Our Development Pipeline

Advancing Novel Immunotherapies for Indications with High Unmet Needs

VAXIMM’s pipeline is built on our versatile oral T-cell immunotherapy platform designed to combat cancer through multiple mechanisms.

Our lead clinical candidate, VXM01, is an oral immunotherapy that activates T-cells against VEGFR2, a key validated protein in the tumor vasculature. By activating this process with VXM01, tumor blood supply is abolished while enabling infiltration of immune cells with broad anti-tumor effects.

Building on this validated approach, we are advancing a pipeline programs targeting other critical and validated cancer pathways. Together, these programs represent a deep and diversified strategy to address unmet needs in oncology.

A Phase I/II trial evaluating VXM01 in combination with avelumab, a human anti-PD-L1 antibody, for the treatment of glioblastoma has been completed. The trial is part of a collaboration agreement with Merck KGaA, Darmstadt, Germany and Pfizer Inc.

VXM01 has received orphan designation from the European Commission and from the US Food and Drug Administration (FDA) for the treatment of glioblastoma.

Learn more about the study (NCT03750071) here.

A Phase I pilot study was designed to evaluate the safety and tolerability of VXM01, as well as clinical and immunogenic response, in patients with recurrent glioblastoma.

Fourteen patients were treated with VXM01, including three who were also treated with the anti-PD-1 checkpoint inhibitor, nivolumab. Of the fourteen patients treated, one patient experienced an objective response with VXM01 monotherapy and a durable response with the addition of nivolumab. During the observation period of up to 20 months, seven patients were still alive, all of them living for more than one year.

Learn more about the study (NCT02718443) here.

A Phase I trial in advanced pancreatic cancer showed that VXM01 was well tolerated and led to the activation of VEGFR2-specific cytotoxic T-cells, which was associated with significantly improved patient survival.

The data have been published (Niethammer et al. 2012; Schmitz-Winnenthal et al. 2015, 2018).

References

Niethammer, Andreas G., Heinz Lubenau, Gerd Mikus, Philipp Knebel, Nicolas Hohmann, Christine Leowardi, Philipp Beckhove, et al. 2012. “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.” BMC Cancer 12 (August): 361. https://doi.org/10.1186/1471-2407-12-361.
Schmitz-Winnenthal, Friedrich H., Nicolas Hohmann, Andreas G. Niethammer, Tobias Friedrich, Heinz Lubenau, Marco Springer, Klaus M. Breiner, et al. 2015. “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.” Oncoimmunology 4 (4): e1001217. https://doi.org/10.1080/2162402X.2014.1001217.
Schmitz-Winnenthal, Friedrich H., Nicolas Hohmann, Thomas Schmidt, Lilli Podola, Tobias Friedrich, Heinz Lubenau, Marco Springer, et al. 2018. “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.” Oncoimmunology 7 (4): e1303584. https://doi.org/10.1080/2162402X.2017.1303584.