Biostock published April 28th an article about Iconovo that can be found in its entirety below

Iconovo has invested heavily in developing a new pre-metered dual cavity inhaler under the name ICOpre. The company is now presenting the inhaler to the outside world for the first time at the international Respiratory Drug Delivery 2021 conference. Details of the design, function and development process of ICOpre will be presented at a workshop at the RDD conference.

Iconovo develops complete inhalation products, i.e., inhalers and associated dry powder formulations, which are licensed to pharmaceutical and generic companies. This means that customers do not have to carry out complex and costly stages in the development process, leading to a faster way to the inhalation market together with lower risk and lower cost.

The fourth and latest addition to Iconovo’s family with inhalation platforms is the pre-filled dual cavity inhaler ICOpre. Yesterday, the company announced that ICOpre will be shown publicly for the first time at a workshop at the Respiratory Drug Delivery 2021 (RDD) virtual conference, which will take place 4-7 May. During the workshop, ICOpre will be used as an example of how Iconovo’s concept can help overcome challenges when developing generic inhalation products.

ICOpre is a significant investment

Iconovo made the decision to develop this new inhalation platform in 2019. Even then, the company had announced that the new platform would be a generic version of GlaxoSmithKline’s Ellipta, both in terms of inhaler and powder formulations, and that the platform would be intended for a global market including the US.

»This is the biggest and most important investment in Iconovo’s five-year history. With the ICOpre-platform we will be able to reach, not only the European market, but also the very valuable US market.« – Orest Lastow, CTO Iconovo 

Since then, Iconovo has made significant progress in the development of ICOpre. The development started in the first quarter of 2020, and, after less than 12 months of development, excellent in vitro equivalence with the original Ellipta was achieved. According to Iconovo, ICOpre has been developed in Iconovo’s own laboratories by experts in inhaler engineering, powder formulations and analytical characterisation.

Workshop at RDD 2021

The newly developed inhaler will now be presented to the outside world for the first time at the RDD conference. This is a large international conference for researchers, regulators, business professionals and suppliers active in pulmonary and nasal drug administration.

At the conference, Iconovo will arrange a workshop with the theme ”Development of a Generic Dry Powder Inhaler Platform for a Global Market.” During the workshop Iconovo will present the design, different features and development process of ICOpre.

The idea of the workshop is to use ICOpre as an example to show how an integrated development process can accelerate the development time of a complete inhalation product. Dr Orest Lastow, CTO of Iconovo, founder and inventor of Iconovo’s inhalers, will show an on-demand video on ICOpre that can be seen by participants at RDD.

The ICOpre design

Iconovo’s newly developed ICOpre

ICOpre is a pre-metered dual cavity dry powder inhaler with 30 doses individually sealed and protected by aluminum foil. A dose counter shows the number of remaining doses and the exterior of the inhaler has a Scandinavian design according to the company. The inhaler is operated in three steps: open-inhale-close. Each dose comes from two compartments that are inhaled simultaneously, which makes ICOpre suitable for mono, duo or triple products.

ICOpre is designed to be operated in the same way as GSK’s Ellipta, however, ICOpre is based on aproprietary mechanism with an injection-molded disk and cavity opening. Thanks to its unique technical solutions, ICOpre is not limited by Ellipta’s patent protection, which lasts until 2030. This minimises the risk of patent infringement and enables Iconovo to obtain patent protection for ICOpre for 20 years. The first twopatent applications for ICOpre were filed in February 2021.

Great market potential for generic products of Ellipta

The idea is that ICOpre will become an AB-rated (therapeutic equivalent) substitute for GSK’s Ellipta portfolio,which currently consists of five inhalation products: Relvar/Breo, Anoro, Incruse, Trelegy and Arnuity. Total sales of these products are expected to increase to 4.9 BUSD by 2025.

GSK has patent protection for both the inhaler and the drug substances in the inhalation products. When the patents and market exclusivity for the drug substances expire, a major market opportunity is opened up for generic products.

Ready for five launches

Iconovo is carrying out the parallel development of generics for all Ellipta products and plans to out-license these products to a potential partner, which is expected to take place in H1 2022. Iconovo aims to be ready for launch at the time of patent expiry for each of the products in the Ellipta portfolio.

The first patent that expires concerns Breo/Relvar in 2025 in the US. Iconovo plans to launch a generic Breo/Relvar product in the valuable US market soon after that patent expiration. According to Iconovo, such a product has a sales potential of at least 100-150 million USD. However, the main launch is expected for 2030 with the launch of a generic Trelegy, the best-selling inhalation product in the Ellipta portfolio.

