José l. Subiza, MD, PhD CEO-President,Inmunotek
If mass vaccination can control the spread of SARS-CoV-2, as can be expected, our prediction for the business in 2021 is quite good. Although in many countries the economic damage caused by lock-downs and restrictions has been enormous, this has not been the case in other or in all sectors, as exemplified by the pharma sector. However, once the pandemic is over, short and medium-term strong financial problems derived from COVID-19 can affect all business in some way, or another, during the following years.
The subsector of immunotherapies, including vaccines, has been reinforced globally by the challenge posed by COVID-19. A vast majority of people believe that having effective vaccines is the definitive solution to the current pandemic. The speed with which an effective vaccine against SARS-CoV-2 has been obtained using synthetic mRNA platforms, a task considered impossible in less than a year, besides an outstanding achievement, may represent a new era in vaccinology to urgently control a new virus outbreak. On the other hand, vaccines developed with more conventional platforms will be authorized in 2021 and the following years. This will make available a wide range of alternatives in terms of efficacy, safety and immunogenicity in the medium and long term.
This pandemic has also valued alternative immunotherapies, such as TIbVs (trained immunity-based vaccines), intended to increase nonspecific antiviral resistance in high-risk populations to fill the gap before a conventional vaccine is ready, or to improve the clinical effect of these vaccines in especially vulnerable subjects. INMUNOTEK has been working in recent years on two TIbV-candidates (MV130 and MV140) capable of conferring broad protection against recurrent infections of the respiratory (MV130) or urinary (MV140) tracts caused by viruses and/or bacteria. The pivotal clinical studies with MV130 in adults with patients with chronic-obstructive pulmonary disease (acute exacerbations triggered by bacteria and viruses) or children with recurrent wheezing attacks (triggered by viruses), or with MV140 in adult women with recurrent cystitis caused by bacteria, have been completed successfully. We are currently building full dossiers for both products to begin filing the registration procedure in several countries.
In the allergy immunotherapy field, we have progressed with the development of our new proprietary mannan-allergoid conjugated vaccines after successfully completing phase 2 dose-finding studies for house dust mites (sublingual and subcutaneous) and birch pollen (subcutaneous). Similar studies for grass pollen (sublingual and subcutaneous) are underway and will be completed in the first quarter of 2021. During this year (2021), a prospective open-label follow-up study will be conducted with mannan-conjugated birch pollen allergoids administered subcutaneously. Based on the results collected in the dose-finding studies (mites and birch pollen), phase 3 clinical trials for both allergens will be initiated.
Taken together, we see 2021 as a transition year to more normal times ahead of us. As this hopefully will be achieved by virtue of mass vaccination, this prophylactic approach and immunotherapy in general, will be widely recognized. This is good news for a company like INMUNOTEK focused on bringing new concepts in immunotherapy to market, in order to cover unmet needs of patients with recurrent infections, or allergies.