Generex Biotechnology Corp.
  • Co-Chairs to guide the development of Ii-Key-SARS-CoV-2 Vaccine as a safe & effective vaccine targeted for the pediatric population
  • Dr. Jonathan Davis is Vice-Chair of Pediatrics and Chief of Newborn Medicine at Tufts Children’s Hospital and Professor of Pediatrics at Tufts University School of Medicine
  • Dr. John Sanders is chief of Infectious Diseases within the section of Internal Medicine at Wake Forest Baptist Health
  • Dr. Gary Noel is the Chief Medical Officer of the Institute for Advanced Clinical Trials for Children (I-ACT for Children)
  • Dr. Craig Eagle, Vice President of Medical Affairs Oncology for Genentech, Board of Directors, Generex Biotechnology & NuGenerex Immuno-Oncology

MIRAMAR, Fla., Oct. 06, 2020 (GLOBE NEWSWIRE) — Generex Biotechnology Corporation ( ) (OTCQB:GNBT) ( ) today announced that the company has formed the COVID-19 Vaccine Scientific & Clinical Advisory Board (SAB) to help guide the clinical development program for the Ii-Key-SARS-CoV-2 vaccine with a special emphasis on development of a safe and effective vaccine for the pediatric population and for pregnant women, populations with significant unmet need in the COVID vaccine race. Dr. Jonathan Davis and Dr. Gary Noel will co-chair the pediatric vaccine panel and Dr. John W. Sanders will chair the adult vaccine panel, as Dr. Craig Eagle, a member of the Generex and NuGenerex Boards of Directors, will provide the SAB with expertise on drug development, regulatory affairs, and business development.

Dr. Jonathan Davis, MD is Vice-Chair of Pediatrics and Chief of Newborn Medicine at Tufts Children’s Hospital and Professor of Pediatrics at Tufts University School of Medicine. He is also Chair of the Neonatal Advisory Committee in the Office of the Commissioner at FDA, Director of the International Neonatal Consortium (INC) through FDA, the European Medicines Agency, and the Critical Path Institute, and Associate Director of the Tufts Clinical and Translational Science Institute. Dr. Davis’ research has focused on neonatal drug development and he is currently funded by NIH and FDA to develop better biomarkers and outcome measures for clinical trials and new and existing therapeutics to improve neonatal outcome.  He is Co-PI of a recent $8M NIH award to Tufts to fund a national clinical trial studying the integration of targeted genomic sequencing into neonatal diagnosis and care and a $5M FDA award to generate real world evidence for neonatal clinical trials.

Dr. Gary Noel, MD, FAAP, FIDSA, FPIDS is a pediatrician, specialist in infectious diseases and immunology and an expert in drug development, having spent more than 30 years in leadership roles in the biopharmaceutical industry and academia. He joined I-ACT for Children as Chief Medical Officer from Johnson & Johnson, where he most recently served as a member of the Child Health Innovation Leadership Department in the Office of the Chief Medical Officer and as chair of its Pediatric Expert Panel. Dr. Noel has held various leadership roles at Johnson & Johnson and was previously Vice President and Chief Medical Officer at Paratek Pharmaceuticals and Vice President of Early Clinical Development in Infectious Diseases at AstraZeneca. Prior to his time in industry, Dr. Noel served on the full-time faculty at Cornell University Medical College; was the Chief of Pediatric Infectious Diseases and Immunology at The New York Hospital-Cornell Medical Center and led the Pediatric Infectious Diseases Fellowship Program and an NIH-funded laboratory. He was the Associate Director of the Cornell University Children’s Clinical Research Center and administrative lead for The New York Hospital’s Program for Children with AIDS.

Dr. John Sanders, MD, is Professor of Medicine and Chief of the Infectious Disease Section at Wake Forest School of Medicine (WFSM) in Winston-Salem, North Carolina. He joined the Wake Forest faculty in 2015 after retiring from the U.S. Navy as the Commanding Officer of the Naval Medical Research Center. While in the Navy, he led research programs for the development of new vaccines, diagnostics, and medicines. He has continued that work at Wake Forest and is currently conducting several pre-clinical and clinical vaccine studies. Dr. Sanders is a Fellow of the Infectious Disease Society of America, the American College of Physicians, and the American Society of Tropical Medicine and Hygiene.

Dr. Craig Eagle is currently the Vice President of Medical Affairs Oncology for Genentech where he oversees the medical programs across the oncology portfolio. Prior to his current role, Dr Eagle worked at Pfizer in several positions including as the oncology business lead in United Kingdom and Canada delivering significant business growth. Previously, Dr Eagle was the global lead for Oncology Strategic Alliances and Partnerships based in New York at Pfizer Inc. and was involved in multiple deals on both the sell and buy side. Dr Eagle started work in Pfizer New York as the global head of the Oncology Therapeutic Area Global Medical and Outcomes Group for Pfizer, including the US oncology business, in this role he oversaw an extensive oncology clinical trial program, health outcomes assessments and scientific collaborations with key global research organizations like the  National Cancer Institute (NCI), and EORTC. As part of this role Dr Eagle led the worldwide development of several compounds including celecoxib, aromasin, irinotecan, dalteparin and ozagomicin, Concurrently Dr. Eagle has been a Member of Scientific Advisory Board at Generex Biotechnology Corp. since August 2010. He has served on the scientific advisory committee and board of directors for several start up biotechnology companies.

Generex CEO, Joseph Moscato said, “I would like to thank these distinguished and highly respected physician researchers, all from prestigious institutions, for joining us in our efforts to create a safe and effective vaccine against COVID-19 that can be used not only in adults, but also in pediatric populations who have so far been excluded from the vaccine discussion. Our Ii-Key vaccine is designed as a “Complete Vaccine”, which can generate neutralizing antibodies via the humoral immune response and can activate the CD4+ and CD8+ cellular responses in a safe manner to avoid the complications of off target immune effects that lead to the cytokine storm and autoimmune diseases. As all of our Ii-Key vaccines are peptide-based and targeted to specific regions of the coronavirus rather than gene therapy based and including the entire spike protein of the virus, and since we have demonstrated the safety of our other Ii-Key vaccines in Phase IIb human clinical trials, we believe that our technology offers the safest and best route for the rapid development of a pediatric Ii-Key-SARS-CoV-2 vaccine. Of course, we plan to move forward with the first in human studies of the vaccine in healthy adults, however, because of the clean safety profiles of our other Ii-Key vaccines, we hope to conduct clinical trials in adolescents, children, and pregnant women on a safe and expedited path to address this glaring unmet need in our fight against this COVID-19 pandemic. We look forward to working closely with our SAB as we move the Ii-Key-SARS-CoV-2 vaccine through the global regulatory process.”

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.

About NuGenerex Immuno-Oncology
NuGenerex Immuno-Oncology, a subsidiary of Generex Biotechnology, is a clinical stage oncology company developing immunotherapeutic peptide vaccines for cancer and infectious disease based on the CD4 T-Cell activation platform, Ii-Key. NuGenerex Immuno-Oncology (NGIO) has been spun out of Generex as a separate public company to advance the platform Ii-Key technology, particularly in combination with the immune checkpoint inhibitors for the treatment of cancer. 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. The company has also turned its Ii-Key technology on infectious disease, responding to the coronavirus pandemic with a SARS-CoV-2 vaccine development program.

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.

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