Evaxion (EVAX) wraps EVX-01 phase 2 extension with 75% response
Filing Impact
Filing Sentiment
Form Type
6-K
Rhea-AI Filing Summary
Evaxion A/S reports that the one-year extension of its phase 2 trial of personalized cancer vaccine EVX-01 in advanced melanoma has been completed, with the last patient visit now finished. Three-year clinical efficacy data are expected to be presented in the second half of 2026.
Earlier phase 2 results showed an Objective Response Rate of 75%, with 12 of 16 patients responding and four achieving complete responses. At two-year follow-up, 92% of patients were still responding with no relapses, tumor reduction was seen in 15 of 16 patients, and 81% of targeted neoantigens triggered potent T-cell responses. EVX-01 was reported as well tolerated.
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Key Figures
Objective Response Rate: 75%
Patients with objective responses: 12 of 16 patients
Complete responses: 4 patients
+5 more
8 metrics
Objective Response Rate
75%
Phase 2 EVX-01 trial in advanced melanoma
Patients with objective responses
12 of 16 patients
Phase 2 EVX-01 efficacy results
Complete responses
4 patients
Subset of responders in phase 2 EVX-01 trial
Patients still responding at two years
92%
Two-year follow-up durability, no relapses observed
Patients with deepened response
54%
Improved from stable/partial to partial/complete response
Tumor reduction observed
15 of 16 patients
Target lesion reduction in phase 2 trial
Immunogenic neoantigens
81%
Targeted neoantigens generating potent T-cell responses
Three-year data timing
Second half of 2026
Planned presentation of extended phase 2 EVX-01 data
Key Terms
Objective Response Rate, neoantigens, anti-PD-1 therapy, monotherapy, +2 more
6 terms
Objective Response Rate clinical
"The trial has already yielded encouraging one- and two-year data including a 75% Objective Response Rate"
The objective response rate (ORR) is the percentage of patients in a clinical trial whose tumors measurably shrink or disappear according to preset rules. Investors use it as a quick, objective signal of a drug’s ability to produce a clear treatment effect—like counting how many plants visibly respond after applying a new fertilizer—and higher ORR can improve odds of regulatory approval, commercial success, and company valuation.
neoantigens clinical
"81% of the targeted neoantigens generating potent specific T-cell responses"
Neoantigens are new protein fragments that appear on the surface of diseased cells, most often cancer cells, because of changes in their DNA; the immune system can recognize these as foreign. For investors, neoantigens matter because they are targets for precision therapies and vaccines that aim to teach the immune system to attack only diseased cells—think of them as unique fingerprints that enable treatments to be more specific and potentially more effective, which can drive clinical and commercial value.
anti-PD-1 therapy clinical
"patients were treated with EVX-01 in combination with MSD’s anti-PD-1 therapy, Keytruda"
Anti-PD-1 therapy are drugs that block the PD-1 protein on immune cells, effectively releasing the “brakes” that can prevent the body from attacking cancer cells; think of it like removing a safety lock so security guards can better recognize intruders. Investors care because these therapies can transform treatment outcomes, drive significant sales if approved for multiple cancers, and carry regulatory, patent and competitive risks that affect a company’s valuation.
monotherapy clinical
"In the third year, patients received EVX-01 as monotherapy"
Monotherapy is a treatment approach that uses only one type of medicine or therapy to address a condition, instead of combining multiple options. For investors, understanding monotherapy matters because it can influence a company's development strategy, risk profile, and potential market size, especially if the single-treatment approach proves effective or faces limitations compared to combination therapies.
phase 2 trial clinical
"completed the one-year extension of its phase 2 trial with personalized cancer vaccine EVX-01"
A phase 2 trial is an intermediate-stage clinical study that tests whether a new treatment works and is reasonably safe in a group of patients who have the condition it targets. Think of it as a field test of a prototype product: it checks real-world effectiveness and side effects on a modest number of users to decide whether the treatment should move to larger, definitive testing. Investors watch phase 2 results because positive outcomes can sharply increase the likelihood of regulatory approval and future sales, while failures often halt development.
personalized cancer vaccine clinical
"phase 2 trial with personalized cancer vaccine EVX-01"
A personalized cancer vaccine is a medicine made to match an individual patient’s tumor and immune system, designed to train their immune cells to recognize and attack that patient’s specific cancer—like a tailor-made key developed to fit one unique lock. Investors watch this area because it promises highly targeted, potentially long-lasting treatments but also involves complex manufacturing, high development costs and regulatory uncertainty that can strongly affect company value.
FAQ
What did Evaxion A/S (EVAX) announce about its EVX-01 phase 2 cancer vaccine trial?
Evaxion announced completion of the one-year extension of its phase 2 trial of personalized cancer vaccine EVX-01 in advanced melanoma. The last patient visit has occurred, and three-year clinical efficacy data are expected to be presented in the second half of 2026.
What are the key efficacy results so far from Evaxion’s EVX-01 phase 2 trial?
The trial reported a 75% Objective Response Rate, with 12 of 16 patients showing objective responses and four achieving complete responses. Tumor reduction in target lesions occurred in 15 of 16 patients, indicating broad antitumor activity in this advanced melanoma study population.
How durable were responses in Evaxion (EVAX) EVX-01 phase 2 trial?
At two-year follow-up, 92% of patients in the EVX-01 phase 2 trial were still responding and no relapses were observed. Additionally, 54% of patients experienced a deepened response over time, improving from stable or partial responses to partial or complete responses.
How was EVX-01 administered during the Evaxion phase 2 trial in advanced melanoma?
During the first two years, patients received EVX-01 combined with MSD’s anti-PD-1 therapy Keytruda (pembrolizumab). In the third year, patients received EVX-01 as monotherapy, allowing assessment of the vaccine’s effect both alone and in combination with checkpoint inhibition.
What immune responses were observed with Evaxion’s EVX-01 personalized cancer vaccine?
EVX-01 induced an immune response in all enrolled patients. About 81% of the vaccine’s targeted neoantigens generated potent, specific T-cell responses, which the company highlights as highly encouraging and supportive of its AI-Immunology platform’s precision in neoantigen selection.
Was Evaxion’s EVX-01 cancer vaccine well tolerated in the phase 2 trial?
The company states that EVX-01 was confirmed to be a well-tolerated treatment in the phase 2 trial. This safety profile, combined with the observed clinical responses and durable benefit, supports further evaluation of the personalized vaccine in advanced melanoma patients.