Getting close to a solution for the Coronavirus - Project Proposal Helping MIGAL's Coronavirus Vaccine Development - Keren ...

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Getting close to a solution for the Coronavirus - Project Proposal Helping MIGAL's Coronavirus Vaccine Development - Keren ...
Project
                    Proposal

   Getting close to a solution
      for the Coronavirus
Helping MIGAL’s Coronavirus Vaccine Development
Getting close to a solution for the Coronavirus - Project Proposal Helping MIGAL's Coronavirus Vaccine Development - Keren ...
The 2020 Coronavirus Epidemic
                   As of March 7, 2020, over 102,000 cases of
                   patients infected with the new coronavirus,
                   SARS-CoV-2, had been reported, including 57,624
                   with symptoms, 3,497 of whom had died. Of
                   the remaining patients (41,120), 34,967 were
                   classified in moderate condition and 6,153 in
                   serious condition.
                   The number of patients worldwide continues to
                   increase: there are large and growing outbreaks
                   in South Korea, Italy and Iran, and the disease
                   has been reported in 88 countries. The highly
                   contagious nature of the disease, coupled with
                   uncertainty regarding its severity and the lack of effective treatment, has led to severe disruptions in
                   the economy and day-to-day functioning of the entire developed world. The incubation period of the
                   disease is generally 2-14 days, but in some exceptions, it has appeared after 27 days.
                   There is currently no certainty as to what drugs could be effective in treating human coronavirus, and
                   no vaccines. A number of drugs currently used in the treatment of patients with other viral diseases,
                   such as AIDS and Malaria (and ebola), are now being used with COVID 19 patients including Remdesivir
                   and Chloroquine, and it is expected that drugs that have been effective for viral diseases (and primarily
                   RNA viruses) are likely to help with recovery.

                    Overview
                   MIGAL, an internationally-recognized multi-disciplinary
                   applied research institute (Non-Profit Organization) located
                   in Israel’s Northern Galilee, is developing an oral Coronavirus
                   vaccine that will be ready for in-vivo testing in 90 days. Migal
                   was established in 1979, and today is addressing the world’s
                   most pressing challenges by research in agriculture, food,
                   feed, health and environment.
                   Based on inter-disciplinary research of groups in the fields of
                   immunology, microbiology, bioinformatics virology enzymology
                   and computational chemistry, Migal is uniquely qualified to carry
                   out this work based on its successful development of a vaccine
                   against Infectious Bronchitis Virus (IBV), an avian (poultry)
                   coronavirus with high similarity to today’s human COVID-19 that
                   uses the same infection mechanism. Given the similarity, and
                   following required genetic adjustments, the same vaccination
                   concepts should apply.
                   MIGAL’s interdisciplinary vaccine development team has been collaborating for several years
                   on other vaccine development projects, and is highly qualified to carry out this project. Now it
                   seeks partners to help it fund, complete and commercialize its development process.

                        Getting close to a solution
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Project Proposal        Helping MIGAL’s Coronavirus Vaccine Development                                                        2
Getting close to a solution for the Coronavirus - Project Proposal Helping MIGAL's Coronavirus Vaccine Development - Keren ...
The MIGAL Galilee Research Institute
                   The MIGAL Galilee Research Institute Ltd is a regional
                   R&D center of the Israeli Science and Technology
                   Ministry owned by the Galilee Development Company
                   ltd. An internationally-recognized multi-disciplinary
                   applied research institute, Migal specializes in
                   biotechnology and computer sciences, plant
                   science, precision agriculture and environmental
                   sciences, and food, nutrition and health. Recognized
                   as a powerhouse of applied research, for forty years
                   MIGAL has cooperated closely with industry leaders,
                   innovative startups, and technological accelerators.
                   MIGALs' employees include 90 PhDs and 190 researchers distributed across 44 research groups,
                   operating as an innovative research ecosystem that encourages collaboration across scientific,
                   industrial, agricultural, academic and technological specialties.

                    Vaccine Development
                   Besides Migal, a number of research groups
                   throughout the world are now working
                   intensively to create a vaccine against this
                   virus. Israel’s Biology Institute has engaged
                   a large group of scientists experienced in the
                   development, testing and manufacture of
                   vaccines to work on the project. Moderna has
                   announced the development of a vaccine
                   prototype based on the virus’s genetic material
                   within 4 days of publishing its findings, and will
                   soon begin human trials. GSK is developing a
                   partnership with a Chinese company, and
                   Johnson & Johnson has announced the
                   development of a vaccine and treatments
                   against the disease.
                   The significant advantage of Migal’s efforts is that its successful 4-year project to develop
                   a vaccine against avian coronavirus has given it a 4-year “head start” which it believes will
                   translate into a rapid development process for an effective human vaccine.

                    MIGAL’s Corona-vaccine Development Program
                   MIGAL initiated its Corona-vaccine development program four years ago with NIS 12 million funding
                   by the Israeli Ministry of Agriculture. As part of the project, MIGAL researchers developed a new sub-
                   unit vaccine for oral delivery of Corona S1 and N-immune potent antigens. In addition, the team
                   developed a commercial GMP standardized production method, including fermentation and protein
                   collection. Proof-of-concept was achieved using an Avian coronavirus sequence for vaccination of
                   chickens against the Avian Infectious Bronchitis (IBV) virus.

