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GeneFab and RegCell Announce Strategic Partnership to Advance Autoimmune Cell Therapy into U.S. Clinical Trials
GeneFab and RegCell Announce Strategic Partnership to Advance Autoimmune Cell Therapy into U.S. Clinical Trials
Alameda, Calif., May 7, 2025 – GeneFab, a next-generation cell and gene therapy-focused contract research, development, and manufacturing organization (CRDMO), has partnered with RegCell, a biotech company advancing regulatory T cell (Treg) therapies for autoimmune diseases. This collaboration will see GeneFab support the tech transfer and clinical manufacturing of RegCell’s Treg platform as it transitions from Japan to GeneFab's manufacturing facility in Alameda.
GeneFab will provide full cohesive CRDMO support, including technology transfer, process development, scale-up, IND-enabling activities, and clinical-grade manufacturing at its 92,000 square foot state-of-the-art Alameda facility, which includes seven GMP clean rooms. It will also support RegCell to accelerate U.S. clinical trials for autoimmune indications, including autoimmune hepatitis.
Its ability to provide flexible, end-to-end services with expert teams across business development, technical development, operations, and regulatory support, alongside its location in the San Francisco Bay area, were key differentiators for RegCell in selecting GeneFab. With close proximity to RegCell’s leadership team, GeneFab’s presence in the Bay Area underpins its growing role as a local manufacturing hub for clinical-stage biotech and early-stage innovator companies in the region and beyond.
“This collaboration embodies what we do best, partnering with cutting-edge therapeutic developers to accelerate their journey to the clinic,” said Dr. Philip Lee, CEO at GeneFab.
“RegCell has developed a best-in-class platform to generate stable, epigenetically reprogrammed, antigen-specific Tregs, and our team is proud to help bring that momentum to the U.S. We’re particularly excited to support their transition through IND filing and apply our advanced technologies to scale their production to meet the demands of broader patient populations.”
In addition, beyond the current program, the two companies are exploring co-development opportunities to further optimize Treg therapies, harnessing GeneFab’s expertise in synthetic biology. “These initiatives may include integrative designs and optimizations aimed at improving the safety and potency of the next generation of therapies,” said Dr. Duncan Liew, Senior VP of Business Development at GeneFab.
Dr. Michael McCullar, CEO, RegCell, commented: “This partnership marks the next step of our mission to bring our groundbreaking immunology therapy to market and transform outcomes for patients with autoimmune diseases. Working with GeneFab feels like an extension to our team. Its end-to-end capabilities, coupled with its specialist expertise in the design, manufacture, and commercialization of cell therapies, enables us to develop the foundation of a commercially viable manufacturing process.”
RegCell recently closed an oversubscribed seed round, including funding from Japan’s Agency for Medical Research and Development (AMED), and completed a headquarters transition to the U.S. The funding will accelerate the development of RegCell’s epigenetic reprogramming platform through transformative clinical milestones in the U.S. and further propel RegCell’s commitment and mission to bring the advancements of Treg technologies to the forefront of cell therapy innovations.
As part of its broader growth strategy, GeneFab is investing in automation platforms and scaling capabilities to support pivotal trials and commercial readiness. The build-out of an additional 45,000 square feet at its Alameda site is planned, aligning with the company’s vision of enabling cost-effective and scalable access to advanced cell therapies.
ENDS
About GeneFab
GeneFab is a U.S.-based contract research, development, and manufacturing organization (CRDMO) specializing in cell therapy and synthetic biology. It offers end-to-end services for therapeutic innovators, including process development, GMP manufacturing, and regulatory support. With two facilities in Northern California and a site in Singapore, GeneFab is committed to enabling the next wave of curative medicines.
http://www.genefab.com
About RegCell
RegCell is a global biotechnology company pioneering cell therapies for autoimmune diseases and transplantation. With newly established U.S. headquarters and deep roots in Japan’s renowned scientific community, RegCell is founded on the pioneering discoveries of Co-Founder Professor Shimon Sakaguchi, a leader in regulatory T-cell (T-reg) biology.
RegCell has developed a proprietary, best-in-class platform to generate stable, epigenetically reprogrammed, antigen-specific Tregs designed to restore immune tolerance. Driven by a vision to redefine self-tolerance, RegCell is committed to delivering safe, life-changing cell therapies that can restore immune tolerance, reverse autoimmune disorders, and overcome challenges in transplantation.
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