Bladder Cancer

NON-MUSCLE INVASIVE AND MUSCLE INVASIVE BLADDER CANCER

Pioneering a novel approach to treat a high unmet medical need.

Bladder cancer is the most common malignancy involving the urinary system. Non-muscle invasive bladder cancer, or NMIBC and muscle invasive bladder cancer, or MIBC has a yearly incidence of 81,000 patients in the US. NMIBC occurs in the tissue that lines the inner surface of the bladder and where the bladder muscle is not yet involved. NMIBC and MIBC are currently treated with a combination of surgery, immunotherapy, and chemotherapy, and unfortunately a large proportion of subjects may progress to needing cystectomy, or removal of the bladder.

Market opportunity - Non-muscle invasive and muscle invasive bladder cancers

BELZUPACAP SAROTALOCAN (BEL-SAR) FOR THE TREATMENT OF BLADDER CANCER

We are currently developing bel-sar for the local treatment of NMIBC and MIBC. While metastatic bladder cancer has several approved systemic therapies, there are limited effective options for the targeted local treatment of NMIBC and MIBC. Preclinical in vivo data demonstrates that our dual mechanism of action can lead to direct, acute tumor cell killing with durable tumor regression and long-term antitumor immunity, which is synergistic with checkpoint inhibitors and may further reduce the risk of metastasis for patients. We believe this innate and adaptive immune response can play a large role in bladder cancer, given that bladder cancer has a well-documented response to immune activation with Bacillus Calmette Guerin (BCG). We have received Fast Track Designation by the FDA and initiated a Phase 1 “window of opportunity” trial evaluating the safety, and tolerability, of bel-sar for the local treatment of NMIBC and MIBC.

Aura’s novel route of administration is intended to place high levels of the drug at the base of the tumor where laser activation of Bel-sar can cause necrosis and prevent residual tumor cells from further growth and recurrence.