Announcement • Aug 18
Evaxion Expands And Refocuses R&D Pipeline With EVX-05, An AI-Designed Off-The-Shelf Brain Cancer Vaccine Program Evaxion expanded its pipeline of cancer vaccine programs with EVX-05 against the deadly brain cancer glioblastoma. EVX-05 is an off-the-shelf therapeutic glioblastoma (brain cancer) vaccine designed based on patient tumor samples. It targets novel conserved antigens identified using Evaxion’s AI-Immunology platform. Glioblastoma is characterized by high mortality rates and significant unmet medical needs. EVX-05 is being developed as a novel therapeutic approach to treat glioblastoma. Evaxion is collaborating with a world-leading academic medical research institution, which is expected to conduct initial clinical testing of EVX-05. Evaxion is currently undertaking optimization of a lead vaccine candidate for the EVX-05 program as part of advancing it towards initial clinical testing. This is expected to be carried out by Professor Khasraw and his team, allowing for world-leading clinical expertise and knowledge of patient needs to help guide clinical development. The collaboration also potentially allows a cost-efficient way for Evaxion to study EVX-05 in a clinical phase 1 trial. EVX-05 builds on the same ground-breaking ERV-targeting concept as EVX-04, Evaxion’s vaccine candidate against acute myeloid leukemia. Both programs draw on learnings from the EVX-03 program, which has now been discontinued and removed from our R&D pipeline as a matter of portfolio management. The costs related to EVX-05 are captured within Evaxion’s existing budgets and hence does not impact on our cash runway, which continues to stretch into second half of 2027. Announcement • Jul 17
Evaxion Presents Three-Year Clinical Efficacy Data For Personalized Cancer Vaccine EVX-01 At ESMO Congress Evaxion A/S presented three-year clinical efficacy data from its phase 2 trial with personalized cancer vaccine candidate EVX-01 at the European Society for Medical Oncology Congress 2026 to be held in Madrid, Spain, from October 23-27, 2026. The data stems from a one-year extension of the phase 2 trial evaluating EVX-01 in patients with advanced melanoma (skin cancer). In the third year, patients received EVX-01 as stand-alone therapy, meaning the data will offer insight into the vaccine’s effect also when not administered in combination with anti-PD-1 therapy. Further, the data may also provide additional insights into potentially enhanced treatment effects and durability of the EVX-01-induced immune response. The three-year data will add to already convincing results from the phase 2 trial. The two-year data demonstrated an Objective Response Rate (ORR) 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. 54% of patients had a deepened response during treatment, improving from stable disease or partial response to partial or complete response. Tumor reduction (target lesions) was observed in 15 out of the 16 patients enrolled in the trial. In the trial, EVX-01 induced an immune response in all patients, with 86% of the targeted neoantigens generating potent specific T-cell responses. The phase 2 trial investigated EVX-01 in patients with advanced melanoma. Each patient enrolled in the trial received a unique vaccine designed and manufactured based on their individual biology. In the first two-years, patients received EVX-01 in combination with MSD’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab). In the third year, a subset of patients received EVX-01 as stand-alone therapy. Presentation details: Abstract title: EVX-01, a personalized cancer vaccine, induces sustained T-cell responses and durable disease control in advanced melanoma after three-year of follow-up. Presentation#: 2006P. Location: Poster Area – Hall 5. Topic: Investigational immunotherapy. Date/Time: October 24, 2026, at 12:00 - 12:45 CET. Presenter: Dr. Muhammad Adnan Khattak, Director, Oncology, One Clinical Research, Hollywood Private Hospital & Edith Cowan University, Perth, WA, Australia. EVX-01 is a personalized peptide-based cancer vaccine intended for first-line treatment of multiple advanced solid cancers. It is Evaxion’s lead clinical asset. Designed with AI-Immunology platform, EVX-01 and is tailored to target the unique tumor profile and immune characteristics of each patient. It engages the patient's immune system to fight off cancer by mounting a targeted response against tumors. Melanoma accounted for approximately 1 in 5 of the 1,500,000 new skin cancer cases estimated globally in 2020 with approximately 325,000 cases and 57,000 deaths. The global burden from melanoma is estimated to increase to 510,000 new cases and 96,000 deaths by 2040. The global market for melanoma treatments is estimated to grow to $7,400 million by 2029. Announcement • Jul 13
Evaxion Presents New Preclinical Data For Cytomegalovirus Vaccine Program EVX-V1 Evaxion A/S presented new data further supporting the multi-component concept of its cytomegalovirus (CMV) vaccine program EVX-V1. Data is presented in a poster session at the International Herpesvirus Workshop (IHW) 2026 taking place in Montreal, Canada. EVX-V1 is a next-generation, multi-component CMV vaccine program designed with AI-Immunology™. It combines novel protective B-cell antigens and T-cell epitopes complemented by known optimized structural B-cell antigens. This broader multi-targeted strategy is expected to strengthen the protective potential of a future vaccine. The concept represents a scalable strategy for rational vaccine development across other herpesviruses. The new data show that the AI-Immunology™ discovered novel T-cell epitopes have the potential to improve control of acute infection, latency and reactivation in CMV-infected mice. This complements previous findings of the novel B-cell antigens significantly reducing viral infection in preclinical models and the optimized known structural B-cell antigens mediating superior viral neutralization. EVX-V1 is a next-generation, multi-component cytomegalovirus (CMV) vaccine candidate combining novel AI-discovered antigens with AI-optimized versions of established CMV vaccine antigens. Through this combination, EVX-V1 attacks the virus from multiple, complementary angles. This broader multi-targeted strategy is expected to strengthen the protective potential of the vaccine. With AI-Immunology™ platform, novel antigens that are entirely new to the CMV vaccine research field have been uncovered. These previously unexplored CMV-antigens induce specific immune responses, inhibit viral infection and reduce cell-to-cell spread in cellular and animal viral infection models. EVX-V1 is a combination of these antigens with proprietary AI-optimized pre-fusion glycoprotein B (gB) antigen which has demonstrated superior performance compared to the traditional gB antigen, including enhanced CMV neutralization. About 1 in 200 babies is born with congenital CMV infection. About 1 in 5 babies with the infection will have congenital disabilities or other long-term health problems. CMV infects approximately 60% to 70% of adults in developed countries and nearly 100% in developing economies, driving demand for CMV treatment. Despite decades of research, no CMV vaccine has been approved to date. CMV treatment market size was valued at $474.6 million in 2023 and is anticipated to register an annual growth (CAGR) of 6.6% between 2024 and 2032. This growth is propelled by increasing awareness and prevalence of CMV infection and the development of new and effective treatments. CMV is the most complex of all herpes viruses and is a widespread infection transmitted in body fluids. Once infected, the virus stays for life. People with weakened immune systems, including organ transplant patients, can develop severe symptoms affecting, for example, eyes, lungs, and liver, and congenitally infected babies may suffer from intellectual disability and loss of vision and hearing.