#Switzerland #Basel #VXM01 #Avelumab #Vaximm AG

Vaximm AG's Groundbreaking Phase 2a Trial Results

On March 26, 2025, Vaximm AG, a cutting-edge biotechnology firm and a subsidiary of OSR Holdings, disclosed significant findings from its Phase 2a clinical trial involving VXM01 combined with Avelumab. This trial focused on patients suffering from recurrent glioblastoma, a notoriously aggressive form of brain cancer. The results offer a promising glimpse into the future of glioblastoma therapies and underscore the efficacy of innovative immunotherapies.

Key Findings from the Trial

The Phase 2a study aimed to evaluate the combined safety and tolerability of VXM01, an oral anti-VEGFR-2 vaccine, with Avelumab, a PD-L1 inhibitor. As per the findings, the combination therapy exhibited a commendable safety profile. Most adverse events reported during the trial were mild to moderate, aligning with previous findings from Avelumab alone. Importantly, no serious adverse events were directly linked to VXM01, emphasizing its manageable safety characteristics, especially in a patient cohort that is typically vulnerable.

Out of the patients who were not candidates for surgery, 12% exhibited an objective response rate, with 12% showing partial remission and 4% maintaining stable disease. This suggests that further exploration of VXM01’s potential in combination with PD-L1 inhibitors could yield meaningful advancements for this challenging group.

In the resected patient subgroup, overall survival figures varied significantly, ranging from 2.2 to 46.5 months. This variability highlights the necessity of conducting further investigations to determine the most effective treatment strategies tailored for different glioblastoma patient populations. In particular, while the small size of the study (25 participants) warrants cautious optimism, the median time to progression of 2.7 months and an overall survival median of 11.1 months signal positive initial results against a backdrop of limited prognosis, where recurrent glioblastoma often sees medians of 1.5 to 6 months for progression-free survival and 2 to 9 months for overall survival.

Addressing Tumor Size

Interestingly, decreasing tumor size was documented among the responding patients, irrespective of their initial tumor size when treatment commenced. This trend suggests that VXM01 vaccine therapy may be effective not only for larger tumors but also for those in early stages or very small sizes, further expanding its potential clinical applicability.

Additionally, initial biomarker investigations pointed out potential indicators for a VXM01-mediated tumor response, opening avenues for personalized treatments that could greatly benefit future patients.

A Message from Leadership

Dr. Constance Hoefer, CEO of Vaximm AG, emphasized the importance of these findings by stating, “The completion of this Phase 2a study is a significant milestone for Vaximm AG, as it provides strong evidence that VXM01, in combination with Avelumab, is generally well-tolerated in patients with recurrent glioblastoma. We are encouraged by these early results and the potential to improve outcomes for patients with this aggressive cancer.”

What is VXM01?

VXM01 is a pioneering oral T-cell immunotherapy designed to trigger the immune system's T-cells to target the tumor's vasculature, as well as the cancer cells directly. This is facilitated by a live attenuated bacterial vaccine strain modified to introduce the vascular endothelial growth factor receptor-2 (VEGFR2) as the focal target. The treatment aims to stimulate specific cytotoxic T-cells that actively destroy tumor vasculature cells, leading to improved immune cell infiltration within the tumor, which is crucial in the battle against glioblastoma and potentially other cancers.

The encouraging results from preclinical studies linked the vaccine to significant anti-tumor activity across various cancer types. In earlier Phase I trials involving patients with advanced pancreatic cancer, VXM01 demonstrated safety, tolerability, and notable enhancements in patient survival rates related to VEGFR-2 specific T-cell responses.

Vaximm's Vision Moving Forward

Vaximm AG remains dedicated to advancing its innovative therapies as a vital component in treating glioblastoma and exploring other malignancies where VXM01 could offer substantial advantages. As research transitions to the next stages, the biopharmaceutical community closely watches these developments, hopeful for breakthroughs that could transform standard care protocols for glioblastoma and beyond.

For further details on Vaximm and its groundbreaking projects in immunotherapy, visit their official site at www.vaximm.com.