Non-muscle Invasive Bladder Cancer (NMIBC)
Non-muscle Invasive Bladder Cancer (NMIBC) makes up 70% of all newly diagnosed bladder cancers. Generally speaking, NMIBC is defined as being confined to the bladder mucosa and sub-mucosa with no detectable presence of tumor in the surrounding detrusor muscle. NMIBC has a high rate of recurrence and a relatively low risk of progression until advanced refractory disease develops. The high rate of recurrence of NMIBC calls for consistent and frequent patient procedures for monitoring and treatment, making it one of the most costly oncology indications to treat over the life of disease.
NMIBC patients are divided into low-, intermediate-, and high-risk categories calculated by the widely used "EORTC risk table", which serves to establish risk classification based on several clinical and pathological features that include but are not limited to tumor stage and grade, tumor size, number of tumors, number of recurrences, and time to recurrence. NMIBC tumor stages include papillary lesions that have not invaded sub-mucosal lamina propria (Ta), papillary lesions that have invaded the lamina propria but not the muscle (T1), and carcinoma in situ (referred to as CIS or Tis), a flat lesion confined to the urothelium.
Vaxiion is developing VAX014 for Instillation as a novel bladder cancer-targeted anti-neoplastic agent for use in multiple different NMIBC patient sub-populations. Strong pre-clinical in vitro and in vivo pharmacology data suggest that VAX014 has excellent potential to translate into clinical benefit by helping to reduce overall recurrence rates and as a bladder-sparing salvage therapy.
Irrespective of risk classification, care for NMIBC begins with transurethral resection of bladder tumor (TURBT). Following TURBT, each risk category has a distinct recommended adjuvant therapy regimen that follows an evidence-based treatment algorithm that has developed over the last 40 years. Adjuvant treatment guidelines issued by both the European Association of Urology and American Urological Association recommend low-risk patients receive a single post-operative administration of chemotherapy, intermediate-risk patients receive multiple instillations of chemotherapy and recurrent intermediate- and high-risk patients (includes CIS) receive localized intravesical immunotherapy with Bacillus Calmette-Guerin (BCG), a toxic but effective live bacterial therapy. For those patients recurring following 2 attempts with BCG within an allotted timeframe, the bladder-sparing treatment options are few and the recommended path is cystectomy (bladder removal). While cystectomy is effective at preventing deadly metastatic disease, it is a procedure fraught with costly complications, chronic co-morbidity and a major negative impact on patient quality of life.
70% of all bladder cancers are diagnosed as NMIBC at disease stages Ta, T1, and Tis (CIS) where tumors are still confined to the mucosa and submucosa of the bladder urothelium.