Date: 2017-05-18
Type of
information: Presentation of results at a congress
phase: 1
Announcement: presentation of results at the American Society of Clinical Oncology (ASCO) annual meeting, in Chicago
Company: Vaximm (Germany)
Product: VXM01
Action
mechanism:
- immunotherapy product/therapeutic vaccine. VXM01 is an oral T-cell immunotherapy that is designed to activate T-cells to attack the tumor vasculature, and, in several tumor types, attack cancer cells directly.
- It is based on a live attenuated, safe, orally available, bacterial vaccine strain, which is modified to carry vascular endothelial growth factor receptor-2 (VEGFR2) as the target gene. VXM01 stimulates the patient's immune system to activate VEGFR2-specific, cytotoxic T-cells (so-called killer cells). These immune killer cells then actively destroy cells in the tumor vasculature, leading to an increased infiltration of various immune cells into the tumor. In several tumor types, including brain cancer, VEGFR2 is highly over-expressed on the cancer cells themselves. In preclinical studies, a murine analog VXM01 vaccine showed broad anti-tumor activity in different tumor types. This activity was linked to a VEGFR2-specific T-cell response and was accompanied by the destruction of the tumor vasculature and increased immune cell infiltration.
Disease: glioblastoma
Therapeutic
area: Cancer - Oncology
Country: Germany
Trial
details:
- VXM01 phase I pilot study in patients with operable recurrence of a glioblastoma has ben designed to examine safety, tolerability, immune and biomarker response to the investigational VEGFR-2 DNA vaccine VXM01.
- The study is being conducted at the University Hospital in Heidelberg, Germany.
- All patients in the study must have recurrence of their disease following at least one prior treatment that must have included radiochemotherapy with temozolomide and be candidates for routine reoperation with a safe option for delaying surgery for 4-5 weeks. Patients will receive four doses of oral VXM01 four to five weeks before surgery, and two safety magnetic resonance images at 3 and 1 weeks, prior to reoperation. Following surgery, patients may receive optional VXM01 administrations every four weeks up to week 48. The primary objectives of the study are safety and tolerability. The trial will also investigate a number of pharmacodynamic endpoints and clinical response. A special focus of the study is the measurement of the VXM01-related cytotoxic T-cell response, the assessment of immune cell infiltration and of changes in the vascularization and the PD-1/PD-L1 status of the tumor, as a response to the treatment.
- (NCT02718443)
Latest
news:
- On May 18, 2017 , Vaximm announced that the first clinical data in glioblastoma with VXM01, are being presented at the upcoming American Society of Clinical Oncology (ASCO) 2017 Annual Meeting . The Phase I trial was designed to evaluate the safety and tolerability, as well as clinical and immunogenic response, to VXM01 in patients with recurrent glioblastoma whose disease had progressed following treatment with at least radiochemotherapy including temozolomide. The data being reported are from eight patients. Patients were given a single dose of VXM01 on days 1,3,5 and 7 before the planned surgery on day 35. Following surgery, patients could then receive a single administration every four weeks during the follow-up period. Median dosage was seven vaccinations.
- Of the eight patients treated, surgery was performed on seven. One patient experienced an objective and durable response, and three other patients had stable disease. Additionally, peripheral immune responses were observed, and five of seven patients had an increase in CD8+ T-cells in tumor tissue following re-operation compared to the primary tumor tissue. Four out of eight patients showed a specific T-cell response. In addition, in four patients a relevant increase in cerebral blood volume and apparent diffusion coefficient on post-vaccination MRI was observed. VXM01 was shown to be well tolerated. Due to the promising early results in this trial, the study has been expanded to include an additional patient cohort.
• On July 12, 2016, Vaxxim announced the treatment and successful operation of the first patient in a Phase 1 clinical trial. The study will initially enroll six patients with operable recurrence of a glioblastoma.
Is
general: Yes
