FORTRESS BIOTECH (f/k/a Coronado Biosciences) FORMS NEW SUBSIDIARY, HELOCYTE, INC. (f/k/a DiaVax Biosciences) TO DEVELOP NOVEL IMMUNOTHERAPIES FOR CYTOMEGALOVIRUS
DiaVax Secures Rights to Two Clinical-Stage Programs Including a Universal Vaccine Set to Enter Phase II Studies Later This Year
New York, NY – April 2, 2015 – Coronado Biosciences, Inc., (NASDAQ: CNDO) has formed a new subsidiary company, DiaVax Biosciences, to develop novel immunotherapies for the prevention and treatment of cytomegalovirus (CMV), a common virus that affects people of all ages. According to the U.S. Centers for Disease Control and Prevention (CDC), while CMV is typically asymptomatic in healthy individuals, it can cause serious, often life-threatening disease in those with weakened or uneducated immune systems (including developing fetuses exposed to the virus in utero).
The licensed immunotherapies were developed in the laboratory of Don J. Diamond, Ph.D., Chair of the Department of Experimental Therapeutics at City of Hope National Medical Center in Duarte, California. Dr. Diamond will chair the Scientific Advisory Board of DiaVax. Under the agreement with City of Hope, DiaVax secured worldwide rights to two T-cell immunotherapeutic vaccines for controlling CMV in allogeneic hematopoietic stem cell transplant (HSCT) and solid organ transplant (SOT) recipients. Known as Triplex and PepVax, the programs are expected to enter Phase II clinical studies later this year and are supported by grants from the National Cancer Institute. In connection with the licensing of Triplex and PepVax, DiaVax further entered into an option agreement with City of Hope for exclusive worldwide rights to Pentamer, a universal immunotherapeutic vaccine being developed for the prevention of CMV transmission in utero. If DiaVax exercises its option, and successfully develops and commercializes PepVax, Triplex and Pentamer, City of Hope could receive in excess of $100MM in upfront, milestone and other payments.
Dr. Lindsay A. Rosenwald, Chairman and CEO of Coronado Biosciences, stated, “We are pleased to enter into this collaboration with City of Hope and Dr. Don Diamond. Studies have shown that CMV reactivation in HSCT recipients is linked to low levels of CMV-specific CD8+ T-cells. The vaccines we have licensed represent a promising new T-cell-based, immunotherapeutic approach for controlling CMV in patients with weakened immune systems, particularly those undergoing bone marrow and solid organ transplants. Current antiviral therapies used in this context are often toxic and merely suppress CMV during treatment. An effective vaccine could educate the body’s immune system to fight CMV. We look forward to commencing Phase II studies later this year.”
George Megaw, City of Hope’s Director of the Office of Technology Licensing stated, “We are thrilled to partner with Coronado Biosciences on the formation of DiaVax Biosciences and the advancement of these exciting CMV immunotherapies. The executive team at Coronado has an impressive track-record of designing and executing clinical studies across multiple therapeutic areas in a diligent and effective manner. We are confident this collaboration will further the mission of City of Hope to alleviate human suffering and disease, particularly as it relates to CMV.”
Cytomegalovirus (CMV) is a double-stranded DNA virus and member of the herpesviridae family, which includes the varicella-zoster, Epstein-Barr and herpes simplex viruses. The CDC estimates that 50 to 80
percent are infected with CMV in the United States by the age of 40. Most healthy adults infected with CMV have no symptoms. However, CMV may cause severe and often life-threatening symptoms in immune-compromised patients, including HIV/AIDS patients. In bone marrow and organ transplant recipients, the rate of CMV reactivation is up to 60 percent. While current preemptive antiviral therapies have reduced the rate of CMV disease-related mortality in these patients, such treatments have been linked to increased toxicity, as well as delayed immune reconstitution and late onset of CMV. The virus has further been linked to a variety of other conditions including glioblastoma, atherosclerosis, restenosis after angioplasty, and premature senescence of the immune system.
About Coronado Biosciences
Coronado Biosciences is a biopharmaceutical company dedicated to acquiring, developing and commercializing novel pharmaceutical and biotechnology products. As part of its growth strategy, the company is leveraging its biopharmaceutical business and drug development expertise to acquire rights to innovative pharmaceutical and biotechnology products and technologies, using a variety of approaches including, but not limited to, licensing, partnerships, joint ventures, and/or public and private spin-outs. For more information, visit www.coronadobiosciences.com.
About City of Hope
City of Hope is a leading research and treatment center for cancer, diabetes and other life-threatening diseases. Designated as a comprehensive cancer center, the highest recognition bestowed by the National Cancer Institute, City of Hope is also a founding member of the National Comprehensive Cancer Network, with research and treatment protocols that advance care throughout the nation. City of Hope’s main hospital is located in Duarte, California, just northeast of Los Angeles, with community clinics in southern California. It is ranked as one of “America’s Best Hospitals” in cancer by U.S. News & World Report. Founded in 1913, City of Hope is a pioneer in the fields of bone marrow transplantation and genetics.
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Lucy Lu, MD, Executive Vice President & Chief Financial Officer
Coronado Biosciences, Inc.