Evaxion Annoucnes It Has Dosed First Patient In Extension Of Phase 2 Trial Exploring The Full Potential Of AI-Designed Personalized Cancer Vaccine Evx-01

• Generation of additional clinical data allows for a more comprehensive assessment of the full potential of EVX-01, while strengthening the already strong clinical data package
• Will provide insights into the durability of immune and clinical responses up to three years
• Extension phase enables exploration of EVX-01 as monotherapy, following initial combination with standard of care
• Minimal costs are associated with the extension as clinical sites are already running and the vaccines are produced
• The trial remains on track for two-year data readout in the second half of 2025
  
  
  
   

COPENHAGEN, Denmark, May 22, 2025 - Evaxion A/S (NASDAQ:EVAX) ("Evaxion"), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, has dosed the first patient in its one-year extension of the ongoing phase 2 trial with its lead asset EVX-01. Designed with Evaxion's AI-Immunology™ platform, EVX-01 is a personalized cancer vaccine currently being evaluated as a treatment for advanced melanoma (skin cancer).

The extension will further explore the full potential of EVX-01 as a possible new and innovative treatment of advanced melanoma, particularly its long-term clinical and immune benefits. The trial extension involves minimal cost as trial sites are running and the vaccine product has already been produced.

Having completed the initial two-year treatment, the first patient in the extension of the trial has now received the first additional dose of EVX-01. Patients entering the one-year extension of the trial will in total receive two additional EVX-01 doses as monotherapy.

In the first two years of the trial, EVX-01 was administered in combination with standard anti-PD-1 therapy (checkpoint inhibitors). With checkpoint inhibitor treatment restricted to a two-year duration, the extension phase provides an opportunity to evaluate the benefits of EVX-01 monotherapy. This could position EVX-01 as a potential standalone treatment for advanced melanoma.

"Extending the trial allows us to explore EVX-01's potential beyond its combination use with checkpoint inhibitors. By studying EVX-01 as a monotherapy, we aim to assess the independent effects of EVX-01, including its induced immune response and clinical outcome. Given that checkpoint inhibitor therapy is not approved beyond two years of treatment, this additional EVX-01 treatment option could offer a meaningful option for patients", says Birgitte Rønø, Chief Scientific Officer of Evaxion.

EVX-01 is designed with Evaxion's AI-Immunology™ platform and tailored to target the unique tumor profile and immune characteristics of each individual patient. It engages the patient's immune system to fight off cancer by mounting a targeted response against tumors.

The phase 2 trial investigates EVX-01 in combination with MSD's (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients with advanced melanoma (skin cancer). Each patient enrolled in the trial has received a unique vaccine designed and manufactured based on their individual biology. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Convincing one-year phase 2 data

Initially planned to run for two years, the trial remains on track to yield two-year data for presentation in the second half of 2025. Convincing interim one-year data from the trial was presented at the European Society for Medical Oncology (ESMO) Congress in September 2024. Data demonstrated a 69% Overall Response Rate, reduction in tumor target lesions in 15 out of 16 patients, and a positive correlation between the AI-Immunology™ platform predictions and immune responses induced by the individual neoantigens in the EVX-01 vaccine (p=0.00013).

Further, 80% of EVX-01's vaccine targets triggered a targeted immune response, as presented at American Association for Cancer Research (AACR) Annual Meeting in April 2025. This number compares very favorably to what is seen with other approaches.