About Us
NuGenerex Immuno-Oncology, Inc. is a platform biotechnology company focused on harnessing the power of the innate immune system to treat cancer and infectious disease with a pipeline of immunotherapy indications based on our proprietary, patented platform technology, Ii-Key.
The Company’s lead immunotherapy product candidate is
AE37, an Ii-Key-HER2 peptide vaccine for breast, prostate, and bladder cancer which incorporates our li-peptide linker to a designated antigen that activates the immune system targeting specific cancer cells. Ex-Vivo human studies are currently underway for our Ii-Key-SARS-CoV-2 vaccine and clinical trials are expected to begin in early 2021.

OUR COLLABORATIONS
AE37
- Merck Sharpe & Dohme B.V. (“Merck”) Clinical Trial Collaboration and Supply Agreement for a Phase II clinical trial to evaluate the safety and efficacy of AE37 in combination with the anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in patients with metastatic triple-negative breast cancer. NGIO is sponsoring the clinical trial protocol in collaboration with the National Surgical Adjuvant Breast and Bowel Project (NSABP). (Clinicgov Identifier: NCT04024800)
- Shenzhen Bioscien of China has licensed the rights to the use of AE37 in China for the treatment of prostate cancer.
Ii-Key-SARS-CoV-2 Vaccine
- Bintai Kinden of Malaysia has signed a licensing and distribution agreement to support the development of a COVID-19 vaccine in the U.S in exchange for distribution rights in Southeast Asia.
Ii-Key-SARS-CoV-2, Ii-Key-Swine Flu, Ii-Key-Cancer-Infectious Diseases Vaccines
- Youfeng International Consulting Co., Ltd, & The National Institute for Viral Disease Control and Prevention, Chinese Centre for Disease Control and Prevention (NIVDC) and Beijing Guoxin Haixiang Equity Investment Partnership (collectively referred to as the China Partners) Have set up a joint entity in China to develop and industrialize the Generex internationally patented Ii-Key innovative technology for a Flu peptide vaccine and other vaccines in the People’s Republic of China.
Highlighted joint developments are.
- Ii-Key Vaccine for COVID-19 – Ii-Key-SARS-CoV-2
- Ii-Key Vaccine for Swine Flu – Ii-Key-H1 Swine Influenza Vaccine & Plans to incorporate Ii-Key-H1 vaccine into universal seasonal influenza vaccine
- Ii-Key Platform for Cancer and Infectious Diseases
Our Mission
Developing safe and effective immuno-therapeutic vaccines with our proprietary platform technology by supercharging and harnessing the power of the immune system to fight infectious disease and cancer.
Our Vision
To become the global innovative leader in combatting infectious disease and cancer; saving lives one vaccine at a time.
What makes us different
- AI Platform for biomarker discovery
- Targeted immune system modulation
- T-Cell activation for long-term immunity
- Cellular and humoral (antibody) activation for a Complete Vaccine
- Neo-antigen approaches to personalized vaccines
- Synthetic peptide manufacturing; produce mass quantities quickly with no incubation time (100 Kg = 100 million vaccines)
Our History
NuGenerex Immuno-Oncology (NGIO) has 20 Years of Experience in Immunotherapeutic Vaccine Development for Infectious Diseases & Cancer; harnessing the power of the immune system using its patented Ii-Key delivery platform.
NGIO, formerly known as Antigen Express began in 1993. Our foundational immunotherapeutic technology, Ii-Key, was first discovered and patented by Dr. Robert Humphreys at the University of Massachusetts. In August 2003, all of Antigen Express stock was acquired by Generex Biotechnology Corporation (“Generex”). In January 2017, a new management team took over Generex and reinvigorated the immunotherapy clinical programs for Ii-Key vaccines. With this new leadership, we changed our name to NuGenerex Immuno-Oncology.