The presentation of ICOpre at RDD is a stepping stone towards finding suitable partners and eventuallylaunching up to five generic products that are expected to create great value for Iconovo.

Read the article at the Biostock webpage

Biostock published April 23th an article about Iconovo that can be found in its entirety below

ICOone is Iconovo’s single-dose inhaler for simple and cost-effective administration of vaccines and biomolecules. The first US patent has now been approved for the inhaler and thus the company has approved patents for ICOone in Sweden, Europe (EPO), India, and the USA. The patents for ICOone provide, among other things, strong protection for the Covid-19 vaccination opportunities that Iconovo is exploring together with ISR Immune System Regulation.

Iconovo, based in Lund, is a company with expertise in inhalers and dry powder formulations that has developed four inhalation platforms – ICOone, ICOcap, ICOres and ICOpre.

In March, a patent for ICOone was approved in India and Iconovo has now announced that the US Patent and Trademark Office also intends to approve a patent for ICOone. Iconovo’s CTO and founder Orest Lastow commented the importance of this new patent:

»This patent is a confirmation that ICOone is a very unique and innovative inhaler. With granted patents in USA, EU and India we now have a very strong protection on markets in great need of simple and cost-effective vaccination« – Dr. Orest Lastow, CTO Iconovo 

Exciting vaccine opportunities

ICOone

The approved patent in the US is not the only positive news for ICOone in April. At the beginning of the month, Iconovo entered into a collaboration with ISR Immune System Regulation for the development of Covid-19 inhalation vaccine in ICOone. The inhaler is intended for single use, and the manufacturing cost is very low, which makes it ideal for this purpose.

In addition, there are several advantages with dry powder vaccines, such as simpler administration and cheaper and smoother transport/storage without low temperature requirements. The use of inhaled vaccines eliminates the need for disposable syringes and thus avoids the build-up of hazardous waste with blood contaminated material. The simple design enables healthcare professionals, but also patients, to learn how to handle the inhaler with minimal training, making it very user friendly.

Oxytocin for postpartum bleeding

The patent for ICOone in the US will also provide immaterial protection for the use of the inhaler to develop inhaled oxytocin against postpartum haemorrhage (PPH). The drug product is currently being developed for a first clinical trial together with Monash University. In 2019, more than 3.7 million babies were born in the United States, which means that there is great market potential for the inhaled oxytocin against PPH in thecountry.

Iconovo also has pending patent applications for ICOone in China and Japan, two large and importantmarkets. With the first US patent for ICOone secured, Iconovo continues its work to strengthen patentprotection for its inhalation products on key markets.

The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.

 

Read the article at the Biostock webpage

United States Patent and Trademark Office has announced the intention to grant a patent (Notice of Allowance) regarding Iconovo’s inhalation device ICOone. Iconovo has previously granted ICOone patents in Sweden, Europe (EPO) and India. The new patent covers a unit dose inhaler used in Iconovo’s two innovative customer projects with Oxytocin and Covid-19 vaccine.

ICOone® is Iconovo’s platform for simple and cost-efficient delivery of vaccines and biomolecules to the lung. Since ICOone® delivers a dry powder, there is no need for expensive and complicated cold storage. Inhaling the drug eliminates the use of disposable syringes and no hazardous waste with blood contaminated syringes is generated.

”This patent is a confirmation that ICOone is a very unique and innovative inhaler. With granted patents in USA, EU and India we now have a very strong protection on markets in great need of simple and cost-effective vaccination”, says CTO Dr. Orest Lastow.

About ICOone®

ICOone® is a unique, patented dry powder inhaler for single use. The smart design generates an ultra-low manufacturing cost combined with simple and discreet use. It is particularly suitable for short-term treatment and as-needed use as it provides an unsurpassed low treatment cost and price point for treatments with a low number of doses. The simple design also enables patients and caregivers to learn how to handle the inhalers with minimal training. ICOone® can deliver large inhalation doses that are well protected against moisture, an important factor for many biomolecules.

Ett svenskutvecklat covidvaccin som ges med en svensk inhalator till behövande i stora delar av världen. Det är målet när ISR köper rättigheterna till att använda Iconovos engångsinhalator för sitt covid-19-vaccin som är under utveckling.

– Möjligheterna är enorma om produkten når marknaden, säger Iconovos vd Johan Wäborg till Life Science Sweden.

Artikeln i sin helhet, se Life Science Sweden.

