Generex Biotechnology Corp’s (OTCMKTS:GNBT) subsidiary NuGenerex Immuno-Oncology has announced the submission of a response to the FDA’s comments on a Pre-IND Written Response.
NuGenerex Immuno-Oncology responds to FDA’s comments Ii-Key vaccine
The response package offers important information requested by the FDA, including Li-Key epitope sequences, picked based on the ex-vivo blood screening program. It also includes the transgenic mouse immunogenicity study results showing vaccine-specific antibody production and GMP manufacturing information for Ii-Key-SARS-CoV-2 epitopes in the vaccine. There is also a revised protocol incorporating FDA’s requests and comments.
The company has previously reported ex-vivo blood screening program results, which enabled the selection of Ii-Key-SARS-CoV-2 epitopes from membrane and spike proteins based upon T-cell activation profiles. Notably, the company tested the five Ii-Key epitopes in a mouse model engineered with a human immune system part.
NuGenerx Immuno-Oncology CEO Joe Moscato said that the company has made considerable progress in Ii-Key SARS-CoV-2 vaccines. He said that a year a goo chose to use the Ii-Key tech to offer a targeted, safe, and specific Complete Vaccine™ that creates neutralizing antibodies and T-Cell activation for enhanced immune memory.
NuGenerex creating COVID-19 vaccine for pediatric and pregnant women
Generex Biotechnology and NuGenerex Immuno-Oncology have announced a partnership with Last Chance for Children’s Mission to help save the lives of children across the globe. With the COVID-19 pandemic, the company’s efforts are on helping eradicate the virus by vaccinating children in need. The pandemic has disrupted children’s lives, and so far, there is no approved vaccine for children under 12 or pregnant women.
As a result, NuGenerex’s Ii-Key COVID-19 vaccine could be vital in protecting against the virus. The Ii-Key vaccine is based on amino acid sequences mimicking the COVID-19 spike and membrane proteins. It selectively regulates immune responses targeting the SARS-CoV-2 virus without genetic material like most vaccines that use DNA and RNA vectors.
NuGenerex is focusing on creating a safe and effective COVID-19 vaccine for pregnant women and pediatric populations, populations with significant unmet needs in the race for the COVID-19 vaccine.
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