EVX-01 / Evaxion - LARVOL DELTA

EVX-01, a personalized cancer vaccine, induces sustained T-cell responses and durable disease control in advanced melanoma after three-year of follow-up (ESMO 2026) - No abstract available

Metastases • Melanoma • Oncology • Solid Tumor

EVX-01, a personalized cancer vaccine, induces potent T cell responses and durable disease control in advanced melanoma: 2-year follow-up (ESMO 2025) - P2 | "Conclusions The personalized EVX-01 cancer vaccine, in combination with pembrolizumab, induced early and sustained T-cell responses, achieved high response rates and durable disease control. These findings support continued development of EVX-01 in high-risk melanoma."

IO biomarker • Metastases • Melanoma • Oncology • Solid Tumor • CD4 • CD8 • IFNG

Evaxion A/S states that it will present three-year clinical efficacy data from its phase 2 trial of personalized cancer vaccine EVX-01 in advanced melanoma at the ESMO Congress 2026 in Madrid. (StockTitan.net) - "The company highlights previously reported two-year results in 16 patients: an Objective Response Rate of 75% with 12 objective responses and 4 complete responses; 92% of patients were still responding at two years with no relapses, tumor reduction in 15 patients, and EVX-01–induced immune responses in all patients, with 86% of targeted neoantigens generating potent T-cell responses."

P2 data • Melanoma

Immune signatures associated with clinical response to the personalized neoantigen vaccine EVX-01 and pembrolizumab in advanced melanoma (CIMT 2026) - P2 | "Collectively, we report that EVX-01 induces strong, long-lasting IFNγ responses in all evaluable patients, driven predominantly by CD4+ T cells, and in a subset of patients, CD8+ T cells, with a proinflammatory, activated memory phenotype. Ongoing efforts to integrate the phenotypes of EVX-01 neoAg-specific T cells and treatment-induced peripheral immune changes with clinical outcomes will support the identification of biomarkers associated with clinical response."

Clinical • IO biomarker • Metastases • Tumor-specific neoantigens • Melanoma • Solid Tumor • CD4 • CD8 • IFNG • PD-1

AI-designed personalized neoantigen vaccine, EVX-01, induces durable de novo T-cell responses in advanced melanoma patients (AACR 2026) - P2 | "EVX-01 was administered in combination with pembrolizumab, following a 12-week run-in period with pembrolizumab as monotherapy. In conclusion, the AI-Immunology™ platform can effectively identify highly immunogenic neoantigens, design manufacturable and safe personalized cancer vaccines with pharmacodynamic activity. Combined with PD-1 blockade, EVX-01 achieves a 75% ORR and induces durable, vaccine-specific T-cell immunity in all treated patients, validating the platforms predictive precision."

Clinical • IO biomarker • Metastases • Tumor-specific neoantigens • Melanoma • Oncology • Solid Tumor • CD4 • CD8 • IFNG

T-cell immunogenicity and biomarker profiling in advanced melanoma patients receiving the personalized vaccine EVX-01 in combination with pembrolizumab (AACR 2025) - P2 | "The immune and biomarker analyses enhance our understanding of the complex interactions between the immune and tumor compartments, while also shedding light on treatment induced adaptations. This new understanding can aid in refining therapeutic strategies and identifying predictive biomarkers that may guide treatment decisions in the future."

Biomarker • Clinical • Combination therapy • IO biomarker • Metastases • Melanoma • Oncology • Solid Tumor • PD-L1

Evaxion announces last patient visit in one-year extension of phase 2 trial with personalized cancer vaccine EVX-01 (The Manila Times) - "Patients in the trial will continue to be monitored and data prepared for expected presentation in the second half of 2026...Data from the first two years of the trial demonstrated an Objective Response Rate of 75%, as 12 out of 16 patients had objective clinical responses, with four patients obtaining a complete response. Additionally, a durable clinical benefit was observed as 92% of patients were still responding at two years follow-up and no relapses were observed...Tumor reduction (target lesions) was observed in 15 out of the 16 patients enrolled in the trial....Data also confirmed EVX-01 to be a well-tolerated treatment."

P2 data • Trial status • Melanoma

Evaxion to present new data at AACR Annual Meeting (GlobeNewswire) - "One abstract will include new biomarker and immunogenicity data for cancer vaccine EVX-01....The data stems from the phase 2 trial investigating EVX-01 in combination with...KEYTRUDA (pembrolizumab) in patients with advanced melanoma. Each patient enrolled in the trial has received a unique vaccine designed and manufactured based on their individual biology....The other abstract includes data on the use of AI-Immunology to identify endogenous retrovirus (ERV)-derived neoantigens to include in personalized vaccines to treat glioblastoma..."

