Publications

Home 5 Our Science 5 Publications

Prospective, randomized, single‑blinded, multi‑center phase II trial of two HER2 peptide vaccines, GP2 and AE37, in breast cancer patients to prevent recurrence Received: 27 October 2019 / Accepted: 8 April 2020

Adams S, Humphreys RE. Invariant chain peptides enhancing or inhibiting the presentation of antigenic peptides by major histocompatibility complex class II molecules. Eur J Immunol. 1995 Jun;25(6):1693-702.

Adams S, Albericio F, Alsina J, Smith ER, Humphreys RE. Biological activity and therapeutic potential of homologs of an Ii peptide which regulates antigenic peptide binding to cell surface MHC class II molecules. Arzneimittelforschung. 1997 Sep;47(9):1069-77.

Xu M, Jackson R, Adams S, Humphreys RE. Studies on activities of invariant chain peptides on releasing or exchanging of antigenic peptides at human leukocyte antigen-DR1. Arzneimittelforschung. 1999 Sep;49(9):791-9.

Humphreys RE, Adams S, Koldzic G, Nedelescu B, von Hofe E, Xu M. Increasing the potency of MHC class II-presented epitopes by linkage to Ii-Key peptide. Vaccine. 2000; 18:2693-7.

Xu M, Qiu G, Jiang Z, von Hofe E, Humphreys RE. Genetic modulation of tumor antigen presentation. Trends Biotechnol. 2000;18:167-72. Review.

Xu M, Li J, Gulfo JV, Von Hofe E, Humphreys RE. MHC class II allosteric site drugs: new immunotherapeutics for malignant, infectious and autoimmune diseases. Scand J Immunol 2001; 54:39-44.

Drabner B, Reineke U, Schneider-Mergener J, Humphreys RE, Hartmann S, Lucius R. Identification of T helper cell-recognized epitopes in the chitinase of the filarial nematode Onchocerca volvulus. Vaccine. 2002; 20:3685-94.

Hillman GG, Kallinteris NL, Li J, Wang Y, Lu X, Li Y, Wu S, Wright JL, Slos P, Gulfo JV, Humphreys RE, Xu M. Generating MHC Class II+/Ii- phenotype after adenoviral delivery of both an expressible gene for MHC Class II inducer and an antisense Ii-RNA construct in tumor cells. Gene Ther 2003; 10:1512-8.

Hillman GG, Xu M, Wang Y, Wright JL, Lu X, Kallinteris NL, Tekyi-Mensah S, Thompson TC, Mitchell MS, Forman JD. Radiation improves intratumoral gene therapy for induction of cancer vaccine in murine prostate carcinoma. Human Gene Therapy 2003; 14: 763-75.

Lu X, Kallinteris NL, Li J, Wu S, Li Y, Jiang Z, Hillman GG, Gulfo JV, Humphreys RE, Xu M. Tumor immunotherapy by converting tumor cells to MHC class II-positive, Ii protein-negative phenotype. Cancer Immunol Immunother 2003; 52:592-8.

Kallinteris NL, Lu X, Wu S, Hu H, Li Y, Gulfo JV, Humphreys RE, Xu M. Ii-Key/MHC class II epitope hybrid peptide vaccines for HIV. Vaccine 2003; 21:4128-32.

Hillman GG, Kallinteris NL, Lu X, Wang Y, Wright JL, Li Y, Wu S, Forman JD, Gulfo JV, Humphreys RE, and Xu M. Turning tumor cells in situ into T-helper cell-stimulating, MHC class II tumor epitope-presenters: immuno-curing established tumors. Cancer Treatment Reviews 2004; 30:281-90.

Gillogly ME, Kallinteris NL, Xu M, Gulfo JV, Humphreys RE, Murray JL. Ii-Key/HER-2/neu MHC class-II antigenic epitope vaccine peptide for breast cancer. Cancer Immunol Immunother. 2004; 53:490-6.

Xu M, Lu X, Kallinteris NL, Wang Y, Wu S, von Hofe E, Gulfo J, Humphreys RE, Hillman GG. Immunotherapy of cancer by antisense inhibition of Ii protein, an immunoregulator of antigen selection by MHC class II molecules. Curr Opin Mol Ther. 2004; 6:160-5.

