Press release 2022-06-28
ISR 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 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 product”.
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.
For more information, please contact:
Ola Winqvist, CEO, ISR Immune System Regulation Holding AB (publ) Email: firstname.lastname@example.org
About ISR Immune System Regulation Holding AB (publ)
ISR is an innovation-driven drug development company in the field of immunotherapy. The company’s business model is to convert promising preclinical immunological research into next generation vaccine products. By stimulating the immune system in conjuction with the administration of a target immunostimulatory immunolids and Immunorhelins molecules, The company aims to fight chronic infections such as HiV, HBV and cancer.
The company has its headquarters in Stockholm.
Mangold Fondkommission AB is the company’s Certified Adviser and can be reached at +46850301550
Catalent is the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world. With broad and deep scale and expertise in development sciences, delivery technologies, and multi-modality manufacturing, Catalent is a preferred industry partner for personalized medicines, consumer health brand extensions, and blockbuster drugs. Catalent helps accelerate over 1,000 partner programs and launch over 150 new products every year. Its flexible manufacturing platforms at over 50 global sites supply over 70 billion doses of nearly 7,000 products to over 1,000 customers annually. Catalent’s expert workforce exceeds 19,000, including more than 2,500 scientists and technicians. Headquartered in Somerset, New Jersey, the company generated $4 billion in revenue in its 2021 fiscal year. For more information, visit www.catalent.com.
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About Catalent Inhalation (Dry Powders and Nasal)
Catalent Inhalation has the capabilities, expertise and state-of-the-art facilities to expedite product development, from concept and feasibility studies through commercial manufacture and release testing. With over 30 years of inhalation product experience, Catalent can handle the most complex projects and help bring your therapy to market, faster. Whether a single service or a comprehensive development package is required, Catalent offers end-to-end expertise in Dry Powder Inhalers (DPIs), unit-dose, bi-dose and preserved multi-dose nasal sprays.