REGiMMUNE and Kiji Therapeutics to Merge

On Oct. 18, 2024, REGiMMUNE and Kiji Therapeutics announced the two companies are intending to merge, creating a specialty company, REGiMMUNE/Kiji TX, for regulatory T cells (Tregs) targeting drugs for multiple modalities and indications. The two companies’ complementary portfolios will be used to create the new Treg biotech to address unmet needs by the modulation of the Treg function.

Treg function has been increased by both companies in different ways; REGiMMUNE has regulated the role of the Treg with a molecule enhancer to increase Treg function, and Kiji TX uses next-generation multigene engineered cell therapy IL10 enhancers to increase Treg anti-autoimmune functions. To reduce or eliminate Treg function, REGiMMUNE uses monoclonal antibodies. By combining these technologies, the companies hope to create an international Treg specialist that will focus on immune-oncology and autoimmunity.

REGiMMUNE/Kiji TX will target its pipeline on four therapies. “It will establish proof of concept with gene engineered mesenchymal stem cells (KJ01) in graft-versus-host disease (GvHD), and prepare for clinical entry in the second half of 2025, develop its iPSC platform (KJ02) for inflammatory bowel disease (IBD), psoriasis and CNS disorders, define clinical readiness with a Treg depleting/inhibiting monoclonal antibody (RGI6004) and advance clinical development with the launch of a Phase III clinical trial with a clinical stage small molecule Treg enhancer targeting GvHD (RG2001),” the companies stated in a press release (1).

“Tregs have proved themselves to be a leading promising modality in the cell and gene therapy field, both therapeutically and commercially. As a result of this potential, we have collectively created a global Treg specialist super-company to realize this potential,” said Miguel Forte, CEO, Kiji TX, in the release. “We will also be able to combine several fields, including small molecule, CGT and monoclonal antibodies to use Tregs to their full potential. 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. The new company now has a variety of options, including an IPO by mid-2025 in the Taiwan Stock Exchange. This will enable REGiMMUNE/Kiji TX to develop our multiple therapeutic pipeline in-house, as well as partnering for co-development or out-licensing.”

“Modulating Treg function in both directions has significant potential in a variety of conditions with major commercial benefits. Creating the new Treg specialist REGiMMUNE/Kiji TX will result in a company that will have the resources to achieve this potential. With a planned IPO in 2025, we will be able to combine leading modalities to develop therapies for conditions involving significant numbers of patients globally,” said Kenzo Kosuda, CEO, REGiMMUNE, in the release. “The global reach of the company and experience of the senior management also enables us to explore development across the globe to match the therapeutic potential and size of the market that is open to us.”

REGiMMUNE Limited, a clinical-stage biopharmaceutical company based in Taiwan, specializes in immunotherapies by harnessing Tregs for immune diseases and cancer. Kiji Therapeutics specializes in next-generation IPSC-MSC engineered cell therapy for inflammatory diseases. Kiji TX is developing superior potency multi-gene engineered stem cell therapies.

Reference

1. Kiji Therapeutics and REGiMMUNE. REGiMMUNE and Kiji Therapeutics Announce Intention to Merge. Press Release. Oct. 18, 2024.