Entering Phase 2 clinical trials for the treatment of Lymphatic Malformations which include a number of rare and orphan diseases.
PHILADELPHIA /PRNewswire/ -- Aevi Genomic Medicine, Inc. (NASDAQ: GNMX, "Aevi") today announced it has entered into an exclusive license agreement with OSI Pharmaceuticals, LLC, an indirect wholly-owned subsidiary of Astellas Pharma Inc. ("Astellas") for the worldwide development and commercialization of Astellas' second generation mTORC1/2 inhibitor, ASP7486 (OSI-027). Aevi's initial focus of study with ASP7486 will be for congenital Lymphatic Malformations, which includes a number of rare and orphan diseases. The mTORC1/2 pathway is believed to be involved in greater than 80% of patients with congenital Lymphatic Malformations.
Under the terms of the license agreement, Aevi will pay Astellas an up-front license fee of $500,000 and Astellas will be eligible to receive milestones payments based upon the achievement of specified development and regulatory milestones. Upon commercialization, Astellas will be entitled to a tiered, single-digit royalty on worldwide annual net sales. Aevi will be responsible for all clinical development, manufacturing, and commercialization activities and costs.
Lymphatic Malformations are rare congenital and potentially life-threatening diseases of the lymphatic system. Some of the diseases involved are Generalized Lymphatic Anomaly (GLA), Kaposiform lymphangiomatosis (KLA), and Gorham-Stoudt disease (GSD). Most lymphatic malformations are evident at birth or within the first two years of age. The exact prevalence of lymphatic malformations in the general population is unknown, but is thought to be approximately 1 in every 4000 live births. There may be as many as 30,000 to 60,000 Americans living with congenital lymphatic malformations. In some cases, the disease may be familial and have a recognizable genetic cause. In most cases it appears to be sporadic, although genetic mutations are often present.
There are currently no approved drug therapies for these conditions. ASP7486 represents a new targeted therapy that may address the underlying cause in the majority of these patients.
"We are delighted to enter into this agreement with a world class company like Astellas," said Mike Cola, Chief Executive Officer Aevi. "We believe that the mTOR pathway is a promising novel target with clinical proof of concept that may benefit many children and adults with these potentially devastating diseases. Entry into this license agreement highlights the broad potential of our unique R&D capabilities and further supports Aevi's strategy to rapidly bring novel and life altering therapies to children and adults suffering from rare and life-threatening orphan diseases.
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Aevi Genomic Medicine, Inc.