 

Biostock published April 1th an article about Iconovo that can be found in its entirety below

Yesterday, Inhalation device company Iconovo, which offers complete inhalation products, signed an agreement with immunotherapy company ISR Immune System Regulation. The agreement concerns the development of an inhalation vaccine against Covid-19 in Iconovo’s disposable inhaler ICOone. The parties see significant potential for the product, which is expected to be tested thoroughly in humans in the second half of 2021.

Iconovo develops and outlicenses 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 specifically applies to the single-use dry powder inhaler ICOone, making it particularly suitable for easy and cost-effective administration of vaccines.

Many benefits of inhalable vaccines

An inhaled dry powdered vaccine, like the one ISR develops, has many advantages over a liquid-based one, including being user-friendly, not requiring refrigerated storage and being cheaper to transport. In addition, there are also clinical benefits of a dry powder vaccine; it reaches the affected area of the lung tissue directly, and it does not require needle jabs with the risk of transmission of blood-borne viruses.

Promising results in an animal model

Earlier this year, ISR completed a provocation study with SARS-CoV-2 in mice transgenic for the ACE2 receptor, and results showed that the mice that were administered two doses of the vaccine in the respiratory tract were fully protected against the virus. With this positive outcome behind it, the company moved on to the next phase of vaccine development, which is now under joint management with Iconovo, which has strong patent protection for ICOone in Europe and India and with several patent applications under consideration in China, the US and Japan.

»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« — Johan Wäborg, CEO of Iconovo.

Clinical study begins H2, 2021

ICOone

The agreement between the parties gives ISR an exclusive global right to use ICOone for vaccination against SARS-CoV-2, using a technology based on the virus’s spike proteins with adjuvant.

Iconovo’s commitment is to contractually develop an inhalation product with the goal of evaluating it in a clinical study starting in 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, RS-virus, and new strands of Covid virus vaccines based on the same technology.

High market potential

The parties rely on World Bank data showing that there are currently 3.9 billion people in lower-middle-income and low-income countries that will have later access to vaccines. The data also creates a price benchmark against AstraZeneca’s and J&J’s vaccines, which cost USD 8 – 10 per vaccination. This thus provides a total market potential of USD 31-39 billion, depending on the vaccination rate of a stable inhaled vaccine in these countries. Yesterday’s press release also mentions a scenario in which the virus mutates, which would require annual vaccinations as is happening today for influenza. The market for annual flu vaccinations is estimated at least USD 5.5 billion per year.

»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« – Ola Winqvist, CEO of ISR

Milestone payments and royalties

The agreement includes stepwise payments of a 9 MSEK technology access fee, set up as five increasing milestone payments over the development to market authorisation. 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.

The agreement means that Iconovo now has two projects in its innovative inhalation project portfolio – one with ISRfor an inhalable Covid-19 vaccine and one with Monash University for inhalable oxytocin. BioStock will follow thedevelopment of both projects and potential future projects in the new strategic area of innovative inhalation products.

Read the article at the Biostock webpage

Iconovo AB (publ), a company developing complete inhalation products for a global market, today announced that it has signed an agreement with the immunotherapy company Immune System Regulation AB (ISR), an affiliate to ISR Immune System Regulation Holding AB (publ), 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 and confirms the suitability of ICOone to be used also for vaccines.

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.

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.

Today there are 3.9 billion people in lower-middle-income and low-income countries who will have a late access to covid-19 vaccines, according to the World Bank. With a price corresponding to the vaccines from AstraZeneca or J&J (8 – 10 USD per vaccination) this represents a full market potential of totally 31 – 39 billion USD. The size of the sales potential for an inhaled covid vaccine will depend on the rate of vaccination in these countries. There is also a scenario where the virus will mutate and, in the future, create the need for annual vaccinations similar to how influenza is managed today. As a comparison, the market for annual influenza vaccinations amount to at least 5.5 billion USD per year.

”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.

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,” said 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.

About ISR

ISR is an innovation-driven development company of pharmaceuticals within immunotherapy. The business idea is to convert preclinical immunological research to clinical development stimulating the the immune system to fight chronic infections like HIV, HBV and cancer by developing the company’s pipeline of immunostimulants Immunolider and Immunorheliner and utilize the immune system to develop designer vaccines. The company has its headquarter in Stockholm.

About ICOone®

ICOone is a unique, patented dry powder inhaler for single use. The smart design generates an ultra-low manufacturing cost combined with simple and discreet use. It is particularly suitable for short-term treatment and as-needed use as it provides an unsurpassed low treatment cost and price point for treatments with a low number of doses. The simple design also enables patients and caregivers to learn how to handle the inhalers with minimal training. ICOone can deliver large inhalation doses that are well protected against moisture, an important factor for many biomolecules.

