MIRAMAR, Fla.–(BUSINESS WIRE)–Altor BioScience Corporation (Altor), a leading developer of novel cytokine-based immunotherapeutics for cancer and infectious diseases, announced today that it has received Fast Track designation from the U.S. 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 program. 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 program in this important indication.”
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. 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. Combination studies of ALT-803 with antibodies, targeted agents, and vaccines are underway and will further explore the role of ALT-803 in immunotherapy combinations for various disease indications. ALT-803 is currently being evaluated in multiple clinical trials for patients with solid or hematological tumors and in HIV infected individuals.
About Altor BioScience
Altor is a privately held, clinical-stage biopharmaceutical company developing novel immunotherapeutics for the treatment of cancer and infectious diseases. Altor’s engineered cytokine technology platforms are centered on the immunostimulatory properties of the cytokines IL-15 and IL-2. These cytokines provide essential links between the innate and adaptive arms of the immune system and induce the activation, proliferation, and persistence of NK and T cells, which are critical in the body’s defense against cancer and infection.
Altor is leveraging its extensive network of research and clinical collaborations, including leading cancer institutes and universities, toward actively exploring the potential clinical utilities of product candidates ALT-803 and ALT-801 against cancer and infectious diseases. In various experimental models, ALT-803 and ALT-801 exhibit potent immunostimulatory activity when administered in combination with other types of therapeutic agents. Altor is positioning its immunotherapeutic platform to be employed as the backbone therapy in next-generation combination immunotherapy approaches. For more information, please visit www.altorbioscience.com.