Our mission at Immusoft is to develop novel cell therapies by programming B cells to produce therapeutic proteins that improve the lives of patients with rare diseases.
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.
Wendell King is the CEO of King Consulting, a consulting company working primarily in the genomics and medical device field.
Earlier, he held various positions with Medtronic, Inc. Medtronic is a Fortune “200”, Minneapolis-based, medical device company. Mr. King served as Vice President and General Manager of the BioInterface Division, Medtronic’s second largest division, which manufactured and marketed temporary and permanent pacing leads, diagnostic catheters, physiologic sensors and angioplasty catheters. Prior to becoming Vice President and General Manager, he was Director of Research and Development at Medtronic where he was responsible for developing numerous commercially successful new products.
After leaving Medtronic, Mr. King co-founded and served as CEO and Chairman of Angeion Corporation, a developer of medical device products. Mr. King raised more than $50 million in private financing to fund the development of Angeion and successfully took the company public. Angeion today is a NASDAQ traded company, traded under the MGCD symbol.
After Angeion, Mr. King co-founded Gateway Alliance, LLC. Gateway was an early-stage business incubator. Gateway Alliance founded several successful companies including: Vascular Solutions, Rave Sports, and WorldKnit.com.
Vascular Solutions, Inc., successfully completed an IPO and is a publicly traded medical device company and trades on the NASDAQ stock exchange.
Mr. King has numerous publications and has been granted more than 40 patents. He earned a B.S. in engineering physics from the University of Minnesota, Institute of Technology. Mr. King has completed the Executive Business Administration Program at Dartmouth, Amos Tuck School of Business, and course work toward a Ph.D. in polymer physics at the University of Akron, Polymer Institute.
In addition to Immusoft, Mr. King currently serves on the following Boards: Recombinetics and Cardiology Prevention.
Tony Sun, a biotechnology industry consultant, has been involved in numerous life science company activities from company formation to fundraising to capital market exits to acquisitions.
He has spent the last 13 years on the investment side of the business, first at Perseus-Soros BioPharmaceutical Fund and then at Aisling Capital where he served as Partner. Previously, Tony was an Adjunct Instructor of Medicine at the Hospital of the University of Pennsylvania.
Tony received his MD from Temple University School of Medicine with A.O.A. honors. He received his MBA from The Wharton School at the University of Pennsylvania and his BS in Electrical Engineering from Cornell University. In addition, he has been Board Certified in Internal Medicine.
Matthew Scholz is Immusoft’s founder and served as the company’s Chief Executive Officer from 2009 through 2017.
Immusoft’s inflection point as a company came when Matthew conceived how a research system developed by Nobel Laureate and former President of Caltech, David Baltimore, could be modified for a practical application: programming resting B cells to secrete therapeutic proteins. He negotiated an exclusive license to the system, then developed and patented a way to improve its efficiency to the point it was clinically viable. This modified system remains the core of Immusoft’s technology platform today.
After Immusoft, Matthew co-founded Oisín Biotechnologies. He serves as Oisín’s Chief Executive Officer and its oncology-focused spin-out OncoSenX, two biotech firms commercializing a breakthrough platform technology for killing unwanted cells based on their genetics.
Matthew speaks and presents regularly to scientific, association and academic audiences, including those at his alma mater, the University of Washington. He served for several years as a mentor to recipients of the Thiel Fellowship, a program that awarded grants to some of the world’s brightest scientific minds under age 20.
Julia Moore is a Partner at Breakout Ventures, investing in early stage life sciences companies. Julia and her partners also run Breakout Labs, a seed fund within Peter Thiel’s foundation that focuses on breakthrough technologies across hard sciences. Julia has spent her career investing in, analyzing and operating life sciences companies. Earlier in her career, she was an investor with Kearny Venture Partners, a research analyst at Thomas Weisel Partners, the head of business development and strategy at TriVascular (NASDAQ: TRIV; Acquired by Endologix) and at an institute at Stanford. She is a graduate of the University of Virginia, with a degree in finance from the McIntire School of Business and Bioethics from the College of Arts and Sciences. Julia is also a Kauffman Fellow.
Peter Sage, Ph.D., is an Assistant Professor of Medicine at Harvard Medical School and an Associate Immunologist at Brigham and Women’s Hospital. Dr. Sage is also a member of the Committee on Immunology (COI) at Harvard Medical School. Dr. Sage obtained his PhD in Immunology from Harvard Medical School in 2013, during which he received the Jeffrey Modell Prize. He completed a post-doctoral fellowship in the laboratory of Dr. Arlene Sharpe in the Department of Immunology at Harvard Medical School in 2017. Dr. Sage started his independent laboratory in 2017 at the Transplantation Research Center in the Division of Renal Medicine of Brigham and Women’s Hospital. Dr. Sage’s laboratory focuses on studying how the immune system controls B cell and antibody responses in settings of health and disease.
