San Diego, CA. October 23, 2025 – Medical Affairs 360 LLC, a medical advisory firm offering services to pharmaceutical and biotechnology companies, is pleased to announce the major publication in the current issue of Blood (The Journal of the American Society of Hematology) by Regimmune, Inc., a client partner. The peer-reviewed study results for RGI-2001 for the prophylaxis of acute graft-versus-host disease after allogeneic hematopoietic cell transplantation (HCT) was published today in the October 23, 2025, Volume 146, Issue 17.
“We are honored to support Regimmune in achieving this significant milestone,” said Dana Lee, Chief Clinical Development Officer at Medical Affairs 360 LLC. “The publication of this study of RGI‑2001 in Blood underscores the growing importance of immunoregulatory strategies, specifically regulatory T-cells (Tregs), to prevent acute graft-versus-host disease. This field has now been recognized at the highest level—indeed, the 2025 Nobel Prize in Physiology or Medicine was awarded for discoveries in Treg biology and immune tolerance. These results therefore not only reflect Regimmune’s commitment to scientific innovation but also align with a paradigm-shifting area of medicine that is rapidly translating into therapeutic advances.”
Medical Affairs 360 provided strategic medical and scientific support throughout the program’s development, from clinical protocol design and safety oversight to Key Opinion Leader (KOL) advisory and publication strategy, ensuring scientific rigor and alignment with global standards of excellence. “This publication not only validates Regimmune’s commitment to scientific innovation but also demonstrates the value of sustained collaboration between biotechnology innovators and specialized medical advisory partners working together to advance transformative therapies to patients in need, ” said Kenneth Tong, President and Founder of Medical Affairs 360 LLC.
About RGI-2001
RGI-2001, is a liposomal formulation of an alpha-galactosylceramide (alpha-GalCer) analog. alpha-GalCer is a ligand for CD1d expressed on antigen presenting cells and invariant NKT cells. It was discovered that a liposomal alpha-GalCer promotes tolerogenic immune cascade, resulting in the activation and expansion of Tregs. RGI-2001 has been evaluated for prevention of Graft-versus-Host Disease (GvHD) in patients undergoing HLA-matched allogeneic hematopoietic stem cell transplantation (HSCT) for the treatment of hematological malignancies. A Phase 2b study (NCT04014790) has completed the enrollment of 49 patients: RGI-2001 was well tolerated and demonstrated preliminary signs of efficacy.
REGiMMUNE is a clinical-stage biopharmaceutical company focused on creating innovative immunotherapies for rare diseases and cancer by leveraging underexploited biological opportunities. We specifically target well-characterized biological pathways with compelling scientific data supporting their importance in regulating the immune response against disease. For more information, please visit www.regimmune.com.
About Medical Affairs 360 LLC
Medical Affairs 360 is boutique medical advisory firm offering services to pharmaceutical and biotechnology companies. Our partnership services encompass strategic and clinical guidance from early research to full launch readiness and ongoing medical affairs activities. For more information, please visit www.medicalaffairs360.com.
Contacts
Kenneth Tong, President and Founder
Medical Affairs 360 LLC.
info@medicalaffairs360.com