Vx-001 / Vaxon Biotech - LARVOL DELTA

Telomerase-based vaccines: a promising frontier in cancer immunotherapy. (PubMed, Cancer Cell Int) - "While DNA vaccines demonstrate promising immunogenicity, peptide vaccines, such as UV1, UCPVax, and Vx-001, have shown clinical efficacy in certain cancer types. Accordingly, we discuss the mechanisms of action, preclinical and clinical data, and the potential of these vaccines to elicit robust and durable anti-tumor immune responses. This review highlights the potential of telomerase-based vaccines as a promising strategy for cancer treatment and identifies areas for future research."

Journal • Review • Gene Therapies • Oncology • TERT

Therapeutic vaccines for advanced non-small cell lung cancer. (PubMed, Cochrane Database Syst Rev) - "Adding a vaccine resulted in no differences in overall survival, except for racotumomab, which showed some improvement compared to placebo, but the difference in median survival time was very small (1.4 months) and the study only included 176 participants. Regarding progression-free survival, we observed no differences between the compared treatments, except for TG4010, which may increase progression-free survival slightly. There were no differences between the compared treatments in serious treatment-related adverse events, except for SRL172 (killed Mycobacterium vaccae) added to chemotherapy, which was associated with an increase in the proportion of participants with at least one serious treatment-related adverse event, and OSE2101, which may decrease slightly the proportion of people having at least one serious treatment-related adverse event. These conclusions should be interpreted cautiously, as the very low- to moderate-certainty evidence prevents drawing solid ..."

Journal • Metastases • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Randomized double blind phase IIb trial in advanced NSCLC patients who did not progress after first line platinum based chemotherapy : Vx-001, a therapeutic cancer vaccine, vs placebo as maintenance therapy. (ESMO 2017) - P2; "These results suggest that Vx-001 might be efficient in patients without natural immunity and particularly in never smokers."

Clinical • Late-breaking abstract • P2 data • Non Small Cell Lung Cancer

Induction of pre-s antobodies in HBeAg negative chronic hepatitis B patients by thereupatic vaccination with the pre-s based vaccine VVX001 - interim analysis (EASL-ILC 2022) - P2 | "Five patients received placebo and 15 received VXX001. VVX001 is safe and well tolerated and induces a preSspecific immune response in patients with chronic HBeAg-neg hepatitis B. In 87% of vaccinated patients, no repeated treatment with NUCs was necessary after stopping NUCs. A longer follow-up is needed to evaluate the long-term impact of vaccination and stop of NUC therapy."

Clinical • Hepatitis B • Hepatology • Infectious Disease • Inflammation • CD4 • CD8

Clinical Activity of an hTERT-Specific Cancer Vaccine (Vx-001) in "Immune Desert" NSCLC. (PubMed, Cancers (Basel)) - "These results support the hypothesis that Vx-001 may be efficient in patients with non-immunogenic/cold but not with immunogenic/hot tumors."

Clinical • IO biomarker • Journal • Immunology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD8 • GZMB • TMB

A phase II trial evaluating the clinical and immunologic response of HLA-A2+ non-small cell lung cancer patients vaccinated with an hTERT cryptic peptide (Lung Cancer) - P2, N=46; “The disease control rate was significantly higher in patients with non-squamous histology compared to those with squamous-cell histology [n=14 (45%) versus n=2 (13%); p=0.03]. The median progression-free survival (PFS) and overall survival (OS) was 3.8 (range, 0.7-99.4) and 19.8 months (range, 0.7-99.4), respectively. Patients who developed immune response had a numerically higher PFS compared to those who failed to mount any (6.7 versus 2.7 months; p=0.090).” 

P2 data • Non Small Cell Lung Cancer

Clinical activity of a htert (vx-001) cancer vaccine as post-chemotherapy maintenance immunotherapy in patients with stage IV non-small cell lung cancer: final results of a randomised phase 2 clinical trial. (PubMed, Br J Cancer) - P2 | "Vx-001 could induce specific CD8 immune response but failed to meet its primary endpoint. Subsequent studies have to be focused on the identification and treatment of subgroups of patients able to mount an effective immunological response to Vx-001."

Clinical • Journal • P2 data

Telomerase-based cancer therapeutics: a review on their clinical trials. (PubMed, Curr Top Med Chem) - "Since the discovery of Imetelstat, several research groups have contributed to enrich the therapeutic arsenal against cancer. Such contributions include the application of new classes of small molecules, peptides, and hTERT-based immunotherapeutic agents (p540, GV1001, GRNVAC1 or combinations of these such as Vx-001). Many of these therapeutic tools are under different stages of clinical trials and have shown promising outcomes. In this review, we highlight the current status of telomerase-based cancer therapeutics and the outcome of these investigations."

Clinical • IO Biomarker • Journal

Efficacy Study of Vx001 Vaccine in NSCLC Patients (clinicaltrials.gov) - P2; N=221; Completed; Sponsor: Vaxon Biotech; Active, not recruiting ➔ Completed

Clinical • Trial completion