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Clinical Trial of Personalized Cancer Vaccine EVX-01 Meets Primary Endpoints of Safety and Tolerability
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Positive clinical responses were reported in 8 of 12 patients treated with EVX-01
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High-quality neoantigens predicted by AI technology were associated with longer progression-free survival
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Strong vaccine-specific immune responses were induced in all 12 patients treated with EVX-01
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Higher doses of EVX-01 elicited stronger immune responses and were associated with improved clinical outcomes
COPENHAGEN, DENMARK, June 3, 2023 (Globe Newswire) — Evaxion Biotech A/S (NASDAQ: EVAX) (“Evaxion” or the “Company”) specializes in developing AI-powered immunotherapies A clinical-stage biotechnology company. today announced encouraging clinical data from the EVX-01 Phase 1 dose escalation study in metastatic melanoma at the 2023 ASCO Annual Meeting in Chicago, Illinois.
Phase 1 study successfully met primary endpoints for safety and tolerability of EVX-01 in patients with metastatic melanoma, with positive clinical response in 8 of 12 (67%) treated patients was shown. In addition, Evaxion’s proprietary AI technology, PIONEER™, was able to identify high-quality cancer vaccine targets, so-called neoantigens, associated with longer progression-free survival.
“We are excited that our AI technology can effectively identify vaccine neoantigens associated with better clinical responses and longer progression-free survival. The response rate is almost double that observed in the data, suggesting treatment efficacy.Our findings in this study will enable future clinical trials to explore the benefits of personalized cancer immunotherapy. The benefit to the patient could be even greater as it allows us to proactively identify which patients receive it,” said Per Noren, CEO of Evaxion.
This study demonstrated that the PIONEER™ platform can identify vaccine targets associated with improved patient outcomes. Stratification based on the PIONEER™ score outperformed tumor mutational burden as a predictive biomarker, with patients with high-quality neoantigens having better treatment response and longer progression-free survival.
Evaluation of treatment-related immune responses revealed strong neoantigen T-cell responses in all 12 patients. This was mediated by her CD4 + T cells that were activated in all cases and by her CD8 + T cells in 7 of 12 patients. Furthermore, the magnitude of the immune response correlated with vaccination dose.
“The positive association between clinical outcome and the prevalence of immunogenic cancer neoantigens demonstrates that the PIONEER™ platform can be used for personalized cancer vaccines and provides a platform for designing neoantigen vaccines. The importance of a robust AI system is underscored, and increased dose-dependent responses are helping dose selection for Phase 2 in ongoing clinical trials.We will announce later this year We are very excited about the interim results of the planned Phase 2,” Per Norlén continues.
Phase 1 study with EVX-01
An open-label, single-arm, single-center Phase 1 trial entitled “Personalized Neoantigen Vaccine in Advanced Solid Tumors (NeoPepVac)” (ClinicalTrials.gov ID: NCT03715985) investigated The Center for Genomic Medicine at Rett and CCIT-DK aimed to evaluate the safety and efficacy of the EVX-01 vaccine in combination with anti-PD1 (pembrolizumab or nivolumab) in patients with metastatic melanoma. This design consists 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 confirm the safety and tolerability of the combination of EVX-01 and checkpoint inhibitors. Additional objectives were to assess feasibility of manufacturing, immune response, and clinical efficacy.
About Evaxion Biotech
Evaxion Biotech A/S is a clinical-stage biotechnology focused on harnessing the power of artificial intelligence to decipher the human immune system and develop immunotherapies for cancer, bacterial diseases and viral infections. It’s a company. Evaxion aims to revolutionize cancer treatment by identifying unique immunogenic neoantigens and designing personalized therapies through its proprietary AI platform, PIONEER™. We are committed to transforming the lives of cancer patients with unmet clinical needs by providing innovative and targeted treatment options. For more information on Evaxion Biotech and its groundbreaking personalized immuno-oncology therapies, please visit www.evaxion-biotech.com.
Forward-Looking Statements
This announcement 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. “aim”, “believe”, “expect”, “hope”, “aim”, “intend”, “may”, “may”, “anticipate”, “consider” , “continue”, “estimate” the words “plan”, “could”, “predict”, “plan”, “will”, “could have”, “possible words and terms of similar meaning are forward-looking statements. Actual results may differ materially from those indicated in such forward-looking statements as a result of a variety of factors, including but not limited to risks associated with: our development work. the cost and success of our product development activities and preclinical and clinical trials; Commercialize approved medicines developed using our AI platform technology. This includes the rate and degree of market acceptance of our product candidates. Reliance on third parties, including conducting clinical trials and manufacturing products. unable to form a partnership. government regulation. Protecting Our Intellectual Property Rights. Managing employee issues and growth. Our ADSs and common stock, the impact of international economic, political, legal, compliance, social and business factors, including inflation, and ongoing events in the region surrounding the global COVID-19 pandemic and Ukraine and Russia. impact of disputes on our business; and other uncertainties that affect our business operations and financial condition. For more information on these risks, please see the Risk Factors contained in our most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC). www.sec.gov. We undertake no obligation to update any forward-looking statements, except as required by law.
CONTACT: Contact information Evaxion Biotech A/S Per Norlén Chief Executive Officer pno@evaxion-biotech.com Source: Evaxion Biotech
