Isarna Therapeutics GmbH has announced that it has signed a strategic manufacturing agreement with Sanofi under which Sanofi will manufacture clinical- and commercial-grade antisense oligonucleotide (ASO) compounds for Isarna, enabling Isarna to advance its promising next generation ASOs rapidly into clinical trials. Financial details of the agreement have not been disclosed.
“At Isarna, we are convinced that the best possible manufacturing is critical as we seek to maintain an accelerated timeline for product development,” explained Dr. Philippe Calais, CEO of Isarna Therapeutics.
Dr. Calais continued, “Having Sanofi as our partner for the production of these exciting new immunotherapy compounds is a firm step forward in the development of the company and is consistent with our strategy to establish key relationships with leaders in the industry.”
As per the agreement, Sanofi’s Industrial Affairs division will act as Isarna Therapeutics’ contract manufacturing organization. Sanofi will scale-up and validate the production of ASOs and supply future commercial batches.
Isarna will benefit from Sanofi’s Commercial and External Partnership (CEPiA)’s organization, the commercial branch of Sanofi’s Industrial Affairs activities, which brings strong GMP manufacturing expertise within the field of ASOs.
The manufacturing site of Frankfurt, Germany, which will manufacture Isarna Therapeutics’ next generation ASOs, is FDA, EMEA and PMDA approved and has all the capabilities to support the registration of the compounds.