                        Getting close to a solution
                        for the Coronavirus
Project Proposal        Helping MIGAL’s Coronavirus Vaccine Development                                                     3
Getting close to a solution for the Coronavirus - Project Proposal Helping MIGAL's Coronavirus Vaccine Development - Keren ...
The main achievements of the program included:
                   • Definition of specific structural motifs of the corona S and N proteins, sufficient for induction of
                      effective immune response.
                   • Development of three chimeric proteins for carrying three distinct structural domains, with
                      enhanced mucosal activity for mucosal vaccination.
                   • Development of an E. coli-based protein expression system which produces and secretes the
                      chimeric proteins to the growth media.
                   • Proof-of-concept for safety, specific antibody induction, activation of cellular immune response,
                      and protection against challenge, was performed in two medium-scale animal studies, in chicken
                      models and Avian corona H120 IBV.
                   • Development of fermentation media and process for protein production, following pharma
                      regulations and GMP standards.
                   MIGAL is currently in the process of
                   adjusting the genetic system to enable
                   production of specific polypeptides of the
                   recently-published Corona sequence. It has
                   characterized the structural domains and is in
                   the process of developing relevant chimeric
                   proteins. Using its already-developed
                   fermentation process, Migal believes that
                   its proposed oral (mucosal) vaccination
                   technology can be ready for testing in 90
                   days.
                   MIGAL’s proposed COVID 19 vaccine is based
                   on a new protein expression vector, which
                   forms and secretes a chimeric soluble protein
                   that delivers the viral antigen into mucosal tissues by self-activated endocytosis. In an In-Vivo study, it
                   was demonstrated that the oral vaccination induces high levels of specific anti-IBV antibodies. Moreover,
                   vaccinated birds were protected against challenge with a live virulent IBV strain, as demonstrated by
                   rapid clearance of the virus.
                   Business Model for development and commercialization of the COVID-19 vaccine:
                   MIGAL currently seeks partners to support its development and commercialization of a human COVID
                   19 vaccine in the following areas:
                   •   Partners that can initiate a preclinical study, in a short pathway, according to worldwide regulations,
                       accepted by the authorities of Israel, USA, Europe and China.
                   •   Partners that can further promote clinical studies.
                   •   Partners that can further promote industrial product development and production of vaccine, and
                       approved by the authorities to produce.
                   •   Partners that can provide funding in return for equity.

                        Getting close to a solution
                        for the Coronavirus
Project Proposal        Helping MIGAL’s Coronavirus Vaccine Development                                                          4
Getting close to a solution for the Coronavirus - Project Proposal Helping MIGAL's Coronavirus Vaccine Development - Keren ...
Supporting the project:
Contribution and funding of the Migal Vaccine Knowledge Center will accelerate the center's research
activities and advance the capabilities of the current COVID-19 vaccine development and additional
vaccines for future epidemics. This platform will allow the rapid adaptation of new vaccines to viruses
and epidemics that are constantly undergoing changes and continue to attack every few years in
different parts of the world.
Contribution of US $155,000 will fund a PhD Scientist for 1 year.
Contribution of US $130,000 will fund a Research Assistant MSc/PhD for 1 year.
Contribution of US $85,000 will fund a lab equipment and materials for 1 year.
• Migal intends to transfer the IP developed through this project via a commercial company to
   purchasers for final product development and marketing.
• The IP for the platform will remain owned by Migal, enabling the development of new
   vaccines for other viruses and diseases.

  From the press:
English
https://scrip.pharmaintelligence.informa.com/SC141784/Israeli-RD-Team-Claim-To-Be-Near-
COVID19-Vaccine
https://www.newsweek.com/coronavirus-vaccine-weeks-away-being-developed-says-head-israeli-
science-research-institute-1489694
https://nocamels.com/2020/03/israeli-scientists-avian-vaccine-adapt-coronavirus/
https://www1.cbn.com/cbnnews/israel/2020/february/breakthrough-israeli-scientists-say-they-
rsquo-ll-have-a-coronavirus-vaccine-in-just-weeks
https://www.jpost.com/HEALTH-SCIENCE/Israeli-scientists-In-three-weeks-we-will-have-coronavirus-
vaccine-619101

French
http://www.actuj.com/2020-03/israel/8548-rencontre-avec-ouri-ben-herzl-vice-directeur-general-
de-l-institut-israelien-de-recherche-migal-il-s-agit-d-un-vaccin-preventif-qui-sera-administre-par-
voie-orale#
https://fl24.net/2020/02/27/vrai-ou-faux-israel-annonce-avoir-decouvert-le-vaccin-contre-le-
coronavirus/
https://www.la- croix.com/Sciences- et- ethique/Coronavirus-temps-perdu-recherche -
Sras-2020-03-03-1301081779
http://www1.alliancefr.com/actualites/israel-dans-quelques-semaines-nous-aurons-un-vaccin-
contre-le-coronavirus-6084883

Videos
https://youtu.be/zjPKCSa24a8
https://www.ynet.co.il/articles/0,7340,L-5685810,00.html

For further information please contact your local Keren Hayesod - UIA emissary or Projects Department:
                         48 King George St. P.O.B 7583, Jerusalem 91074, Israel.
                                                                                                          5
Tel. +972-2-670-1836 Fax.+972-2-670-1928 | info@khuia.org | www.kh-uia.org.il |
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