Drugs / EVX-01
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT05309421 | Sep 2022 → Sep 2025 overdue | metastatic melanoma | Evaxion Biotech A/S | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 21
| Date | Issuer | Release |
|---|---|---|
| 2026-04-17 | Evaxion Biotech A/S | Results Evaxion’s AI-Immunology™ platform demonstrates 86% vaccine target precision in phase 2 personalized cancer vaccine trial evaxion.ai ↗
86% of the vaccine targets included in Evaxion’s personalized cancer vaccine EVX-01 trigger a tumor-specific immune response. |
| 2025-11-07 | Evaxion Biotech A/S | Results Evaxion presents new immune data from phase 2 trial with AI-designed personalized cancer vaccine EVX-01 evaxion.ai ↗
In subsets of analyzed patients, clinical responses were accompanied by a rapid and sustained induction of EVX-01-specific T-cells. |
| 2025-10-17 | Evaxion Biotech A/S | Results Evaxion reports 75% Objective Response Rate in phase 2 trial with AI-designed personalized cancer vaccine EVX-01 evaxion.ai ↗
The two-year phase 2 data demonstrates an Objective Response Rate (ORR) of 75% as 12 out of 16 patients had objective clinical responses, with four patients obtaining a complete response. |
| 2025-04-28 | Evaxion Biotech A/S | Results 80% of the EVX-01 vaccine targets trigger a tumor-reactive immune response - Evaxion presents striking EVX-01 data at the AACR Annual meeting evaxion.ai ↗
The data demonstrates that 80% of EVX-01 vaccine targets triggered a tumor-specific immune response. |
| 2024-10-09 | Evaxion Biotech A/S | Results Strong validation of Evaxion’s AI-Immunology™ platform in multiple clinical trials evaxion.ai ↗
In all three clinical trials, a statistically significant correlation was observed between the AI-Immunology™ prediction scores and the immunological responses measured in the patients, with the most robust responses being generated by vaccine targets with the highest AI-Immunology™ prediction scores. |
| 2024-10-03 | Evaxion Biotech A/S | Results Recent clinical data confirms significantly improved predictive power of Evaxion's AI-Immunology™ platform evaxion.ai ↗
In the ongoing phase 2 trial, 81 out of 103 (79%) vaccine targets assessed to date triggered a tumor-specific immune response, a notable increase from the 58% observed in the phase 1 trial completed last year. |
| 2024-09-16 | Evaxion Biotech A/S | Results Evaxion reports convincing one-year data from phase 2 trial on AI-designed personalized cancer vaccine EVX-01 evaxion.ai ↗
Evaxion Biotech A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, announces positive one-year data from the ongoing phase 2 trial with its lead asset EVX-01, an AI-designed personalized cancer vaccine. |
| 2024-09-09 | Evaxion Biotech A/S | Results Evaxion reports 69% Overall Response Rate in its phase 2 trial on lead cancer vaccine candidate EVX-01 evaxion.ai ↗
The data show that 11 out of 16 patients had objective clinical responses, equaling a 69% Overall Response Rate (ORR). |
| 2024-06-17 | Evaxion Biotech A/S | Results Evaxion Publishes Data, Showing 67% Objective Response Rate in Metastatic Melanoma for the AI-Designed Personalized Cancer Vaccine EVX-01, in Leading Medical Journal evaxion.ai ↗
The study results, published in the Journal for ImmunoTherapy of Cancer, demonstrated that eight out of 12 patients (67%) experienced objective clinical responses (ORR) with six partial and two complete responses. |
| 2024-06-03 | Evaxion Biotech A/S | Results Evaxion Presents Positive and Validating Immune Data from Ongoing Phase 2 Trial with AI-Designed EVX-01 Vaccine at the ASCO Annual Meeting 2024 evaxion.ai ↗
Evaxion’s AI-designed cancer vaccine, EVX-01, triggered a specific and tumor-targeting immune response in all assayed melanoma patients |
