Altor BioScience Corporation, a leading developer of novel cytokine-based immunotherapeutics for cancer and infectious diseases, has received Fast Track designation from the US Food and Drug Administration (FDA) for its investigational interleukin-15 (IL-15) agonist complex, ALT-803, in combination with bacillus Calmette-Guérin (BCG), for the treatment of patients with non-muscle invasive bladder cancer (NMIBC). The FDA’s Fast Track program is designed to expedite the development and review of drugs to treat serious conditions and fill unmet medical needs.
ALT-803 is currently being evaluated in a Phase Ib/II clinical trial to investigate the safety and efficacy of intravesical ALT-803 in combination with BCG in adult patients with BCG-naïve NMIBC as well as a separate phase II clinical trial to investigate the safety and efficacy of intravesical ALT-803 in combination with BCG in adult patients with BCG-unresponsive NMIBC. Results from the recently completed phase Ib NMIBC study will be presented at the American Urological Association Annual Meeting in Boston on May 12, 2017. The FDA Fast Track designation will apply to clinical development of ALT-803 in combination with BCG for the treatment and prophylaxis of carcinoma in situ (CIS) of the urinary bladder, as well as for the prophylaxis of primary or recurrent stage Ta and/or T1 papillary tumors following transurethral resection (TUR) in patients with NMIBC.
Hing C. Wong, Ph.D., chief executive officer of Altor BioScience, said: “We are thrilled that the FDA has granted Fast Track designation for ALT-803 in NMIBC. This is a key milestone for advancing our NMIBC programme. Patients with NMIBC have few treatment options and there is a significant unmet medical need for novel therapies in NMIBC, particularly in patients who are unresponsive to BCG. We are looking forward to working closely with FDA to facilitate our clinical programme in this important indication.”