Shares of Aura Biosciences, Inc. (NASDAQ: AURA) increased sharply on Thursday following the presentation of encouraging clinical study findings. In after-hours trading, AURA shares increased to $11.02 rising 7.09% on the US stock charts. Early results from Aura’s current Phase 1 study of bel-sar (AU-011), a possible therapy for non-muscle invasive bladder cancer (NMIBC), were well received by the market.
Early Clinical Trial Success
Aura Biosciences reported positive initial results from a Phase 1 clinical trial of bel-sar in patients with NMIBC. The purpose of the 13-person experiment is to assess the viability and safety of using bel-sar both by itself and in conjunction with light activation. Three of the 13 individuals had high-grade illness, and ten had low-grade NMIBC.
In patients receiving bel-sar with light activation, 4 out of 5 individuals with low-grade disease achieved a complete clinical response, as confirmed through histopathological evaluation. Additionally, 2 out of 3 high-grade patients experienced visible tumor shrinkage observed during cystoscopy.
Unique Tumor Response and Immune Activation
The data also revealed a potentially transformative aspect of bel-sar: the rapid tumor response combined with immune oncology (IO) effects. Notably, a significant infiltration of CD8+ T-cells into the tumor microenvironment (TME) was observed within days after administering a low dose.
This could suggest the possibility of a durable and long-lasting response. Aura Biosciences plans to expand the Phase 1 trial and initiate a Phase 2 trial to further assess the clinical activity and durability of the treatment.
Positive Safety Profile
The ongoing trial is an open-label, two-part study designed to assess bel-sar’s safety, biological activity, and feasibility as a monotherapy. The treatment is administered before the standard of care transurethral resection of bladder tumor (TURBT), with participants followed for a 56-day period.
As of September 9, 2024, bel-sar demonstrated a favorable safety profile, with fewer than 10% of patients experiencing Grade 1 adverse events and no reports of more severe drug-related side effects.
