AskBio Inc, a gene therapy company that operates as a wholly owned yet independent subsidiary of Bayer AG, has announced that the US Food and Drug Administration has accepted its Investigational New Drug application for AB 1009. The therapy is an adeno associated virus based gene treatment being developed for patients with late onset Pompe disease. With the IND now cleared, AskBio will move the AB 1009 program into a Phase one slash two clinical study in the United States. The company expects to enroll its first patient in early 2026 as part of the initial safety evaluation.
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The IND acceptance follows a strategic collaboration formed in September 2024 between AskBio and Belief BioMed. Under this partnership, the two companies agreed to explore the development of next generation gene therapies. As part of the agreement, Belief BioMed granted AskBio a sublicense to use its proprietary AAV capsid technology for the AB 1009 program and also supported the effort through AAV vector manufacturing services. Throughout the development process, teams from both organizations worked closely together, with Belief BioMed playing a key role in supporting the data and technical requirements that led to the IND clearance.
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Dr Xiao Xiao, Co founder Chairman and Chief Science Officer of Belief BioMed, shared that the company was pleased to see AskBio reach this important regulatory milestone. He noted that the IND acceptance reflects the strong research capabilities and execution strength of the AskBio team, as well as the value created through close collaboration between the two organizations. Dr Xiao emphasized that this progress highlights how shared technology platforms and aligned development efforts can accelerate innovation in the global gene therapy landscape. He added that Belief BioMed looks forward to expanding its partnership with AskBio to help advance new therapies for patients worldwide.
The FDA decision marks a significant step forward for the AB 1009 program and underscores the growing momentum behind collaborative approaches to developing gene therapies for rare diseases such as late onset Pompe disease.
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