biosciences is hosting a Virtual Urologic Oncology Investor Event today to discuss the early data and its implications.
These results are based on a press release statement and should be considered within the context of the trial's early phase and the need for further research to confirm the drug's efficacy and safety.
In other recent news, Aura Biosciences announced a change in its financial leadership as CFO Julie Feder stepped down, with Amy Elazzouzi stepping in as interim CFO. Aura Biosciences also reported promising results from a Phase 2 study of its investigational drug, bel-sar (AU-011), for early-stage choroidal melanoma, showing an 80% tumor control rate and a 90% rate of visual acuity preservation. H.C. Wainwright and TD Cowen have reiterated their Buy ratings on Aura Biosciences following these outcomes.
Furthermore, Aura Biosciences is currently conducting a pivotal Phase 3 trial for bel-sar, with data expected in 2026. This trial is a crucial step towards seeking regulatory approval for the treatment. These are recent developments for Aura Biosciences, which is being closely monitored by key opinion leaders in the field, signaling confidence in the company's ongoing efforts.
Finally, Aura Biosciences has hosted a virtual ocular oncology investor event to discuss these findings with key opinion leaders in the field, providing further insights into the study results and their potential impact on early-stage choroidal melanoma treatment.
InvestingPro Insights
As Aura Biosciences (NASDAQ: AURA) reports promising preliminary results for its bladder cancer treatment, investors might be interested in the company's financial health and market performance. According to InvestingPro data, Aura's market capitalization stands at $462.83 million, reflecting investor interest in the company's potential.
The stock has shown significant momentum recently, with a 21.59% return over the last week and a 45.8% return over the past six months. This aligns with the positive clinical trial results and could indicate growing investor confidence in Aura's pipeline.
However, it's important to note that Aura is not currently profitable, with an adjusted operating income of -$90.35 million over the last twelve months as of Q2 2023. This is not unusual for biotechnology companies in the development stage, as they often invest heavily in research and clinical trials before generating revenue.
InvestingPro Tips highlight that Aura holds more cash than debt on its balance sheet, which could provide financial flexibility as the company advances its clinical programs. Additionally, Aura's liquid assets exceed short-term obligations, potentially offering a buffer against immediate financial pressures.
Investors should be aware that the stock's recent performance has pushed it into potentially overbought territory, according to the Relative Strength Index (RSI). This suggests that the stock might be due for a price correction in the short term.
For a more comprehensive analysis, InvestingPro offers 8 additional tips for Aura Biosciences, providing deeper insights into the company's financial position and market outlook.
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