ImmunoGenetix Therapeutics, Inc. is a for-profit company developing advanced DNA-based therapies. All communications with ImmunoGenetix Therapeutics may be directed to:
ImmunoGenetix Therapeutics
8527 Bluejacket Street
Lenexa, KS 66214
(888) 7-IGXBIO toll free
(888) 744-9246 fax
James B. Laufenberg, President and CEO
jbl@igxbio.com
Executive Summary
ImmunoGenetix Therapeutics, Inc. is a 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 is advancing towards 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.
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Board of Directors
James B. Laufenberg, MBA, is the President and CEO of ImmunoGenetix and a member of the board of directors. 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 Marketing. 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 Sales and Marketing 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.
Edward M. Connolly, Jr., 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 include building strong collaborations, among the scientific, academic and business communities. He is affiliated with Vistage International, Inc. the world’s largest CEO membership organization, where he is Board Chair of a Vistage Group.
He serves on the Board of EPIQ Systems NASDAQ: ( EPIQ) and is also on the Board of Children’s Mercy Hospital. He holds a B. A. in Psychology from Bellarmine University.
Edward H. Stratemeier, J.D., MBA, is an attorney and consultant to the life science industry. He was previously Senior Vice President of Legal, Government Relations and Policy at 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 principal areas of focus are: Intellectual Property Licenses and Litigation, Biosciences Commercialization, Government Relations and Policy, 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.
William J. Garner, M.D. is an experienced entrepreneur and investor and is currently a Kauffman Finalist (Class 16). He served as President and Chief Executive Officer of Urigen Pharmaceuticals, Inc. (URGP.PK) from December 2005 to December 2010 where he moved a procedure-based drug from a university license to a phase II multi-center clinical trial which achieved statistical significance on all end points in Painful Bladder Syndrome/Interstitial Cystitis. He is founder and managing director of EGB Advisors, LLC, a pharmaceutical commercialization boutique. Through this entity, Dr. Garner has worked on a number of pharmaceutical business transactions and has raised financing for both Urigen Pharmaceuticals, Inc. and another company that he founded, Inverseon, Inc., which is developing a novel therapy for smoking cessation, asthma and other pulmonary diseases. Before this, Dr. Garner worked in medical affairs at Hoffmann LaRoche in oncology. Prior to Roche, Dr. Garner was in the venture capital department at Paramount Capital Investments in New York City. He serves on the boards of DelMar Pharmaceuticals, Inc. in Vancouver, Canada and Angel Investor Card in San Francisco. 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.
David L. Tousley, MBA, CPA, is currently 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. Among his current clients is Deciphera Pharmaceuticals, LLC, where he advises on and manages the financial aspects of the business. Mr. Tousley has over 25 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 airPharma, LLC, PediaMed Pharmaceuticals, Inc., AVAX Technologies, Inc. and Pasteur, Merieux, Connaught, (known today as Sanofi-Pasteur) 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 holds an undergraduate degree from Rutgers College and earned his MBA in accounting from Rutgers Graduate School of Business. Having earned his certification as a public accountant, he belongs to the New Jersey Society of Certified Public Accountants and the American Institute of Certified Public Accountants.
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Scientific Advisory Board
Mike Beckloff, MS, is President of Beckloff and Associates, a Cardinal health Company, and has broad development experience working with regulatory agencies worldwide, and maintains a network of recognized consultants and experts. Mr. Beckloff has provided development support for formulations ranging from solid dosage to sterile products, including AIDS drugs. This broad knowledge base allows Mr. Beckloff to assist in the strategic planning process in order to ensure fast and efficient product development.
John E. Dillberger, D.V.M., Ph.D. has spent more than 15 years in the pharmaceutical industry, holding positions of increasing responsibility at MMD, GlaxoSmithKline, Gilead (formerly Triangle) Pharmaceuticals, and Charles River Laboratories. He currently has an active practice as a Preclinical Development Consultant specializing in pharmacology, toxicology, pathology, and biocompatibility. His clients include nonprofit foundations and biopharmaceutical companies in the United States, Korea, and Japan that are developing drugs, biologics, and medical devices, as well as investment firms with healthcare portfolios. Dr. Dillberger was certified as a Veterinary Pathologist by the American College of Veterinary Pathologists in 1987 and as a Toxicologist by the American Board of Toxicology in 1992. He also is one of a handful of pathologists accepted as a Fellow in the International Academy of Toxicologic Pathology. He is the author of numerous scientific papers and a book chapter entitled “Nonclinical Development of Drugs and Biologics: Pharmacology and Toxicology,” serves as reviewer for Antimicrobial Agents and Chemotherapy, and is presently serving a second term on the editorial board of Veterinary Pathology.
Gino Girard, M.D. joined INC Research in 2011 as Vice President, Clinical Development.
Dr. Girardi received both his B.A. and M.D. from Georgetown University in Washington, D.C. There, he specialized in internal medicine where he was also appointed chief medical resident. He subsequently completed a fellowship in infectious diseases at the State University of New York at Stony Brook.
He spent one year in academic private practice in Virginia before joining the Food and Drug Administration in the Division of Anti-Infective Drug Products in CDER where he was a medical officer. There, he worked on several NDAs and was involved in the initial approvals for antibiotics to treat Helicobacter pylori. He was also responsible for crafting written guidances for several anti-infective indications. He then joined Quintiles, Inc. as Senior Technical Director for Anti-infective therapeutics. Afterwards, and for ten years subsequent to his time with Quintiles, Dr. Girardi provided consulting services in product development, pharmacovigilance, regulatory strategy, and clinical data analysis to the pharmaceutical and biotech industries prior to joining the National Institutes of Health in Bethesda, Maryland. There, for the year prior to joining INC Research, he served as Medical Officer in the Office of Clinical Research Affairs. Responsibilities included planning and oversight of studies in parasitology, bacteriology, bio-defense, and virology. His areas of expertise include clinical development of anti-infectives and anti-virals, vaccines, monoclonal antibodies, and devices.
Dr. Girardi maintains an active license to practice medicine. He is on staff at the Arlington Free Clinic in Arlington, VA. His hobbies include reading, tennis, and crossword puzzles. He speaks Italian and Spanish.
His therapeutic area experiences include:
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Infectious Diseases
Pulmonary
Neuropharmacology
Endocrinology
Ophthalmology
Cardiovascular
Oncology
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.
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Associates
Les Walker, PhD – CMC contractor for ImmunoGenetix. 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.
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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.
