Evaxion A/S (NASDAQ:EVAX) said its second-quarter progress centered on advancing its cancer vaccine pipeline, adding a new glioblastoma program and maintaining a cash runway into the second half of 2027.
Chief Executive Officer Helen Tayton-Martin said the company continued business-development discussions around its programs and AI-Immunology platform, supported by new clinical and preclinical data. She also highlighted recognition of the company’s technology through a Prix Galien UK award, its second Prix Galien award for the platform in the past 12 months.
Schmidt said Evaxion ended the quarter with DKK 14 million in cash and DKK 9.5 million in equity. He said the company’s projected runway into the second half of 2027 remains unchanged and that cash spending is not expected to be linear from quarter to quarter. Evaxion also activated part of its at-the-market facility following what Schmidt described as positive news and trading volume in its shares.
EVX-01 Data Update Planned for ESMO
Evaxion plans to present three-year outcome data for EVX-01, its personalized neoantigen cancer vaccine for advanced melanoma, at the ESMO Congress in October. The update is expected to include results for the vaccine alone and in combination with anti-PD-1 treatment, as well as information on the durability of vaccine-induced immune responses.
Chief Scientific Officer and Chief Operating Officer Birgitte Rønø recapped earlier EVX-01 data, including findings presented at the AACR meeting in April showing that 86% of vaccine targets triggered a tumor-specific immune response. Of the immunogenic targets, 86% induced de novo T-cell responses, she said.
At ESMO last year, Evaxion reported two-year data showing a 75% overall response rate, 25% complete responses and 92% of patients remaining in response. More than half of patients improved their clinical response following EVX-01 treatment, according to Rønø.
During the question-and-answer session, Rønø said a positive three-year result would include maintaining, or improving, overall response rates, with durable responses and continued T-cell responses. Tayton-Martin said recent positive Phase III results from Moderna and Merck in personalized cancer vaccines for melanoma were supportive for the broader field and could aid partnership discussions.
New Glioblastoma Program Uses ERV Targets
Evaxion introduced EVX-05, an off-the-shelf cancer vaccine program for glioblastoma being developed with Duke University. The program uses the company’s AI-Immunology platform to identify conserved tumor-specific antigens derived from endogenous retrovirus elements, or ERVs.
Rønø said glioblastoma is the most common and aggressive primary malignant brain tumor and that median overall survival remains approximately one year despite surgery and chemoradiation. Evaxion analyzed patient sequencing data and identified about 1.5 million ERV fragments, selecting 16 fragments for inclusion in EVX-05.
The company has completed target discovery and is now testing several vaccine candidates for lead selection. Following selection of a lead candidate, Evaxion expects to undertake IND-enabling activities before beginning a first-in-human study in collaboration with Duke University. Management did not provide a timeline for clinical-trial initiation.
Rønø said the company is still evaluating which glioblastoma patient subgroups may be most appropriate for the program and has not finalized the clinical-trial design. Management said the ERV-targeting approach could potentially extend to other solid tumors and hematologic cancers, depending on the ERV profiles of specific patient populations.
EVX-04 and CMV Program Advance
Evaxion also said its EVX-04 off-the-shelf cancer vaccine program for acute myeloid leukemia is progressing toward a regulatory filing later this year. The company presented data at the European Hematology Association Congress in June indicating that the vaccine’s 16 ERV targets activated human immune cells across different HLA types and that ERV-reactive immune cells could mediate targeted cell killing.
Management said EVX-04 is in IND-enabling work, including GMP manufacturing, immune-response testing, clinical-site engagement and regulatory documentation. Tayton-Martin said these activities remain on track for a regulatory filing by year-end.
In infectious disease, Evaxion presented data in July for EVX-V1, its cytomegalovirus vaccine program. Rønø said AI-Immunology-discovered T-cell epitopes showed potential to control acute infection, latency and reactivation in CMV-infected mice. The results complement prior findings involving B-cell antigens and will help guide selection of antigens for a broadly protective CMV vaccine candidate.
Tayton-Martin said the company’s near-term priorities remain focused on creating value from its pipeline and platform while pursuing partnerships where appropriate. “We are in active conversations,” she said regarding potential deals, while noting that the timing of partnership processes can vary.
About Evaxion A/S (NASDAQ:EVAX)
Evaxion A/S is a clinical-stage biotechnology company headquartered in Copenhagen, Denmark, with additional operations in the United States. The company specializes in the development of immunotherapies and vaccines driven by its proprietary AI-based computational immunology platform. By leveraging machine learning and deep learning algorithms, Evaxion identifies and optimizes antigen targets for both therapeutic cancer vaccines and prophylactic vaccines against infectious diseases.
At the core of Evaxion’s business is its AI platform, which analyzes large datasets of genomic, proteomic and immunological information to predict immune-stimulating epitopes.
