Delivering breakthrough immune medicines by harnessing the power of regulatory T cells.
REGiMMUNE is a clinical-stage biopharmaceutical company focused on creating innovative immunotherapies for rare diseases and cancer by leveraging underexploited biological opportunities. We specifically target well-characterized biological pathways with compelling scientific data supporting their importance in regulating the immune response against disease. To target new pathways, we are building a robust and highly efficient discovery capability to create and optimize highly differentiated biologic product candidates.
Our focus is on a critical cell subset with potent immunmodulating activities, Regulatory T cells (Tregs). Decades of scientific research have demonstrated that Tregs act to control immune responses, which may be beneficial to harness this activity for alleviating autoimmune disease manifestation and for facilitating transplantation tolerance. Our approach for controlling the expansion of Tregs takes advantage of a natural pathway with a synthetic small molecule formulated with liposome technology to treat GvHD. Our lead molecule, RGI-2001, has been well tolerated by patients in phase 1 clinical studies with demonstrated target engagement and measurable pharmacological activity in-vivo to expand Tregs. More recently with Tregs, emerging data in the immuno-oncology field has pointed towards a potent subset of these cells mediating acquired resistance to checkpoint inhibitors and limiting patient responders to bispecific T cell engaging biologics. We are developing antibody therapeutic approaches that will specifically target Tregs and reduce their undesired function in the tumor microenvironment. As the immuno-oncology market evolves toward the use of combination therapies, a key element of our strategy is to build a tailored portfolio of product candidates that target a wide range of complementing immune mechanisms. Consistent with this strategy, we are developing additional antibody drug candidates that may become the foundation for the next generation of combination therapies for immuno-oncology.
History & Milestones
AUG RGI-2001 Haplo Peripheral Blood Sct phase 1 study started
NOV RGI-2001 phase 2 study started
JUN Restructured as a Taiwan registered corporation
APR Treg-specific antibody drug discovery started
APR Type 1 diabetes research agreement with JDRF and Pfizer started
DEC RGI-2001 phase 1/2a study completed.
SEP Orphan drug designation on the GvHD prevention by FDA
SEP RGI-2001 phase 1/2a study started
MAR Licensing from RIKEN
NOV REGiMMUNE USA established; preclinical study started
REGiMMUNE established in Japan
Chief Executive Officer; Member of the Board of Directors
Mr. Kenzo Kosuda currently serves as the Chief Executive Officer of REGiMMUNE since 2016 and as a member of Board of Directors since 2013. He previously served as the company’s Chief Financial Officer from 2013 to 2018. In this role, he was responsible for finance, investor relations, operations, strategy and corporate development. He has over twenty years of extensive experience in financial area throughout his experience at Deloitte Touche Tohmatsu, PwC as professional consultant, and his own accounting firm to help emerging companies. Prior to join REGiMMUNE, he served as Chief Financial Officer at Sparx Asset Management where he led the first IPO of an asset management company in Japan. He has a B.A. degree in Economics from the Keio University in Japan and is a Chartered Accountant.
Ping Zhong, Ph.D.
Chief Technology Officer
Dr. Ping Zhong currently serves as the Chief Technology Officer of REGiMMUNE. Dr. Ping Zhong has served as Chief Technology Officer of REGiMMUNE since 2019, leading all efforts on the antibody program. Dr Zhong has over 30-year experiences in startup biotech, med-size and global pharmaceuticals, and academic institution. He joined the industry in Silicon Valley after his postdoc training at Stanford, was involved in drug discovery at Neurex Corp. & Elan Pharmaceutical. He later co-founded Abmaxis, an antibody technology startup. After a corporate merger, he continued his leadership in antibody technology & discovery in Merck. He then joined Singapore Immunology Network of A*STAR (Agency of Science, Technology and Research, Singapore), and extended his research to immune checkpoint antibodies, bispecific molecules, and protein scaffolds. He was the winner of Singapore National Research Foundation’s grant on developing antibody-like molecules for next generation biologics, for which he was also supported by industry fund for developing these molecules to monitor immune checkpoint biomarkers in vivo. Dr. Zhong received his Ph.D. of Pharmacology in Georgetown University.
Executive Vice President, Clinical Development
Leonard Presta, Ph.D.
Dr. Leonard Presta, with more than 20 years of experience in the biotechnology industry, is one of the most internationally respected scientists in the fields of antibody and protein engineering. Most recently, Len served as a Distinguished Fellow at Merck & Co., Inc. where he was responsible for the protein engineering of all internal therapeutic antibodies. Len also held positions of increasing responsibility at Genentech, Inc., including Director of the Antibody Technology Group where he was directly responsible for or led the protein engineering of notable antibody therapeutics including Herceptin®, Perjeta® Raptiva®, Xolair®, Avastin®, and Lucentis®. Len is an inventor on more than 130 U.S. patents and has served on the editorial boards of notable journals including the Journal of Biological Chemistry, PROTEINS, and MABS. Len received his Ph.D. in Biochemistry from Texas A&M University in the computational modeling of protein-ligand interactions.
Omar Duramad, Ph.D.
Dr. Omar Duramad has over 15 years of industry experience in Immunology research and early drug development for both small molecule and antibody therapeutics. Most recently, he was the founder & CEO of Abmuno Therapeutics, a company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer and infectious diseases. Notably, he led the early development of a checkpoint therapeutic antibody to TIGIT, which was out-licensed to Arcus Biosciences for clinical development. Prior to Abmuno, he held a variety of positions with increasing responsibility at IGM Biosciences and Neothera Biosciences, leading immunology research & preclinical teams focused on oncology and autoimmune disease indications. As a researcher at Dynavax Technologies, he was part of the Drug Discovery group that identified novel Toll-like Receptor inhibitors for diseases such as lupus, psoriasis, and rheumatoid arthritis. Additionally, Dr. Duramad previously advised multiple clients including Loxo Oncology, Sirenas MD, Holoclara, and Bryologyx, each a biopharmaceutical company and iQ Biosciences, a contract research organization, regarding early development programs or therapeutic platform development. Dr. Duramad has received several awards such as the Schissler Foundation Fellowship in Cancer Research, American Legion Auxiliary Fellowship for Outstanding Scholarship, and the Vivian L. Smith Award for Outstanding Immunologist. He has been an invited speaker at prestigious conferences such as Keystone Symposia, American Society of Hematology, and American Transplant Congress. Dr. Duramad obtained his B.S. in Biochemistry & Cell Biology from University of California, San Diego and Ph.D. in Immunology & Cancer Biology from the University of Texas, MD Anderson Cancer Center in Houston.
Board of Directors
Environmental, Social, and Governance