IGXBio, Inc. is a for-profit company developing advanced DNA-based therapies. All communications with IGXBio may be directed to:

IGXBio, Inc.
4220 Shawnee Mission Parkway
Suite 350B
Fairway KS 66205
(510) 393-6523

David Foster, PhD, JD
David@igxbio.com

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Executive Summary

IGXBio, Inc. is a clinical stage biotechnology company developing advanced DNA immunotherapies for HIV infection. The Company’s lead product candidate, GenePro®, is a DNA therapeutic incorporating a proprietary DNA composition that yields high levels of gene expression and non-infectious HIV protein production, and induces a robust antibody and cellular immune response in animal models, including non-human primates.

The Company has completed a comprehensive non-clinical and clinical development plan for GenePro®, and has achieved an IND.

The Company’s organizational structure consists of a highly qualified and experienced team with complimentary expertise in clinical research, biopharmaceutical development, strategic planning, finance, law, and business operations. A Scientific Advisory Board and Board of Directors comprise this team.

Board of Directors

The Company’s Board of Directors has extensive experience in clinical research, strategic planning, business operations, finance, law, and the establishment, funding and management of new biotechnology companies.

JimLaufenbergPS0-070716James B. Laufenberg, MBA, is the Executive Chairman of IGXBio, Inc. and co-founder. Mr. Laufenberg has over 25 years in the pharmaceutical and biotech industry. Most of his career was at Marion Laboratories (now Sanofi-Aventis), managing both large organizations and small. During this tenure he accepted increasing responsibilities, including management in a start-up division. After leaving Marion, he joined Oxo Chemie as Vice President of Commercial Development. Responsibilities included preparing the company for the launch of an AIDS therapeutic, developing the label for an NDA submission, and an interim period as CEO. His most recent experience was as Vice President Commercial Development at Iomed, Inc. Responsibilities included strategic planning with all functional heads, integrating operational plans including regulatory and manufacturing, and raising funds for product launch. Mr. Laufenberg has an MBA from Rockhurst University, Kansas City, MO.

DavidFoster6477(x250)David Foster, Ph.D., J.D. is President and CEO of IGXBio and is a co-founder of two biotechnology companies, Tuevol Therapeutics and FPRT Bio. He has more than 17 years legal experience working as patent counsel in international law firms as well as in-house at Medarex, a biopharmaceutical company acquired by Bristol-Myers Squibb. David has developed and implemented international IP strategies that protect and complement business initiatives. In addition he has identified foundational and complementary IP and coordinated licensing programs to supplement IP strategies for numerous products. David currently serves as partner of Roberts Foster LLP, focusing on emerging technology companies, and as Board secretary of BioNorthTx, a regional life science trade association he co-founded. David received his Ph.D. from The University of Texas Southwestern Medical Center and J.D. from Golden Gate University School of Law.

Edward M. Connolly, Jr. BA, has more than 25 years’ experience in corporate leadership. His background includes executive human resources management for five major corporations where he advised senior executives and directed compliance, labor relations, and associate relations. His experience spans a broad range of business environments including mergers, acquisitions, internal growth, and spin offs. As President of corporate foundations, Ed’s strategic philanthropic initiatives included building strong collaborations, among the scientific, academic and business communities. He serves on the Board of EPIQ Systems NASDAQ: (EPIQ) and is also past Chairman of the Board of Children’s Mercy Hospital. He holds a B. A. in Psychology from Bellarmine University.

wgarnerWilliam J. Garner, M.D. is the founder of EGB Advisors, LLC, a pharmaceutical commercialization boutique, where he has worked on going-public transactions. He is currently Chairman of Update Pharma. Prior to this he was CEO of Invion Limited (ASX:IVX), a clinical-stage drug development company focused on the development of treatments for major market opportunities in inflammatory diseases including chronic bronchitis and lupus, after the merger of Inverseon, Inc. in 2012. He is a co-founder & Director of DelMar Pharmaceuticals (OCTQX). In 2007, he listed Urigen Pharmaceuticals (URGP.PK) via a reverse-merger as CEO and moved procedure-based drug from a university license to a successful phase II multi-center clinical trial.

