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VAXIMM Research & Development | VAXIMM
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RESEARCH & DEVELOPMENT

Technology

VAXIMM’s technology is based on first-in-class oral T-cell activators that can be readily adapted to target a wide range of cancer-related antigens.

The platform is based on the live attenuated bacterial vaccine strain Ty21, which has been administered to millions of people as a prophylactic vaccine to temporarily protect them from typhoid fever. This strain has been proven to be very safe and well tolerated. All immunotherapies resulting from this platform are taken orally by the patient.

After oral ingestion, the modified Ty21a bacteria, which contain the cDNA of the desired cancer target(s), pass the stomach and invade the patient’s Peyer’s patches located in the small intestine. Uptake of the bacteria in macrophages, the eating cells present in these lymphoid tissues, leads to strong expression of and subsequently to a specific cellular immune response towards the encoded cancer antigen(s). These so-called “killer” T-cells then destroy the respective antigen expressing tumor or tumor stroma cells.

The oral bacterial technology enables delivery to the most immunocompetent organ of the body, targeting the lymphatic tissue of the gut, and has been shown to generate robust T-cell responses against many different antigens in animals and humans in first clinical studies. The low therapeutic doses required for specific T-cell activation make this approach suitable for continuous dosing (prime & boost administrations, without raising anti-carrier immunity) and provides another safety margin for carrier-related toxicity. The platform is suitable for addressing multiple targets with one treatment and can be combined with additional immune therapies. Another major advantage of this approach is the high modularity (plug and play), the low cost and robustness of the production process, and the rapid development timelines taking products from concept to clinical stage.

Pipeline Chart

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VAXIMM is advancing VXM01 in several clinical trials targeting different important cancer indications

VXM01

VXM01 carries the vascular endothelial growth factor receptor-2 (VEGFR2) as the target gene and activates T-cells against the tumor-specific vasculature and certain immune-suppressive cells. The active, T-cell-mediated destruction of tumor vasculature cells leads to an increased infiltration of various immune cells into tumor tissue (inflammation). In preclinical studies, a murine analog VXM01 vaccine showed broad anti-tumor activity in different tumor types. In a Phase I double-blind, randomized, placebo-controlled study in 71 patients with advanced pancreatic cancer, VXM01 was safe and well tolerated and led to the activation of VEGFR2-specific cytotoxic T-cells, which was associated with significantly improved patient survival. Further clinical trials with VXM01 are completed or ongoing in advanced colorectal cancer and recurrent glioblastoma.

VAXIMM is developing a number of preclinical oral T-cell immunotherapies as monotherapies or combination therapies for various cancer indications

VXM NEO

Recent technological innovations have made it possible to identify tumor-specific mutations, which lead to so-called neoantigens or neoepitopes. Targeting neoantigens by generating specific cytotoxic T-cells is becoming a major factor in the development of clinical immunotherapies against cancer. Our platform technology allows for a fast generation and delivery of personalized T-cell vaccines for the treatment of cancer.

VXM04

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.

VXM06

VXM06 carries a modified Wilms Tumor Protein (WT1) 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 3-month toxicity study in animals.

VXM08

VXM08 targets a human tumor-associated antigen overexpressed in many solid tumors including colorectal cancer, lung cancer, gastric cancer, and pancreatic cancer. In preclinical studies VXM08 has shown potent T-cell activation against its target antigen as well as stand-alone therapeutic activity in models of colorectal and lung cancer.

VXM10

VXM10 targets an immunomodulatory antigen upregulated in many solid tumors as well as hematological malignancies. VXM10 is currently in preclinical development.

VXM05

VXM05 targets a human tumor-associated antigen overexpressed in many solid tumors, including lung, gastric and endometrial cancer. In preclinical studies VXM05 has shown stand-alone therapeutic activity in models of lung cancer.

VXM65

VXM65 targets a human tumor-associated antigen overexpressed in brain tumors. VXM65 is in early-stage development.

Live attenuated oral Salmonella platform for effective targeting of PD-L1 and multiple tumor-associated epitopes

Heinz Lubenau et al., AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics 2017

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A live attenuated Salmonella Typhimurium oral T cell vaccine against PD-L1 protects 100% of animals from a leukemia challenge

Heinz Lubenau et al., Third Cri-CIMT-EATI-AACR International Cancer Immunotherapy Conference 2017

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Non-clinical safety, immunogenicity and anticancer efficacy of VXM06, a live attenuated Salmonella Typhimurium oral T cell vaccine against WT1

Sébastien Wieckowski et al., Third Cri-CIMT-EATI-AACR International Cancer Immunotherapy Conference 2017

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VXM01 phase I study in patients with operable progression of a glioblastoma to examine safety, tolerability, immune and biomarker response to the VEGFR-2 DNA vaccine VXM01

Wolfgang Wick et al., ASCO Annual Meeting 2017

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Non-clinical safety, immunogenicity and antitumor efficacy of live attentuated Salmonella Typhimurium-based oral T-cell vaccines VXM01m, VXM04m and VXM06m

Sébastien Wieckowski, PhD, et al., AACR Annual Meeting 2017

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Non-clinical safety and antitumor efficacy of live attentuated Salmonella typhimurium-based oral T-cell vaccines VXM01m, VXM04m and VXM06m

Sébastien Wieckowski, PhD, et al., EORTC-NCI-AACR Symposium 2016

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A phase 1 trial extension to assess immunologic efficacy and safety of prime – boost vaccination with VXM01, an oral T cell vaccine against VEGFR2, in patients with advanced pancreatic cancer

Schmitz-Winnenthal, F.H. et al., ASCO Annual Meeting 2016

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Preclinical studies related to a phase 1/2a TRIAL to investigate the immunologic impact, anti-tumor efficacy and safety of VXM01, an oral T-cell inducing vaccine, in late stage colorectal cancer patients

Podola, L. et al., CIMT Annual Meeting 2016

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Anti-angiogenic activity of VXM01, an oral T-cell vaccine against VEGF receptor 2, in patients with advanced pancreatic cancer: A randomized, placebo-controlled, phase 1 trial

Schmitz-Winnenthal, F.H. et al., Oncoimmunology 2015, 4 (4):e1001217

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VXM01, an oral T-cell vaccine targeting the tumor vasculature:
Results from a double blind, randomized, controlled, first-in-man study in pancreatic cancer patients

Schmitz-Winnenthal, F.H. et al., ASCO Annual Meeting 2013

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Double-blind, placebo-controlled first in human study to investigate an oral vaccine aimed to elicit an immune reaction against the VEGF-Receptor 2 in patients with stage IV and locally advanced pancreatic cancer

Niethammer, A. G. et al., BMC Cancer 2012, 12: 361

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A DNA vaccine against vascular endothelial growth factor receptor 2 prevents effective angiogenesis and inhibits tumor growth

Niethammer A.G. et al., Nature Medicine 2002, 8(12):1369-755

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