The FDA has accepted a Pre-IND Briefing Package from Generex Biotechnology Corporation (OTCMKTS:GNBT) for its Ii-Key-SARS-CoV-2 Vaccine

The FDA has accepted a Pre-IND Briefing Package from Generex Biotechnology Corporation (OTCMKTS:GNBT) for its Ii-Key-SARS-CoV-2 Vaccine


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Generex Biotechnology Corporation (OTCMKTS:GNBT) has such a strong portfolio of immune-oncology assets, diagnostics, and medical devices. An acquisition strategy the company applies from time to time has enabled it to offer end-to-end solutions to the healthcare industry. It has established a powerful network with pharmacies, clinical laboratories, and medical device companies.

Generex is now seeking a new vaccine to its pipeline, Ii-Key-SARS-CoV-2. The coronavirus prophylactic vaccine is said to have an impending potential for inducing the T-Cell and antibody immune responses. The FDA has accepted a pre-IND briefing package for the vaccine submitted earlier by the company. However, the FDA is no longer conducting face-to-face Pre-IND meetings; hence the company is waiting for a written response from the agency.

The Ii-Key Technology Directly Charges the CD4+ T-cell Response against Target Epitopes

According to Joseph Moscato, Generex CEO, they aim to provide comprehensive patient-centric care from rapid diagnosis and personalized therapies. Apart from having strong antibody immune responses, the CEO says Ii-Key-SARS-CoV-2 also features a long-lasting neutralizing antibody response alongside a CD4+ Th1 T-cell response.

The company has been having a strong focus on the activation of the cellular CD4+ and CD8+ immune responses. These are considered essential in the generation of long-term memory immunity. The Ii-Key technology will play a significant role in charging the CD4+ T-cell response against target epitopes.

‘’…we are developing a vaccine that activates neutralizing antibodies while eliminating those peptides that may cause antibody-dependent disease enhancement (ADE) or cytokine storm, thereby providing a complete and safe immune response against SARS-CoV-2…’’ Moscato explained.

 Commercialization of the Ii-Key-SARS-CoV-2 Vaccine

Generex has been working with a dedicated team of internal and external professionals to reality the Ii-Key-SARS-CoV-2 Vaccine. Have completed the most comprehensive and final protocols, the company is determined about enrolling new subjects into additional trials of the vaccine.

Meanwhile, Moscato says they acknowledge the effects of COVID-19, which include circulatory problems, blood clotting, neurological deficits, and respiratory distress. Sadly very few COVID-19 patients have the necessary or long-term antibody responses, giving them the possibility of a quick recovery. This is risky because even those that have recovered from the disease could be re-infected.

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