NON-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 and approximately 84,000 Americans will be diagnosed with bladder cancer in 2021. An estimated 70% of all new primary bladder cancer cases are classified as non-muscle invasive bladder cancer, or NMIBC. NMIBC occurs in the tissue that lines the inner surface of the bladder and where the bladder muscle is not involved. NMIBC is currently treated with a combination of surgery, immunotherapy, and chemotherapy, and there have been no new advances in the treatment of NMIBC in over two decades.

70% diagnosed at the NIMBC stage

First line treatment options characterized by lack of efficacy

40% do not respond to BCG and require cystectomy

AU-011 FOR THE TREATMENT OF NMIBC

We are currently developing AU-011 for the treatment of NMIBC. Bladder cancer is the most common malignancy involving the urinary system. While metastatic bladder cancer has several approved therapies, there are limited effective options for the treatment of NMIBC. We have generated preclinical in vivo data that supports that our dual mechanism of action can lead to tumor cell killing and long-term antitumor immunity which may further reduce the risk of metastases for patients. We believe this immune response can play a large role in bladder cancer, given that bladder cancer has a well-documented response to immune activation.

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 AU-011 can cause necrosis and prevent residual tumor cells from further growth and recurrence.