Periodic Reporting for period 1 - VACCELERAID (A novel vaccine technology leading to accelerated availability of vaccines and improved delivery)
Reporting period: 2016-11-01 to 2017-04-30
Common to some vaccines is the long lead-time before a respective vaccine can be made available to the public. Manufacturing methods might be very time consuming with challenging scale-ups, in particular if sudden demands have to be met. However, the ability to start vaccination campaigns earlier than currently possible would be particularly advantageous in view of seasonal influenza, influenza pandemics or sudden outbreaks of dangerous, hereto unknown infectious diseases. Resulting delays of initiation of vaccination campaigns definitely pose a high risk for health and lives of many people.
Long-term and overall objective of VACCELERAID:
(1) To validate and commercialize a novel technology platform for faster, safer, adjuvant-free, more efficient and more cost-effective manufacturing and delivery of vaccines for prevention of infectious diseases.
(2) Geza Ad Ltd. (GZA) aims at marketing approval of a novel influenza vaccine resulting from said technology. The technology has further potential for use in other indications.
(3) The business model of GZA will be based upon co-development and licensing agreements with established pharma companies active in the vaccine sector. GZA will receive milestone payments and royalties based on their global vaccine sales.
Long-term and overall objective of VACCELERAID:
(1) To validate and commercialize a novel technology platform for faster, safer, adjuvant-free, more efficient and more cost-effective manufacturing and delivery of vaccines for prevention of infectious diseases.
(2) Geza Ad Ltd. (GZA) aims at marketing approval of a novel influenza vaccine resulting from said technology. The technology has further potential for use in other indications.
(3) The business model of GZA will be based upon co-development and licensing agreements with established pharma companies active in the vaccine sector. GZA will receive milestone payments and royalties based on their global vaccine sales.
A business plan was elaborated with updated evaluations of markets, competitors, intellectual property, a project/development plan and budget to further highlight the attractiveness of the business case and to prepare initiation of a full development program.
Furthermore, input from experienced regulatory professionals was obtained and a draft regulatory strategy aiming at marketing approval for the novel influenza vaccine starting in the EU was elaborated (including type of early and continued interaction with regulatory authorities and timing thereof).
Two quality control assays to monitor efficiency & reproducibility of said technology were developed and methods for most efficient targeting/delivery of a vaccine were fine-tuned.
GZA has completed this phase 1 feasibility study successful. The results strongly support continuation of the project. In any case, GZA is planning to submit a phase 2 proposal to be able to continue VACCELERAID with EU support. In particular, the very high innovation and extremely attractive commercial potential of the VACCELERAID technology – later to be exemplified by full development of a novel influenza vaccine – have been underpinned even further.
Furthermore, input from experienced regulatory professionals was obtained and a draft regulatory strategy aiming at marketing approval for the novel influenza vaccine starting in the EU was elaborated (including type of early and continued interaction with regulatory authorities and timing thereof).
Two quality control assays to monitor efficiency & reproducibility of said technology were developed and methods for most efficient targeting/delivery of a vaccine were fine-tuned.
GZA has completed this phase 1 feasibility study successful. The results strongly support continuation of the project. In any case, GZA is planning to submit a phase 2 proposal to be able to continue VACCELERAID with EU support. In particular, the very high innovation and extremely attractive commercial potential of the VACCELERAID technology – later to be exemplified by full development of a novel influenza vaccine – have been underpinned even further.
Despite the costs for vaccinations, overall they are known to significantly reduce the economic burden of each country affected globally. This is due to averted costs for medical visits, hospitalization and absence from work, for example. Thus, earlier start of vaccination campaigns due to earlier availability of vaccines is likely to reduce the human and economic overall burden even further.
The improvement potential, i.e. the benefits for all users are improved cost-efficiency and competitiveness (e.g. significantly reduced costs as compared to egg-dependent manufacturing; manufacturers able to serve sudden vaccine demands first are more likely to receive contracts).
In addition, the technology has a strong upside potential since the technology might be used for delivery of other vaccines.
The improvement potential, i.e. the benefits for all users are improved cost-efficiency and competitiveness (e.g. significantly reduced costs as compared to egg-dependent manufacturing; manufacturers able to serve sudden vaccine demands first are more likely to receive contracts).
In addition, the technology has a strong upside potential since the technology might be used for delivery of other vaccines.