Boehringer Ingelheim signs gene therapy manufacturing deal with AnGes

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Boehringer Ingelheim’s BioXcellence contract development and manufacturing organisation (CDMO) has agreed a new deal with AnGes to supply the drug substance for its peripheral arterial disease treatment.

AnGes recently completed the clinical trials programme for its Hepatocyte Growth Factor (HGF) gene therapy product Collategene and is preparing to submit its Biologics License Application to US regulators.

The Tokyo-headquartered biopharmaceutical firm’s manufacturing agreement builds on its existing collaboration with BioXcellence that has seen the CDMO’s microbial technology in E. coli used to manufacture Collategene’s active pharmaceutical ingredient (API).

That plasmid DNA molecule has been made at Boehringer‘s Vienna site since the companies’ clinical trial supply agreement began nearly 20 years ago.

Ute Lehmann, BioXcellence’s Head of Key Account Management and Business Development, said: “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.

“We deeply value the opportunity to collaborate with AnGes on their journey toward product launch, and we look forward to contributing to the future success of this important partnership.”

A chronic arterial occlusive disease of the lower extremities, peripheral arterial disease (PAD) is caused by atherosclerosis and affects over 200 million people around the world. It can lead to a range of potentially serious complications, including ulceration, infection and limb amputation.

Collategene received a Breakthrough Therapy designation from the FDA in September 2024 on the back of favourable phase II clinical trial results and in expectation that the gene therapy could provide significant improvement over existing treatments for PAD.

AnGes said further updates about Collategene’s Chemistry, Manufacturing, and Controls (CMC) would be provided to the US Food and Drug Administration (FDA) along with a pre-BLA meeting in the near future.