Humphreys RE, Hillman GG, von Hofe E, Xu M. Forcing Tumor Cells to Present Their Own Tumor Antigens to the Immune System: A Necessary Design for an Efficient Tumor Immunotherapy. J Cellular and Mol Imm 2004; 1:180-185

Wang Y, Xu M, Che M, Hofe EV, Abbas A, Kallinteris NL, Lu X, Liss ZJ, Forman JD, Hillman GG. Curative Antitumor Immune Response Is Optimal with Tumor Irradiation Followed by Genetic Induction of Major Histocompatibility Complex Class I and Class II Molecules and Suppression of Ii Protein. Hum Gene Ther. 2005;16:187-99.

Kallinteris NL, Wu S, Lu X, von Hofe E, Humphreys RE, Xu M. Linkage of Ii-Key segment to gp100(46-58) epitope enhances the production of epitope-specific antibodies. Vaccine. 2005;18:2336-8.

Kallinteris NL, Wu S, Lu X, Humphreys RE, von Hofe E, Xu M. Enhanced CD4+ T-cell response in DR4-transgenic mice to a hybrid peptide linking the Ii-Key segment of the invariant chain to the melanoma gp100(48-58) MHC class II epitope. J Immunother. 2005 Jul-Aug;28(4):352-8.

Kallinteris NL, Powell D, Blackwell CE, Kim M, Lu X, Wu S, Humphreys RE, Xu M, von Hofe E. Ii-Key/MHC class II epitope peptides as helper T cell vaccines for cancer and infectious disease. Front Biosci. 2006 Jan 1;11:46-58.

Kallinteris NL, Lu X, Blackwell CE, von Hofe E, Humphreys RE, Xu M. Ii-Key/MHC class II epitope hybrids: a strategy that enhances MHC class II epitope loading to create more potent peptide vaccines. Expert Opin Biol Ther. 2006 Dec;6(12):1311-21. Review.

Lu X, Wu S, Blackwell CE, Humphreys RE, von Hofe E, Xu M. Suppression of major histocompatibility complex class II-associated invariant chain enhances the potency of an HIV gp120 DNA vaccine. Immunology. 2007 Feb; 120(2):207-16.

Sotiriadou NN, Kallinteris NL, Gritzapis AD, Voutsas IF, Papamichail M, von Hofe E, Humphreys RE, Pavlis T, Perez SA, Baxevanis CN. Ii-Key/HER-2/neu (776-790) hybrid peptides induce more effective immunological responses over the native peptide in lymphocyte cultures from patients with HER-2/neu+ tumors. Cancer Immunol Immunother. 2007 May;56(5):601-13.

Voutsas IF, Gritzapis AD, Mahaira LG, Salagianni M, von Hofe E, Kallinteris NL, Baxevanis CN. Induction of potent CD4+ T cell-mediated antitumor responses by a helper HER-2/neu peptide linked to the Ii-Key moiety of the invariant chain. Int J Cancer. 2007 Nov 1;121(9):2031-41.

Wambre E, Van Overtvelt L, Maillère B, Humphreys R, von Hofe E, Ferhat L, Ebo D, Moingeon P. Single cell assessment of allergen-specific T cell responses with MHC class II peptide tetramers: methodological aspects. Int Arch Allergy Immunol. 2008 Jan;146(2):99-112.

Chou CL, Mirshahidi S, Su KW, Kim A, Narayan K, Khoruzhenko S, Xu M, Sadegh-Nasseri S. Short peptide sequences mimic HLA-DM functions. Mol Immunol. 2008 Apr;45(7):1935-43.

Van Overtvelt L, Wambre E, Maillère B, von Hofe E, Louise A, Balazuc AM, Bohle B, Ebo D, Leboulaire C, Garcia G, Moingeon P. Assessment of Bet v 1-specific CD4+ T cell responses in allergic and nonallergic individuals using MHC class II peptide tetramers. J Immunol. 2008 Apr 1;180(7):4514-22.

Holmes JP, Benavides LC, Gates JD, Carmichael MG, Hueman MT, Mittendorf EA, Murray JL, Amin A, Craig D, von Hofe E, Ponniah S, Peoples GE. Results of the first phase I clinical trial of the novel II-key hybrid preventive HER-2/neu peptide (AE37) vaccine. J Clin Oncol. 2008 Jul 10;26(20):3426-33.

