RegCell, a biotechnology company developing epigenetic reprogramming-based regulatory T-cell (Treg) therapies for autoimmune diseases and transplantation, has closed an oversubscribed $8.5 million seed round and is transitioning to a U.S.-based corporation.
The seed financing was co-led by The University of Tokyo Edge Capital Partners (UTEC) and Fast Track Initiative (FTI), with participation from Celadon Partners, Mitsubishi UFJ Capital, Osaka University Venture Capital (OUVC), and Kyoto University Innovation Capital (Kyoto i-Cap). Additionally, RegCell secured up to $37.3 million in non-dilutive funding from Japan’s Agency for Medical Research and Development (AMED). These funds will support clinical proof-of-concept development and validate RegCell’s technology.
RegCell plans to initiate a first-in-human trial in 2025 for an antigen-specific autoimmune indication. AMED’s funding will enable IND-enabling studies, GMP optimization, and clinical proof-of-concept establishment in the U.S.
Professor Shimon Sakaguchi, RegCell’s scientific founder and discoverer of regulatory T cells, stated, “This funding accelerates our mission to develop potentially curative treatments for autoimmune diseases and transplantation, providing a streamlined path to clinical proof of concept.”
The strategic U.S. corporate restructuring expands RegCell’s access to international talent, capital, and partnerships, enhancing R&D capabilities and global business development. RegCell will maintain core scientific operations in Japan while leveraging its U.S. presence for regulatory and commercialization expertise.
About RegCell
RegCell is a global biotechnology company developing cell therapies for autoimmune diseases and transplantation, headquartered in the U.S. and rooted in Japan’s scientific community. Founded on Professor Shimon Sakaguchi’s Treg discoveries, RegCell’s platform generates stable, epigenetically reprogrammed, antigen-specific Tregs to restore immune tolerance.
RegCell’s technology addresses key limitations of current autoimmune treatments by overcoming the need for immunosuppression and targeting unknown or multiple pathogenic antigens. Compared to genetic modification, epigenetic reprogramming simplifies manufacturing, enhances safety, and enables scalable production.
RegCell aims to deliver transformative cell therapies that restore immune tolerance, reverse autoimmune disorders, and improve transplantation outcomes.
https://endpts.com/japans-regcell-raises-45-8m-for-treg-cell-therapies-will-move-to-us/
About PackGene
PackGene Biotech is a world-leading CRO and CDMO, excelling in AAV vectors, mRNA, plasmid DNA, and lentiviral vector solutions. Our comprehensive offerings span from vector design and construction to AAV, lentivirus, and mRNA services. With a sharp focus on early-stage drug discovery, preclinical development, and cell and gene therapy trials, we deliver cost-effective, dependable, and scalable production solutions. Leveraging our groundbreaking π-alpha 293 AAV high-yield platform, we amplify AAV production by up to 10-fold, yielding up to 1e+17vg per batch to meet diverse commercial and clinical project needs. Moreover, our tailored mRNA and LNP products and services cater to every stage of drug and vaccine development, from research to GMP production, providing a seamless, end-to-end solution.
