Clinical Trials

Date: 2016-05-04

Type of information: Recruitment of the first patient

phase: 2a

Announcement: recruitment of the first patient

Company: Vaximm (Germany)

Product: VXM01

Action mechanism:

immunotherapy product. VXM01 is an oral T-cell immunotherapy that targets the tumor-specific vasculature and certain immune-suppressive cells. It is based on a live attenuated, safe, orally available, bacterial vaccine strain, which is modified to carry vascular endothelium growth factor receptor-2 (VEGFR-2) as the target gene. VXM01 stimulates the patient's immune system to activate VEGFR-2-specific, cytotoxic T-cells (so-called killer cells). These immune killer cells then actively destroy the cells in the tumor vasculature leading to an increased infiltration of various immune cells into the tumor. In pre-clinical studies, a murine analog VXM01 vaccine has shown broad anti-tumor activity in different tumor types. This activity was linked to a VEGFR-2 specific T-cell response and was accompanied by the destruction of the tumor vasculature and increased immune cell infiltration. In pre-clinical studies, VXM01 appeared to be safe and well tolerated. A double-blind, randomized, placebo-controlled study in 72 patients with advanced pancreatic cancer confirmed that VXM01 was safe and well tolerated and demonstrated the activation of VEGFR-2 specific cytotoxic T-cells after VXM01 treatment, which was associated with improved patient survival.

Disease: patients with metastatic colorectal cancer whose disease has progressed following one or two prior therapies

Therapeutic area: Cancer - Oncology

Country: Germany

Trial details:

All patients in the study will receive four doses of oral VXM01 in the first week followed by a single dose every four weeks up to week 64. Patients will also receive standard chemotherapy. The primary objectives of the study are safety and tolerability. The trial will also assess immunological response to VXM01, objective response rate, progression-free survival and overall survival. Immune biomarker changes in tumor tissue as a response to VXM01 will also be measured.
The study is being conducted at the National Center of Tumor Diseases (NCT) in Heidelberg, Germany, in cooperation with the University Hospital in Heidelberg.

Latest news:

• On May 4, 2016, Vaximm, a biotech company focused on developing oral T-cell vaccines, announced the enrollment of the first patient in a Phase 2a clinical trial. The study will enroll 24 patients with metastatic colorectal cancer whose disease has progressed following one or two prior therapies.