Mittendorf EA, Holmes JP, Murray JL, von Hofe E, Peoples GE. CD4+ T cells in antitumor immunity: utility of an li-key HER2/neu hybrid peptide vaccine (AE37). Expert Opin Biol Ther. 2009 Jan;9(1):71-8. Review.

Xu M, Lu X, Sposato M, Zinckgraf JW, Wu S, von Hofe E. Ii-Key/HPV16 E7 hybrid peptide immunotherapy for HPV16+ cancers. Vaccine. 2009 Jul 23;27(34):4641-7.

Zinckgraf JW, Sposato M, Zielinski V, Powell D, Treanor JJ, von Hofe E. Identification of HLA class II H5N1 hemagglutinin epitopes following subvirion influenza A (H5N1) vaccination. Vaccine. 2009 Aug 27;27(39):5393-401.

Perez SA, von Hofe E, Kallinteris NL, Gritzapis AD, Peoples GE, Papamichail M, Baxevanis CN. A new era in anticancer peptide vaccines. Cancer. 2010 May 1;116(9):2071-80.

Perez SA, Kallinteris NL, Stratos B, Tzonis PK, Georgakopoulou K, Thanos A, Varla-Leftherioti M, Papamichail M, von Hofe E, Baxevanis CN. Results From a Phase 1 Clinical Study of the Novel Ii-Key/HER-2/neu(776-790) Hybrid Peptide Vaccine in Patients with Prostate Cancer. Clin Cancer Res. 2010 Jul 1;16(13):3495-506. Epub 2010 May 13

Gates JD, Clifton GT, Benavides LC, Sears AK, Carmichael MG, Hueman MT, Holmes JP, Jama YH, Mursal M, Zacharia A, Ciano K, Khoo S, Stojadinovic A, Ponniah S, Peoples GE. Circulating regulatory T cells (CD4+CD25+FOXP3+) decrease in breast cancer patients after vaccination with a modified MHC class II HER2/neu (AE37) peptide. Vaccine. 2010 Nov 3;28(47):7476-82. -82. Epub 2010 Sep 19

Benavides LC, Sears AK, Gates JD, Clifton GT, Clive KS, Carmichael MG, Holmes JP, Mittendorf EA, Ponniah S, Peoples GE. Comparison of different HER2/neu vaccines in adjuvant breast cancer trials: implications for dosing of peptide vaccines. Expert Rev Vaccines. 2011 Feb;10(2):201-10.

Vadacca M, Valorani MG, von Hofe E, Kallinteris NL, Buzzetti R, Pozzilli P. Recognition of Ii-Key/HC Class II Epitope Hybrids Derived from Proinsulin and GAD Peptides by T Cells in Type 1 Diabetes. Horm Metab Res. 2011 Jun;43(7):483-8. Epub 2011 Apr 21

Erskine CL, Krco CJ, Hedin KE, Borson ND, Kalli KR, Behrens MD, Heman-Ackah SM, von Hofe E, Wettstein PJ, Mohamadzadeh M, Knutson KL. MHC Class II Epitope Nesting Modulates Dendritic Cell Function and Improves Generation of Antigen-Specific CD4 Helper T Cells. J Immunol. 2011 Jul 1;187(1):316-24. Epub 2011 May 25.

Sears AK, Perez SA, Clifton GT, Benavides LC, Gates JD, Clive KS, Holmes JP, Shumway NM, Van Echo DC, Carmichael MG, Ponniah S, Baxevanis CN, Mittendorf EA, Papamichail M, Peoples GE. AE37: a novel T-cell-eliciting vaccine for breast cancer. Expert Opin Biol Ther. 2011 Sep 6. [Epub ahead of print]

von Hofe E. A new ally against cancer. Scientific American 2011 Oct;305(4):66-71.

Primary analysis of a prospective, randomized, single-blinded phase II trial evaluating the HER2 peptide AE37 vaccine in breast cancer patients to prevent recurrence

Intellectual Property

Platform Patents.

The foundational “Platform Patents” for Ii-Key technology focus on methods of increasing the antigen-specific activation of CD4+ T cells. This cell type is a critical component of the immune system, involved both in the recognition of new pathogenic agents as well as in autoimmune syndromes. The first technology platform (Ii-Key hybrid) relates to a means for increasing the vaccine potency of virtually any protein and while the second (Ii-suppression) relates to generation of an effective cell-based vaccine.

