Any one watching GNBT. It has been under a lot of dilution sell pressure but the news they put out yesterday looks very promising:
Generex and NuGenerex Immuno-Oncology Provide Update on Ii-Key
COVID-19 Vaccine Development Program and
Files Trademark Application for The Complete Vaccine™
− The trademark application can be found at USPTO.gov by searching “Complete Vaccine”
in the Trademark Electronic Search System (TESS)
− Ii-Key-SARS-CoV-2 vaccine enters GMP production for clinical supply
− Ii-Key epitopes selected that elicit both CD4+ T Helper cell (Th1) and CD8+ responses
that are necessary for long-term immune memory
− Ii-Key epitopes elicited no Th2 T cell responses that have been linked to antibody
dependent enhancement of disease and cytokine storm
− Ii-Key epitopes have been used to purify Anti-SARS-CoV-2 antibodies from convalescent
COVID-19 patient serum
− Neutralizing antibodies purified with Ii-Key epitopes have potential as a therapeutic
treatment for COVID-19
− Addressing emergence of mutant coronavirus strains
− Exploring new opportunities to utilize Ii-Key-SARS-CoV-2 vaccines as a targeted universal
booster designed to alleviate the immune related side effects reported with the current
RNA vaccines
MIRAMAR, FL, December 31, 2020 - Generex Biotechnology Corporation (www.generex.com)
(OTCQB:GNBT) (http://www.otcmarkets.com/stock/GNBT/quote) today announced that its
majority owned public entity, NuGenerex Immuno-Oncology, Inc. (NGIO), has filed for and
expects to receive a trademark for The Complete Vaccine™. A complete vaccine is designed to
regulate the immune system to provide a targeted, neutralizing antibody response without
generating off-target, non-neutralizing antibodies that can lead to antibody dependent
enhancement of disease (ADE); further a complete vaccine should activate the appropriate T cell
responses to yield long-term immune memory without activating detrimental Th2 responses that
have been associated with immune-related complications of COVID-19 disease.
Generex also announced that significant progress has been made on the li-Key-SARS-CoV-2
vaccine program. The team at NGIO has completed the T Cell assays and HLA typing of blood
samples from 46 convalescent COVID-19 patients and 30 healthy pre-COVID donors (from 2017
and 2018), screening the immune regulatory activity of 33 Ii-Key epitopes. The results of the T
cell screen demonstrated that numerous Ii-Key epitopes activate CD4+ Th1 and CD8+ responses;
none of the Ii-Key epitopes tested activated any negative Th2 responses.
Additionally, the Ii-Key epitopes have been used to bind and purify IgG antibodies from
convalescent COVID-19 patient samples. These antibodies are being tested against live SARSCoV-2 virus in a level 3 biocontainment laboratory to ensure that they neutralize the virus. Once
confirmed as neutralizing, these Ii-Key epitope binding antibodies can be purified and genetically
engineered to develop antibody therapeutics against COVID-19.
Based on the results of the ex-vivo human studies, Generex has initiated GMP production of
several Ii-Key-SARS-CoV-2 epitopes that will be formulated for Phase I and Phase II clinical trials;
an IND is being prepared for FDA submission in early 2021. With multiple epitopes that are
targeted to generate specific, neutralizing regions of the coronavirus without off-target effects,
and which have demonstrated positive T cell regulation necessary for long-term immune
memory, the Ii-Key COVID-19 vaccine has the potential to be a complete vaccine.
It has been widely reported that the SARS-CoV-2 virus, like all viruses, is mutating. Some of the
mutational variants, with mutations that mainly occur in the virus spike protein, appear to have
biological differences that may alter infectivity, transmission, and severity of infection. The Ii-Key
vaccine platform is built to address issues of mutation. First, there are multiple Ii-Key-SARS-CoV2 peptides, each containing multiple epitopes in the vaccine formulation. So even if there is one
mutation, the other epitopes should provide protection. Second, if a new strain emerges, the IiKey platform can be rapidly deployed to make the new, mutant sequence with Ii-Key and add it
to the current vaccine. This is the beauty of the Ii-Key technology. Further, the epitopes predicted
by computational algorithms exclude regions of the coronavirus that are susceptible to mutation,
so the Ii-Key vaccine largely eliminates mutagenic regions from the start.
