Generex Biotechnology Corp. (fka GNBTQ)

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COVID-19 & the 2019-nCOV Ii-Key Vaccine Project
http://generex.com http://epivax.com
NuGenerex Immuno-Oncology, a Subsidiary of Generex Biotechnology (NGIO) has developed our
proprietary, patented Ii-Key immune system activation technology that holds promise for stopping
pandemic viral outbreaks like the current SARS-COV-2 coronavirus epidemic in China. NGIO has invested
over $50 million in the last 15 years to develop the Ii-Key technology for infectious disease and cancer
immunotherapy. Though the current focus of NGIO is on cancer immunotherapy, the company previously
maintained a robust research and development effort for potentially pandemic viruses avian flu (H5N1),
swine flu (H1N1) and SARS, creating on-demand peptide vaccines that have been extensively studied
through human clinical trials. NGIO’s Ii-Key antigenic peptides have been shown to supercharge the
immune system up to 100 times more than peptides alone. The activity and safety of Ii Key peptide vaccines
has been proven in Phase I and II clinical trials involving over 300 patients or volunteers, so new Ii-Key
vaccines should be able to proceed directly to human studies without significant pre-clinical toxicology
testing. With human clinical data in hundreds of patients that demonstrate safety and immune system
activation against infectious disease and tumor antigens, as well as preclinical in vitro and in vivo studies
that prove the mechanism of T-Cell activation, the Ii-Key technology offers a rapid path to human
protection from the SARS-COV-2 and COVID-19 epidemic.
NGIO is working with EpiVax to utilize their proprietary computational vaccinology algorithms and
databases to guide the rapid development of Ii-Key peptide vaccines to protect against the spread of
SARS-COV-2. EpiVax has developed a suite of online computational vaccinology tools for the
accelerated design of proteome-derived, epitope-driven vaccines. NGIO and EpiVax are generating
new patents and intellectual properties from this collaborative agreement.
Rapid Path to SARS-COV-2 Vaccine:
3 Months to Human Vaccination
1. Generex & Epivax have identified SARS-COV-2 amino acid
peptides for epitope evaluation
2. Synthesize 2019-nCoV epitope peptides for screening (standard
peptide chemistry – 11 - 15 amino acids)
3. Screen common HLA-DR alleles in vitro vs SARS-COV-2
sequences
4. Test chemical linkers with for best fit for Ii-Key (LRMK) hybrid
vaccine – optimize for immunogenicity
5. Select Ii-Key Hybrid/2019-nCoV peptides for vaccine evaluation
6. Collect blood samples & isolate PBMCs from 2019-nCoV
infected & recovered individuals
7. Test Ii-Key/ SARS-COV-2 hybrid peptide vaccines vs. PBMcs
8. Conduct Elispot analysis to test for IFN-? expression indicating
CD-4 T-cell activation
9. Select active Ii-Key/ SARS-COV-2 hybrid peptide vaccines for
human clinical testing
10. Conduct Clinical Trial with Lead Ii-Key/SARS-COV-2 Peptides
• Evaluate safety & immunogenicity (DTH Assay)
11. Select peptides for Multi-valent Ii-Key/ SARS-COV-2 Peptide
Vaccine
12. Commercial Manufacturing & Distribution in 5 to 9 months
Contact Richard Purcell, Executive Vice President R&D [e-mail] 732-492-1797
Ii-Key Hybrid Technology for Rapid Response to Pandemics
Many non-cellular vaccines are based on protein and peptide sequences derived from infectious disease agents,
including recombinant peptide vaccines for influenza, hepatitis and HPV. Ii-Key Hybrid vaccines are synthetic,
peptide-based agents that are engineered to stimulate strong and specific CD4+ T cell responses. We have
published extensively on the development of Ii-Key peptide vaccines for potentially pandemic viruses such as the
H5N1 (avian flu) and H1N1 (swine flu) influenza strains. The advantage of the technology is that synthetic
production methods are rapid, cost effective, and scalable, enabling the speedy production of very large batches in a
matter of months. The Ii-Key addition significantly augments MHC Class II loading and presentation by directly
charging MHC Class II molecules on the surface of antigen presenting cells, bypassing the usual intracellular
processing mechanism. By this means, Ii-Key hybrids effectively hijack MHC Class II molecules on the surface of
any antigen presenting cell to potently activate CD4+ T helper cells in an antigen-specific manner, resulting in
stronger cellular and humoral immunity through the interaction of CD4+ cells with CD8+ and B cells, respectively.
Avian (Bird) Flu, Swine Flu & SARS Vaccine Research Program
In the mid-2000’s, NGIO launched a major R&D initiative to combat the SARS virus, which caused significant
morbidity and mortality as well as billions in economic losses. At that time, the company identified several
promiscuous HLA-DR-restricted SARS epitopes that react with >80% of the tested SARS-recovered immune
system cells (PBMCs). As SARS is also a coronavirus the Ii-Key-SARS vaccine, which can be synthetically
manufactured in weeks, may have immunologic reactivity with 2019-nCoV. NGIO can test the Ii-Key-SARS
peptide vaccines for reactivity against the bloods of individuals who have recovered from 2019-nCOV infections. If
found to be reactive, an Ii-Key coronavirus peptide vaccine could be produced in weeks. Also, bird Flu is emerging
in Wuhan Provence alongside the coronavirus outbreak. NGIO has Phase I human data in 100 individuals
demonstrating the safety and immune system activation by our Ii-Key-H5N1 peptide vaccine. This vaccine can be
made immediately available for large-scale clinical trials in China.