 Oncology Patents.

This group of patents relate more specifically to the use of the platform technologies for generating anti-cancer vaccines. We have generated Ii-Key hybrid compounds specifically for patients with breast, prostate, bladder, melanoma and HPV-related cancers.

 

These patents cover:

  •  Compositions and Methods Related to Ii Technology
  • Ii hybrid peptides used for the enhancement of antigen presentation
  • Constructs for the expression of Ii-Key/antigen epitope fusion peptides
  • Hybrid Ii-Key/antigen epitope fusion peptides
  • Methods for inhibiting Ii expression

©2020, NuGenerex Immuno-Oncology, Inc. All rights reserved | Privacy Policy | Disclaimer

The phrase “Complete Vaccine” stated throughout this site is a description of the Ii-Key vaccine technology that is designed to activate a targeted cellular immune response and generate a specific neutralizing antibody response to produce long-term immune system memory. Ii-Key vaccines are not currently approved for sale by the FDA.

Anthony S. Crisci, Esq., C.P.A. Corporate Counsel and Chief Legal Officer

Anthony S. Crisci, Esq., C.P.A.

Anthony S. Crisci, Esq., C.P.A. is Chief Legal Officer for NGIO and is also the Chief Legal Officer for Generex since August 2019. Mr. Crisci is an attorney and certified public accountant with over twenty (20) years of experience in tax, accounting, finance, corporate, health care and employee benefit matters. Mr. Crisci has built a stellar career as a business legal executive across a number of regulated industries.

From November 2018, Mr. Crisci was Corporate Counsel for Generex and remains as the Chief Administrative Officer and Chief Legal Counsel for Generex’s wholly owned subsidiary, NuGenerex Distribution Solutions, where he oversees business, accounting, and legal matters for NuGenerex’s distribution enterprise. Most recently, Mr. Crisci was General Counsel, COO, CFO, and Controller for a publicly traded holding company, specializing in financial services and technology software companies. Previously, he served as Corporate Counsel for a major health system with $1 Billion in annual revenues, and General Counsel for a National Pharmacy Benefit Management Company that includes mail and specialty drug dispensing.

Mr. Crisci brings a broad range of capabilities with his legal, business, financial, and regulatory background, and his expertise is instrumental in the execution of Generex’s strategic objectives, including mergers & acquisitions, joint venture and development agreements, in-licensing and out-licensing agreements, and most importantly, long term supply and distributorship agreements for nation-wide pharmacy, laboratory, and medical management services. Mr. Crisci holds a Bachelor of Business Administration degree in Accounting from Hofstra University and a Juris Doctor degree, with distinction, from Hofstra University School of Law. He is a licensed CPA and a Member of the New York State and New Jersey State Bar Associations.

Brian T. McGee Chairman of the Generex Audit Committee | Member of the Generex Compensation and Corporate Governance and Nominating Committees

Brian T. McGee

Mr. Brian T. McGee serves as an independent Director of Generex since 2004. Mr. McGee has served as Chairman of the Generex Audit Committee and a member of the Generex Compensation and Corporate Governance and Nominating Committees. Mr. McGee has been a partner of Zeifmans LLP ("Zeifmans") since 1995. Mr. McGee began working at Zeifmans shortly after receiving a B.A. degree in Commerce from the University of Toronto in 1985. Zeifmans is a Chartered Accounting firm based in Toronto, Ontario. A significant element of Zeifmans’ business is public corporation accounting and auditing. Mr. McGee is a Chartered Accountant. Throughout his career, Mr. McGee has focused on, among other areas, public corporation accounting and auditing. In 1992, Mr. McGee completed courses focused on International Taxation and Corporation Reorganizations at the Canadian Institute of Chartered Accountants and in 2003, Mr. McGee completed corporate governance courses on compensation and audit committees at Harvard Business School. In April 2004 Mr. McGee received his CPA designation from The American Institute of Certified Public Accountants. Mr. McGee has received a certificate in International Financial Reporting Standards issued by The Institute of Chartered Accountants in England and Wales in 2010. The Board believes that Mr. McGee’s knowledge and understanding of accounting and finance, his education and training in accounting and corporate governance, and his extensive experience in the accounting industry.