| 2024-05-23 | Evaxion Biotech A/S | Results Evaxion to Present New Positive Data from Ongoing Phase 2 Study on Lead Vaccine Candidate EVX-01 at the American Society of Clinical Oncology Annual Meeting 2024 evaxion.ai ↗
The immune signatures induced by EVX-01 are both specific and strong, with booster immunizations pointing to further increased immune responses. |
| 2023-11-06 | Evaxion Biotech A/S | Results Evaxion Shares Latest EVX-01 Phase 2 Clinical Data in Webinar with Key Opinion Leader Adnan Khattak evaxion.ai ↗
EVX-01 is Evaxion’s lead clinical asset based upon its AI-Immunology™ platform and has recently published a phase 2 clinical update confirming former phase 1 results |
| 2023-10-31 | Evaxion Biotech A/S | Results Evaxion Announces Encouraging Initial Phase 2 Clinical Data on Its Personalized Cancer Vaccine EVX-01 evaxion.ai ↗
Upon EVX-01 treatment, a pronounced and ongoing tumor reduction was observed in a patient with progressive disease |
| 2023-06-03 | Evaxion Biotech A/S | Results Evaxion’s AI technology identifies cancer vaccine targets associated with longer progression-free survival of melanoma patients in the EVX-01 Phase 1 clinical trial evaxion.ai ↗
The clinical trial of the personalized cancer vaccine EVX-01 met its primary endpoints of safety and tolerability |
| 2023-05-25 | Evaxion Biotech A/S | Results Evaxion announces promising clinical Phase 1 data for its personalized cancer vaccine EVX-01 evaxion.ai ↗
Eight out of the twelve patients (67%) had an objective response, including two complete responders and six partial responders |
| 2023-01-19 | Evaxion Biotech A/S | Regulatory Evaxion receives FDA fast-track designation for personalized cancer immunotherapy evaxion.ai ↗
We are extremely pleased that our cancer vaccine candidate EVX-01 has received the FDA fast track designation, as it enables a potentially faster approval of the vaccine. |
| 2023-01-03 | Evaxion Biotech A/S | Regulatory Evaxion receives approval from FDA to proceed with the clinical Phase 2b study for EVX-01 evaxion.ai ↗ |
| 2022-01-26 | Evaxion Biotech A/S | Results Evaxion Biotech Announces Publication of Clinical Data of EVX-01 Heading into Phase 2b in Collaboration with Merck evaxion.ai ↗
Results from five patients in the study demonstrated that EVX-01 is safe and has encouraging early indications of clinically and meaningful antitumor activity. |
| 2022-01-18 | Evaxion Biotech A/S | Regulatory Evaxion Biotech Receives Regulatory Clearance to Initiate Phase 2 Trial of EVX-01 in Combination with KEYTRUDA® for Treatment of Melanoma evaxion.ai ↗
Australian clearance for our Phase 2b trial of our lead product EVX-01 is a significant step forward for Evaxion and our exciting pipeline of immunotherapies. |
| 2021-07-08 | Evaxion Biotech A/S | Results Evaxion Biotech Reports Data from Phase 1/2a Trials of EVX-01 and EVX-02 evaxion.ai ↗
Combined therapy with EVX-01 demonstrated an objective response rate of 67% across all nine patients compared with historical data of 40% with anti-PD1 treatment alone1. |
| 2019-01-09 | Evaxion Biotech A/S | Regulatory Evaxion Granted Approval for Clinical Trial Application and Investigation Medicinal Product Dossier evaxion.ai ↗
The clinical trial application (CTA) and investigational medicinal product dossier (IMPD) for EVX-01 NeoPepVac was approved by the European Medicines Agency (EMA) on September 26th, 2018. |
All press releases naming this drug 35 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | EVX-01 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05309421 ↗ |
| Modality | Vaccine | “EVX-01, a personalized neoepitope vaccine” PMID 36047545 ↗ Sep 2022 |
| Route | Intramuscular | “10 doses of EVX-01 will be administered intramuscularly” NCT05309421 ↗ |