Ii-Key Partnerships
Generex has a signed contract for the clinical & commercial development of Ii-Key peptide vaccines
with partners in China, and we are seeking government and private partners to develop and
distribute the eventual Ii-Key-SARS-COV-2 peptide vaccine on a global basis.
Beijing Zhonghua Investment Fund Management Co, LTD & Sinotek-Advocates international Industry
Development Company, Ltd. NGIO has signed a development and commercial licensing agreement with partners
in China to develop a vaccine against the SARS-COV-2 coronavirus. The agreement provides exclusive rights to
the Ii-Key- SARS-COV-2 peptide vaccines in China; NGIO retains worldwide rights to the Ii-Key peptide
vaccines.
Shenzhen BioScien Pharmaceuticals. NGIO has a research partnership with Merck to evaluate the Ii-Key-HER2/neu peptide vaccine AE37 in combination with Keytruda® for the treatment of triple negative breast cancer. We
have also signed a licensing and research agreement with Shenzhen BioScien Pharmaceuticals Co., Ltd. to develop
AE37 for prostate cancer in China. Under the terms of the deal, Shenzen is financing and conducting the Phase II
trials in the European Union and China, and Phase III trials globally under ICH guidelines, with NuGenerex
retaining the rights to all clinical data for regulatory submissions and commercialization in the rest of the world
outside China.
Contact Richard Purcell, Executive Vice President R&D [e-mail] 732-492-1797
The NuGenerex/EpiVax COVID-19 Response Team
Eric von Hofe, PhD, Chief Scientific Officer at NGIO, has led the Ii-Key development program since its
inception. As President of Antigen Express, he oversaw the development of Ii-Key peptide vaccines for
cancer and infectious diseases, including SARS, HIV, and Swine and bird flu. Dr. von Hofe has extensive
experience with technology development projects, including his previous position at Millennium Pharmaceuticals
as Director of Programs & Operations, Discovery Research. He received his Ph.D. from the University of Southern
California in Experimental Pathology and was a postdoctoral fellow at both the University of Zurich and Harvard
School of Public Health.
Richard Purcell, EVP R&D at Generex and NGIO has extensive experience in the field of infectious disease
and immunology, including his research in the mid-80’s on HIV while at Roche, his clinical strategy
consulting work on FluMist influenza vaccine, a clinical data program with Wyeth and the Department of
Defense to expand the stockpile of smallpox vaccine following 9/11, and his work with the development of
viral vectors and peptide vaccines for cancer therapy.
Anne DeGroot, PhD, is the CEO and CSO of EpiVax. She is internationally known for her research on the
human immune system’s response to vaccines and therapeutics. She graduated from Smith College in 1978
and earned her medical degree at University of Chicago in 1983. After internal medical residency, she
obtained advanced training in immunoinformatics and vaccinology with Michael Good, Russell Howard and
Jay Berzofsky at the National Institutes of Health, and then returned for a fellowship in ID at New England
Medical Center.
William Martin is the principal architect and developer of the EpiMatrix System, which powers the computational
prediction & discovery of antigenic epitopes for many Class I and Class II HLA alleles. Mr. Martin has worked
with Dr. DeGroot since 1998 developing a suite of protocols, ancillary tools and database structures allowing for
fast and efficient analysis of input protein sequences for vaccine development. His innovations in computational
vaccinology result in new and expanded patent portfolios for EpiVax and their partners.
Special Note Regarding Forward-Looking Statements: Certain statements included or incorporated by reference in
this Platform Summary, including information as to the future financial or operating performance of the Company
and its drug development programs, constitute forward-looking statements. The words "believe," "expect,"
"anticipate," "contemplate," "target," "plan," "intend," "continue," "budget," "estimate," "may," "schedule" and
similar expressions identify forward-looking statements. Forward-looking statements include, among other things,
statements regarding future plans, targets, estimates and assumptions. Forward-looking statements are necessarily
based upon a number of estimates and assumptions that, while considered reasonable by the Company, are inherently
subject to significant business, economic and competitive uncertainties and contingencies. Many factors could cause
the Company's actual results to differ materially from those expressed or implied in any forward-looking statements
made by, or on behalf of, the Company. Due to these various risks and uncertainties, actual events may differ
materially from current expectations. Investors are cautioned that forward-looking statements are not guarantees of
future performance and, accordingly, investors are cautioned not to put undue reliance on forward-looking
statements due to the inherent uncertainty therein. Forward-looking statements are made as of the date of this news
release and the Company disclaims any intent or obligation to update publicly such forward-looking statements,
whether as a result of new information, future events or results or otherwise.