NuGenerex Immuno-Oncology Announces Plans to Address the New Emerging Pandemic Threat from G4 EA H1N1 Swine Influenza Virus Using Ii-Key-H1 Peptide Vaccine

• NGIO has previously developed Ii-Key-H1 peptides for vaccines against epitopes to 2009 Swine Flu and 2004 Bird Flu with positive Phase I clinical safety and immunologic data for Ii-Key-H1 peptide vaccine
• Ii-Key-H1 peptide sequence is 100% homologous in previous pandemic influenza threats
• Potential to launch Ii-Key-H1 peptide vaccine for emerging pandemic threat from G4 EA H1N1 swine flu
• Published reference: Honglei et al. Prevalent Eurasian Avian-like H1N1 Swine Influenza Virus with 2009 Pandemic Viral Genes Facilitating Human Infection. Proceedings of the National Academy of Sciences; June 2020. (See Link) https://www.pnas.org/content/early/2020/06/23/1921186117?referringSource=articleShare

MIRAMAR, Fla., July 02, 2020 (GLOBE NEWSWIRE) -- NuGenerex Immuno-Oncology today announced that the company is launching a vaccine development effort to address the new, emerging pandemic threat from a newly identified swine influenza virus. On June 29, 2020 scientists in China published a paper in the Proceedings of the National Academy of Sciences identifying a new virus in pigs that has the capacity to infect humans. This emerging virus is similar to the 2009 swine flu virus that is estimated to have killed nearly 500,000 globally. Between April 12, 2009, and April 10, 2010, the CDC estimates that the 2009 swine flu virus caused 60.8 million illnesses, 273,304 hospitalizations and 12,469 deaths in the United States. Of particular concern is that an infection surveillance program with swine workers showed an elevated level of antibodies to the G4 EA H1 influenza virus, indicating swine to human transmission and the potential for another viral pandemic. NGIO is uniquely positioned to respond this pandemic threat as the company has successfully completed a Phase I human clinical trial with an Ii-Key peptide vaccine designed to elicit an immune response against the H1 hemagglutinin protein of the 2009 H1 swine influenza strain.

Joseph Moscato, CEO of NGIO stated, “Our Ii-Key immune activation technology is designed to create targeted, highly specific vaccines that activate both the T-Cell and antibody responses that make a “Complete Vaccine” against cancer antigens and viruses. The Ii-Key technology platform was established to respond quickly, economically, and effectively to create vaccines against viral and cancer antigens based upon the amino acid peptide sequences of the target proteins that can be neutralized by an immune response. Importantly, Ii-Key peptide vaccines have demonstrated safety, without signs of off-target immune responses or cytokine storm effects in any of the Phase I and Phase II trials conducted to date. As such, the Ii-Key platform is perfectly suited for inclusion in a pandemic preparedness portfolio, and we plan to pursue this avenue to augment our clinical development program for Ii-Key immunotherapeutic cancer vaccines as we progress toward a public listing for NuGenerex Immuno-Oncology on a national exchange.”

Mr. Moscato continued, “With the explosion of the SARS-CoV-2 pandemic, we restarted the pandemic vaccine development program conducted by NGIO from 2004 to 2010 and submitted proposals to government agencies and international organizations to fund the development of a COVID-19 vaccine. As we await the funding decisions, we continue to advance the Ii-Key-SARS-CoV-2 peptide vaccine initiative. Now, as another pandemic threat is emerging with G4 SA H1N1 swine influenza, we are in position to rapidly respond with our Ii-Key-H1 peptide vaccine for which we have Phase I clinical safety and immunogenicity data. The Ii-Key-H1 peptide vaccine uses an H1 epitope sequence that is 100% identical to the pandemic viruses 2009 H1N1 swine influenza and the 2004 H5N1 avian influenza, so the company is planning to evaluate the sequence of the G4 EA H1N1 virus to determine if the Ii-Key-H1 vaccine program can be reignited to rapidly respond to this new threat.”

About NuGenerex Immuno-Oncology

NuGenerex Immuno-Oncology, a subsidiary of Generex Biotechnology, is a clinical stage oncology company developing immunotherapeutic peptide vaccines based on the CD4 T-Cell activation platform, Ii-Key. NuGenerex Immuno-Oncology (NGIO) has been spun out of Generex as a separate, independent public company to advance the platform Ii-Key technology, particularly in combination with the immune checkpoint inhibitors. NGIO is currently engaged in a Phase II clinical trial of its lead cancer immunotherapeutic vaccine AE37 in combination with pembrolizumab (Merck’s Keytruda®) for the treatment of triple negative breast cancer.

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.

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Generex Contact:

NuGenerex Immuno-Oncology

Generex Biotechnology Corporation

Joseph Moscato

646-599-6222

Todd Falls

1-800-391-6755 Extension 222

[email protected]