Before this, Dr. Garner worked in medical affairs at Hoffmann LaRoche in oncology. Prior to Roche, Dr. Garner was at Paramount Capital Investments in New York City. Dr. Garner has a Master of Public Health from Harvard and received his M.D. degree from New York Medical College. Dr. Garner did residency training in Anatomic Pathology at Columbia-Presbyterian and is currently a licensed physician in the State of New York.

Edward H. Stratemeier, J.D., MBA,recently retired General Counsel of NPS Pharma. Prior to NPS, he was Senior Vice President of Legal, Government Relations and Policy at Sanofi Aventis Pharmaceuticals. His extensive list of responsibilities included leading a team of over 40 lawyers in the United States, Canada, and Europe in general commercial work, litigation, employment law, securities matters, business development transactions, compliance, privacy and FDA regulatory matters. His practice areas are: Intellectual Property & Technology Litigation, Biosciences and Commercialization, Government Relations, Trade Secrets, and Strategic Alliances. Mr. Stratemeier earned his J.D. at the University of Missouri Kansas City in 1973, an MBA at Rockhurst University in 1990 and a BA at the University of Kansas in 1971.

Dave-TousleyDavid L. Tousley, MBA, CPA, is past Chief Financial Officer for DARA Biosciences, a publicly traded specialty pharmaceutical company focused on oncology treatment and oncology supportive care. Mr. Tousley is currently the Principal of Stratium Consulting Services assisting companies with strategic and financial planning and management, and brings an impressive list of professional achievements in all aspects of financial, pharmaceutical development and process management. Mr. Tousley has over 35 years of business experience including biotech, specialty pharmaceuticals and full phase pharmaceutical companies. He has held President, Chief Operating Officer and Chief Financial Officer roles in companies such as Pasteur, Merieux, Connaught, (known today as Sanofi-Pasteur), AVAX Technologies, Inc., airPharma, LLC, and PediaMed Pharmaceuticals, Inc., and and has led companies in all aspects of operations, including pharmaceutical development. He has managed in both the private and public company environment, taking a company public, raising over ninety million dollars in debt and equity financings and has led business development activities, including joint ventures, partnerships, acquisitions and divestitures in the U.S., Europe and Australia. Mr. Tousley is a Ceritified Public Account, a member of the American Institute of Certified Public Accountants, holds an undergraduate degree from Rutgers College and earned his MBA in accounting from Rutgers Graduate School of Business.

Scientific Advisory Board

Richard Ogden Ph.D co-founded RORR Inc., a Medical, Scientific Consulting and Education company with Dr Regina Rooney.

Dr. Ogden joined Agouron Pharmaceuticals, Inc. as a founding scientist at its inception in 1984, where he held positions of Group Leader of Medicinal Chemistry, Principal Scientist, and Senior Director of Scientific Development. He was a team member in the HIV project which led to the discovery and development of Nelfinavir (Viracept®). Responsibilities in Scientific Development included presenting Agouron R&D activities to potential corporate partners and investors, assessing technology and compound acquisitions, including the therapeutic vaccine Remune and the reverse transcriptase inhibitor Capravirine. He was also responsible for the process by which new drug targets were selected and projects initiated, and communicating research and clinical activities to clinicians, other healthcare providers and patient groups post merger with Pfizer. He has gone on to become a recognized leader in the HIV clinical research community.

Anthony Japour, M.D. began his scientific career studying the HIV/AIDS virus at Boston’s Beth Israel-Deaconess Hospital at Harvard Medical School (’89-’96). Specifically, he studied surrogate markers for HIV progression and the molecular mechanisms of drug resistance to antiretroviral agents as well as the clinical significance of drug-resistant HIV in HIV-positive persons. In addition, Japour has worked in the area of drug development in both the academic setting with the Harvard-affiliate of the NIH-NIAID sponsored AIDS Clinical Trials Group and in industry at Abbott Laboratories (’96-’02). In 2002, his colleagues recommended him to President George W. Bush as a candidate for Commissioner of the U.S. Food and Drug Administration.

Dr. Japour is presently a medical and scientific consultant with academic appointments at the Florida International University Herbert Wertheim College of Medicine and the University of Miami Miller School of Medicine. He is on the medical staff of the Jackson Health System specializing in the treatment of hepatitis.

