On April 11, 2024 REGiMMUNE Limited, a clinical-stage biopharmaceutical company focused on creating innovative immunotherapies for immune disorders and cancer, reported the poster presentation at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (Press release, REGimmune, APR 11, 2024, View Source [SID1234642233]). The poster presentation is to highlight RGI-2001 phase 2b result, including the latest correlative analyses of changes in regulatory T (Treg) and natural killer T (NKT) cell populations to assess the cellular kinetics of RGI-2001 in the prevention of acute Graft versus host disease.

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Based on literature, higher numbers of NKT cells are associated with a reduced risk of acute graft-versus-host disease (aGVHD) after allogeneic hematopoietic cell transplantation (alloHCT) (Rubio et al. 2017; Rubio et al. 2012). Patients with rapid NKT cell expansion exhibit a lower risk of GVHD and improved survival (Chaidos et al. 2012; Malard et al. 2016).

Flow cytometry studies indicate peripheral NKT expansion at Day 28 in patients receiving clinical benefit from RGI- 2001.The mean levels of absolute Tregs at Day 42, 1 week following the last dose of RGI-2001, were higher in subjects who were alive and had not developed Grade II-IV aGVHD by Day 180 compared with those who had died and/or did develop aGVHD. A large percentage of activated Tregs were proliferating, with activated Tregs proliferating to a greater extent compared with nonactivated Tregs. The proliferation was greater in after- treatment compared to baseline samples. This effect was also observed in the single-dose study (Phase 1/2a RGI-2001-002). The results from exploratory correlative analyses are consistent with the proposed mechanism of action of RGI-2001. RGI-2001 may induce activation and proliferation of NKT cells, leading to a reduction in aGVHD through increasing the proliferation of activated Tregs.

"Our data suggest that RGI-2001 prevents acute GVHD through NKT and Treg cells without compromising general immune function and has the potential to become a best-in-class drug for preventing acute GVHD," said Kenzo Kosuda, CEO of REGiMMUNE. Based on these results, a phase 3 randomized controlled study is being planned to confirm the efficacy and safety of RGI-2001 in alloHCT.

Dr Jack Bui,MD,Ph.D. from University of California, San Diego, is the presenter for this important poster for RGI-2001. Details of presentation, please see RGI-2001 AACR (Free AACR Whitepaper) Poster Presentation.

Title: Phase 2b study of alloHSCT patients receiving RGI-2001, an NKT cell activator, demonstrates safety and protection from acute GVHD, correlating with increased NKT cell number in patient blood.
Authors: J. D. Bui1, C. Lee1, C. Caron1, D. Lee2, Z. DeFilipp3, Y.-B. Chen3;
Session Title: PO.CT02.02 – Phase II Clinical Trials 2
Session Date and Time: April 8th 2024, 1:30 PM – 5:00 PM