VITRAC Therapeutics Initiates a Phase 1/2 Clinical Trial with the Aurora Kinase A inhibitor VIC-1911 in GVHD Prophylaxis

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VITRAC Therapeutics, LLC (VITRAC) initiated a Phase 1/2 clinical trial of VIC-1911 in combination with sirolimus and post-transplant cyclophosphamide (PTCy) as graft-versus-host disease (GVHD) prophylaxis in myeloablative allogeneic stem cell transplantation. VIC-1911 is an oral selective Aurora kinase A inhibitor (AURKA). The trial is being carried out at the University of Minnesota Medical School, Hematology and Transplantation, with Shernan G. Holtan, M.D., the Principal Investigator, and Brian C. Betts, MD. The scientific rationale is based on preclinical work led by Dr. Betts, where AURKA inhibition reduced xenogeneic GVHD in mice and enhanced human regulatory T cell suppression over pathogenic, alloreactive T cells (Betts BC et al. Science Translational Medicine. 2017).

Aurora kinase A is an important resistance mechanism for sirolimus efficacy in GVHD prevention”

Allogeneic hematopoietic cell transplantation (HCT) is the only potentially curative treatment for many high-risk or relapsed/refractory hematologic malignancies. HCT with myeloablative conditioning is currently the standard of care for young, fit patients suitable for HCT. However, GVHD continues to impair survival and contribute to post-transplant morbidity, with 35-50% of transplanted patients diagnosed with this complication. Acute GVHD occurs when donor T cells react against genetically defined proteins on normal host cells. The attack on the host cells can cause an array of symptoms from skin rashes, nausea, vomiting, diarrhea, hepatitis, jaundice, and increase the risk for infection, which typically occur within the first six months post-HCT. Chronic GVHD occurs later in most patients (average of 9-12 months post-HCT) and can lead to scarring and fibrosis of many organs, including the skin and subcutaneous tissues, mucous membranes, lungs, liver, and other organs. The challenge in HCT is to design strategies that reduce the incidence and severity of GVHD without sacrificing graft-versus-tumor effects.

This is a single-arm, Phase 1/2 GVHD prevention trial. The trial is testing the safety and efficacy of a calcineurin inhibitor-free GVHD prophylaxis regimen that includes PTCy, VIC-1911, and sirolimus (PTCy/VIC/SIR). PTCy/VIC/SIR is specifically designed to substantially reduce GVHD, facilitate the full potential of graft-versus-leukemia (GVL) effect, and maximize GVHD-free, relapse-free survival (GRFS). This trial will transplant 8/8 HLA-matched related or unrelated peripheral blood stem cells after myeloablative conditioning with total body irradiation (TBI).

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