- A 67% objective response rate (ORR) is reported in the publication summarizing results from the Phase 1 study assessing Evaxion's personalized cancer vaccine, EVX-01, in patients with metastatic melanoma
- The findings also demonstrate strong and clinically relevant immune responses after EVX-01 administration to metastatic melanoma patients co-treated with anti-PD-1 standard of care
- The clinical study results substantiate the precision and predictive power of Evaxion's AI-Immunology platform
- Evaxion has advanced the EVX-01 program into a Phase 2 study, and strong immune data readouts from the ongoing study were presented at ASCO in early June. The one-year clinical efficacy readout from the Phase 2 study is on track for Q3 2024
COPENHAGEN, Denmark, June 17, 2024, demonstrated that eight out of 12 patients (67%) experienced objective clinical responses (ORR) with six partial and two complete responses. Further, EVX-01 immunization did not induce vaccine-related serious adverse events in patients co-administered with anti-PD1 therapy.
The EVX-01 cancer vaccine is designed to target neoantigens - antigenic sequences derived from cancer mutations - that are displayed on the surface of cancer cells, allowing the immune system to recognize, attack and eliminate the malignant cells. Since the neoantigen tumor profiles vary from one cancer patient to another, the EVX-01 cancer vaccine is truly personalized and tailored to the unique characteristics of each patient's tumor and immune system profile. This represents a novel treatment paradigm with potential broad application in cancer therapy.
At this year's ASCO annual meeting, the Company presented comprehensive immune data from its ongoing EVX-01 Phase 2 study, with 71% of the administered neoantigens inducing a specific T-cell response. Furthermore, a positive correlation between the neoantigen prediction score assigned by AI-Immunology and the reported induced immune response confirmed the Phase 1 study findings and further substantiated the predictive power of Evaxion's AI platform.
"This publication provides a clear conclusion to our Phase 1 study, with peer-reviewed validation of our reported outcomes. We are very impressed with EVX-01 achieving a 67% objective response rate in the trial. This is encouraging as it verifies a true reduction in tumor burden following dosing and compares favorably with historical data from anti-PD-1 monotherapy trials. With the encouraging data from our ongoing Phase 2 study of EVX-01 presented at this year's annual ASCO meeting, we are on track to report our one-year readout in the third quarter of this year," said Christian Kanstrup, CEO of Evaxion.
For more information about the recent EVX-01 Phase 2 immune data presented at ASCO, please visit our recent press release.
About EVX-01 Phase 2 Clinical Trial
EVX-01 is Evaxion's lead clinical asset and constitutes a peptide-based personalized cancer vaccine. The ongoing Phase 2 clinical study is a self-sponsored, open-label, single-arm, multi-center trial carried out in collaboration with Merck Sharp & Dohme LLC, together with leading principal investigators and research centers from Italy and Australia. It aims to evaluate the efficacy and safety of EVX-01 vaccination in combination with the anti-PD1 treatment pembrolizumab.
About EVAXION
Evaxion Biotech A/S is a pioneering TechBio company based upon its AI platform, AI-Immunology. Evaxion's proprietary and scalable AI prediction models harness the power of artificial intelligence to decode the human immune system and develop novel immunotherapies for cancer, bacterial diseases, and viral infections. Based upon AI-Immunology, Evaxion has developed a clinical-stage oncology pipeline of novel personalized vaccines and a preclinical infectious disease pipeline in bacterial and viral diseases with high unmet medical needs. Evaxion is committed to transforming patients' lives by providing innovative and targeted treatment options. For more information about Evaxion and its groundbreaking AI-Immunology platform and vaccine pipeline, please visit our website.
Forward-Looking Statement
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