Michael S. McGrath, M.D., Ph.D. is currently a Professor of Laboratory Medicine, Medicine and Pathology at the University of California at San Francisco (UCSF) with research laboratories located at San Francisco General Hospital (SFGH). He received his MD from Stanford University in 1980 and his PhD in Cancer Biology from Stanford in 1985, and has advanced medical training in the area of Hematology. Since 1985 he has been the director of the AIDS Immunobiology Research Laboratory at UCSF and his research activities have been concentrated in the area of HIV pathogenesis. He has authored over 100 papers and 12 patents in basic research areas involving HIV disease and cancer. Most recently his research activities have been focused on the role that macrophages play in the pathogenesis of chronic human disease. Drug and diagnostic development programs involving aspects of this research have been carried out with a variety of small biotechnology companies in which he was either a co-founder or scientific advisor. He is currently working with SLIL Biomedical, a Madison WI based biopharmaceutical company that makes a class of drug that shows both anti-cancer and anti-pathogenic macrophage activities in vitro and in vivo studies.

Dinesh K. Singh, Ph.D, DVM is Professor of Microbiology, Department of Life Sciences, Winston Salem State University, and Adjunct Associate Professor, Department of Microbiology and Immunology, Wake Forest University School of Medicine, Winston Salem, NC. Dr. Singh has coauthored numerous published articles on GenePro®

Harold Smith, Ph.D. is a tenured professor of biochemistry and biophysics at the University of Rochester, School of Medicine and Dentistry. Dr. Smith’s primary function at the University is basic research and in this context he is fully engaged in biomedical laboratory research as well as training postdocs, graduate and undergraduate students. He received his undergraduate degree and MS from Purdue University and an MA and PhD in Cell and Molecular Biology from SUNY at Buffalo NY. He completed four postdoctoral training positions in the areas of virology with Dr. David Rekosh, in DNA replication with Dr. Craig Chinault at Baylor College of Medicine and in RNA biology with Drs. Harris Busch and Susan Berget.

Dr. Smith’s academic lab’s primary interest is understanding the composition, regulation and structure of macromolecular complexes involved in regulating a family of enzymes known as RNA and DNA editing enzymes. These enzymes are responsible for host defense against viral invaders and are required for antibody diversity during B cell development.

Dr. Smith founded OyaGen, Inc that develops therapeutics based on the editing enzyme platform. He currently serves as President and CEO for the company as they develop leads on novel HIV targets for clinical trials.

Associates

Les Walker, PhD – CMC contractor for IGXBio. Les was most recently at Epimmune where he was responsible for the development of a number of plasmid DNA vaccines candidates. Two of those were directed against HIV and were composed of encoded CTL and helper epitopes covering a range of HIV proteins and HLA supertypes. He contracted and supervised the manufacturing, preclinical toxicology studies as well as the stability programs for all of drug candidates. Additionally, Les wrote the CMC sections for all of the IND submissions. Les has worked closely with Ichor Medical Systems and used their Tri-Grid device for delivery of one of the Epimmune vaccines (a plasmid DNA malaria vaccine that is currently in testing by the NIH).

Les attended KUMC for a portion of his graduate studies and earned his Ph.D. in Biochemistry at Oklahoma State University.

Scientific Collaboration

The Company has exclusive world wide rights to the related DNA compositions invented at the University of Kansas Medical center.

The Marion Merrell Laboratory of Viral Pathogenesis at KU Medical Center is currently staffed with approximately 20 scientists and technicians, and is equipped with a P3 suite and the latest scientific instrumentation and equipment to conduct all levels of SIV and HIV research and preclinical development. The laboratory is a multidisciplinary laboratory occupied by investigators with experience in molecular biology, molecular virology, medical virology, tissue culture operations involving virus cultivation and measurement, immunology including antibody and cell-mediated immune studies, flow-cytometry, histopathological, immunocytochemical, and immunohisto¬chemical studies, and expertise in specific techniques such as construction of DNA molecules intended as DNA vaccines, evaluation of viral RNA expression in tissues by real-time RT PCR, in situ hybridization and immunocytochemistry, and experience in animal operations including inoculations, sampling of tissues, necropsies, and evaluation of tissues from infected animals using virological, pathological, immunological, and molecular (DNA/RNA) procedures. Studies from this laboratory have yielded more than 200 peer-reviewed publications and national and international recognition.