With an impending IND submission for Phase I and II human clinical trials to evaluate safety and
immunogenicity of the Ii-Key vaccine, NGIO is exploring additional opportunities to deploy the
targeted Ii-Key COVID-19 vaccine as a universal booster for RNA, DNA, and inactivated virus
vaccines that contain the entire spike protein and have the potential to elicit off-target and overactive immune responses. Recent reports of immune related side effects after booster
inoculation with RNA vaccines include fever, chills, fatigue, and joint pain. These immune related
side effects to the RNA vaccine mimic the immune response to coronavirus infection to provide
immunity to COVID-19 as evidenced by 90+% efficacy rate. However, these strong immune
responses also have the potential to lead to ADE, as has been shown in SARS-1, and questions
remain as to the ability of the RNA vaccines to generate long-term immune memory. The targeted
Ii-Key-SARS-CoV-2 vaccine is designed to generate long-term immune memory through specific
T cell activation by the Ii-Key, and the antibody purification studies demonstrate the potential for
the Ii-Key vaccine to elicit a targeted, neutralizing immune response without off-target effects.
Using a targeted Ii-Key-SARS-CoV-2 vaccine as a universal booster may provide long-term
immunity without causing the immune related side effects from off-target responses. Such a
universal Ii-Key vaccine booster could significantly extend the currently limited supply of RNA
vaccines, and with a clean side effect profile the Ii-Key booster may increase consumer
acceptance.
Generex CEO, Joseph Moscato said, “Throughout this challenging year of 2020, we have
overcome numerous hurdles to reach this point with our Ii-Key COVID-19 vaccine. We have filed
an extensive patent application that covers our Ii-Key-SARS-CoV-2 vaccine and provides the
foundation for a new patent estate for the Ii-Key platform. The results of our ex vivo human
studies have been better than expected, and we have several Ii-Key epitopes that regulate the
immune responses we seek in a vaccine formulation. The antibody data are especially
encouraging. The results confirm that we are targeting immunologically important regions of the
virus and demonstrate the ability to purify neutralizing antibodies from patient serum that can
be developed as a targeted antibody therapeutic against COVID-19.
The Ii-Key vaccine is designed to be a Complete Vaccine, and we believe that our technology
offers the safest and best route for the rapid development of a COVID-19 vaccine that can be
safely administered to everyone, including adolescents, children and pregnant women without
worry of immune related side effects. As we prepare for our first in human studies of the vaccine
in healthy adults, we also plan to include underserved populations with risk factors for COVID19, elderly subjects who are at high risk for serious complications from coronavirus infection, and
working with our SAB, we are planning a focused clinical program for adolescents, children, and
pregnant women.”
Mr. Moscato continued, “On the international front, we are moving forward with our partners in
Malaysia and China on the development of the Ii-Key-SARS-CoV-2 vaccine. Bintai Kinden is
supporting our US development efforts in exchange for exclusive distribution rights in Malaysia
and Southeast Asia. We have also initiated discussions with our Chinese partners on the
technology transfer, GMP production, and regulatory filings with the NMPA for the Phase I, II and
III clinical programs in China. This partnership in China will also enable us to explore the potential
of the Ii-Key-SARS-CoV-2 vaccine as a universal booster.”
“We look forward to an exciting 2021 as we advance the Ii-Key COVID vaccine into the clinic with
the goal of gaining FDA approval for a Complete Vaccine™. On behalf of the Generex and NGIO
management teams, we wish our shareholders and investors a happy, healthy, and prosperous
New Year as we continue to execute our plans to build value for the future.”
