On October 31, 2023 Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion" or the "Company"), a clinical-stage TechBio company specializing in the development of AI-Immunology powered vaccines, reported initial results from the EVX-01 Phase 2 clinical trial, confirming previous successful Phase 1 findings (Press release, Evaxion Biotech, OCT 31, 2023, View Source [SID1234636526]). A comprehensive clinical update will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 38th annual meeting, taking place in San Diego, California, from November 1-5, 2023.
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Key highlights of the initial Phase 2 results for the first five metastatic melanoma patients treated with EVX-01 include:
Phase 2 data confirm the favorable safety profile of EVX-01 observed in the Phase 1 trial
Promising immunological and clinical outcomes align with the Phase 1 outcomes
Upon EVX-01 treatment, a pronounced and ongoing tumor reduction was observed in a patient with progressive disease
Phase 2 data confirms Evaxion’s AI-Immunology platform’s ability to identify therapeutically relevant cancer vaccine targets
Christian Kanstrup, CEO of Evaxion, stated, "We firmly believe that our AI-Immunology platform has the potential to revolutionize the field of oncology and infectious diseases. Today’s update underscores its promise in immuno-oncology, with our EVX-01 vaccine safely eliciting robust immune responses in all patients. Notably, a pronounced tumor reduction in a metastatic patient with initial progressive disease following EVX-01 treatment offers hope for those with life-threatening cancer. We are looking forward to discussing these results with potential partners."
Join us at the SITC (Free SITC Whitepaper) meeting to explore the poster titled "Effects of an AI-generated personalized neopeptide-based immunotherapy, EVX-01, in combination with pembrolizumab in patients with metastatic melanoma. A clinical trial update", presented on Saturday, November 4, between 9 a.m. – 8:30 p.m. PDT.
Additionally, don’t miss an in-depth presentation of Evaxion’s EVX-01 Phase 2 clinical results by joining an online webinar featuring the study’s principal investigator, Professor Adnan Khattak, held on November 8 at 11:30 a.m. EST. To register for the event, please follow this link.
Earlier this year, Evaxion reported a successful Phase 1 clinical trial for EVX-01 in combination with a checkpoint inhibitor. The trial demonstrated a 67% clinical response rate while meeting safety standards and reporting only mild adverse events. Further, high-quality neoantigens predicted by AI-Immunology were associated with longer progression-free survival. To learn more, please read here.
About EVX-01 Phase 2 Clinical Trial
EVX-01 is Evaxion’s lead clinical asset and constitutes a peptide-based personalized cancer vaccine. The Phase 2 clinical study is a self-sponsored open-label, single-arm, multi-center trial carried out in collaboration with Merck Sharp & Dohme LLC, and together with leading principal investigators and research centers from Italy and Australia aims at evaluating the efficacy and safety of EVX-01 vaccination in combination with anti-PD1 treatment (pembrolizumab) in treatment-naive patients with metastatic or unresectable malignant stage III or IV melanoma. More information can be accessed under clinical trial ID NCT05309421.