Plan to enter Phase 2 in Adult Onset Still's Disease and other serious rare and orphan diseases
PHILADELPHIA, Aug. 7, 2019 /PRNewswire/ -- Aevi Genomic Medicine, Inc. (NASDAQ: GNMX, "Aevi") today announced that it has obtained the right to exercise an exclusive global license for MEDI2338, a Phase 2-ready fully human monoclonal antibody (mAb) that targets interleukin 18 (IL-18). The Company plans to initially develop MEDI2338 for adult onset Still's disease (AOSD), a serious rare and orphan rheumatological disease with no currently approved biologic therapies in the US. Further development for several other rare autoinflammatory disorders that are driven by IL-18 will follow.
Under the terms of the agreement, Aevi will have the right to exercise an exclusive global license to develop and commercialize MEDI2338. The Company will pay a combined mid-single digit millions in cash and equity upon exercise of the option, up to $162 million upon achievement of certain development and sales-related milestones and tiered low double-digit royalties on global annual product sales. Exercising the option is contingent on Aevi securing additional funding. The Company will be fully responsible for the development and commercialization of the program.
"We are very excited to license this program from AstraZeneca and look forward to advancing this potential rare disease therapy into clinical development," said Garry Neil, M.D., Chief Scientific Officer at Aevi Genomic Medicine. "AOSD is a rare, life-altering inflammatory disease characterized by fevers, rash and joint pain and striking elevation of IL-18. Many patients also suffer liver, cardiopulmonary and renal complications. Patients have limited available therapeutic options. Because IL-18 appears to play a central role in the disease, we believe that MEDI2338 could prove to be an effective treatment for these patients. A clear mechanism of action and safety profile have already been established in patients."
About Adult Onset Still's Disease (AOSD)
Adult onset Still's disease (AOSD) is a rare and severe autoinflammatory disease affecting adults. The disease is similar to systemic onset juvenile idiopathic arthritis (sJIA), that affects children. The etiology of AOSD is unknown with both genetic and infectious factors being implicated. The hallmarks of the disease are persistent daily fever, rash and arthralgias. Many patients suffer complications including splenomegaly, heart and liver disease. Some AOSD patients develop macrophage activation syndrome, a severe acute complication that may cause rapid multi-organ failure and even death.
MEDI2338 is a fully human anti-IL-18 monoclonal antibody which binds IL-18. Aevi Genomic Medicine will exclusively license the composition of matter patents, and the Company expects to establish new biological product exclusivity for 12 years from the date of FDA approval of the antibody in the U.S., and at least 10 years from the date of first authorization in Europe.
About Aevi Genomic Medicine, Inc.
Aevi Genomic Medicine, Inc. is dedicated to unlocking the potential of genomic medicine to translate genetic discoveries into novel therapies. Driven by a commitment to patients with pediatric onset life-altering diseases, the Company's research and development efforts include working with the Center for Applied Genomics (CAG) at Children's Hospital of Philadelphia (CHOP) to leverage novel genetic discoveries to progress our genomic medicine strategy
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Aevi Genomic Medicine, Inc.