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# Fast Track Given to Alto Bio Bladder Cancer Therapy
- URL: https://www.fdaweb.com/fast-track-given-to-alto-bio-bladder-cancer-therapy/
- Published: 2017-05-04T12:00:00.000Z
- Updated: 2026-09-14T22:21:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138618

FDA has granted Altor BioScience a fast track designation for its investigational interleukin-15 (IL-15) agonist complex, ALT-803, in combination with bacillus Calmette-Guérin (BCG), for treating patients with non-muscle invasive bladder cancer (NMIBC). ALT-803 is currently being studied in a Phase 1b/2 clinical trial in adult patients with BCG-naïve NMIBC, as well as a separate Phase 2 clinical trial in combination with BCG in adult patients with BCG-unresponsive NMIBC.

  
ALT-803 is a proprietary, novel IL-15 superagonist complex, which “demonstrates improved pharmacokinetic properties and enhanced anti-tumor activity compared to IL-15 in preclinical studies,” the company says. “These studies also demonstrated that ALT-803 simultaneously mobilizes both the innate and adaptive arms of the immune system to elicit rapid, robust, and long-lasting responses against cancer and virally-infected cells. ALT-803 also potently activates NK cells and enhances antibody-dependent cell-mediated cytotoxicity (ADCC) of antibodies in various experimental models.”