Beskrivning
| Land | Sverige |
|---|---|
| Lista | First North Stockholm |
| Sektor | Hälsovård |
| Industri | Bioteknik |
ISR has signed agreements with Catalent to facilitate the development of its spray dried, SARS-CoV-2, dry powder, nasal vaccine, including 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 has taken another important step in the development of our next generation of Covid-19 vaccine. This agreement with Catalent will allow ISR to produce our formulation at a scale suitable to support our pivotal clinical program. In combination with the Gerresheimer collaboration previously announced, ISR is establishing the global supply chain it needs to support the future launch of our exciting dry powder, nasal, SARS-CoV-2 vaccine," commented Ola Winqvist, CEO of ISR.
"ISR's decades of experience in immunology, coupled with Catalent's expertise in spray drying, and scaling up multiple programs will support ISR as they progress toward commercializing this nasally-inhaled vaccine against Covid-19," said Jonathan Arnold, President of Oral and Specialty Delivery at Catalent. "We are delighted to be partnering with ISR on this important program".
ISR is now entering a new phase of development and commercialization, which requires securing long-term partners, needed to produce its vaccine for phase III clinical studies and the 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 clinical trial in Dhaka. The company is now planning its pending phase III studies, where Catalent will be a key part of ISR's global production and supply chain.