ISR Immune System Regulation Holding AB (publ) has signed agreements with Catalent to facilitate the development of its spray dried, SARS-CoV-2, dry powder, nasal vaccine, including and readiness for its phase III clinical campaign. Upon technical transfer to Catalent, the global leader in enabling pharma, and biotech partners to optimize product development, it will scale up production of the spray dried powder and provide analytical support from its Chelsea, Massachusetts, facility, which has extensive spray drying infrastructure and expertise necessary to meet clinical trial and commercial-scale volumes. ISR is now entering a new phase, which requires securing long-term partners, needed to produce its vaccine for phase III and the commercial market.

Iconovo is now starting part two of the previously signed cooperation agreement. Its trial investigators recently submitted clinical documentation to the BMRC (Ethics), to start the phase I/II vaccination study, and the ISR clinical team staff have established good working relationships with all involved for this phase I/II trial in Dhaka. The company is now looking to its pending phase III studies, where Catalent will be a key part of ISR's global supply chain.