Biomarker • P2 data • Preclinical • Glioblastoma • Melanoma

Evaxion presents new immune data from phase 2 trial with AI-designed personalized cancer vaccine EVX-01 (GlobeNewswire) - "The new biomarker and immune data stems from the phase 2 trial evaluating EVX-01 in combination with...pembrolizumab in patients with advanced melanoma (skin cancer)....Circulating T-cell subsets were characterized aiming at increasing the understanding of the immune responses induced by EVX-01. In subsets of analyzed patients, clinical responses were accompanied by a rapid and sustained induction of EVX-01-specific T-cells."

Biomarker • P2 data • Melanoma

Immune correlates of clinical response following treatment with the personalized cancer vaccine EVX-01 and Pembrolizumab in advanced melanoma patients (SITC 2025) - P2 | "Longitudinal profiling of vaccine-specific T cells for expression of activation, exhaustion, memory, and cytotoxicity markers and deep characterization of functionally diverse immune cell subsets are ongoing and may assist in the identification of pharmacodynamic biomarkers that correlate with clinical response.Conclusions The personalized cancer vaccine EVX-01 induces strong and durable immune responses driven by reactive CD4+ and CD8+ T cells. Ongoing immune and biomarker analyses may increase our understanding of how the therapy shapes anti-tumor immunity and assist in identifying predictive biomarkers that may guide treatment decisions in the future."

Clinical • IO biomarker • Metastases • Melanoma • Oncology • Solid Tumor • CD4 • CD8 • IFNG

Evaxion reports 75% Objective Response Rate in phase 2 trial with AI-designed personalized cancer vaccine EVX-01 (GlobeNewswire) - "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. The ORR is even higher than the 69% observed after one year of treatment. Additionally, a durable clinical benefit was observed as 92% of patients were still responding at 24 months follow-up and no relapses were observed....Data is presented today at the ESMO Congress..."

P2 data • Melanoma

Evaxion A/S…will present two-year clinical data from its phase 2 trial of personalized cancer vaccine EVX-01 at the European Society for Medical Oncology (ESMO) Congress in Berlin (Investing.com) - "The presentation, scheduled for October 17, will include efficacy, immunogenicity and safety data for the AI-designed melanoma treatment. According to the company, the data will cover response rates, durability of response, and T-cell response measurements following booster immunization."

P2 data • Melanoma

Evaxion to present new biomarker data for AI-designed personalized cancer vaccine EVX-01 at the SITC 2025 Annual Meeting (GlobeNewswire) - "Evaxion will present new biomarker and immune data stemming from the ongoing phase 2 trial with EVX-01."

Biomarker • P2 data • Melanoma

KEYNOTE-D36: A Single Arm Trial Evaluating the Efficacy and Safety of EVX-01 in Combination With Pembrolizumab in Adults With Unresectable or Metastatic Melanoma (clinicaltrials.gov) - P2 | N=17 | Active, not recruiting | Sponsor: Evaxion Biotech A/S | Recruiting ➔ Active, not recruiting | N=90 ➔ 17 | Trial completion date: Jul 2025 ➔ Mar 2026 | Trial primary completion date: Jun 2025 ➔ Sep 2025

Checkpoint inhibition • Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Melanoma • Oncology • Solid Tumor • BRAF

Evaxion to present two-year clinical efficacy data from phase 2 trial with AI-designed personalized cancer vaccine EVX-01 at the ESMO Congress 2025 (GlobeNewswire) - "Evaxion A/S...will be presenting two-year clinical efficacy data from its phase 2 trial with lead compound EVX-01 at the European Society for Medical Oncology (ESMO) Congress 2025 to be held in Berlin, Germany, from October 17-21, 2025."

P2 data • Melanoma

Evaxion doses first patient in extension of phase 2 trial exploring the full potential of AI-designed personalized cancer vaccine EVX-01 (GlobeNewswire) - "Evaxion A/S...has dosed the first patient in its one-year extension of the ongoing phase 2 trial with its lead asset EVX-01....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....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."

P2 data • Trial status • Melanoma

80% of the EVX-01 vaccine targets trigger a tumor-reactive immune response - Evaxion presents striking EVX-01 data at the AACR Annual meeting (GlobeNewswire) - P2 | N=90 | NCT05309421 | Sponsor: Evaxion Biotech A/S | "80% of EVX-01 vaccine targets triggered a tumor-specific immune response, a substantially higher frequency than what has been reported for other similar vaccine candidates; The data underscores the precision of Evaxion’s AI-Immunology platform in selecting therapeutically relevant vaccine targets; New findings show EVX-01 inducing a robust and durable immune response, further enhanced by booster immunizations; The ongoing phase 2 trial with EVX-01 remains on track for two-year data readout in the second half of 2025."

