Vaximm AG Reports Phase 2a Trial Results for VXM01 and Avelumab in Glioblastoma

31 March 2025
Vaximm AG has announced the successful conclusion of its Phase 2a clinical trial assessing the safety and tolerability of the combination therapy of VXM01 and avelumab in patients with recurrent glioblastoma. This study represents a significant achievement for the company, marking progress in its quest to develop novel immunotherapies for aggressive cancers. VXM01 is an innovative oral anti-VEGFR-2 vaccine being investigated for its potential to enhance immune responses against glioblastoma, an aggressive form of brain cancer. Conducted with Merck KGaA, Darmstadt, Germany, the trial provided promising data that supports continued research into the VXM01 vaccine.

Dr. Constance Hoefer, CEO of Vaximm AG, highlighted the importance of these findings. She emphasized that the study offers substantial evidence indicating the combination treatment of VXM01 with avelumab is generally well-tolerated by patients with recurrent glioblastoma. Encouraged by the preliminary results, Dr. Hoefer expressed optimism about the potential of this therapy to improve outcomes for individuals battling this aggressive cancer. She reaffirmed Vaximm’s commitment to advancing VXM01 as a key therapeutic option not only for glioblastoma but also for other cancer types and diseases where this vaccine could positively impact treatment results.

VXM01 is based on an orally available bacterial vaccine strain that has been genetically modified to carry the target gene, vascular endothelial growth factor receptor-2 (VEGFR2). It activates the patient’s immune system, stimulating VEGFR2-specific cytotoxic T-cells to attack tumor vasculature and, in some cases, cancer cells directly. This action leads to greater infiltration of various immune cells into the tumor, potentially enhancing the immune response against the cancer. Notably, VEGFR2 is often over-expressed in different tumor types, including brain cancer. Preclinical studies demonstrated that VXM01’s murine analog had a broad anti-tumor activity across various cancers, showcasing the link between VEGFR2-specific T-cell responses and tumor destruction.

Earlier clinical trials, including a Phase I study involving patients with advanced pancreatic cancer, indicated that VXM01 was safe and well-tolerated, prompting the activation of VEGFR2-specific cytotoxic T-cells. In this study, those T-cells were associated with significantly improved patient survival rates. Furthermore, clinical activity manifesting in objective responses and survival improvements has been noted in recurrent glioblastoma cases.

Vaximm AG is dedicated to pioneering biotechnology innovations, particularly in the realm of immunotherapy. The company aims to unlock the potential of cancer vaccines and immune-oncology therapies, addressing the unmet needs of patients suffering from various cancers. This latest achievement in the Phase 2a trial further solidifies Vaximm’s position as a leader in innovative cancer treatment research.

The promising results from this trial underscore the potential of VXM01 combined with avelumab as a treatment for recurrent glioblastoma. These findings warrant further investigation into the combination’s efficacy and safety, with the hope of providing improved therapeutic options for patients facing aggressive cancers. Vaximm AG continues to focus on advancing its research and development efforts to offer transformative therapies that can significantly impact patient outcomes in the future.

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