Taiwan’s REGiMMUNE and Europe-based Kiji Therapeutics are merging to create a globally minded regulatory T-cell biotech that already has its eyes set on an IPO.
REGiMMUNE’s lead therapy, dubbed RGI-2001, is designed to activate regulatory T cells (Tregs) through a novel mechanism that the company has claimed could also have applications for the treatment of other autoimmune and chronic inflammatory diseases. The candidate has been shown to prevent graft-versus-host disease (GvHD) after stem cell transplants in a phase 2 study, and the biotech has been gearing up for a late-stage trial.
Meanwhile, Kiji, which is based in France and Spain, has been working on a next-gen multigene engineered stem cell therapy IL10 enhancer, which is designed to boost Treg anti-autoimmune function.
Tregs' role in the body is to calm unwanted immune responses. The aim of today’s merger is to create “the leading company globally in modulating Treg function,” the companies said in an Oct. 18 release.
The new entity, which will operate under the REGiMMUNE name, is planning to IPO on Taiwan’s Emerging Stock Market by mid-2025.
As well as taking RGI-2001 into phase 3 and putting the word out for potential partners for the asset, the new company will have three other therapies in development. These include taking gene engineered mesenchymal stem cells into a phase 1 trial for GvHD in the second half of 2025 and developing Kiji’s induced pluripotent stem cells platform for potential use on inflammatory bowel disease, psoriasis and central nervous system disorders.
The company will also work on REGiMMUNE’s preclinical Treg depleting/inhibiting monoclonal antibody, dubbed RGI6004.
Kiji’s CEO Miguel Forte—who will helm the combined company along with REGiMMUNE’s CEO Kenzo Kosuda—told Fierce Biotech that the merger will be a stock exchange deal but wouldn’t go into the financial details.
“Tregs have proved themselves to be a leading promising modality in the cell and gene therapy field, both therapeutically and commercially,” Forte said in a statement. “We have collectively created a global Treg specialist super-company to realize this potential.”
“We will also be able to combine several fields, including small molecule, CGT and monoclonal antibodies to use Tregs to their full potential,” the CEO added. “These approaches are off-the-shelf and allogeneic, with a competitive advantage over autologous or patient-matched Treg approaches currently in development in the sector.”
Big Pharmas have been taking an interest in Tregs for a few years, including Eli Lilly’s licensing deal with TRexBio, Bristol Myers Squibb’s partnership with GentiBio and AstraZeneca’s collaboration with Quell Therapeutics on a “one and done” cure for Type 1 diabetes.