Disclaimer

Certain statements in this website or in documents contained in, referred to or linked from this website (including, without limitation, press releases, financial statements, annual reports and other documents) may constitute “forward-looking statements” with respect to opinions, forecasts, projections, plans, objectives, assumptions and/or future performance of NuGenerex Immuno-Oncology, Inc. Forward-looking statements may be identified through the use of words such as “expects,” “will,” “anticipates,” “intends,” “estimates,” “believes,” or by statements indicating certain actions “may,” “could,” “should” or “might” occur. Forward-looking statements involve risks and uncertainties, and there can be no assurance that the forward-looking statements will prove to have been correct. Actual results, performance or achievements could differ, or may have differed, materially from those expressed or implied by those statements. Forward-looking statements are based largely upon the expectations of NuGenerex Immuno-Oncology, Inc. and are subject to a number of risks and uncertainties that are subject to change based on factors, which are, in many instances, beyond the control of NuGenerex Immuno-Oncology, Inc. Undue reliance should not be placed on any forward-looking statements.

The information contained in the press releases, financial statements, annual reports, and other documents contained in, referred to or linked from this website speaks only as of the particular date of the original release, filing or publication of such information. Accordingly, such information may have become out of date. Neither NuGenerex Immuno-Oncology, Inc. nor any other person undertakes any obligation, and NuGenerex Immuno-Oncology, Inc. disclaims any duty, to update, supplement or correct any of the information contained in the press releases, financial statements, annual reports and other documents contained in, referred to or linked from this website.

All statements and expressions are the sole opinion of NuGenerex Immuno-Oncology, Inc. and are subject to change without notice. NuGenerex Immuno-Oncology, Inc. is not liable for any investment decisions by its readers or any other person. It is strongly recommended that any purchase or sale decision be discussed with a financial adviser, a broker-dealer, or a member of any financial regulatory body. The information contained herein has been provided as an information service only.

Dr. Carol Nacy, PhD Founder and the Chief Executive Officer of Sequella, Inc.

Dr. Carol Nacy, PhD

Dr. Carol Nacy, PhD is a founder and the Chief Executive Officer of Sequella, Inc., a privately held pharmaceutical company that discovers and develops new and more effective treatments for life threatening infectious diseases. Previously, Dr. Nacy was Executive Vice President and Chief Scientific Officer at EntreMed,Inc. from 1993 through its successful public offering in June 1996. Prior to her career in biotechnology, Dr. Nacy worked for 17 years at the Walter Reed Army Institute of Research in Washington, DC, where she studied tropical infectious diseases. She has published over 165 scientific papers to date. Dr. Nacy has a long and successful career in infectious disease research and has been widely recognized for her achievements in the biotechnology industry. She was singled out as a Top 50 Innovator in the U.S. by Inc. Magazine in 2002, named Entrepreneur of the Year by Women in BIO in 2004, the state of Maryland named her in its Top 100 Business Women in 2005, and the Washington Business Journal named her as a top 25 female executive in the Washington DC metropolitan area in 2005. In 2006, she received a National Leadership Award in Healthcare from the National Urban Technology Center in New York City, and in 2007 she was honored with a Special Outstanding Achievement Award for Clinical Trials by Women in BIO. In 2009 she was awarded the Humanitarian Award, Hope is a Vaccine, by the Global Alliance for Immunization against Aids (GAIA) for her work to create new drugs for TB. She is an Editor for the American Academy of Microbiology journal, mBio, and an adjunct faculty member of the Department of Tropical Diseases at the George Washington University, Washington, DC. She earned her A.B., M.S., and Ph.D. degrees from the Catholic University of America in Washington, DC, which awarded Dr. Nacy with a Lifetime Achievement Award in Science.

Dr. Craig Eagle, MDVice President of Medical Affairs Oncology for Genentech

Dr. Craig Eagle, MD

Dr. Craig Eagle, MD 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 lead 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.

Dr. Eagle attended Medical School at the University of New South Wales, Sydney, Australia and received his general internist training at Royal North Shore Hospital in Sydney. He completed his hemato-oncology and laboratory hematology training at Royal Prince Alfred Hospital in Sydney. He was granted Fellowship in the Royal Australasian College of Physicians (FRACP) and the Royal College of Pathologists Australasia (FRCPA). After his training, Dr. Eagle performed basic research at the Royal Prince of Wales hospital to develop a new monoclonal antibody to inhibit platelets.

