GSK2130579A / GSK - LARVOL DELTA

First-in-Human Study of WT1 Recombinant Protein Vaccination in Elderly Patients with AML in Remission: A Single-Center Experience (ASH 2021) - P1 | "Here we report a single-center experience of a phase I/II clinical trial (NCT01051063) of a first-in-human vac strategy based on WT1 recombinant protein (WT1-A10) together with vaccine adjuvant AS01 B in 5 elderly AML pts...Conclusions This vac strategy showed good feasibility, with a very acceptable safety profile, and appeared to extend remissions beyond the expected duration, together with MRD clearance. Thus, our data provide evidence of potential clinical efficacy of WT1 protein-based vac therapy in AML pts, making this maintenance approach an attractive alternative to more complex strategies, particularly in elderly pts with comorbidities."

Clinical • IO biomarker • P1 data • Acute Myelogenous Leukemia • Hematological Disorders • Immunology • Inflammation • Oncology • Pain • Solid Tumor • Wilms Tumor • BRAF • CD4 • CD8 • FLT3 • IFNG • KRAS • NPM1 • SRSF2 • STAG2 • WT1

First-in-human study of WT1 recombinant protein vaccination in elderly patients with AML in remission: a single-center experience. (PubMed, Cancer Immunol Immunother) - P1 | "Here we report our experience of a phase I/II clinical trial (NCT01051063) of a vaccination strategy based on WT1 recombinant protein (WT1-A10) together with vaccine adjuvant AS01 in five elderly AML patients (median age 69 years, range 63-75) receiving a total of 62 vaccinations (median 18, range 3-20) after standard chemotherapy...Detected humoral and cellular CD4 T cell immune responses point to efficient immune stimulation post-vaccination, complementing hints for induced conventional T cell infiltration into the bone marrow and a shift from senescent/exhausted to a more activated T cell profile. Overall, the vaccinations with WT1 recombinant protein had an acceptable safety profile and were thus well tolerated.To conclude, our data provide evidence of potential clinical efficacy of WT1 protein-based vaccination therapy in AML patients, warranting further investigations."

IO biomarker • Journal • P1 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • Solid Tumor • Wilms Tumor • CD4 • WT1