Happy New Year!
Generex and NuGenerex Immuno-Oncology Provide Update on Ii-Key
COVID-19 Vaccine Development Program and
Files Trademark Application for The Complete Vaccine™
− The trademark application can be found at USPTO.gov by searching “Complete Vaccine”
in the Trademark Electronic Search System (TESS)
− Ii-Key-SARS-CoV-2 vaccine enters GMP production for clinical supply
− Ii-Key epitopes selected that elicit both CD4+ T Helper cell (Th1) and CD8+ responses
that are necessary for long-term immune memory
− Ii-Key epitopes elicited no Th2 T cell responses that have been linked to antibody
dependent enhancement of disease and cytokine storm
− Ii-Key epitopes have been used to purify Anti-SARS-CoV-2 antibodies from convalescent
COVID-19 patient serum
− Neutralizing antibodies purified with Ii-Key epitopes have potential as a therapeutic
treatment for COVID-19
− Addressing emergence of mutant coronavirus strains
− Exploring new opportunities to utilize Ii-Key-SARS-CoV-2 vaccines as a targeted universal
booster designed to alleviate the immune related side effects reported with the current
RNA vaccines
MIRAMAR, FL, December 31, 2020 - Generex Biotechnology Corporation (www.generex.com)
(OTCQB:GNBT) (http://www.otcmarkets.com/stock/GNBT/quote) today announced that its
majority owned public entity, NuGenerex Immuno-Oncology, Inc. (NGIO), has filed for and
expects to receive a trademark for The Complete Vaccine™. A complete vaccine is designed to
regulate the immune system to provide a targeted, neutralizing antibody response without
generating off-target, non-neutralizing antibodies that can lead to antibody dependent
enhancement of disease (ADE); further a complete vaccine should activate the appropriate T cell
responses to yield long-term immune memory without activating detrimental Th2 responses that
have been associated with immune-related complications of COVID-19 disease.
Generex also announced that significant progress has been made on the li-Key-SARS-CoV-2
vaccine program. The team at NGIO has completed the T Cell assays and HLA typing of blood
samples from 46 convalescent COVID-19 patients and 30 healthy pre-COVID donors (from 2017
and 2018), screening the immune regulatory activity of 33 Ii-Key epitopes. The results of the T
cell screen demonstrated that numerous Ii-Key epitopes activate CD4+ Th1 and CD8+ responses;
none of the Ii-Key epitopes tested activated any negative Th2 responses.
Additionally, the Ii-Key epitopes have been used to bind and purify IgG antibodies from
convalescent COVID-19 patient samples. These antibodies are being tested against live SARSCoV-2 virus in a level 3 biocontainment laboratory to ensure that they neutralize the virus. Once
confirmed as neutralizing, these Ii-Key epitope binding antibodies can be purified and genetically
engineered to develop antibody therapeutics against COVID-19.
Based on the results of the ex-vivo human studies, Generex has initiated GMP production of
several Ii-Key-SARS-CoV-2 epitopes that will be formulated for Phase I and Phase II clinical trials;
an IND is being prepared for FDA submission in early 2021. With multiple epitopes that are
targeted to generate specific, neutralizing regions of the coronavirus without off-target effects,
and which have demonstrated positive T cell regulation necessary for long-term immune
memory, the Ii-Key COVID-19 vaccine has the potential to be a complete vaccine.
It has been widely reported that the SARS-CoV-2 virus, like all viruses, is mutating. Some of the
mutational variants, with mutations that mainly occur in the virus spike protein, appear to have
biological differences that may alter infectivity, transmission, and severity of infection. The Ii-Key
vaccine platform is built to address issues of mutation. First, there are multiple Ii-Key-SARS-CoV2 peptides, each containing multiple epitopes in the vaccine formulation. So even if there is one
mutation, the other epitopes should provide protection. Second, if a new strain emerges, the IiKey platform can be rapidly deployed to make the new, mutant sequence with Ii-Key and add it
to the current vaccine. This is the beauty of the Ii-Key technology. Further, the epitopes predicted
by computational algorithms exclude regions of the coronavirus that are susceptible to mutation,
so the Ii-Key vaccine largely eliminates mutagenic regions from the start.
