[August 19, 2014]

Altor BioScience Awarded SBIR Phase II Grant by NCI for Clinical Development of its Novel IL-15 Super Agonist for Non-muscle Invasive Bladder Cancer

Altor BioScience Corporation (Altor), a leading developer of cancer immunotherapies, announced today that it has been awarded a Small Business Innovation Research (SBIR) Phase II grant by the National Cancer Institute (NCI) for the clinical development of ALT-803, a proprietary interleukin-15 (IL-15) superagonist protein complex, against non-muscle invasive bladder cancer (NMIBC). NCI ranks bladder cancer as the 6^th most common cancer in the U.S., and approximately 70 percent of patients with bladder cancer have NMIBC at diagnosis, making it one of the most prevalent cancers in the U.S.

ALT-803 is considered one of the most promising cancer immunotherapeutic agents by NCI, displaying robust anti-tumor responses in various preclinical cancer models. In preclinical studies, ALT-803 stands out as a potent immunostimulant capable of simultaneously activating the innate and adaptive arms of the immune system to elicit both rapid and long-lasting protective responses against hematologic malignancies and solid tumors, including bladder cancer.

The $1.2 million grant was awarded on August 11, 2014, and will support a multi-center Phase I/II clinical trial to evaluate the tolerability and efficacy of ALT-803 in patients with NMIBC. Patient enrollment for this trial has been initiated at the University of Hawaii Cancer Center (UHCC), the leading site for the study. Dr. Charles J. Rosser, M.D., the lead clinical investigator at UHCC, commented, "Bladder cancer is an all too prevalent disease troughout the world, as well as in the islands of Hawaii. Thus, we are extremely honored to be the lead site in the nation for this groundbreaking clinical trial geared toward improving the lives of patients suffering from bladder cancer." Patients will be treated at The Queen's Medical Center, which has the only in-patient Clinical Trials Unit focusing on translational research in Hawaii - in particular, Phase I/II trials. Dr. Rosser is the corresponding author of an article published in the June 4, 2014 issue of PLOS ONE, describing the superiority of ALT-803 in combination with Bacillus Calmette-Guérin (BCG), over BCG alone in reducing tumor burden in a carcinogen-induced bladder cancer model.

Hing C. Wong, Ph.D., Altor's founder and CEO, commented, "Altor is thrilled to receive the recognition and support from NCI to advance the clinical development of ALT-803 for NMIBC. Our objective is to develop ALT-803 in combination with BCG as a durable or potentially curative treatment for bladder cancer."

The NCI estimates in 2014, nearly 74,700 new cases of bladder cancer will be diagnosed and 15,600 patients will die from this disease. Bladder cancer is also the most expensive cancer to treat on a per patient basis over their lifetime, due to 50-80% recurrence rates and the requirement of life-long surveillance. There also have been no advancements or changes to bladder cancer treatment over the past 20 years, and thus Altor is focused on exploring ALT-803 therapy to meet this major unmet medical need.

About Altor's IL-15 Technology

The cytokine IL-15 plays a major role in the development of cellular immune responses, driving T and natural killer cell proliferation and activation. Altor has developed ALT-803, a novel IL-15 superagonist complex, with improved pharmacokinetic properties, long serum half-life and enhanced anti-tumor activity compared to recombinant human IL-15. Altor is collaborating with more than twenty leading research institutes and universities in the U.S. to explore potential clinical utilities of ALT-803 against cancer and viral infections. ALT-803 is currently in four clinical trials for patients with hematologic malignancies and solid tumors.

About Altor BioScience

Altor is a privately held biotechnology company developing immunotherapies for treating cancer, viral infections, and inflammatory diseases based on its proprietary IL-15, T cell receptor and Tissue Factor antagonist platform technologies. Altor currently has four Phase I and two Phase II trials underway for its immunotherapeutics against cancer.

Visit www.altorbioscience.com for details.

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