VTRU200 / VITRUVIAE - LARVOL DELTA

GRACE: A Phase 1/2a Study of VTRU200 in Relapsed/Refractory AML, High-risk MDS, DLBCL Post CART Failure and Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=108 | Not yet recruiting | Sponsor: Vitruviae

First-in-human • New P1/2 trial • Acute Myelogenous Leukemia • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Myelodysplastic Syndrome • Non-Hodgkin’s Lymphoma • Oncology • Pediatrics • Solid Tumor

Anti-tumor activity of Man 9 x PS targeting immunotherapies in diffuse intrinsic pontine glioma (DIPG) and pancreatic cancers. (ASCO 2026) - "Man9 x PS dual targeting is a promising strategy for treating solid tumors. VTRU200 and VCAR300 are potential therapeutic candidates with potent anti-tumor activity across multiple tumor types and impressive safety. Following a successful pre-IND interaction with the FDA, first-in-human studies are planned to initiate in 2027."

First-in-human • IO biomarker • Acute Myelogenous Leukemia • Brain Cancer • Breast Cancer • Diffuse Intrinsic Pontine Glioma • Glioma • Hematological Malignancies • Leukemia • Oncology • Pancreatic Cancer • Solid Tumor • CD133

Immunotherapy of Acute Myeloid Leukemia Enabled By Targeting of Pan-Cancer Molecular Patterns with a Novel Trispecific T Cell Engager (ASH 2024) - "Additional structure activity relationship testing revealed that the potency of the molecule could be further improved when employing a more proximal anti-CD3 domain (to facilitate synapse formation between T cells and tumor cells) and thus, this optimized structure (VTRU200) was selected as the lead molecule for further preclinical and clinical development...In conclusion, we validated two highly promising non-protein targets for AML immunotherapy and developed innovative T cell engager-based Man9/PS dual targeting strategies characterized by the absence of on-target off-tumor toxicity and antigen negative relapse potential, which are major safety and efficacy limitations of currently available immunotherapies. Our goal is to develop a first-in-class, breakthrough Man9 x PS x CD3 trispecific T cell engager for AML patients with an anticipated timeline to IND of 18 months."

IO biomarker • Pan tumor • Trispecific • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • CD8 • KIM1

Employing novel pan-cancer targets for immunotherapy in leukemias and solid tumors. (ASCO 2025) - "In vivo studies in human CD3 transgenic mice treated with intravenous doses of VTRU200 (Man9 x PS x CD3) showed significant therapeutic responses, based on in vivo bioluminescence imaging... Our data supports Man9 and PS as promising non-protein targets for pan-cancer immunotherapy. The dual targeting approach with T cell engagers reduces on-target, off-tumor toxicity and antigen-negative relapse, advancing a first-in-class Man9 x PS x CD3 trispecific T cell engager. We have also designed and validated a bispecific (Man9 x PS) chimeric antigen receptor (CAR) and research is ongoing for CAR-T therapy for pancreatic cancer."

IO biomarker • Pan tumor • Acute Myelogenous Leukemia • Brain Cancer • Hematological Malignancies • Leukemia • Oncology • Pancreatic Cancer • Solid Tumor • CD8