FMPV-1 / Hubro Therap - LARVOL DELTA

Generation of frameshift-mutated TGFβR2-specific T cells in healthy subjects following administration with cancer vaccine candidate FMPV-1/GM-CSF in a phase 1 study. (PubMed, Cancer Immunol Immunother) - P1 | "These findings support clinical studies in patients with, or at risk of, cancers carrying TGFβR2 frameshift mutations.Clinical trial identification: ClinicalTrials.gov: NCT05238558. EudraCT: 2020-004363-80."

Journal • P1 data • Gastrointestinal Cancer • Gastrointestinal Disorder • Genetic Disorders • Hematological Disorders • Immunology • Microsatellite Instability • Oncology • Solid Tumor • CSF2 • MSI • TGFB1 • TGFBR2

Generation of frameshift mutated TGF_R2-specific T cells in healthy subjects following administration with cancer vaccine candidate FMPV-1/GM-CSF (ESMO-IO 2023) - "This provides a rationale for FMPV-1 treatment of MSI-H cancer patients in combination with immune checkpoint inhibitors. With the favourable safety profile and ability to induce frameshift mut TGFβR2 specific memory T cells, FMPV-1/GM-CSF may play an important role in both therapeutic and prophylactic settings of cancer."

Clinical • IO biomarker • Microsatellite Instability • Oncology • CSF2 • MSI • TGFB1 • TGFBR2

Safety and Immune Response to FMPV-1 (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: Hubro Therapeutics AS | Active, not recruiting ➔ Completed

Trial completion • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

A Phase I Study of the cancer-specific vaccine FMPV-1 in Healthy Male Subjects to Assess Safety and Immune Response (ESMO-IO 2022) - P1 | "In vitro T cell proliferation post-vaccination increased compared to pre-vaccination in subjects tested, with analysis ongoing. Conclusions The excellent safety profile of FMPV-1/GM-CSF and vaccine-specific immune responses in healthy subjects support further clinical development in a patient population for a phase 2 study in MSI-high colorectal cancer."

Clinical • P1 data • Colorectal Cancer • Gastrointestinal Cancer • Microsatellite Instability • Oncology • Solid Tumor • CSF2 • MSI • TGFB1 • TGFBR2

Safety and Immune Response to FMPV-1 (clinicaltrials.gov) - P1 | N=16 | Active, not recruiting | Sponsor: Hubro Therapeutics AS | Recruiting ➔ Active, not recruiting

Enrollment closed • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor