EVX-01 / Evaxion - LARVOL DELTA

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

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 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

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

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

Buy Rating for Evaxion Biotech: EVX-01’s Personalized Cancer Vaccine Shows Promising Efficacy and Safety (Markets Insider) - "Analyst Swayampakula Ramakanth of H.C. Wainwright reiterated a Buy rating on Evaxion Biotech...retaining the price target of $14.00....Swayampakula Ramakanth’s rating is based on the unique positioning and promising clinical data of Evaxion Biotech’s EVX-01 as a personalized cancer vaccine. Ramakanth highlights the distinction between EVX-01 and other therapies, such as BNT111, noting that EVX-01 targets a personalized set of neoantigens specific to each patient’s cancer, potentially leading to a wider range of efficacy and safety. He posits that EVX-01’s design to address individual tumor characteristics could offer superior efficacy and reduced toxicity compared to less personalized approaches."

Stock price • Melanoma • Oncology • Skin Cancer • Solid Tumor

Evaxion to Present One-Year Clinical Efficacy Data from its Phase 2 Study on Lead Cancer Vaccine Candidate, EVX-01, at the ESMO Congress 2024 in September (GlobeNewswire) - "Evaxion Biotech ...is proud to announce the presentation of one-year clinical efficacy Phase 2 data for its lead compound EVX-01 at the European Society for Medical Oncology (ESMO) Congress 2024, taking place in Barcelona, Spain, from September 13-17, 2024. The EVX-01 vaccine is a personalized therapy currently being assessed in patient with advanced melanoma (skin cancer)."

P2 data • Melanoma

Evaxion Showcases Improved Performance of Key Building Block in AI-Immunology at Computational Biology Conference (GlobeNewswire) - "The improved EvaxMHC building block is used in the ongoing Phase 2 trial with Evaxion’s lead vaccine candidate, the personal cancer vaccine EVX-01. Key highlights showcased at the presentation: A state-of-the-art deep-learning framework was utilized, enhancing the accuracy of peptide-MHC predictions; Our approach includes three new strategies: Creating a unified representation for both MHC class I and -II molecules, utilizing a deep transformer encoder-decoder architecture, and adopting a generative adversarial network (GAN) pretraining mechanism; The updated EvaxMHC building block led to improved vaccine designs demonstrated in preclinical studies."

Preclinical • Melanoma • Oncology • Skin Cancer • Solid Tumor

Evaxion Publishes Data, Showing 67% Objective Response Rate in Metastatic Melanoma for the AI-Designed Personalized Cancer Vaccine EVX-01, in Leading Medical Journal (GlobeNewswire) - P1/2 | N=12 | NCT03715985 | "A 67% objective response rate (ORR) is reported in the publication summarizing results from the Phase 1 study assessing Evaxion’s personalized cancer vaccine, EVX-01, in patients with metastatic melanoma; The findings also demonstrate strong and clinically relevant immune responses after EVX-01 administration to metastatic melanoma patients co-treated with anti-PD-1 standard of care....Evaxion has advanced the EVX-01 program into a Phase 2 study....The one-year clinical efficacy readout from the Phase 2 study is on track for Q3 2024."

P1 data • P2 data • Melanoma • Oncology

Immunogenicity of an AI-designed personalized neoantigen vaccine, EVX-01, in combination with anti-PD-1 therapy in patients with metastatic melanoma. (ASCO 2024) - P2 | "Patients initiated anti-PD1 therapy (Pembrolizumab) 12 weeks prior to EVX-01 administration. EVX-01 induced neoAg-specific immune responses in all analyzed patients and a broad response against the neoAgs. These results further validate the precision and predictive power of our proprietary vaccine target discovery AI-Immunology platform. The combination of EVX-01 and anti-PD1 was safe and well tolerated."

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

Evaxion Presents Positive and Validating Immune Data from Ongoing Phase 2 Trial with AI-Designed EVX-01 Vaccine at the ASCO Annual Meeting 2024 (GlobeNewswire) - P2 | N=90 | NCT05309421 | Sponsor: Evaxion Biotech A/S | "Evaxion Biotech A/S...reported data from its ongoing Phase 2 study at the American Society of Clinical Oncology (ASCO) Annual Meeting 2024....The neoantigen-reactive immune responses were mediated by both CD4+ and CD8+ T-cells; EVX-01 booster immunizations tended to increase the immune responses and did not impose any safety concerns; A statistically significant positive correlation between neoantigen quality, as predicted by AI-Immunology, and vaccine-induced immune response was demonstrated; The EVX-01 vaccine candidate was found to be well-tolerated, with only grade 1 and 2 adverse events."

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