Bruce Levine, Ph.D., Barbara and Edward Netter Professor in Cancer Gene Therapy is the Founding Director of the Clinical Cell and Vaccine Production Facility in the Department of Pathology and Laboratory Medicine and the Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania. First-in-human adoptive immunotherapy trials include the first use of a lentiviral vector, the first infusions of gene edited cells, and the first use of lentivirally-modified cells to treat cancer. Dr. Levine has overseen the production, testing and release of 3,100 cellular products administered to more than 1,300 patients in clinical trials since 1996. Dr. Levine is a recipient of the William Osler Patient Oriented Research Award, the Wallace H. Coulter Award for Healthcare Innovation, the National Marrow Donor Program/Be The Match ONE Forum 2020 Dennis Confer Innovate Award, serves as President of the International Society for Cell and Gene Therapy, and on the Board of Directors of the Alliance for Regenerative Medicine. Dr. Levine received a B.A. in Biology from the University of Pennsylvania and a Ph.D. in Immunology and Infectious Diseases from Johns Hopkins University.
Hans-Peter Kiem, M.D., Ph.D., is the Stephanus Family Endowed Chair for Cell and Gene Therapy at Fred Hutchinson Cancer Research Center. He is a world-renowned pioneer in stem-cell and gene therapy and in the development of new gene-editing technologies. His focus has been the development of improved treatment and curative approaches for patients with genetic and infectious diseases or cancer. For gene editing, his lab works on the design and selection of enzymes, known as nucleases, which include CRISPR/Cas. These enzymes function as molecular scissors that are capable of accurately disabling defective genes. By combining gene therapy’s ability to repair problem-causing genes and stem cells’ regenerative capabilities, he hopes to achieve cures of diseases as diverse as HIV, leukemia and brain cancer. He is also pioneering in vivo gene therapy approaches to make gene therapy and gene editing more broadly available and accessible to patients and those living with HIV, especially in resource-limited settings. He received his M.D. and Ph.D. at the University of Ulm, Germany.
Michael C. Carroll, Ph.D., is a Senior Investigator at Boston Children’s Hospital and Professor of Pediatrics, Harvard Medical School. His recent research focuses on two major areas, i.e. neuroimmunology and peripheral autoimmunity. Using murine models of neuro-psychiatric lupus, his group is testing their hypothesis that interferon alpha from peripheral inflammation enters the brain and mediates synapse loss and symptoms of cognitive decline observed in patients. Following-up on a large genetic screen in schizophrenia patients, they recently reported that over-activation of a process known as “complement-dependent, microglia-mediated synaptic pruning” in novel strains of mice can induce psychiatric symptoms of schizophrenia. In a murine lupus model, his lab has identified that self-reactive B cells evolve with kinetics similar to that of foreign antigen responding B cells providing a novel explanation for epitope spreading. Dr. Carroll received his PhD from UT Southwestern Medical School and his postdoctoral training with the Nobel Laureate, Professor Rodney R. Porter at Oxford University. He is a recipient of awards from the Pew Foundation, American Arthritis Foundation and the National Alliance for Mental Health.
Paula Cannon, Ph.D.,is a Distinguished Professor of Molecular Microbiology and Immunology at the Keck School of Medicine of the University of Southern California, where she leads a research team that studies viruses, stem cells and gene therapy. She obtained her PhD from the University of Liverpool in the United Kingdom, and received postdoctoral training at both Oxford and Harvard universities. Her research uses gene editing technologies such as CRISPR/Cas9, to develop treatments for infectious and genetic diseases of the blood and immune systems. In 2010, her team was the first to show that gene editing could be used to mimic a natural mutation in the CCR5 gene that prevents HIV infection, and which has now progressed to a clinical trial in HIV-positive individuals.
Robert Sikorski, M.D., Ph.D., is Head of the SAB and consulting Chief Medical Officer at Immusoft. Dr. Sikorski currently serves as the Managing Director of Woodside Way Ventures, a consulting and investment firm that helps biotechnology companies and investors advance lifesaving technologies through clinical development. Prior to that, he was Chief Medical Officer of Five Prime Therapeutics (acquired by Amgen). Earlier in his career, he played a leading role in building MedImmune’s oncology portfolio through partnering and acquisition efforts. Before joining Medimmune, he led late-stage clinical development and post-marketing efforts for several commercial drugs and drug candidates at Amgen. Dr. Sikorski began his career as a Howard Hughes Research Fellow and Visiting Scientist at the National Cancer Institute and the National Human Genome Research Institute in the laboratory of Nobel Laureate Harold Varmus. Additionally, he has served as an editor for the journal Science and Journal of the American Medical Association. Dr. Sikorski obtained his MD and PhD degrees as a Medical Scientist Training Program awardee at the Johns Hopkins School of Medicine.