With an impending IND submission for Phase I and II human clinical trials to evaluate safety and
immunogenicity of the Ii-Key vaccine, NGIO is exploring additional opportunities to deploy the
targeted Ii-Key COVID-19 vaccine as a universal booster for RNA, DNA, and inactivated virus
vaccines that contain the entire spike protein and have the potential to elicit off-target and overactive immune responses. Recent reports of immune related side effects after booster
inoculation with RNA vaccines include fever, chills, fatigue, and joint pain. These immune related
side effects to the RNA vaccine mimic the immune response to coronavirus infection to provide
immunity to COVID-19 as evidenced by 90+% efficacy rate. However, these strong immune
responses also have the potential to lead to ADE, as has been shown in SARS-1, and questions
remain as to the ability of the RNA vaccines to generate long-term immune memory. The targeted
Ii-Key-SARS-CoV-2 vaccine is designed to generate long-term immune memory through specific
T cell activation by the Ii-Key, and the antibody purification studies demonstrate the potential for
the Ii-Key vaccine to elicit a targeted, neutralizing immune response without off-target effects.
Using a targeted Ii-Key-SARS-CoV-2 vaccine as a universal booster may provide long-term
immunity without causing the immune related side effects from off-target responses. Such a
universal Ii-Key vaccine booster could significantly extend the currently limited supply of RNA
vaccines, and with a clean side effect profile the Ii-Key booster may increase consumer
acceptance.
Generex CEO, Joseph Moscato said, “Throughout this challenging year of 2020, we have
overcome numerous hurdles to reach this point with our Ii-Key COVID-19 vaccine. We have filed
an extensive patent application that covers our Ii-Key-SARS-CoV-2 vaccine and provides the
foundation for a new patent estate for the Ii-Key platform. The results of our ex vivo human
studies have been better than expected, and we have several Ii-Key epitopes that regulate the
immune responses we seek in a vaccine formulation. The antibody data are especially
encouraging. The results confirm that we are targeting immunologically important regions of the
virus and demonstrate the ability to purify neutralizing antibodies from patient serum that can
be developed as a targeted antibody therapeutic against COVID-19.
The Ii-Key vaccine is designed to be a Complete Vaccine, and we believe that our technology
offers the safest and best route for the rapid development of a COVID-19 vaccine that can be
safely administered to everyone, including adolescents, children and pregnant women without
worry of immune related side effects. As we prepare for our first in human studies of the vaccine
in healthy adults, we also plan to include underserved populations with risk factors for COVID19, elderly subjects who are at high risk for serious complications from coronavirus infection, and
working with our SAB, we are planning a focused clinical program for adolescents, children, and
pregnant women.”
Mr. Moscato continued, “On the international front, we are moving forward with our partners in
Malaysia and China on the development of the Ii-Key-SARS-CoV-2 vaccine. Bintai Kinden is
supporting our US development efforts in exchange for exclusive distribution rights in Malaysia
and Southeast Asia. We have also initiated discussions with our Chinese partners on the
technology transfer, GMP production, and regulatory filings with the NMPA for the Phase I, II and
III clinical programs in China. This partnership in China will also enable us to explore the potential
of the Ii-Key-SARS-CoV-2 vaccine as a universal booster.”
“We look forward to an exciting 2021 as we advance the Ii-Key COVID vaccine into the clinic with
the goal of gaining FDA approval for a Complete Vaccine™. On behalf of the Generex and NGIO
management teams, we wish our shareholders and investors a happy, healthy, and prosperous
New Year as we continue to execute our plans to build value for the future.”
Happy New Year!
