Iconovo has signed an agreement with Immune System Regulation (ISR) for the development of an inhaled COVID-19 vaccine in Iconovo’s inhaler ICOone.

The agreement is Iconovo’s second agreement within its newest strategic area innovative inhalation projects. The agreement gives ISR exclusive rights to use ICOone for the treatment of COVID-19 and its variants with a technology based on so-called spike proteins with an adjuvant.

Iconovo will contractually develop an inhalation product with the aim to test the product in a human clinical trial targeted to start during the second half of 2021. In the agreement ISR receives an option to also use its vaccination technology in ICOone for influenza, RS-virus, and new strands of COVID-virus vaccines based on the same technology.

”With this project Iconovo widens its experience within the new strategic area innovative inhalation projects, and we look forward to more similar projects where we can contribute with our inhalation experience. It sends a strong signal to the market that more companies see ICOone as a suitable inhaler for innovative applications,” says Johan Wäborg, CEO of Iconovo.

Milestone payments

The agreement includes stepwise payments of a 9 MSEK technology access fee, set up as five increasing milestone payments over the development to market authorization. The first milestone of 0.2 MSEK was paid at the agreement signature. ISR will also pay Iconovo for the contract development of the inhalation product which in a first binding feasibility trial amounts to 3.6 MSEK, followed by the production of clinical trial material at a preliminary value of 5.5 MSEK. Additionally, the agreement will give Iconovo low single-digit percentage royalties over a period of 14 years from market launch.

“We believe that the product will be of greatest use in developing countries with restricted access to refrigeration and where the vaccination programs have not advanced yet.”

ISR has previously shown in animal models that its vaccine gives good protection against covid and this is the next step in the development of a spray-dried inhaled vaccine formulation for use in Iconovo’s single-use inhaler ICOone. An inhaled formulation gives important benefits such as ease of use, cheaper transportation, storage without the need for refrigeration and no handling of needles and syringes. To remove the need for refrigeration and the handling of contagious material represent a large savings potential and can potentially eliminate the risk of spreading disease through infected needles. Another important benefit is that the vaccine directly reaches the affected area in the pulmonary tissue that will give the needed type of immune response for protection.

“This is a very important step towards taking our inhaled covid-19 vaccine to the market quickly with a suitable single-use inhaler. We believe that the product will be of greatest use in developing countries with restricted access to refrigeration and where the vaccination programs have not advanced yet. We also hope that an inhaled vaccine will give a more adequate immune reaction in the lung which is patrolled by another type of anti-body,” says Ola Winqvist, CEO of ISR.

“The potential for an innovation like this will be huge if it reaches the market. We believe that ICOone has the potential to replace injections of vaccines and other important molecules, thereby offering a smarter way to administer these pharmaceuticals. Iconovo is a global leader and wants to act as a driving force in this development,” said Johan Wäborg.

Photo of Johan Wäborg and Ola Winqvist