Clinical Trials

Date: 2017-03-30

Type of information: Presentation of results at a congress

phase: preclinical

Announcement: presentation of results at the American Association for Cancer Research (AACR) Annual Meeting 2017

Company: Vaximm (Germany)

Product: VXM01m

Action mechanism:

• immunotherapy product/therapeutic vaccine.
• 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 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 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. In a Phase I double-blind, randomized, placebo-controlled study in 71 patients with advanced pancreatic cancer, VXM01 appeared to be safe and well tolerated and led to the activation of VEGFR2-specific cytotoxic T-cells, which was associated with significantly improved patient survival. Clinical studies in colorectal cancer and glioblastoma are ongoing.

Disease:

Therapeutic area: Cancer - Oncology

Country:

Trial details:

Latest news:

• • On March 30, 2017, Vaxxim announced that preclinical data for VXM01m will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2017 being held in Washington, DC, USA, April 1-5. The poster is entitled : Immunogenicity and antitumor efficacy of live attenuated Salmonella typhimurium-based oral T-cell vaccines VXM01m, VXM04m and VXM06m (Abstract No.: #4558).
• The data being presented at the AACR Annual Meeting 2017 support the use of Vaximm’s oral T-cell immunotherapy platform to stimulate an anti-tumor response targeting a variety of tumor-associated antigens. For example, in a pancreatic cancer model, treatment with VXM01 and VXM04 as single agents resulted in a significant reduction in tumor growth compared to control (empty vector). In a leukemia model, VXM06 demonstrated a rapid and sustained anti-tumor effect, with 100% (10 out of 10) of the mice surviving 175 days after tumor challenge. In contrast, the control group did not show any anti-cancer effect, with a median survival of 45 days and 0% (0 out of 10) tumor protection.
• All three immunotherapies were tolerated at the effective doses and have demonstrated consistent anti-cancer activity with significant T-cell responses in various animal tumor models.
• • On December 1, 2016, Vaxxim announced that preclinical data for three of its programs were presented at the EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics Symposium being held in Munich, Germany. The murine analogs of product candidates discussed in the poster – VXM01, VXM04 and VXM06 – encode, respectively, vascular endothelial growth factor receptor 2 (VEGFR2), mesothelin (MSLN) and Wilms’ tumor 1 (WT1) protein antigen. The poster, entitled, “Non-clinical safety and antitumor efficacy of live attenuated Salmonella typhimurium-based oral T-cell vaccines VXM01m, VXM04m and VXM06m,” discussed the safety and efficacy results from preclinical studies with VXM01, VXM04 and VXM06 as single agents.
• In a pancreatic cancer model (Panc02 syngeneic model of pancreatic adenocarcinoma expressing MSLN), treatment with VXM01 and VXM04 as single agents resulted in a significant reduction in tumor growth compared to control (empty vector). For the active treatment groups, tumor size at the end of the experiment was significantly smaller compared to control.
• In a leukemia model (FBL-3 disseminated model of erythroleukemia expressing WT1), VXM06 demonstrated a rapid and sustained anti-tumor effect, with 100% (10 out of 10) of the mice surviving 175 days after tumor challenge. In contrast, the control group did not show any anti-cancer effect, with a median survival of 45 days and 0% (0 out of 10) tumor protection.
• The results from a six-month repeat-dose toxicity study of VXM01 and from three-month toxicity studies of VXM01 in combination with VXM04 as well as of VXM06 as single agent, showed that all the single compounds, as well as the combination of VXM01 and VXM04, were generally well tolerated, with no deaths and no clear treatment-related clinical signs.

 

Is general: Yes