MIRAMAR, Fla.--(BUSINESS WIRE)--Altor BioScience Corporation (Altor), a leading developer of cancer immunotherapeutics, announced today that it has entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), an Institute of the National Institutes of Health (NIH). Under the CRADA, Altor will work with NCI to further develop its proprietary Interleukin-15 (IL-15) superagonist ALT-803 and single-chain T-cell-receptor/Interleukin-2 (IL-2) fusion protein ALT-801. In addition to the research to be conducted with NCI via this CRADA, these cytokine-based immunotherapy candidates are currently in various, unassociated Phase I and Phase II clinical trials for hematologic and solid tumor cancers.
Dr. Jeffrey Schlom, Chief of the Laboratory of Tumor Immunology and Biology (LTIB), NCI, will work with Altor to design and conduct in vitro and in vivo preclinical studies as well as clinical studies to assess patient immune responses following ALT-803 or ALT-801 therapy. Dr. Christopher Heery, Director of the Clinical Trials Group of the LTIB, Dr. James Gulley, Chief, Genitourinary Malignancies Branch (GMB), NCI, and their colleagues in LTIB and GMB, will conduct the clinical studies. ALT-803 and ALT-801 will each be investigated as a monotherapy and in combination with therapeutic regimens such as radiation, chemotherapy, hormonal therapies, monoclonal antibodies, checkpoint inhibitors, and recombinant NK cell-based approaches. Both Phase I and Phase II clinical studies will be conducted at the NIH Clinical Center.
Hing C. Wong, Ph.D., Altor’s founder and CEO commented, “Altor’s immunotherapeutic platform can motivate fundamental components of the immune system by activating natural killer (NK) and T cells in the fight against cancer. We look forward to combining our expertise with that of investigators at the NCI toward a multi-pronged approach for immunotherapy against a wide range of cancers. We are extremely pleased that Drs. Schlom, Heery, Gulley, and their colleagues have partnered with Altor to carry out these important studies. Altor will manufacture the immunotherapeutic products for use in both preclinical and clinical studies conducted at NCI. The data from these Phase I and II studies will potentially provide the rationale for future pivotal studies.”
About Altor BioScience
Altor is a privately held, clinical-stage biotechnology company developing immunotherapies for treatment of cancer and viral infections, based on its engineered cytokine technology platforms. ALT-801 was developed as a fusion protein linking IL-2 to a single-chain T cell receptor domain capable of specifically recognizing tumor cells that overexpress p53 on their surface. When tested in various tumor models, ALT-801 exhibited significantly more potent anti-tumor activity and less toxicity than IL-2. Compared to IL-2, ALT-801 has improved pharmacokinetics and enhanced immunostimulatory activity without severe IL-2-related toxicities in patients, which led to durable immune responses. Altor has also developed ALT-803, a novel IL-15 superagonist complex, with improved pharmacokinetic properties and enhanced anti-tumor activity compared to recombinant human IL-15. Preclinical studies have shown 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 has also been shown to potently activate human effector NK cells and enhance antibody dependent cell-mediated cytotoxicity (ADCC) of anti-CD20 antibodies against human lymphoma cells in various tumor models. These encouraging results have led to a clinical trial using ALT-803 plus rituximab in patients with relapsed/refractory indolent non-Hodgkin lymphoma (iNHL), a common B cell malignancy. Combination studies of ALT-803 and checkpoint inhibitors have also yielded encouraging preliminary results in solid tumor models and have led to the initiation of a clinical trial of ALT-803 combined with nivolumab in patients with non-small cell lung cancer (NSCLC).
Altor’s extensive network of research and clinical collaborations consist of more than fifty leading cancer institutes and universities and are actively exploring the potential clinical utilities of ALT-803 and ALT-801 against cancer and viral infections. In various tumor models, ALT-803 and ALT-801 exhibit potent immunostimulatory activity when administered as monotherapies and also as combination therapies with other types of therapeutic agents. Ten total clinical trials with the two immunotherapy candidates are ongoing in patients with hematologic and solid tumors and in patients with HIV receiving antiretroviral therapy.
For additional information, visit www.altorbioscience.com.