P2 data • Melanoma

Evaxion to present new phase 2 data for AI-designed personalized cancer vaccine EVX-01 at AACR Annual Meeting (GlobeNewswire) - "New biomarker and immune data from the ongoing phase 2 trial with EVX-01 will be presented at the American Association for Cancer Research (AACR) Annual Meeting. These data will further add to the already strong clinical data package for EVX-01. The trial remains on track for two-year clinical efficacy data readout in the second half of 2025....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)."

Biomarker • P2 data • Melanoma

Evaxion extends phase 2 trial with personalized cancer vaccine EVX-01 to further enhance clinical data package (GlobeNewswire) - "Originally planned as a two-year study, the trial has been extended by an additional year to collect three-year clinical outcome data; The additional third year of EVX-01 dosing may provide further insights into potential enhanced treatment effects and durability of induced immune response; The trial already yielded convincing one-year data and remains on track for two-year data readout in the second half of 2025."

P2 data • Trial status • Melanoma

Evaxion completes dosing in phase 2 trial with personalized cancer vaccine EVX-01 (GlobeNewswire) - "Evaxion Biotech A/S...has now completed the dosing of all 16 patients in its phase 2 trial with the company’s lead asset EVX-01. Designed with Evaxion’s AI-Immunology platform, EVX-01 is a personalized cancer vaccine being developed as a treatment of advanced melanoma (skin cancer). Dosing has been completed according to trial protocol and timelines, meaning the trial remains on track for completion and data readout in the second half of 2025. Coincidently, the first patient has now completed the trial and has had last visit according to the protocol. Patients will continue to be monitored and data collected."

P2 data • Trial status • Melanoma

Evaxion announces 2025 milestones reflecting continued strong strategy execution (GlobeNewswire) - "Evaxion expects to discuss the milestones at an investor event in the first quarter of 2025: All patients completed EVX-01 dosing - H1; Supplemental phase 2 biomarker and immunogenicity data - H1; Two-year phase 2 clinical efficacy readout - H2"

P2 data • Trial status • Melanoma • Oncology • Solid Tumor

Recent clinical data confirms significantly improved predictive power of Evaxion’s AI-Immunology platform (GlobeNewswire) - "Evaxion Biotech A/S...continues to gather clinical evidence for the steady improvement of its AI-Immunology platform. The platform’s precision has significantly improved between the two clinical trials with Evaxion’s personalized cancer vaccine EVX-01. 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. The high number of immune-active vaccine targets is observed across all patients."

Clinical data • Melanoma • Oncology • Solid Tumor

Phase II study of AI-designed personalized neoantigen cancer vaccine, EVX-01, in combination with pembrolizumab in advanced melanoma (ESMO 2024) - P2 | "The AI-Immunology™ platform predicted tumor-specific neoAgs with a high success rate. Our results indicate that EVX-01 holds promise as a safe and effective therapeutic approach when used in combination with anti-PD1 therapy."

Combination therapy • Metastases • P2 data • Tumor-specific neoantigens • Melanoma • Oncology • Solid Tumor • IFNG

Evaxion reports convincing one-year data from phase 2 trial on AI-designed personalized cancer vaccine EVX-01 (GlobeNewswire) - P2 | N=90 | NCT05309421 | Sponsor: Evaxion Biotech A/S | "The data demonstrates 69% ORR, reduction in tumor target lesions in 15 out of 16 patients, an immunogenicity rate of 79%, and a positive correlation between Evaxion’s AI-Immunology platform predictions and immune responses induced by the individual neoantigens in the EVX-01 vaccine (p=0.00013)....The 69% ORR is calculated based on 11 out of 16 patients in the trial having objective clinical responses. This rate may increase as more data are collected but will not decrease. Final results are expected in the third quarter of 2025."

P2 data • Melanoma • Oncology • Skin Cancer • Solid Tumor

Evaxion reports 69% Overall Response Rate in its phase 2 trial on lead cancer vaccine candidate EVX-01 (GlobeNewswire) - P2 | N=90 | NCT05309421 | Sponsor: Evaxion Biotech A/S | "Evaxion Biotech A/S...announces new exciting clinical phase 2 data for its lead compound EVX-01. The data show that 11 out of 16 patients had objective clinical responses, equaling a 69% Overall Response Rate (ORR). 15 out of the 16 patients had reduction of their tumors (target lesions)....The complete one-year clinical data will be presented at a poster session at the European Society for Medical Oncology (ESMO) Congress 2024, taking place in Barcelona, Spain, from September 13-17, 2024."

P2 data • Melanoma • Oncology • Skin Cancer • Solid Tumor