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Evaxion's Phase 2 Clinical Trial Sees Progress: Initial Patient Receives Dosing with Personalized Cancer Vaccine EVX-01

Thursday, April 18, 2024

Evaxion Biotech A/S (NASDAQ: EVAX), a clinical-stage TechBio company specializing in AI-Immunology™ powered vaccines, has achieved a significant milestone in its EVX-01 Phase 2 trial for metastatic melanoma. The first patient has received the final dose of the EVX-01 vaccine in combination with KEYTRUDA® (NCT05309421).

Commencing in September 2022, the Phase 2 study aims to assess the efficacy, safety, and ability to induce a tumor-specific immune response of the EVX-01 cancer vaccine in metastatic melanoma patients. This vaccine, developed using Evaxion’s proprietary AI-Immunology™ platform, is tailored to match the unique tumor profile and characteristics of each patient's immune system. Patients in the trial receive a personalized vaccine designed and manufactured based on their individual biology, along with ten doses of EVX-01 administered over 78 weeks, combined with KEYTRUDA®.

Birgitte Rønø, CSO of Evaxion, expressed optimism about the progress, stating, “With advancements in the Phase 2 study, we are moving closer to our goal of saving and enhancing lives with AI-Immunology™. We eagerly await the one-year clinical readout in Q3 this year, bringing us nearer to market with this innovative personalized cancer vaccine.”

Professor Adnan Khattak at One Clinical Research, Hollywood Private Hospital, Western Australia, emphasized the significance of personalized cancer therapies, remarking, “We are entering an era where we tailor treatments to individual patients, combating tumors with precision. This personalized approach signifies the future of medicine.”

In late 2023, Evaxion reported initial Phase 2 data for EVX-01, confirming a favorable safety profile and promising immunological results, consistent with the successful Phase 1 trial.

The EVX-01 Phase 2 clinical trial is a self-sponsored open-label, single-arm, multi-center study conducted in collaboration with Merck Sharp & Dohme LLC and leading research centers in Italy and Australia. It aims to assess the efficacy and safety of EVX-01 vaccination in combination with anti-PD1 therapy KEYTRUDA® in treatment-naive patients with metastatic or unresectable malignant stage III or IV melanoma. More information is available under clinical trial ID NCT05309421.



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