Boehringer Ingelheim Partners with AnGes for HGF Gene Therapy Manufacturing Ahead of FDA Filing
核心洞察
Boehringer Ingelheim has signed a contract development and manufacturing agreement with AnGes for the drug substance of their investigational hepatocyte growth factor gene therapy targeting peripheral arterial disease (搜索).
The partnership follows AnGes' completion of clinical trials and plans to submit a biologics license application to the FDA for their HGF gene therapy (搜索) product.
Peripheral arterial disease (搜索) affects 200 million people worldwide and can lead to severe complications including ulceration, infection, and limb amputation with mortality rates comparable to cancer.
Boehringer Ingelheim has announced a contract development and manufacturing agreement with AnGes Inc (搜索). for the drug substance of AnGes' investigational hepatocyte growth factor (HGF) gene therapy targeting peripheral arterial disease (搜索) (PAD (搜索)). The partnership positions both companies to advance toward regulatory approval following AnGes' completion of clinical trials.
The agreement follows AnGes' August 8, 2025 announcement confirming the completion of clinical studies and its intention to proceed with a Biologics License Application (BLA) to the FDA. AnGes had previously indicated that final arrangements for a supply agreement were underway, which have now been formalized with Boehringer Ingelheim.
Manufacturing Partnership Details
Boehringer Ingelheim BioXcellence, the biopharmaceutical contract manufacturing division of Boehringer Ingelheim, will serve as the contract development and manufacturing organization (CDMO) for AnGes. The company will be responsible for manufacturing and supplying the active pharmaceutical ingredient of the HGF gene therapy (搜索) product.
The plasmid DNA molecule has been manufactured using proprietary microbial technology in E. coli at Boehringer's facility in Vienna, Austria, since the collaboration for clinical trial supply began nearly 20 years ago. This long-standing partnership demonstrates the established manufacturing capabilities and regulatory experience between the two companies.
"We proudly collaborate with Boehringer Ingelheim BioXcellence, one of the top manufacturers of drugs and biologics in the world, and look forward to our mutual efforts toward a successful FDA approval," said Ei Yamada, PhD, President & CEO of AnGes.
Regulatory Pathway Forward
AnGes plans to provide updates regarding Chemistry, Manufacturing, and Controls (CMC) to the FDA along with a pre-BLA meeting in the near future. This represents a critical step in the regulatory approval process as the company prepares its comprehensive BLA submission.
Ute Lehmann, Head of Key Account Management and Business Development at Boehringer Ingelheim BioXcellence, emphasized the company's commitment to supporting partners through regulatory milestones: "At Boehringer Ingelheim BioXcellence, we are committed to leveraging our expertise in biologics manufacturing. Therefore, we support our partners with high-quality, reliable manufacturing services to help them reach key regulatory milestones, such as FDA BLA approval, and to bring innovative therapies to patients worldwide."
Addressing Critical Medical Need
PAD (搜索) represents a significant global health challenge, affecting 200 million people worldwide. The condition can lead to extremely devastating complications in the lower extremity, including ulceration, infection, and ultimately limb amputation. According to research by Armstrong et al., the 5-year mortality rate following a major lower extremity amputation (57%) is second only to lung cancer (80%).
The Global Vascular Guidelines recommend initiation of treatment in the early stages of PAD (搜索). Starting treatment with HGF gene therapy (搜索) product for patients with PAD in a relatively early stage may contribute to increased ulcer- and amputation-free days, thereby improving the patient's quality of life and preventing infections and amputations.
The manufacturing agreement represents a significant milestone in bringing this potential gene therapy to patients with PAD (搜索), leveraging Boehringer Ingelheim's established biologics manufacturing expertise and AnGes' innovative therapeutic approach to address this critical unmet medical need.