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Belief BioMed Congratulates Partner AskBio on IND Acceptance by FDA for Investigational Gene Therapy for Late-Onset Pompe Disease
AskBio Inc. (AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, recently announced that the United States Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for AB-1009, an investigational adeno-associated virus (AAV) gene therapy being developed for the treatment of late-onset Pompe disease. With this announcement, the AB-1009 program advances to Phase 1/2, and AskBio initiates a clinical trial in the
About this update from Bayer Ag
[{"type":"text","content":"SHANGHAI, Jan. 15, 2026 /PRNewswire/ -- AskBio Inc. (AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, recently announced that the United States Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for AB-1009, an investigational adeno-associated virus (AAV) gene therapy being developed for the treatment of late-onset Pompe disease. With this announcement, the AB-1009 program advances to Phase 1/2, and AskBio initiates a clinical trial in the United States to explore the safety of AB-1009. The company anticipates recruiting its first patient in early 2026 [1].","length":659,"tagName":"p"},{"type":"text","content":"In September 2024, Belief BioMed (BBM) and AskBio entered astrategic collaboration to explore the potential for new gene therapies [2]. BBM granted AskBio a sublicense to use the proprietary AAV capsid in the AB-1009 program and provided AAV vector production services. Within the collaborative development framework, BBM worked closely with the AskBio team, and its contributions were instrumental to the IND acceptance.","length":421,"tagName":"p"},{"type":"text","content":"Dr. Xiao Xiao, Co-founder, Chairman and Chief Science Officer of Belief BioMed, said, "We are delighted to learn that our partner AskBio has received IND acceptance for its gene therapy. This marks a significant milestone in our strategic collaboration and represents a practical achievement in globalized innovation within the gene therapy field. On behalf of Belief BioMed, I extend our sincere congratulations to the AskBio team! This IND acceptance reflects AskBio's outstanding R&D capabilities and efficient clinical advancement, while also demonstrating the strong synergy between our technological resources and platforms. Looking ahead, Belief BioMed hopes to deepen our collaboration with AskBio to accelerate the global development of innovative therapies."","length":791,"tagName":"p"},{"type":"text","content":"About Pompe Disease","length":19,"tagName":"p"},{"type":"text","content":"Pompe disease is an inherited lysosomal storage disorder caused by deficiency of the enzyme acid alpha-glucosidase (GAA). Reduced or absent levels of GAA lead to accumulation of glycogen in cells, which is believed to result in the clinical manifestations o...