Programming B Cells to Deliver Novel Therapies for Patients
Immusoft is the world leader in the development of B cells as biofactories for therapeutic protein delivery, a novel approach that we have pioneered. Our approach, called Immune System Programming (ISP™) entails collecting a type of the patient’s immune cells, called B cells. In response to immune stimulation, B cells can turn into biofactories (known as plasma cells), each of which manufactures and secretes thousands of antibodies per second. We harness this biofactory capability of the plasma cell by programming B cells to produce personalized protein therapeutics.
Once we have programmed the B cells we expand the number and differentiate into plasma cells that produce massive amounts of our therapeutic protein. Once in the clinic, we will then infuse the ISP™ programmed cells back into the same patient, where we expect they will take up residence and produce therapeutic proteins for extended periods of time.
This chart provides an overview of our ground breaking technology. Click below for a fuller explanation.
Sean Ainsworth is Immusoft’s Chief Executive Officer and Chairman of the Board. He has 20 years’ experience in pharmaceuticals and biotechnology. Previously, he founded and led RetroSense Therapeutics, a gene therapy company he advanced into human clinical trials and sold to Allergan in 2016 in a deal valued at up to $555 million.
Earlier, he was deeply involved in the launch of Compendia Bioscience, Inc., and GeneVivo, LLC. At both he assisted in developing business models, licensing technologies, building management teams, and securing capital and first customers. Life Technologies acquired Compendia BioScience in 2012.
Sean founded Ainsworth BioConsulting in 2004 to provide licensing, as well as strategic and business planning services to the life science and entrepreneurial community. His clients included large pharma, small biotechs, universities, CROs, and venture investment funds. He has worked with clients at all stages of development.
His other professional experience includes research at Medical Biology Institute (now Avanir Pharmaceuticals, developers of Abreva, the leading cold sore medication) in San Diego, Calif., intellectual property at Koyama and Associates in Tokyo, and international corporate development consulting at The Mattson Jack Group in St. Louis, Mo.
Sean earned an M.B.A. in strategy and finance from Washington University in St. Louis. He holds a B.S. in Microbiology from University of California, San Diego.
Dr. Robert Hayes is the Chief Scientific Officer at Immusoft, where he oversees Immusoft’s preclinical research and spearheads the near-term advancement of ISP-001 for the treatment of Mucopolysaccharidosis type I (MPS I) into a clinical study, and additional Immune System Programming (ISP™) candidates towards clinical development.
With nearly two decades of biologics discovery and development experience, Dr. Hayes has a proven track record for building teams around new scientific concepts and technologies, including cell therapeutics, transposon systems, cancer vaccines, and bispecific monoclonal antibodies. He also has significant experience in forming partnerships to advance the development and application of novel therapeutic platforms.
Dr. Hayes obtained his Ph.D. in Biochemistry at Imperial College London as a Royal College of Science Scholar. He was awarded a Royal Society University Fellowship for the work contained in his thesis and spent three years studying protein biochemistry at University California, Berkeley. He then joined a start-up computational biology company called Xencor located in Pasadena, California where he helped establish their “Antibodies by Design” technology. Xencor has since collaborated with many of the top pharmaceutics companies to bring improved antibodies to the clinic.
After six years at Xencor, Dr. Hayes joined Janssen BioTherapeutics (Johnson & Johnson) where he co-founded and developed the vision and strategy for Centyrex, a stand-alone Janssen R&D biotechnology company that developed alternative scaffolds with applications beyond traditional protein therapeutics. In 2014, he became Head of Biologics at Amgen, responsible for leadership, operational and strategic management of all aspects of biologics preclinical discovery, including bioreagent generation, large molecule lead identification, biologics optimization, and transition into preclinical development and manufacturing.
R. Scott McIvor, Ph.D., Chief Development Officer at Immusoft, is Professor of Genetics, Cell Biology and Development at the University of Minnesota.
Dr. McIvor graduated with degrees in Cell and Molecular Biology, and Pathobiology from the University of Washington and obtained his Ph.D. in Microbiology from the University of Minnesota in 1982. He was a postdoctoral fellow first at the University of California, San Francisco, and then at Genentech, Inc., in South San Francisco, California, where he conducted some of the earliest work on gene transfer into animal tissues in vivo.
He has been at the University of Minnesota since 1986, where he initially was a member of the Department of Laboratory Medicine and Pathology and the University of Minnesota’s Institute of Human Genetics, where he served as Director of the Gene Therapy Program.
He is a two-time former member of the National Institutes of Health (NIH) Recombinant DNA Advisory Committee (RAC) has served extensively on NIH study sections and the Scientific Advisory Board of the NIH National Gene Vector Laboratories. He is currently a member of the Gene Therapy Resource Program Steering Committee for the National Heart, Lung and Blood Institute, and serves on the Editorial Board for Molecular Therapy. His research has been primarily in the area of human gene therapy, where he has extensive experience developing both viral and non-viral vectors for the treatment of genetic diseases and cancer.
Mr. Gallagher has more than 25 years of experience in the life science and biotech industry with a focus on corporate development, marketing, operations and early stage investing. Prior to joining Immusoft, he was a Director and Chief Business Officer at Retrosense Therapeutics, which was acquired by Allergan in 2016. Cam was Managing Director of Nerveda, LLC, a life science seed fund he co-founded in June 2007. Cam currently serves on the board of directors of Zeno Pharma, VelosBio, SelectION and Ocuphire Pharma. Prior to these roles he held management positions at Verus Pharma, CV Therapeutics and Dura Pharma. Mr. Gallagher holds an M.B.A. from the University of San Diego and a B.S. in Business Administration from Ohio University.
Monika Swietlicka is Vice President of Regulatory Affairs at Immusoft. She leads development and implementation of regulatory strategy and quality systems, including overseeing regulatory submissions and compliance. She is responsible for quality oversight and program management of Immusoft’s clinical pipeline.
Monika has broad knowledge of the product lifecycle from Investigational New Drug approval through the Biologics License Application process with the U.S. Food and Drug Administration and the European Medicines Agency. She brings to Immusoft extensive experience in various biotechnology settings, having specialized in discovery, pre-clinical, clinical, commercial and translational research. She is versed in all stages of cellular therapeutics and biologics drug development, and manufacturing.
Previously, Monika managed a continuous improvement program for a first in class immunotherapy product, Provenge (Sipuleucel-T), for which she also developed new processes to monitor method lifecycle. She has authored content for FDA and EMA submissions, led Contract Manufacturing Organization tech transfer activities and compliance audits.
Immusoft is Monika’s third experience with a biotech startup. Earlier, she worked on in-situ therapeutic antibody rescue technology, T-cell activation platform, and the first autologous antigen-presenting cells vaccine designed to stimulate an immune response to a variety of tumor types. She was part of early collaborative efforts with the International AIDS Vaccine Initiative to develop HIV-neutralizing antibodies and has worked on broadly neutralizing antibodies for treating pandemic influenza and severe seasonal influenza.
Monika has degrees from Seattle Pacific University, having earned an M.B.A. in International Business and a B.S. in Biochemistry and Molecular Biology. While earning her master’s, she co-authored an operations management textbook now used by the graduate business program. As an undergraduate, her senior thesis focused on studies of NKG2D and MICA on Surface and in Solution in which MICA ligands were mutated at residues that do not contact NKG2D.
Monika is a strong advocate for disruptive biotechnologies and passionately supports all regulatory activities to advance Immusoft’s strategic initiatives.