Dr. Gary Noel, MD, FAAP, FIDSA, FPIDS Pediatrician, specialist in infectious diseases and immunology and an expert in drug development

Dr. Gary Noel, MD, FAAP, FIDSA, FPIDS

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. Jason B. Terrell, MD. Chief Scientific Officer and Chief Medical Officer

Dr. Jason B. Terrell, MD.

Dr. Jason B. Terrell, MD. is the Chief Medical Officer of NGIO and is also the Chief Scientific Officer and Chief Medical Officer of Generex, providing scientific and medical due diligence for partnerships and mergers/acquisitions, and providing clinical oversight for subsidiary operations and product development strategies. Since 2017, he has also served as Assistant Clinical Professor of Oncology, University of Texas at Austin Dell Medical School as an industry and clinical expert advisor to researchers, innovators, and entrepreneurs for accelerating the translation of innovations to health products for Texas Health Catalyst. Since 2017, he has also been Lead Independent Director and Non-Executive Chairman of Kiromic Biopharma Inc, providing guidance for corporate formation, business development, product development and commercialization strategies. Since 2016, Dr. Terrell has served as CEO and Chief Medical Officer for Volition America Inc. From 2010 to 2015 he was Corporate Medical Director for AnyLabTestNow, Dr. Terrell is a summa cum laude graduate from Hardin-Simmons University with a degree in Biochemistry. He graduated as recipient of the Holland Medal of Honor for the top graduate in the School of Science and Mathematics. Dr. Terrell was honored with the Hardin-Simmons University Outstanding Young Alumni Award and currently serves on the University’s Board of Development. Dr. Terrell attended The University of Texas School of Medicine in Houston and received General Medicine Internship and Pathology Residency training at the Texas Tech University Health Sciences Center.

Dr. John Sanders, MDProfessor of Medicine and Chief of the Infectious Disease Section at Wake Forest School of Medicine

Dr. John Sanders, MD

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. Jonathan Davis, MD 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. Jonathan Davis, MD

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. Marvin S. Hausman, MD Immunologist and Board-Certified Urological Surgeon

Dr. Marvin S. Hausman, MD

Dr. Marvin S. Hausman, MD is an Immunologist and Board-Certified Urological Surgeon with more than 30 years of drug research and development experience with various pharmaceutical companies, including Bristol-Myers International, Mead-Johnson Pharmaceutical Co., E.R. Squibb, Medco Research, and Axonyx. Dr. Hausman currently serves as Chairman of the Board & Chief Science and Technology Officer of Entia Biosciences, Inc.  Previously, Dr. Hausman was a co-founder of Medco Research Inc., a NYSE clinical research organization and biotechnology company specializing in adenosine products that was subsequently acquired by King Pharmaceuticals. Dr. Hausman was also a co-founder of Axonyx, and served in various capacities as President, Chief Executive Officer and Chairman of the Board until the company merged into Torrey Pines Therapeutics in 2006. He has also served as a director of Arbios Technologies and of Regent Assisted Living, Inc. Dr. Hausman has done residencies in General Surgery at Mt. Sinai Hospital in New York, and in Urological Surgery at UCLA Medical Center. He received his medical degree from New York University School of Medicine.

Eric von Hofe, Ph.D. Chief Scientific Officer

Eric von Hofe

Eric von Hofe, Ph.D. the Chief Scientific Officer of NGIO has extensive experience with technology development projects, including his previous position at Millennium Pharmaceuticals as Director of Programs & Operations, Discovery Research and was also President of Antigen Express. Prior to that, Dr. von Hofe was Director, New Targets at Hybridon, Inc., where he coordinated in-house and collaborative research that critically validated gene targets for novel antisense medicines. Dr. von Hofe also held the position of Assistant Professor of Pharmacology at the University of Massachusetts Medical School, where he received a National Cancer Institute Career Development Award for defining mechanisms by which alkylating carcinogens create cancers. He received his Ph.D. from the University of Southern California in Experimental Pathology and was a postdoctoral fellow at both the University of Zurich and Harvard School of Public Health. His work has been published in forty-eight articles in peer-reviewed journals, and he has been an inventor on four patents.

