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Generex Biotechnology Publishes Response to Congressional Letter Calling for COVID-19 Challenge Studies and Alternative Solution to Accelerate Vaccine Development
[April 27, 2020]

Generex Biotechnology Publishes Response to Congressional Letter Calling for COVID-19 Challenge Studies and Alternative Solution to Accelerate Vaccine Development


  • Generex strategy offers ethical and safe solution to rapid vaccine development with Ii-Key-SARS-CoV-2 peptide vaccine
  • SARS-CoV-2 mechanism of infection still largely unknown
  • COVID-19 disease progression remains largely undefined
  • Risk factors for hospitalization include age, cardiovascular disease, hypertension, obesity, and other unknown health and genetic risks
  • Risky strategy of viral challenge studies unnecessarily puts people’s lives in danger

MIRAMAR, Fla., April 27, 2020 (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) (http://www.otcmarkets.com/stock/GNBT/quote) today published a response to the April 20th letter from Congressional members to HHS Secretary Alex Azar and FDA Commissioner Stephan Hahn, MD wherein they call for an accelerated development path for a vaccine to the SARS-CoV-2 coronavirus pandemic using viral challenge studies. Generex President & CEO Joseph Moscato presents a corporate response to the idea of conducting challenge studies with this coronavirus and provides details of how Generex is responding to this global emergency by offering a safer solution with the Ii-Key vaccine technology.

An open letter to Generex shareholders, regulatory authorities, the medical community, legislative leaders, and all concerned Americans:

Upon reading the letter that was sent last week by Congress to Secretary Azar and Commissioner Hahn, the Generex management team and I were sufficiently alarmed to publish this response to the proposal that vaccine developers intentionally infect healthy young people with the deadly SARS-CoV-2 coronavirus to speed up vaccine development.

While we wholeheartedly support the proposition that we accelerate the vaccine development process, especially in this time of emergency pandemic response, the idea of conducting a challenge study using such a new and incompletely understood virus that has wreaked devastation around the globe is incomprehensible when there are safer and better ways available to us right now.

Plus, it is not just the virus that is dangerous. There are serious potential risks of vaccination as well, especially with whole virus and large subunit vaccines that are known to cause off-target effects. Anyone who wants to consider volunteering for a COVID-19 vaccine challenge study should read the article about a vaccine that was developed for the previous SARS outbreak that was published in the American Chemical Society Journal of Infectious Diseases in 2016 (ACS Infect. Dis. 2016, 2, 361-376). That article reports the results of a viral challenge study in monkeys using an inactivated SARS-CoV-1 vaccine.  When the monkeys were vaccinated, their immune systems generated antibodies against the whole virus, a normal immune response to viral infection; then they infected the monkeys with the SARS virus. While some antibodies conferred protection from the viral challenge, other antibodies caused serious lung damage in the monkeys and enhanced OVID disease resulting in the honeycomb lung that we see in patients who have died during the current SARS-CoV-2 outbreak. So, anyone who enrolls in a viral challenge study risks not only a deadly disease, but also worsening of the disease because the non-specific vaccine may produce unwanted immune system overreactions.



At Generex, we understand the risks of developing a vaccine for this coronavirus, because for the last two months the team at Generex has been working around the clock to advance the development of a new COVID-19 vaccine using our targeted Ii-Key vaccine technology to specifically target the immune system against the SARS-CoV-2 virus. We are moving forward with a rational scientific approach and a conservative regulatory strategy that first and foremost ensures the safety of people who volunteer to participate in our clinical research trials of an Ii-Key-SARS-CoV-2 peptide vaccine.

With our development partners, we have used computational algorithms to identify specific antigenic peptides from the viral spike, envelope, and membrane proteins that are highly conserved across other deadly coronaviruses like SARS-1 and MERS, have no human sequences that could cause autoimmune reactions, and contain amino acid sequences most likely to produce a neutralizing antibodies based on historical data and computational analyses. We are manufacturing these peptides with the Ii-Key and will be screening them against blood samples from patients who have recovered from COVID-19. The blood from previously infected individuals contains T-Cells and antibodies that have actually worked to neutralize the coronavirus infection so the patients could recover from COVID-19.  This standard protocol, which has been developed over the years by the NuGenerex Immuno-Oncology team, enables us to identify specific coronavirus peptide epitopes that produce neutralizing, rather than off-target antibodies, and activate appropriate T-helper cell (TH1) responses through the Ii-Key rather than the potentially dangerous TH2 responses that are part of the cytokine storm. In this fashion, we can not only select the proper, specific epitopes for a peptide vaccine, but we also test the specificity of the immune response generated by our Ii-Key-SARS-CoV-2 peptide vaccine in a 100% safe “Ex-Vivo” human clinical trial before we proceed to the clinic.


Generex has had numerous discussions with U.S. government agencies, including HHS, FDA, and BARDA, the government funding agency that has requested that we submit a contract proposal to provide them with details of our Ii-Key-SARS-CoV-2 peptide vaccine development program. Today, we are submitting that proposal, written and compiled by the Generex COVID-19 task force with detailed plans and budgets from our scientific and clinical team, our contract manufacturing partners, clinical laboratories, preeminent infectious disease research laboratories, a major clinical research organization, regulatory consultants, key opinion leaders in vaccine development and infectious disease, and clinical research sites to conduct the safety and efficacy trials required for FDA fast track approval. We have also agreed to partner with a major corporation that is developing a vaccine adjuvant formulation that we plan to evaluate in our proposed clinical trials. Again, our planned clinical trials are 100% focused on patient safety with interim reviews by an independent data safety monitoring board or DSMB that will evaluate the data not only for safety but also for futility if the vaccine does not induce the appropriate immune responses necessary to kill the virus. With this ongoing review of clinical safety and futility, our plan de-risks our vaccine development program for patients, the medical community, the government, and our investors, with patient safety being of the utmost importance.

Generex is highly confident in our rapid vaccine development program and in our plans to scale the manufacturing of Ii-Key- SARS-CoV-2 peptide vaccines to conduct not only the clinical trials required to meet the approval standards of global regulatory authorities, but to meet government expectations for defeating this pandemic threat.

Over the next weeks, we will continue working to solidify the development path and government partnerships to implement our Ii-Key-SARS-CoV-2 “Complete Vaccine” development program. Thanks to all of our investors for your continued support in these difficult times, and please stay safe, be well and take care of your families and friends.

Sincerely,
Joe Moscato
CEO

About Generex Biotechnology Corp.
Generex Biotechnology is an integrated healthcare holding company with end-to-end solutions for patient centric care from rapid diagnosis through delivery of personalized therapies. Generex is building a new kind of healthcare company that extends beyond traditional models providing support to physicians in an MSO network, and ongoing relationships with patients to improve the patient experience and access to optimal care.

Cautionary Note Regarding Forward-Looking Statements

This release and oral statements made from time to time by Generex representatives in respect of the same subject matter may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as "expects," "plan," "believes," "will," "achieve," "anticipate," "would," "should," "subject to" or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.  Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.

Generex Contact:

Generex Biotechnology Corporation

Joseph Moscato
646-599-6222

Todd Falls
1-800-391-6755 Extension 222
investor@generex.com

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