Basel (Switzerland) and Mannheim (Germany), December 1, 2016 – VAXIMM AG, a Swiss/German biotech company focused on developing oral T-cell immunotherapies, today 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. VAXIMM has a versatile technology platform that is being used to discover novel oral T-cell immunotherapies to treat a variety of cancers. 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. The poster is available in the Publications section of the VAXIMM website at www.vaximm.com.
Sébastien Wieckowski, PhD, Senior Scientist, VAXIMM AG, who presented the results, said: “The data presented today support the flexibility of our oral T-cell immunotherapy platform in stimulating anti-tumor immunity against a variety of antigens. The results support our clinical findings with VXM01, with which we have seen promising results in pancreatic cancer. This product candidate is currently in clinical testing for the treatment of glioblastoma and colorectal cancer. Additionally, we have now seen promising preclinical results with our earlier stage programs, VXM04 and VXM06, supporting their continued development.”
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.
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.
VXM04 carries human mesothelin as the target antigen. Mesothelin is a protein that is overexpressed in several solid tumors, including mesothelioma, ovarian cancer and pancreatic adenocarcinoma. VXM04 is currently in preclinical testing with plans to advance the immunotherapy into the clinic to treat solid tumors. In preclinical studies, VXM04 has shown potent T-cell activation against mesothelin and stand-alone therapeutic activity in models of pancreatic cancer. The VXM04 safety profile has been demonstrated in combination with VXM01 in a three-month toxicity study in animals.
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.
VAXIMM is a privately held, Swiss/German biotech company that is developing oral T-cell immunotherapies for patients suffering from cancer. VAXIMM’s product platform is based on a live attenuated, safe, orally available bacterial vaccine strain, which is modified to stimulate patients’ cytotoxic T-cells to target specific structures of the tumor. VAXIMM’s lead product candidate, oral VXM01, activates killer cells targeting tumor-specific vasculature and certain immune-suppressive cells, thereby increasing immune cell infiltration in solid tumors. VXM01 is currently in clinical development for several tumor types, including pancreatic, colorectal and brain cancer. In addition to VXM01, VAXIMM has a pipeline of complementary development candidates targeting different tumor structures. VAXIMM’s investors include BB Biotech Ventures, Merck Ventures, Sunstone Capital and BioMed Partners. VAXIMM AG is headquartered in Basel, Switzerland. Its wholly owned subsidiary, VAXIMM GmbH, located in Mannheim, Germany, is responsible for the Company’s clinical operations. For more information, please see www.vaximm.com.
Dr. Heinz Lubenau
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Katja Arnold, Shaun Brown
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