Joseph Moscato Chairman, Chief Executive Officer and President

Joseph Moscato

Joseph Moscato is the Chairman, CEO and President of NGIO and is also the Chairman, CEO and President of the Board for Generex since January 2017.  Mr. Moscato has over 30 years of experience in healthcare, sales and marketing, distribution management, and finance.  Mr. Moscato brings his marketing and advertising acumen to drug discovery and diagnostic & treatment development and commercialization.  Since 2009, Mr. Moscato has been working as an exclusive consultant to the Company.  Mr. Moscato has originated and negotiated several licensing deals with the top biopharmaceutical companies; has advised on equity financings totaling over $300 million and has implemented the broad strategic vision for the Company.  Mr. Moscato has worked and consulted for Pfizer in several capacities from sales and marketing to new drug discovery & development for licensing.  He has worked with other biopharmaceutical companies such as GlaxoSmithKline, Johnson & Johnson, Parke-Davis, Amgen and others.  Mr. Moscato has consulted for several healthcare focused private equity, hedge funds and family offices.

Mr. Moscato also owned several advertising and marketing agencies focused on media, entertainment, and healthcare with clients ranging from Motorola, Chadmoore Wireless, Nextel, Cannon, Sharp, GlaxoSmithKline, Pfizer, and other biopharmaceutical companies.  Mr. Moscato’s agency was acquired by William Douglas McAdams, one of the largest independent healthcare advertising and marketing agencies.

Mark CorraoChief Financial Officer

Mark Corrao

Mark Corrao is the Chief Financial Officer for NGIO and is also the Chief Financial Officer, Treasurer for Generex since January 2017. Mr. Corrao has experience in financial management with a proven track record of raising capital and extraordinary bottom line management. He has been involved in the initial registration of numerous public companies and subsequent SEC quarterly and annual reporting and has developed, authored and presented numerous business plans and models inclusive of budgets, forecasts, cash flow, cash management and investment strategies. From 2012 to present he has affiliated with of The Mariner Group LLC, which merged with the CFO Squad, creating a much larger and diverse multi-talented organization. The CFO Squad is a financial and business advisory firm providing outsourced and part-time CFO services for emerging to midsized companies (both private and public) in a wide range of businesses and industries. He is the Chief Financial Officer for Kannalife, Inc., a pharmaceutical company specializing in the research and development of novel and new therapeutic agents designed to reduce oxidative stress and act as immune modulators and Neuroprotectants. From 2010-12, he served as Chief Financial Officer of New York Business Efficiency Experts, Inc. which provides professional services in the financial areas of accounting, taxation, auditing, venture capital and SEC registrations (reporting). He served as a Director and Chief Financial Officer for a manufacturer of proprietary software for the prevention of identity theft and the protection of computer systems from unauthorized access.

Richard PurcellDirector, Executive Vice President of Research & Development

Richard Purcell

Richard Purcell is a Director, Executive Vice President of Research & Development and Executive Vice-President of Research & Drug Development for Generex since January 2017.   Mr. Purcell has managed a consulting practice, DNA Healthlink, Inc. advising emerging biopharmaceutical and technology companies on new business strategy, operations management, and clinical development of novel compounds. Mr. Purcell has been the SVP of R&D for RespireRx Pharmaceuticals since 2014. From 2011 to 2017, Mr. Purcell was the President and founder of a Healthcare IT startup, IntelliSanté. Mr. Purcell graduated with a degree in Biochemical Sciences from Princeton University, and attended Rutgers Graduate School of Management majoring in marketing and finance. He is also an Adjunct Professor of Biology at Monmouth University.

S. Gail Eckhardt, MDTenured professor at The University of Texas at Austin’s Dell Medical School

S. Gail Eckhardt, MD

S. Gail Eckhardt, MD is a tenured professor at The University of Texas at Austin’s Dell Medical School where she is also the inaugural director of the Livestrong Cancer Institutes, chair of the Department of Oncology, and associate dean of cancer programs. She has been a faculty member at the institution since January of 2017. Prior to joining UT Austin, Eckhardt was at the University of Colorado School of Medicine where she was division head of medical oncology from 2006-2014, associate director for translational research at the University of Colorado Comprehensive Cancer Center and director of the Phase I Program and Fellowship.

