Together with ISR, Iconovo is developing an inhaled Covid-19 vaccine in ICOone and a nasal version in ICOone Nasal. ISR has now signed a MoU agreement with the CRO Bangladesh Clinical Trials for a clinical phase I study with the vaccine, as well as with UniMed UniHealth Pharmaceuticals for manufacturing and distribution in Bangladesh. However, these agreements are only declarations of intent, not binding agreements, but they are nevertheless good news for Iconovo as it means significant progress within the vaccine project.

Iconovo develops inhalation products that are licensed to other companies to accelerate development and quickly reach the inhalation market.

One of Iconovo’s partners is ISR Immune System Regulation, a Stockholm-based pharmaceutical and research company that, among other things, has a vaccine candidate against SARS-CoV-2 under development.

ISR has developed two dosage forms of the Covid-19 vaccine, one for inhalation through the mouth down to the lungs and one for intranasal application (in the nose). ISR will test which of the routes of administration provides the best immune response and protection against the virus. The company has selected Iconovo’s inhalers ICOone and ICOone Nasal for this purpose.

Broadened collaboration

In late March, Iconovo and ISR announced an agreement giving ISR global exclusive rights to use Iconovo’s ICOoneinhaler for vaccination against SARS-CoV-2. Since then, the collaboration has been broadened to include a nasal version with Iconovo’s new platform ICOone Nasal. There can be great value in having two formulations according to ISR because they can individually lead to market registration. Ola Winqvist, CEO of ISR, said in a press release that he saw the collaboration as a start of a long-term partnership with Iconovo to develop a series of vaccines.

Several benefits with inhaled vaccines

Inhaled/nasal vaccines have a number of advantages over vaccines given in injection form. One advantage is its ease of use – with Iconovo’s inhalers ICOone and ICOone Nasal, patients can administer the vaccine themselves without the aid of a healthcare professional. Vaccine powder formulations for inhalation translated to cheaper transport and storage without the need for cooling or freezing temperature, which can be of great benefit in developing countries. In addition, needle sticks and handling of syringes and other contagious waste are avoided.

MoU agreement for clinical study in Bangladesh

ISR and Iconovo are preparing for a phase I clinical study with the inhaled/nasal Covid-19 vaccine to evaluate the safety, dose, route of administration, immunogenicity, and efficacy of the inhalable/nasal vaccine.

ISR is now evaluating the possibility of conducting the study in Bangladesh as the company has entered into a memorandum of understanding (MoU) with the CRO Bangladesh Clinical Trials, and the two principal investigators Prof Dr ABM Abdullah and Prof Dr Ahmedul Kabir at Mugda Medical College Hospital in Dhaka. In a recent press release, ISR’s CEO Ola Winqvist mentioned how pleased he is to have made contact with these experts:

»We are very pleased to work with experts from Bangladesh to conduct a phase I clinical study with our vaccine formulations designed for optimal immune response at the entrance for the SARS-CoV-2 virus, respiratory tract.«

MoU with UniMed for manufacturing and distribution

In addition to conducting the study in Bangladesh, ISR is also exploring the possibility of producing the Covid-19 vaccine in the country. In early August, ISR announced that it had entered into a MoU agreement with UniMed UniHealth Pharmaceuticals, one of the largest pharmaceutical companies in Bangladesh. The purpose of the MoU is to agree on a long-term cooperation agreement in which Unimed can potentially obtain exclusive rights to manufacture and distribute the vaccine against SARS-CoV-2 in Bangladesh.

If the two parties enter into a licensing agreement, it would mean that ISR would receive compensation in the form of payments upon signing and upon market approval, as well as a double-digit royalty. However, the MoU agreement with UniMed is only a preliminary agreement and not legally binding. The company is currently in negotiations with various parties regarding the delivery of the Covid-19 vaccine.

Great need for vaccine in Bangladesh

In a press release, Ola Winqvist emphasised that Bangladesh has been hit hard by the pandemic and is in dire need of a vaccine against Covid-19 and subsequent mutations. The goal is a quick path to market approval to reach the large population of 160 million people with the inhaled/nasal vaccine.

ISR’s and Iconovo’s vaccine project is now proceeding at a high pace. According to ISR, UniMed has the resources needed to produce and distribute the Covid-19 vaccine effectively. UniMed can produce up to 100 million vaccine units per year and the goal is to be able to produce up to 300 million units or more annually within 5 years. In addition, the ISR’s CEO believes that Iconovo’s platforms ICOone and ICOone Nasal can accelerate the development further: 

»The platform of ICOone with its flexibility enables a rapid, affordable and effective development of a SARS-CoV-2 vaccine for the respiratory tract. The platform can make ISR’s vaccine available on the global market shortly after conducting clinical studies.«

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.

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