TVI-Brain-1 / TVAX Biomedical - LARVOL DELTA

TVI-AST-008: Study of Neoantigen-specific Adoptive T Cell Therapy for Newly Diagnosed MGMT Negative Glioblastoma Multiforme (GBM) (clinicaltrials.gov) - P2/3 | N=120 | Active, not recruiting | Sponsor: TVAX Biomedical | Suspended ➔ Active, not recruiting

Enrollment closed • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • MGMT

TVI-AST-008: Study of Neoantigen-specific Adoptive T Cell Therapy for Newly Diagnosed MGMT Negative Glioblastoma Multiforme (GBM) (clinicaltrials.gov) - P2/3 | N=120 | Suspended | Sponsor: TVAX Biomedical | Recruiting ➔ Suspended

Trial suspension • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • MGMT

TVI-AST-008: Study of Neoantigen-specific Adoptive T Cell Therapy for Newly Diagnosed MGMT Negative Glioblastoma Multiforme (GBM) (clinicaltrials.gov) - P2/3 | N=120 | Recruiting | Sponsor: TVAX Biomedical | Trial completion date: Mar 2026 ➔ Mar 2027 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • MGMT

Study of Neoantigen-specific Adoptive T Cell Therapy for Newly Diagnosed MGMT Negative Glioblastoma Multiforme (GBM) (clinicaltrials.gov) - P2/3 | N=96 | Recruiting | Sponsor: TVAX Biomedical

Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • MGMT

Study of Neoantigen-specific Adoptive T Cell Therapy for Newly Diagnosed MGMT Negative Glioblastoma Multiforme (GBM) (clinicaltrials.gov) - P2/3 | N=96 | Recruiting | Sponsor: TVAX Biomedical | Phase classification: P2b ➔ P2/3

Phase classification • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • MGMT

Study of Neoantigen-specific Adoptive T Cell Therapy for Newly Diagnosed MGMT Negative Glioblastoma Multiforme (GBM) (clinicaltrials.gov) - P2b | N=96 | Recruiting | Sponsor: TVAX Biomedical | Not yet recruiting ➔ Recruiting

Enrollment open • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • MGMT

Study of Neoantigen-specific Adoptive T Cell Therapy for Newly Diagnosed o6-methylguanine-DNA-methyltransferase (MGMT) Negative Glioblastoma Multiforme (GBM) (clinicaltrials.gov) - P2b | N=96 | Not yet recruiting | Sponsor: TVAX Biomedical | Initiation date: Jun 2023 ➔ Sep 2023

Trial initiation date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • MGMT

TVI-Brain-1 in Expanded Access Patient (clinicaltrials.gov) - P=N/A | N=N/A | Available | Sponsor: TVAX Biomedical

New trial • Anaplastic Astrocytoma • Astrocytoma • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

Study To Test the Safety and Efficacy of TVI-Brain-1 As A Treatment for Recurrent Grade IV Glioma (clinicaltrials.gov) - P2 | N=14 | Completed | Sponsor: TVAX Biomedical | N=86 ➔ 14

Enrollment change • Anaplastic Astrocytoma • Astrocytoma • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

Study of Neoantigen-specific Adoptive T Cell Therapy for Newly Diagnosed o6-methylguanine-DNA-methyltransferase (MGMT) Negative Glioblastoma Multiforme (GBM) (clinicaltrials.gov) - P2b | N=96 | Not yet recruiting | Sponsor: TVAX Biomedical | Initiation date: Mar 2023 ➔ Jun 2023

Trial initiation date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • MGMT

Study of Neoantigen-specific Adoptive T Cell Therapy for Newly Diagnosed o6-methylguanine-DNA-methyltransferase (MGMT) Negative Glioblastoma Multiforme (GBM) (clinicaltrials.gov) - P2b | N=96 | Not yet recruiting | Sponsor: TVAX Biomedical

New P2b trial • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • MGMT

TVAX Biomedical announces major advancements in potential Glioblastoma cure (PRNewswire) - "TVAX Biomedical (TVAX), is a cancer immunotherapy company that is moving into its pivotal glioblastoma study for FDA regulatory approval...TVAX received Fast Track Designation and Orphan Product Designation from the FDA...Fast Track Designation affords many advantages, including a pathway to accelerated marketing approval...TVAX plans to initiate a registration study in newly diagnosed glioblastoma patients in 2021."

Fast track designation • IND • New trial • Orphan drug • Glioblastoma • Oncology