Dr. Eckhardt has served on numerous committees/study sections, including the ASCO Molecular Oncology Task Force, the ASCO Board of Directors, the FDA Oncology Drugs Advisory Committee and the NCI Cancer Centers Study Section. She is a member of the NCI Investigational Drug Steering Committee, serves on 10 External Advisory Boards of NCI designated Cancer Centers, is currently on the Board of the Association of American Cancer Institutes (AACI) and was a lead mentor in ASCO’s Leadership Development Program. Dr. Eckhardt is the Principal Investigator on grants involving early clinical trials and colorectal cancer research, has conducted numerous phase I and II clinical trials and has published over 200 manuscripts. She is a Research Scholar of the Cancer Prevention and Research Institute of Texas (CPRIT).

Dr. Eckhardt’s expertise is in the preclinical and early clinical development of novel agents and she has over 25 years of drug development experience. Dr. Eckhardt earned her undergraduate degree in chemistry from Stephen F. Austin State University and her medical degree from the University of Texas Medical Branch in Galveston, TX. She conducted her internship and residency in Internal Medicine at the University of Virginia Medical School in Charlottesville, VA followed by a post-doctoral research fellowship in experimental and molecular medicine at Scripps Research Institute in La Jolla, CA and a fellowship in medical oncology at the University of California, San Diego.

Tamera Coyne-Beasley, M.D., MPHDivision Director. Professor Derroll M. Dawkins, M.D. Endowed Chair in Adolescent Medicine Vice Chair for Community Engagement . Division of Adolescent Medicine

Tamera Coyne-Beasley, M.D., MPH - School of Medicine - Pediatrics | UAB

Dr. Coyne-Beasley completed her undergraduate work at Brown University before  receiving her Master’s in Public Health in Epidemiology at the University of North Carolina at Chapel Hill, and graduating from Duke University Medical School. She is currently a Professor of Pediatrics and Internal Medicine, practicing physician in the William A. Daniel, Jr. Adolescent Health Center at Children’s of Alabama and Director of the University of Alabama at Birmingham Division of Adolescent Medicine. Dr. Coyne-Beasley is also the Vice Chair of Pediatrics for Community Engagement. As a key opinion leader in the field of adolescent medicine, Dr. Coyne-Beasley is Past President of the Society for Adolescent Health and Medicine.

Mr. Thomas Leonard, MPA Pharmaceutical sales, marketing, and management at Bristol Myers Squibb

Mr. Thomas Leonard, MPA has had a long and successful career at Bristol Myers Squibb in pharmaceutical sales, marketing, and management across multiple segments of the healthcare delivery system, most recently as the Northeast Business Manager for Oncology. Mr. Leonard brings a deep understanding of the current oncology market, having responsibility for cutting edge immunotherapy products including Opdivo (PD1 inhibitor), Yervoy (CTLA4 inhibitor), and Empliciti, as well as small molecule cancer drugs like Sprycel. He has worked across the oncology landscape, with experience in Lung/NSCLC, Head/Neck, Liver, CML, Kidney/Renal Cell Carcinoma, Bladder, Urothelial, Melanoma, and Colorectal Cancers. He also brings to NGIO a broad network of clinical oncologists with whom he has developed relationships over his career, and who will help guide the NGIO clinical development programs for our Ii-Key peptide immunotherapeutic vaccines. In addition to his work in oncology, Mr. Leonard has extensive experience interacting with the healthcare payor sector, leading the market access pull through programs and specialty pharmacy strategy at major payors nationwide and as a core team member for major regional Integrated Delivery Networks (IDNs) and Organized Customer Groups (OCGs) including Duke, Kaiser Permanente, Cleveland Clinic, Mayo Clinic, Northwell Health. Mr. Leonard received a master’s degree in Public Administration, Business and Health Management from New York University and graduated St. John’s University with a B.S. in Business and Healthcare Administration.

Thomas Rogers, MD, PhDAdjunct Professor at the University of California at San Diego and the Scripps Institute

Thomas Rogers, MD, PhD

Dr. Thomas Rogers, MD, PhD is an Adjunct Professor and clinical research specialist at the University of California at San Diego. Through a partnership with and the Scripps Research Institute, Dr. Rogers is exploring the immunologic response in COVID-19 patients. His work on neutralizing antibodies to SARS-CoV-2 has formed a foundation for vaccine and therapeutic development.

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