Evaxion Announces Initial Phase 2 Clinical Data On Its Personalized Cancer Vaccine EVX-01

Initial EVX-01 Phase 2 data confirms the strong Phase 1 resultsAfter undergoing EVX-01 treatment, a significant and continuous tumor reduction was observed in a metastatic melanoma patient with initial progressive
  • Initial EVX-01 Phase 2 data confirms the strong Phase 1 results
  • After undergoing EVX-01 treatment, a significant and continuous tumor reduction was observed in a metastatic melanoma patient with initial progressive disease

     

COPENHAGEN, Denmark, Oct. 31, 2023 (GLOBE NEWSWIRE) — Evaxion Biotech A/S (NASDAQ:EVAX) (“Evaxion” or the “Company”), a clinical-stage TechBio company specializing in the development of AI-Immunology™ powered vaccines, is pleased to announce initial results from the EVX-01 Phase 2 clinical trial, confirming previous successful Phase 1 findings. A comprehensive clinical update will be presented at the Society for Immunotherapy of Cancer (SITC) 38th annual meeting, taking place in San Diego, California, from November 1-5, 2023.

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 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.

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