Biostock published March 16th an article about Iconovo that can be found in its entirety below

Last week, Iconovo announced that they have been granted their first patent in India for the inhaler ICOone. The patent opens up significant opportunities for innovative inhalation products, such as inhalable vaccines and biomolecules. Iconovo has already begun a development project with the biomolecule oxytocin with the aim of preventing major bleeding in women after childbirth.

Iconovo develops and outlicenses complete inhalation products with associated dry powder formulation based on the company’s four inhalation platforms – ICOcap, ICOres, ICOone and ICOpre. The company recently received a patent in India for ICOone, a user-friendly disposable inhaler with a low manufacturing cost.

 At the end of 2020, Iconovo entered into collaboration with Monash University in Australia for the development of inhaled ocytoxin in ICOone to prevent Postpartum Haemorrhage (PPH), i.e., severe blood loss after childbirth. PPH is globally the most common cause of maternal mortality with approximately 60,000 deaths annually. Read more about the collaboration with Monash University here. 

First granted patent in India for ICOone

Iconovo already has approved patents on ICOone in Europe and recently India was added to the list of countries with approved patents for the inhalation platform. Several patent applications are also pending in China, the US, and Japan.

The ICOone patent in India will be important in Iconovo’s cooperation with Monash University as India is one of the countries with major problems with PPH. India accounts for about 19 per cent of global maternal mortality, with PPH as the main cause.

Today, oxytocin is injected to avoid major bleeding in the mother following childbirth. However, it is far from all mothers who receive such an injection, especially in India and other developing countries. Injectable oxytocin requires refrigeration storage, which can be difficult to maintain in regions with limited infrastructure.

ICOone has broad potential

Iconovo also sees opportunities in India for other innovative inhalation products, such as dry powder vaccines instead of the temperature-sensitive liquid form:

»A patent in India is extremely important for us since it is a large potential market for which ICOone is particularly well suited. A cheap, simple and safe way to supply vaccines to a large population is of great interest to many of our potential customers, not the least in India« – Orest Lastow, CTO and founder, Iconovo 

The ICOone dry powder inhaler is intended for single use, which makes it particularly suitable for administering vaccines in a simple and cost-effective way. ICOone is also adapted for the administration of biomolecules as it can deliver large inhalation doses that are well protected against moisture, which is important for many biomolecules.

ICOone contains a dry powder and does not require cold storage, which can otherwise be problematic and expensive when transporting and storing, for example, vaccines in liquid form. Inhalable vaccine also eliminates the use of syringes and the hazardous waste that occurs from injections. Iconovo founder Orest Lastow talks more about this in an article in MEDTECH Outlook.

Iconovo’s CEO Johan Wäborg also highlights ICOone’s potential in a presentation from the latest edition of BioStock Live. Like Lastow, Wäborg sees great potential in inhaled vaccines, but also in emergency medicine where syringes are often used, for example, in allergic reactions, epilepsy, hypoglycemia and heart attacks.

New inhalation products

In the past, Iconovo has mainly focused on the development of generic products for the treatment of COPD and asthma, which is a significant market with over 590 million people affected worldwide. Now the company also has its sights set on innovative inhalation products, which the Monash project exemplifies.

Several other companies have previously successfully developed such inhalation products. One example is Mannkind, which has developed an inhalable insulin that was approved by the FDA in 2014. Furthermore, Relief Therapeutics has developed the vascular dilator aviptadil which is currently being evaluated in inhaled form for the treatment of severe Covid-19, but which has previously been used for the treatment of erectile dysfunction. Another example is Alexza Therapeutics, which has developed the inhalation drug loxapine for the treatment of schizophrenia and bipolar disorder.

These are just a few examples of companies that are an inspiration to Iconovo in their own development of innovative inhalation products and BioStock will continue to follow Iconovo’s advancement in the field.

Read the article at the Biostock webpage

Iconovo deltar på Stockholm Corporate Finance 13e Life Science Seminarium den 23 mars 2021, kl. 11.00 då VD Johan Wäborg presenterar senaste utvecklingen och framtiden för bolaget. Stockholm Corporate Finance arrangerar kapitalmarknadsdagen för trettonde året i rad. Om du vill anmäla dig som deltagare till kapitalmarknadsdagen så använd denna länk,
https://www.lyyti.fi/reg/scf-life-science-seminarium-2021