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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: Vaxxim (Germany)

Product: VXM06

Action mechanism:

  • immunotherapy product/therapeutic vaccine.
  • VXM06 carries a modified Wilms’ tumor 1 (WT1) protein as target antigen. WT1 is overexpressed in several hematological malignancies and solid tumors, including acute leukemias, glioblastoma, colon cancer, pancreatic adenocarcinoma, and ovarian cancer. In preclinical studies, VXM06 has shown potent T-cell activation against WT1 and stand-alone therapeutic activity in models of leukemia. The VXM06 safety profile has been demonstrated in a three-month toxicity study in animals.

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