GeneFab has partnered with RegCell in a strategic move aimed at advancing regulatory T cell (Treg) therapy into clinical development in the United States.

The collaboration will see the technology transferred from Japan and clinical manufacturing established at GeneFab’s Alameda, California facility.

RegCell is developing antigen-specific, epigenetically reprogrammed Tregs for the treatment of autoimmune diseases. Through this agreement, GeneFab will provide integrated services ranging from process development and scale-up to IND-enabling activities and GMP manufacturing. The 92,000-square-foot Alameda site features seven clean rooms and is expected to play a key role in supporting the transition to early clinical trials, including for indications such as autoimmune hepatitis.

“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 US.”

According to the companies, proximity was an important consideration in the selection of GeneFab as a manufacturing partner. The Bay Area location offers direct access to RegCell’s leadership team and is positioned within one of the most active biotech ecosystems in the country. The partnership further underlines GeneFab’s emergence as a regional manufacturing hub for early-stage and clinical-stage companies.

RegCell’s CEO, Dr Michael McCullar, highlighted the strategic importance of the collaboration: “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.”

In addition to the current program, both parties are reportedly exploring joint development initiatives focused on improving Treg therapy design. “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.

The announcement follows RegCell’s recent oversubscribed seed round, which included support from Japan’s Agency for Medical Research and Development (AMED). The company also recently relocated its headquarters to the US to support its clinical ambitions.

GeneFab, meanwhile, is expanding capacity as part of its broader growth strategy. This includes a planned 45,000-square-foot expansion at its current Alameda facility and investments in automation technologies to support commercial-scale production in the future.