Iconovo develops and licenses complete inhalation products with associated dry powder formulations based on the company's four inhalation platforms – ICOcap, ICOres, ICOone and ICOpre.
Iconovo's new agreement with ISR Immune System Regulation This specifically applies to the ICOone dry powder inhaler, which is intended for single use, making it particularly suitable for simple and cost-effective administration of vaccines.
Many advantages of inhalable vaccine
An inhalation vaccine in powder form, such as the one ISR is developing, has many advantages compared to a liquid-based one, including easier use, storage without the requirement for refrigeration temperature and cheaper transportation. In addition, there are also clinical advantages of a dry powder vaccine, such as reaching the affected area of the lung tissue directly and not requiring a needle stick with the risk of transmission of blood-borne virus.
Promising results in animal model
Earlier this year, ISR completed a challenge study with SARS-CoV-2 in mice transgenic for the ACE2 receptor and the results showed that mice administered two doses of the vaccine in the respiratory tract were fully protected against the virus. With this positive outcome behind them, the company moved on to the next phase of vaccine development, which is now taking place in collaboration with Iconovo, which has strong patent protection for ICOone in Europe and India and with several patent applications pending in China, the US and Japan.
»The potential for such an innovation will be enormous when it reaches the market. We believe that ICOone can in this way replace the injection of vaccines and several other important substances and thus offer a new, smarter way to use these drugs. Iconovo is a global leader and wants to act as a driving force in this development« – Johan Wäborg, CEO of Iconovo.
Clinical study begins H2, 2021
The agreement between the parties means that ISR receives an exclusive global right to use ICOone for vaccination against SARS-CoV-2, with a technology based on so-called spike proteins with adjuvant.
Iconovo undertakes to contract develop an inhalation product with the goal of testing it in a human clinical trial with the study start estimated for the second half of 2021. In the agreement, ISR has a future option to use its vaccination technology together with ICOone for the prevention of respiratory infections such as influenza, new COVID-XNUMX viruses and RSV based on the same technology.
High market potential
The parties rely on data from World Bank which shows that there are currently 3,9 billion people in lower-middle-income and low-income countries who will have later access to vaccines. A price benchmark is also made against AstraZeneca and J&J's vaccine that costs USD 8 – 10 per vaccination. This thus gives a total market potential of a total of USD 31 – 39 billion, depending on how high the vaccination rate for a stable inhaled vaccine is in these countries. Yesterday's press release also mentions a scenario where the virus mutates, which would require annual vaccinations as is done today for influenza. The market for annual influenza vaccinations is estimated to amount to at least USD 5,5 billion per year.
»This is a very important step on the way to bringing our inhaled vaccine against Covid-19 to market quickly and with a suitable disposable inhaler. We believe that the product will be of greatest benefit when used in developing countries with less access to cold and frozen storage and who have not progressed as far in their vaccination programs. We also hope that with an inhaled vaccine we will get a more adequate immune response in the lung that is patrolled by a different type of antibody« – Ola Winqvist, CEO of ISR
Milestone payments and royalties
The agreement has step-by-step payments of a so-called technology access fee of SEK 9,0 million which will be paid in five incremental milestones during the development to market approval, where the first of SEK 0,2 million was paid upon signature. ISR will also pay Iconovo for the contract development of the inhalation product which in an initial binding feasibility study amounts to SEK 3,6 million, followed by the manufacture of clinical trial material at a preliminary value of SEK 5,5 million. The agreement provides Iconovo with royalty income in low single digits over a 14-year period from launch.
The agreement means that Iconovo now has two projects in its portfolio of innovative inhalation projects – one with ISR for an inhalable Covid-19 vaccine and one with Monash University for inhalable oxytocin. BioStock will follow the development of both projects and potential future projects within the new strategic area of innovative inhalation products.
The content of BioStock's news and analysis is independent, but BioStock's operations are to some extent financed by companies in the industry. This post refers to a company from which BioStock has received funding.