Evaxion AI Technology Identifies Cancer Vaccine Targets Associated with Increased Progression-Free Survival in Melanoma Patients in Phase I Clinical Trial of EVX-01
Monday, June 05, 2023
Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion" or the "Company"), a clinical-stage biotechnology company focused on the development of AI-enabled Immunotherapies, today presented encouraging clinical data from its Phase I dose-escalation study of EVX-01 in metastatic melanoma at the 2023 ASCO Annual Meeting in Chicago, Illinois.
The Phase I study successfully met the primary endpoints for safety and tolerability of EVX-01 in patients with metastatic melanoma and demonstrated positive clinical responses in 8 of 12 (67%) treated patients. In addition, Evaxion's proprietary PIONEER™ AI technology was able to identify high-value cancer vaccine targets, called neoantigens, that are associated with longer progression-free survival.
“We are excited that our AI technology was able to effectively identify vaccine neoantigens associated with better clinical response and longer progression-free survival. And the data suggest a treatment effect, with response rates nearly twice those observed in historical data for checkpoint inhibitors. The results of this study position us well to prospectively identify patients who will benefit from personalized cancer immunotherapy for our upcoming studies, potentially increasing the benefit to patients,” said Per Norlén, Chief Executive Officer of Evaxion .
The study demonstrated the PIONEER™ platform's ability to identify vaccine targets associated with improved patient outcomes. Stratification using PIONEER™ scores surpassed tumor mutation burden as a predictive biomarker, with patients with high-value neoantigens showing better treatment response and longer progression-free survival.
Analysis of treatment-emergent immune responses revealed strong neoantigen T cell responses in all 12 patients, mediated by activated CD4+ T cells in all cases and by CD8+ T cells in 7 of 12 patients. In addition, the magnitude of the immune response correlated with the dose of the vaccine.
“The positive association between clinical outcome and the prevalence of immunogenic cancer neoantigens validates the PIONEER™ platform for use in personalized cancer vaccines and underscores the importance of a robust AI system for neoantigen vaccine development. In addition, the dose-dependent increase in responses was critical for dose selection in Phase II of the ongoing clinical trial. We have great expectations for the forthcoming phase II interim results, which are expected to be presented later this year,” continued Per Norlén.
About the Phase I Trial of EVX-01
The Phase I, open-label, single-arm, single-center trial entitled Personalized Neo-Antigen Vaccine in Advanced Solid Tumors (NeoPepVac)” (ClinicalTrials.gov identifier: NCT03715985) was carried out in collaboration with the DTU, the SSI, the Center for Genomic Medicine at Rigshospitalet and the CCIT-DK and aimed to evaluate the safety and efficacy of the vaccine EVX-01 in combination with anti-PD1 (pembrolizumab or nivolumab) in patients with metastatic investigate melanoma. The design consisted of multiple 15-27mer peptides containing one or more patient-specific neoantigens formulated with the novel liposomal adjuvant CAF®09b to enhance the immune response. The primary objective was to evaluate the safety and tolerability of the combination of EVX-01 and a checkpoint inhibitor. Further goals were the evaluation of the production possibilities, the immune reactions and the clinical effectiveness.
About Evaxion Biotech
Evaxion Biotech A/S is a clinical-stage biotechnology company focused on harnessing the power of artificial intelligence to decode the human immune system and developing immunotherapies for cancer, bacterial diseases and viral infections. With its proprietary AI platform PIONEER™, Evaxion aims to revolutionize cancer treatment by identifying unique and immunogenic neoantigens and developing individualized therapies. The company's mission is to improve the lives of cancer patients with unmet clinical needs through innovative and targeted treatment options. For more information about Evaxion Biotech and the company's breakthrough personalized cancer immunotherapies, please visit www.evaxion-biotech.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words "goal", "believe", "expect", "hope", "aim", "intend", "may", "could", "anticipate", "consider", "continue", "estimate" "Plan," "potential," "predict," "project," "will," "may have," "likely," "should," "would," and other words and phrases of similar import identify forward-looking statements. Actual results could differ materially from those projected in such forward-looking statements due to a variety of factors including, but not limited to, risks related to: our financial condition and need for additional capital; our development work; the costs and success of our product development activities and preclinical and clinical studies; the commercialization of an approved pharmaceutical product developed using our AI platform technology, including the speed and level of market acceptance of our product candidates; our dependence on third parties, including to conduct clinical testing and manufacture our products; our inability to form partnerships; government regulation; protecting our intellectual property rights; employee matters and growth management; our ADSs and common stock, the impact of international economic, political, legal, compliance, social and business factors, including inflation and the impact on our business of the global COVID-19 pandemic and the ongoing conflict in the Ukraine and Russia region, as well as other uncertainties affecting our operations and financial condition. For a further discussion of these risks, see the risk factors included in our most recent Annual Report on Form 20-F and other filings with the US Securities and Exchange Commission (SEC), located atwww.sec.gov are available. We assume no obligation to update any forward-looking statement, except as required by law.
